chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Laboratory test, Postural orthostatic tachycardia syndrome, Troponin
Clinical narrative: I am a physician. My so developed POTS syndrome after the second dose.  He was completely healthy before this., a competitive tennis player.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: ?Covid arm? large red patchy round rash at site of injection that is warm to touch and itchy
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Ophthalmological examination, Unevaluable event
Clinical narrative: eyesight improved both eyes 0.25 diopters
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine .  Tiredness, headache, muscle pain, chills, fever. The symptoms lasted for 24 hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Blood test, Computerised tomogram abnormal, Flank pain
Clinical narrative: 2 events :  1st-4/15- Hives on both arms.  Just watched them and kept an eye on them and used  Benadryl and anti-itch cream, postponed allergy shots from Friday 4-16 until Monday 4/19.  Hives went away in the next day or two.  2nd event-Lower right back pain achy off and on and eventually wrapping around to the right side.  Went to urgent care on 4/29.  They did a CT with contrast and found a large kidney stone that I would not be able to pass without surgery, referred to neurologist. Saw neurologist on 5/3,  kidney X-ray confirmed an 18 mm kidney stone in my right renal  pelvis. Scheduled lithotripsy with stent placement on 5/10. Had  that done on 5/10. Had follow up kidney X-ray and stent removed on 5/17.  Then on 5/24 another follow up kidney X-ray. Results weren?t easy to see due to gaseous distention but he thought I had passed most of the larger particles. Will see him in 6 months. May see him sooner because I?m still experiencing achy  pain in the same areas off and  on  that same side.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nephrolithiasis, Neurological examination, SARS-CoV-2 test, Urinary system X-ray, Urine analysis
Clinical narrative: 2 events :  1st-4/15- Hives on both arms.  Just watched them and kept an eye on them and used  Benadryl and anti-itch cream, postponed allergy shots from Friday 4-16 until Monday 4/19.  Hives went away in the next day or two.  2nd event-Lower right back pain achy off and on and eventually wrapping around to the right side.  Went to urgent care on 4/29.  They did a CT with contrast and found a large kidney stone that I would not be able to pass without surgery, referred to neurologist. Saw neurologist on 5/3,  kidney X-ray confirmed an 18 mm kidney stone in my right renal  pelvis. Scheduled lithotripsy with stent placement on 5/10. Had  that done on 5/10. Had follow up kidney X-ray and stent removed on 5/17.  Then on 5/24 another follow up kidney X-ray. Results weren?t easy to see due to gaseous distention but he thought I had passed most of the larger particles. Will see him in 6 months. May see him sooner because I?m still experiencing achy  pain in the same areas off and  on  that same side.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, X-ray abnormal
Clinical narrative: 2 events :  1st-4/15- Hives on both arms.  Just watched them and kept an eye on them and used  Benadryl and anti-itch cream, postponed allergy shots from Friday 4-16 until Monday 4/19.  Hives went away in the next day or two.  2nd event-Lower right back pain achy off and on and eventually wrapping around to the right side.  Went to urgent care on 4/29.  They did a CT with contrast and found a large kidney stone that I would not be able to pass without surgery, referred to neurologist. Saw neurologist on 5/3,  kidney X-ray confirmed an 18 mm kidney stone in my right renal  pelvis. Scheduled lithotripsy with stent placement on 5/10. Had  that done on 5/10. Had follow up kidney X-ray and stent removed on 5/17.  Then on 5/24 another follow up kidney X-ray. Results weren?t easy to see due to gaseous distention but he thought I had passed most of the larger particles. Will see him in 6 months. May see him sooner because I?m still experiencing achy  pain in the same areas off and  on  that same side.
Sex: U
Vaccine: COVID19
Symptoms: Abortion, Exposure during pregnancy, Human chorionic gonadotropin decreased, Ultrasound scan
Clinical narrative: I got the vaccine while I was pregnant (and I had to the agent in vaccination site before)  About 2 to 3 weeks later ultrasound reported abortion
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Headaches, nausea, vomiting.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Hypoaesthesia, Intention tremor
Clinical narrative: Developed an intention tremor about 7 hours after 2 nd dose.  Noticed by my dentist same day as my vaccine.  Noticed by myself and all of my coworkers.  I am a nurse practitioner and my patient's notice is and comment during examination.  Unable to do sports I have always done that require hand eye coordination.  about 2 weeks after vaccination become numb over total body, Have had basic labs and auto immune panel.  All have been completely normal.  I have been referred to neurologist.  Waiting to get an appointment.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: After patient got her 1st dose of Pfizer Covid 19 vaccine, she was instructed to wait 15 minutes at the resting area in front of pharmacy. On her way from immunization room to the resting area, she fainted. Since her mom was holding her, she didn't fall. She was put down on the floor and regain consciousness within a minute. 911 was called. While waiting for paramedics, Rph took her blood pressure with result of 110/71 HR 89. Patient then walked back to immunization room with mom and Rph's help. When paramedics arrived, they took her blood and it was low. They provided IV fluid and she was taken to hospital by ambulance.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Loss of consciousness, Pallor, Vomiting
Clinical narrative: Patient felt dizzy immediately after the shot was given.  She said she was going to pass out, and did for about 10 seconds.  She was sitting up in a chair during this time, with her mom holding her up.  She came to, the about 20 seconds later, she passed out again for another 10 seconds.  She came to, and was given some water to drink, but 20 seconds after that she threw up the water.  I took her blood pressure, and it was 60/40, with a pulse of 60.  She was very pale.  After resting in the chair and taking deep breaths, her color returned and she felt much better.  she also said her vision wasn't blurry anymore.  Ten minutes later, she left with her mom, feeling ok.  She was very anxious about getting the shot, and told me she had passed out in the pass after giving blood.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Biopsy, Oral disorder
Clinical narrative: Multiple Oral lesions that are lasting for over a month(like large canker sores the size of a pencil eraser and the size of a nickel)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol normal, Blood test normal, Blood triglycerides normal, Cardiac function test normal, High density lipoprotein decreased
Clinical narrative: My ankles swelled up a day later on March 7th nd they are still swelled up now both ankles and up into my calves. Skin is so tight. Have had the following done on April 12th - Heart test along with Kidney and Liver test which were all good. Also had a blood test and for 73 years old I hd a perfect blood test with cholesterol number at 150 and my HDH and LDL and triglycerides were all 2 to 3 times better than recommended. 12-weeks later my ankles and calves are still swelled up. On May 25th I had an Ultra Sound on both legs from the groin down and it came back with NO blood clots.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Liver function test normal, Low density lipoprotein normal, Magnetic resonance imaging normal, Peripheral swelling
Clinical narrative: My ankles swelled up a day later on March 7th nd they are still swelled up now both ankles and up into my calves. Skin is so tight. Have had the following done on April 12th - Heart test along with Kidney and Liver test which were all good. Also had a blood test and for 73 years old I hd a perfect blood test with cholesterol number at 150 and my HDH and LDL and triglycerides were all 2 to 3 times better than recommended. 12-weeks later my ankles and calves are still swelled up. On May 25th I had an Ultra Sound on both legs from the groin down and it came back with NO blood clots.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Renal function test normal, Skin tightness, Ultrasound Doppler normal, X-ray limb normal
Clinical narrative: My ankles swelled up a day later on March 7th nd they are still swelled up now both ankles and up into my calves. Skin is so tight. Have had the following done on April 12th - Heart test along with Kidney and Liver test which were all good. Also had a blood test and for 73 years old I hd a perfect blood test with cholesterol number at 150 and my HDH and LDL and triglycerides were all 2 to 3 times better than recommended. 12-weeks later my ankles and calves are still swelled up. On May 25th I had an Ultra Sound on both legs from the groin down and it came back with NO blood clots.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site warmth, Rash macular, Urticaria
Clinical narrative: Red hot blotchy welts around injection site.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Menstruation delayed
Clinical narrative: Menstrual cycle is off; one week early after first dose of vaccine, and now currently 2+ weeks late and counting after second dose. Not pregnant.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Tinnitus
Clinical narrative: 10 hours after injection I had a short ringing in right ear first, then about 10 minutes later ringing inert ear and it lasted for less than 30 seconds for both ears. Tenderness in arm at injection area about 8 hours after shot.  Slight headache 10 hours after injection.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Haematemesis, Headache
Clinical narrative: About 8 hours after receiving the vaccine, my body started hurting, I got intense chills, and I became exhausted. 13 hours post vaccine, I had a fever of 101.6, I began vomiting, I was sweating, I was trembling, and had diarrhea. The vomiting lasted for about 2 hours. Also, I was vomiting up small amounts of blood. About 24 hours post-shot, my entire body was sore, I still had chills and sweats,  I had a fever of 101.2, fatigue and a headache.  Day 2 after the shot, I was still extremely fatigued and sore. Day 3, I began to feel better. I was still fatigued, but the only soreness was in the arm that I got the vaccine along with some redness around the injection site. I also had no fever. Day 4,  my injection site was a little sore, I was slightly fatigued, and a small rash was on one of my arms for most of the day, but then the rash faded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: About 8 hours after receiving the vaccine, my body started hurting, I got intense chills, and I became exhausted. 13 hours post vaccine, I had a fever of 101.6, I began vomiting, I was sweating, I was trembling, and had diarrhea. The vomiting lasted for about 2 hours. Also, I was vomiting up small amounts of blood. About 24 hours post-shot, my entire body was sore, I still had chills and sweats,  I had a fever of 101.2, fatigue and a headache.  Day 2 after the shot, I was still extremely fatigued and sore. Day 3, I began to feel better. I was still fatigued, but the only soreness was in the arm that I got the vaccine along with some redness around the injection site. I also had no fever. Day 4,  my injection site was a little sore, I was slightly fatigued, and a small rash was on one of my arms for most of the day, but then the rash faded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tremor, Vomiting
Clinical narrative: About 8 hours after receiving the vaccine, my body started hurting, I got intense chills, and I became exhausted. 13 hours post vaccine, I had a fever of 101.6, I began vomiting, I was sweating, I was trembling, and had diarrhea. The vomiting lasted for about 2 hours. Also, I was vomiting up small amounts of blood. About 24 hours post-shot, my entire body was sore, I still had chills and sweats,  I had a fever of 101.2, fatigue and a headache.  Day 2 after the shot, I was still extremely fatigued and sore. Day 3, I began to feel better. I was still fatigued, but the only soreness was in the arm that I got the vaccine along with some redness around the injection site. I also had no fever. Day 4,  my injection site was a little sore, I was slightly fatigued, and a small rash was on one of my arms for most of the day, but then the rash faded.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Constipation, Discomfort, Insomnia
Clinical narrative: Major upset stomach and constipation.  Difficulty sleeping. Uncomfortableness throughout the day.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Started menstruating 12 days early  which is very unusual for me
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Sinus pain, Swelling face, Swollen tongue
Clinical narrative: Swelling of my tongue and face. Could still breath so didn't go to emergency room. Fully went away after about 4 hours. Left arm could barely lift through the next day. Achy sinuses feeling through the next day.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Headache, Nausea
Clinical narrative: Cold chills , then warm , shaking , achy , some nausea and headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Tremor
Clinical narrative: Cold chills , then warm , shaking , achy , some nausea and headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Ear pain, Eye irritation, Eye pain, Ocular discomfort
Clinical narrative: Right ear pain, shooting/stabbing, around 8:40 pm May 31. Woke from sleep around 4 am June 1, severe pain right ear. Walked around 5:20 am, pain outside and top of left foot. Right side ear pain continued through morning, as did foot pain. Foot pain eased around 10 am. Scalp on right side hurt too much to brush hair. Eye pain/discomfort started before noon. Felt like bruise and burning, especially bottom lid and inside half of eye. Went to ER around 2. Ear pain had lessened, only jolts of pain, certain facial expressions exacerbated pain. Eye discomfort more prominent. Scalp most painful right side, rear half.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pain of skin
Clinical narrative: Right ear pain, shooting/stabbing, around 8:40 pm May 31. Woke from sleep around 4 am June 1, severe pain right ear. Walked around 5:20 am, pain outside and top of left foot. Right side ear pain continued through morning, as did foot pain. Foot pain eased around 10 am. Scalp on right side hurt too much to brush hair. Eye pain/discomfort started before noon. Felt like bruise and burning, especially bottom lid and inside half of eye. Went to ER around 2. Ear pain had lessened, only jolts of pain, certain facial expressions exacerbated pain. Eye discomfort more prominent. Scalp most painful right side, rear half.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pruritus, Rash papular
Clinical narrative: Large circular patch around injection site.  Itchy, red, raised area approximately 2.5 inches diameter
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Hardness at injection site, tenderness around entire shoulder,  red splotchy rash, heat in rash, swelling. Started a couple of hours after vaccination
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Hardness at injection site, tenderness around entire shoulder,  red splotchy rash, heat in rash, swelling. Started a couple of hours after vaccination
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Testicular disorder
Clinical narrative: I received my first Moderna COVID vaccine shot on Saturday, around 3pm. No problems immediately and I felt fine. Went to bed late, around 4am. On Sunday, I was awoken at 1:30pm with a throbbing right testicle. The pain went away I thought. Then again it happened. Every 60 seconds my right testicle felt like someone was squeezing it. The testicle was not warm or painful to touch. The pain started soft at first and it would get stronger. The pain would start at a level 1-2, grow to 4-5. The pain would last 5-10 seconds then go away. This happened every 60 seconds. I had a stopwatch and timed it. Pain would come, go away, and then 45-60 seconds later, it would occur all again. This went on for the next 14 hours. I took nighttime Advil to try and sleep and eventually dozed off when the pain subsided around 4am. The next day nothing was wrong until around 8pm. Then the exact same scenario started. Pain, stop, 60 seconds, pain. This day, Monday, again I took nighttime Advil and the pain stopped. Today, Tuesday, as of 8pm, no pain yet. I do not have insurance so I didn't know whom to contact. After the second day of pain I called the pharmacist and then informed me to notify you.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chest X-ray, Chest X-ray normal, Chest pain, Cough
Clinical narrative: Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain began the next day after injection. Followed by runny nose, sore throat, croup sounding cough, shortness of breath, gasping, chest pains, vomiting, back of the skull pain. He described the head pain as a square from the base of the back of his skull to the crown of his head and back down. Felt more like a pressure in the bones of his skull and less like a standard headache. The chest pains are sharp and come on sporadically. At first they were accompanied by hacking cough but then progressed to sharp chest pains at random times especially when lying down.  He has difficulty sleeping and staying asleep. Also, lower abdominal pain but no vowel issues.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Croup infectious, Dyspnoea, Electrocardiogram, Electrocardiogram normal, Headache
Clinical narrative: Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain began the next day after injection. Followed by runny nose, sore throat, croup sounding cough, shortness of breath, gasping, chest pains, vomiting, back of the skull pain. He described the head pain as a square from the base of the back of his skull to the crown of his head and back down. Felt more like a pressure in the bones of his skull and less like a standard headache. The chest pains are sharp and come on sporadically. At first they were accompanied by hacking cough but then progressed to sharp chest pains at random times especially when lying down.  He has difficulty sleeping and staying asleep. Also, lower abdominal pain but no vowel issues.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Oropharyngeal pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain began the next day after injection. Followed by runny nose, sore throat, croup sounding cough, shortness of breath, gasping, chest pains, vomiting, back of the skull pain. He described the head pain as a square from the base of the back of his skull to the crown of his head and back down. Felt more like a pressure in the bones of his skull and less like a standard headache. The chest pains are sharp and come on sporadically. At first they were accompanied by hacking cough but then progressed to sharp chest pains at random times especially when lying down.  He has difficulty sleeping and staying asleep. Also, lower abdominal pain but no vowel issues.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain began the next day after injection. Followed by runny nose, sore throat, croup sounding cough, shortness of breath, gasping, chest pains, vomiting, back of the skull pain. He described the head pain as a square from the base of the back of his skull to the crown of his head and back down. Felt more like a pressure in the bones of his skull and less like a standard headache. The chest pains are sharp and come on sporadically. At first they were accompanied by hacking cough but then progressed to sharp chest pains at random times especially when lying down.  He has difficulty sleeping and staying asleep. Also, lower abdominal pain but no vowel issues.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Nausea, Pain in extremity
Clinical narrative: sharp pains on the left side of body (arm, shoulder, sometimes chest)  nausea derealization
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Blood test, Dry eye
Clinical narrative: No taste, no smell, fatigue, dry eyes, no saliva, extra dry skin, sore joints and muscles. Immune system attacking
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dry skin, Fatigue, Immune system disorder, Myalgia
Clinical narrative: No taste, no smell, fatigue, dry eyes, no saliva, extra dry skin, sore joints and muscles. Immune system attacking
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: No taste, no smell, fatigue, dry eyes, no saliva, extra dry skin, sore joints and muscles. Immune system attacking
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood loss anaemia, Blood test, Computerised tomogram intestine, Death, Electrocauterisation
Clinical narrative: Onset acute blood loss due to internal bleeding on approximately 05/09/21, upper GI bleeding and anemia. Hemoglobin dropped to 5.2 resulting in death. Hospitalization on 05/12/21 discharged to Hospice Care 05/15/21 loss of life on 05/22/21.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy gastrointestinal abnormal, Haemoglobin decreased, Internal haemorrhage, Intestinal mucosal tear, Rectal examination
Clinical narrative: Onset acute blood loss due to internal bleeding on approximately 05/09/21, upper GI bleeding and anemia. Hemoglobin dropped to 5.2 resulting in death. Hospitalization on 05/12/21 discharged to Hospice Care 05/15/21 loss of life on 05/22/21.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Upper gastrointestinal haemorrhage
Clinical narrative: Onset acute blood loss due to internal bleeding on approximately 05/09/21, upper GI bleeding and anemia. Hemoglobin dropped to 5.2 resulting in death. Hospitalization on 05/12/21 discharged to Hospice Care 05/15/21 loss of life on 05/22/21.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenia, Chills, Cytokine abnormal
Clinical narrative: On 1/21/21, approximately 59 hours after I received the Pfizer\BioNTech COVID19 Vaccine #2 without any immediate adverse events, I woke up in the middle of the night with subjective fevers, sweats, chills,  generalized weakness with dizziness and feeling faint, nausea, diarrhea, and severe pelvic/lower abdominal pain (though I was also in the process of starting my menstrual cycle).  I also vaguely noticed an erythematous rash on my chest and abdomen at that time.  I took a dose of ondansetron for nausea and acetaminophen for pain.  Later that morning (1/21/21), I continued to have generalized weakness, subjective fevers and chills, extreme fatigue, nausea, and a morbilliform-type rash most prominently on my torso (chest, abdomen, back) and some areas of my upper arms and thighs, as well as bright red and hyperemic palms and soles that had a prickly sensation throughout.  I no longer had abdominal pain, but did have significant polyarthritis with difficulty moving my joints without pain.  This included my knees, elbows, ankles, wrists, as well as fingers/hands especially.  My fingers and toes felt very swollen and I had trouble putting my normal enclosed shoes on.  I took ibuprofen and Tylenol during this time for symptom control.  Later I added diphenhydramine, loratadine, and famotidine.  These symptoms waxed and waned in intensity for at least 8 days with continued spread of rash, extreme fatigue, ongoing joint pain, and subjective fevers.  The only measured fever was on 1/23/21 when I had access to a thermometer - my oral temperature was 100.7F if I recall correctly.  I never had any respiratory symptoms. On 1/29/21 I saw Hospital Allergist Dr in order to participate in a research study on adverse vaccine reactions; I did not have a formally documented medical appointment with her for my medical records.  By that time, my energy level was slowly improving and I was able to return to work.  My arthritis symptoms had nearly fully resolved, however, my rash had gone from not particularly bothersome to very diffusely pruritic.  I began to take cetirizine for symptoms instead of loratidine. In addition, the skin along my L palm began to slough and peel off, most notably in the webspaces between my thumb and index finger bilaterally and the tip of my L thumb and L ring finger.  These areas of my palm had the most notable peeling and sloughing around 2/2/21 and by 2/7/21 my R palm was also peeling in similar fashion to the L.  On 2/11/21, I noticed that the skin along my L sole, particularly between all five digits had begun to peel quite markedly; large connected pieces of skin were sloughing off.  The sloughing on the L foot spread from between the toes and the ball of the foot to the arch and then the heel over several days.  On 2/14/21, the R foot/sole began having the same findings, with large amounts of sloughing first between the toes and then extending to the ball of the foot, arch, and ultimately the heel.  Some sort of foot/sole peeling continued through the final week of February 2021 and into early March.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Erythema, Fatigue, Hyperhidrosis
Clinical narrative: On 1/21/21, approximately 59 hours after I received the Pfizer\BioNTech COVID19 Vaccine #2 without any immediate adverse events, I woke up in the middle of the night with subjective fevers, sweats, chills,  generalized weakness with dizziness and feeling faint, nausea, diarrhea, and severe pelvic/lower abdominal pain (though I was also in the process of starting my menstrual cycle).  I also vaguely noticed an erythematous rash on my chest and abdomen at that time.  I took a dose of ondansetron for nausea and acetaminophen for pain.  Later that morning (1/21/21), I continued to have generalized weakness, subjective fevers and chills, extreme fatigue, nausea, and a morbilliform-type rash most prominently on my torso (chest, abdomen, back) and some areas of my upper arms and thighs, as well as bright red and hyperemic palms and soles that had a prickly sensation throughout.  I no longer had abdominal pain, but did have significant polyarthritis with difficulty moving my joints without pain.  This included my knees, elbows, ankles, wrists, as well as fingers/hands especially.  My fingers and toes felt very swollen and I had trouble putting my normal enclosed shoes on.  I took ibuprofen and Tylenol during this time for symptom control.  Later I added diphenhydramine, loratadine, and famotidine.  These symptoms waxed and waned in intensity for at least 8 days with continued spread of rash, extreme fatigue, ongoing joint pain, and subjective fevers.  The only measured fever was on 1/23/21 when I had access to a thermometer - my oral temperature was 100.7F if I recall correctly.  I never had any respiratory symptoms. On 1/29/21 I saw Hospital Allergist Dr in order to participate in a research study on adverse vaccine reactions; I did not have a formally documented medical appointment with her for my medical records.  By that time, my energy level was slowly improving and I was able to return to work.  My arthritis symptoms had nearly fully resolved, however, my rash had gone from not particularly bothersome to very diffusely pruritic.  I began to take cetirizine for symptoms instead of loratidine. In addition, the skin along my L palm began to slough and peel off, most notably in the webspaces between my thumb and index finger bilaterally and the tip of my L thumb and L ring finger.  These areas of my palm had the most notable peeling and sloughing around 2/2/21 and by 2/7/21 my R palm was also peeling in similar fashion to the L.  On 2/11/21, I noticed that the skin along my L sole, particularly between all five digits had begun to peel quite markedly; large connected pieces of skin were sloughing off.  The sloughing on the L foot spread from between the toes and the ball of the foot to the arch and then the heel over several days.  On 2/14/21, the R foot/sole began having the same findings, with large amounts of sloughing first between the toes and then extending to the ball of the foot, arch, and ultimately the heel.  Some sort of foot/sole peeling continued through the final week of February 2021 and into early March.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Serum sickness, Skin exfoliation, Swelling
Clinical narrative: On 1/21/21, approximately 59 hours after I received the Pfizer\BioNTech COVID19 Vaccine #2 without any immediate adverse events, I woke up in the middle of the night with subjective fevers, sweats, chills,  generalized weakness with dizziness and feeling faint, nausea, diarrhea, and severe pelvic/lower abdominal pain (though I was also in the process of starting my menstrual cycle).  I also vaguely noticed an erythematous rash on my chest and abdomen at that time.  I took a dose of ondansetron for nausea and acetaminophen for pain.  Later that morning (1/21/21), I continued to have generalized weakness, subjective fevers and chills, extreme fatigue, nausea, and a morbilliform-type rash most prominently on my torso (chest, abdomen, back) and some areas of my upper arms and thighs, as well as bright red and hyperemic palms and soles that had a prickly sensation throughout.  I no longer had abdominal pain, but did have significant polyarthritis with difficulty moving my joints without pain.  This included my knees, elbows, ankles, wrists, as well as fingers/hands especially.  My fingers and toes felt very swollen and I had trouble putting my normal enclosed shoes on.  I took ibuprofen and Tylenol during this time for symptom control.  Later I added diphenhydramine, loratadine, and famotidine.  These symptoms waxed and waned in intensity for at least 8 days with continued spread of rash, extreme fatigue, ongoing joint pain, and subjective fevers.  The only measured fever was on 1/23/21 when I had access to a thermometer - my oral temperature was 100.7F if I recall correctly.  I never had any respiratory symptoms. On 1/29/21 I saw Hospital Allergist Dr in order to participate in a research study on adverse vaccine reactions; I did not have a formally documented medical appointment with her for my medical records.  By that time, my energy level was slowly improving and I was able to return to work.  My arthritis symptoms had nearly fully resolved, however, my rash had gone from not particularly bothersome to very diffusely pruritic.  I began to take cetirizine for symptoms instead of loratidine. In addition, the skin along my L palm began to slough and peel off, most notably in the webspaces between my thumb and index finger bilaterally and the tip of my L thumb and L ring finger.  These areas of my palm had the most notable peeling and sloughing around 2/2/21 and by 2/7/21 my R palm was also peeling in similar fashion to the L.  On 2/11/21, I noticed that the skin along my L sole, particularly between all five digits had begun to peel quite markedly; large connected pieces of skin were sloughing off.  The sloughing on the L foot spread from between the toes and the ball of the foot to the arch and then the heel over several days.  On 2/14/21, the R foot/sole began having the same findings, with large amounts of sloughing first between the toes and then extending to the ball of the foot, arch, and ultimately the heel.  Some sort of foot/sole peeling continued through the final week of February 2021 and into early March.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Excessive bleeding during menstrual period.  Period was on time but it is much heavier than normal, soaking at least one pad per hour for 12hrs. It has not resolved yet as period is not complete but seems to be slowing down.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, C-reactive protein, C-reactive protein increased, Headache, Insomnia
Clinical narrative: muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted and I still have difficulty lifting it; stiff neck; pain it causes in my back, legs, neck; lack of strength making it difficult for me to sleep; lack of strength making it difficult for me to sleep; The levels my doctor sees for the CReactive protein QT test have doubled.; 4 days with fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on 07-APR-2021 11:30 (Lot number: GW0151, Expiry date: Unknown) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Ankylosing Spondylitis, Hypothyroidism, uveitis. The patient previously received first dose of BNT162b2 on 07-MAR-2021 11:45 (Lot number: EN6207, Expiry date was unknown) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID 19 since the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID), folic acid (MANUFACTURER UNKNOWN), methotrexate and adalimumab (HUMIRA) for an unknown indication. On 08-APR-2021 09:30(after 21 hours) experienced fever and on an unknown date muscle pain, headaches, swollen glands, the arm where the vaccine was injected could not be lifted and still have difficulty lifting it, stiff neck, pain it causes in her back, legs, neck, lack of strength making it difficult for me to sleep, lack of strength making it difficult for me to sleep, the levels her doctor seen for the C-Reactive protein QT test have doubled. The patient visited doctor and told him that since she received the vaccine her body was not the same and the pain do not stop. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included C-Reactive protein QT test have doubled on 12Apr2021 was 7500 and on 26Apr2021 was 8510. Therapeutic measures were taken for the events with Medrol-Valium-Mobic. The outcome of the event fever was not recovered and rest of the events was unknown.   Follow-up attempts are possible. Further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted and I still have difficulty lifting it; stiff neck; pain it causes in my back, legs, neck; lack of strength making it difficult for me to sleep; lack of strength making it difficult for me to sleep; The levels my doctor sees for the CReactive protein QT test have doubled.; 4 days with fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on 07-APR-2021 11:30 (Lot number: GW0151, Expiry date: Unknown) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Ankylosing Spondylitis, Hypothyroidism, uveitis. The patient previously received first dose of BNT162b2 on 07-MAR-2021 11:45 (Lot number: EN6207, Expiry date was unknown) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID 19 since the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID), folic acid (MANUFACTURER UNKNOWN), methotrexate and adalimumab (HUMIRA) for an unknown indication. On 08-APR-2021 09:30(after 21 hours) experienced fever and on an unknown date muscle pain, headaches, swollen glands, the arm where the vaccine was injected could not be lifted and still have difficulty lifting it, stiff neck, pain it causes in her back, legs, neck, lack of strength making it difficult for me to sleep, lack of strength making it difficult for me to sleep, the levels her doctor seen for the C-Reactive protein QT test have doubled. The patient visited doctor and told him that since she received the vaccine her body was not the same and the pain do not stop. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included C-Reactive protein QT test have doubled on 12Apr2021 was 7500 and on 26Apr2021 was 8510. Therapeutic measures were taken for the events with Medrol-Valium-Mobic. The outcome of the event fever was not recovered and rest of the events was unknown.   Follow-up attempts are possible. Further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: muscle pain; headaches; swollen glands; the arm where the vaccine was injected could not be lifted and I still have difficulty lifting it; stiff neck; pain it causes in my back, legs, neck; lack of strength making it difficult for me to sleep; lack of strength making it difficult for me to sleep; The levels my doctor sees for the CReactive protein QT test have doubled.; 4 days with fever; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on 07-APR-2021 11:30 (Lot number: GW0151, Expiry date: Unknown) as 2nd dose, single dose for COVID-19 immunisation. Medical history included Ankylosing Spondylitis, Hypothyroidism, uveitis. The patient previously received first dose of BNT162b2 on 07-MAR-2021 11:45 (Lot number: EN6207, Expiry date was unknown) for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not diagnosed with COVID 19 since the vaccination. Concomitant medications included levothyroxine sodium (SYNTHYROID), folic acid (MANUFACTURER UNKNOWN), methotrexate and adalimumab (HUMIRA) for an unknown indication. On 08-APR-2021 09:30(after 21 hours) experienced fever and on an unknown date muscle pain, headaches, swollen glands, the arm where the vaccine was injected could not be lifted and still have difficulty lifting it, stiff neck, pain it causes in her back, legs, neck, lack of strength making it difficult for me to sleep, lack of strength making it difficult for me to sleep, the levels her doctor seen for the C-Reactive protein QT test have doubled. The patient visited doctor and told him that since she received the vaccine her body was not the same and the pain do not stop. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included C-Reactive protein QT test have doubled on 12Apr2021 was 7500 and on 26Apr2021 was 8510. Therapeutic measures were taken for the events with Medrol-Valium-Mobic. The outcome of the event fever was not recovered and rest of the events was unknown.   Follow-up attempts are possible. Further information is expected.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported.; Series schedule interrupted: first dose on 16Dec2019, second dose on 9Mar2020 and third dose on 20Apr2021.; This spontaneous report as received from a pharmacist, referring to 21 years old patient of unknown gender. The patient's historical condition, concurrent condition and concomitant medication were not reported.   On 16-DEC-2019, 09-MAR-2020 and 20-APR-2021, the patient was vaccinated with three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis, respectively (inappropriate schedule of product administration). The reporter did not have lot# and expiration dates for any of the doses administered. The dose and strength for suspect vaccine were not reported. No additional adverse events reported. It was reported that the patient was 20 years old at time of initiation. A pharmacist inquiring if a currently 22 years old patient received 3-doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) but the series schedule was not adhered to should the patient be re-vaccinated.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported no additional AE/PQC at time of call; an expired dose of MMRlI was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 18-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-MAY-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (lot # S013719, expiration date 05-MAY-2021), (route of administration, was not reported) for prophylaxis. The vaccine had no known temperature excursions. The patient experienced no adverse event.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: missed dose; This spontaneous report was received from a healthcare professional concerning a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.   In 2020 (reported as a year ago), the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency and route were not reported) as prophylaxis. It was unable to confirm with the patient that the product was quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient wanted to know if she needed to restart the series. The missed dose (product dose omission issue) was reported.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion / temperature 9C; This spontaneous report was received from a licensed vocational nurse and refers to a 12 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 09-MAR-2021, the dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T006849, expiration date 16-JUN-2022 was stored improperly in a temperature of 9 degree Celsius (C) for 30 minutes and on 19-MAR-2021, it was administered to the patient (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No previous temperature excursion was reported. Digital data logger was involved. No adverse event (AE) was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2105USA007015: US-009507513-2105USA006749: US-009507513-2105USA007032: US-009507513-2105USA006817:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Exposure during pregnancy, Human papilloma virus test positive, Immunisation, Inappropriate schedule of product administration, Papilloma viral infection
Clinical narrative: tested positive for HPV.; had an abnormal test; exposure during pregnancy; started the series of doses at age 10-11 and never received the 3rd booster. She eventually had to restart the series of doses; This spontaneous progressive pregnancy report was received from the patient's mother and refers to a 25-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2006 (reported as at "10-11 years of age"), the patient started vaccination series with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, she received a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but never received the third dose booster. The patient had to eventually restart the series of doses. All vaccines were administered for prophylaxis. She became pregnant (date of last menstrual period (LMP) and estimated due date (EDD) were unknown) (vaccine exposure during pregnancy). Pregnancy outcome was pending. On an unknown date, the patient had an abnormal test and tested positive for human papillomavirus (HPV). The outcome of the events was reported as not recovered.   Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA007385:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VARIVAX had a temperature excursion and was administered to the patient; This spontaneous report was received from a Medical Assistant, referring to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 21-MAY-2021, varicella virus vaccine live (oka/merck) (VARIVAX) was involved on a temperature excursion of 7F for 21 hours and 57 minutes and, on an unspecified date a excursion of 6 degree Fahrenheit (°F) yo 14 °F for 429 hours.   Subsequently, on 26-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # T029535 and expiration date on 01-SEP-2022 (route of administration and strength were not provided) for prophylaxis. The vaccine was exposed to a temperature of 9F, during a 17 hours and 53 minute timeframe. The call was made du to a data logger. No additional adverse events reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: received the first dose of GARDASIL 9 then did not come back for her second dose until a year.; No additional adverse event; This spontaneous report as received from a nurse via agent, referring to a 54 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported) and she did not come back for the second dose until a year later. No additional adverse events.