chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Malaise, Nodule, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came in for swelling and pain to left calf, he also had a nodule to the medial posterior aspect of the calf.  He reported the symptoms were since approx the 5/17/21. Pt said it possibly started sooner on the 15th. Pt came in  today 5/21/21 because he received an ultrasound at a clinic by referral from his pmd and was dx with a DVT to the left calf. His pmd then referred him to come to ER where I triaged him in the triage department. He mentioned that began feeling bad after the Moderna Shot he received on 4/28/2020 and stated the now he has this new problem that he never had in the past. Only hx was mild htn he said.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Patient came in for swelling and pain to left calf, he also had a nodule to the medial posterior aspect of the calf.  He reported the symptoms were since approx the 5/17/21. Pt said it possibly started sooner on the 15th. Pt came in  today 5/21/21 because he received an ultrasound at a clinic by referral from his pmd and was dx with a DVT to the left calf. His pmd then referred him to come to ER where I triaged him in the triage department. He mentioned that began feeling bad after the Moderna Shot he received on 4/28/2020 and stated the now he has this new problem that he never had in the past. Only hx was mild htn he said.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Death, Electrocardiogram, Inflammation
Clinical narrative: Patient appeared to have had suffered a stroke. Admitted to hospital, tests determined no stroke. Patient had pneumonia, and severe inflammatory response. Sepsis.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Sepsis
Clinical narrative: Patient appeared to have had suffered a stroke. Admitted to hospital, tests determined no stroke. Patient had pneumonia, and severe inflammatory response. Sepsis.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Moderna COVID-19 vaccine second dose was given 21 days after first dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blindness, Blood pressure decreased, Dizziness, Dyspnoea
Clinical narrative: I had recovered about 90% (with medication) since having COVID in December when I received my first dose of the COVID vaccine. Thirteen days after the vaccine I began to experience symptoms like when I had COVID. On day 13 I started to itch and my BP dropped and I became light headed. My vision started to go and I had a hard time breathing and forming words for my husband to help me with some water. This lasted about 20 min.    Since then I have been having heart rate increases up into the 150s with minimal effort. Bending like doing dishes or putting away groceries makes me extremely light headed. I have become so tired just folding a little bit of laundry. It wasn?t until a few weeks in that I noticed this was all exactly like when I had COVID. Including being okay in the morning but having so many issues by the evening. So weird.   I?m 3 weeks and 4 days past my second shot and finally starting to have some better days again but no day has been symptom free. I wish could know if this is happening to other long haulers and that it will most likely resolve, I have been starting to wonder about disability and really having a hard time facing the fact that I no longer can complete simple house hold chores like I used to.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Laboratory test, Loss of personal independence in daily activities, Pruritus
Clinical narrative: I had recovered about 90% (with medication) since having COVID in December when I received my first dose of the COVID vaccine. Thirteen days after the vaccine I began to experience symptoms like when I had COVID. On day 13 I started to itch and my BP dropped and I became light headed. My vision started to go and I had a hard time breathing and forming words for my husband to help me with some water. This lasted about 20 min.    Since then I have been having heart rate increases up into the 150s with minimal effort. Bending like doing dishes or putting away groceries makes me extremely light headed. I have become so tired just folding a little bit of laundry. It wasn?t until a few weeks in that I noticed this was all exactly like when I had COVID. Including being okay in the morning but having so many issues by the evening. So weird.   I?m 3 weeks and 4 days past my second shot and finally starting to have some better days again but no day has been symptom free. I wish could know if this is happening to other long haulers and that it will most likely resolve, I have been starting to wonder about disability and really having a hard time facing the fact that I no longer can complete simple house hold chores like I used to.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia, Pruritus, Rash, Skin warm
Clinical narrative: I took the vaccine on April 6th around 8:40 PM, and the next day around 2:30 AM I noticed multiple pumps on my chest area and the back part of my thighs, and they were quite itchy. On April 8th, I woke up with my lips completely swollen, very tingly, and feeling warm - I, unfortunately, had a college test on that exact day and could not go to the hospital straight away. They told me to go get it checked and go to the hospital in case I have trouble breathing. My lips ended up going back to normal eventually. I went to three different doctors after a couple of days because I kept getting sick and also to explain the situation and ask if I could even take the second dose of the vaccine since it was approaching. All three doctors told me not to because my body could go into anaphylactic shock, so I did not take it.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: "Covid arm"- large and red raised patch on skin. Warm to touch with minimal itching and pain.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "COVID arm" painful rash on my arm. Didn't start until over a week past the injection
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: On May 13th my right arm (where I got the shot) was in extreme pain as of this report it hasn't gotten much better..
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I experienced numbness in my right hand. It switched between my hand and 2 middle fingers. Since I have had covid, my nose would run off and on. My head would hurt and I always had some type of congestion and high bpm. When I received the shot, my congestion and runny nose dried up. It felt as if the shot was pulling something through my veins and drying up the congestion instantly and clearing up my head congestion as well.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: large painful lymph nodes above and below left clavicle,
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Mobility decreased, Pain, Rash
Clinical narrative: 3 days after vaccine on left arm, woke up with large bumps covering right arm. Throughout the day, the rash/bumps worsened and spread over my whole body. That night, aches/chills began. The next day the rash was very severe, red bumps covering body, with it slowly spreading up next onto face. Most concentrated and severe on stomach, sides, upper thighs and creases of knees, buttocks, elbows. That day, aches and chills were severe  and could not get out of bed. Heavy chest occurred later that day. These symptoms lasted 2-3 days, with the rash lasting over a week. Doctor prescribed oral steroids (30 pills total) to get rash under control.  Also had lack of appetite and bad headaches
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: 3 days after vaccine on left arm, woke up with large bumps covering right arm. Throughout the day, the rash/bumps worsened and spread over my whole body. That night, aches/chills began. The next day the rash was very severe, red bumps covering body, with it slowly spreading up next onto face. Most concentrated and severe on stomach, sides, upper thighs and creases of knees, buttocks, elbows. That day, aches and chills were severe  and could not get out of bed. Heavy chest occurred later that day. These symptoms lasted 2-3 days, with the rash lasting over a week. Doctor prescribed oral steroids (30 pills total) to get rash under control.  Also had lack of appetite and bad headaches
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Ultrasound scan
Clinical narrative: After 4 days left upper arm started hurting and kept hurting worse. Went to clinic due to pain and received injection. Continues to hurt and returned to clinic and received medication for pain and muscle relaxer. Returned 5/22/21 due to continued pain and was sent to get ultrasound. To follow up with Orthropedic Doctor on May 24,2021.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Corneal reflex decreased, Drooling, Dysphagia, Hypoaesthesia
Clinical narrative: Left side of my face started numbing, felt like if a nerve popped while eating a sub, next day in the morning lost control on my left side lip, started dripping saliva while sleeping and water while brushing my teeth., couldn?t drink water, couldn?t blink my eye. Im still the same until now.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Left side of my face started numbing, felt like if a nerve popped while eating a sub, next day in the morning lost control on my left side lip, started dripping saliva while sleeping and water while brushing my teeth., couldn?t drink water, couldn?t blink my eye. Im still the same until now.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever, body aches, headache, tingly limbs. Symptoms started around 4am, so about 17 hours later. Symptoms were gone by 48 hours later.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: I had 3 stages of reactions to the first dose. 1. Same day of the vaccine, I had a mild soreness in my arm which was normal for a vaccine shot. Nothing out of the ordinary. 2. Second day, I felt tired, similar to what I would feel if I am getting  the flu. I felt as if I had a elevated body temperature, but the forehead thermometer was normal. 3. Third day, I felt better overall, only had the soreness in the arm left. 4. Day 12, I noticed 3 patches of a rash on and around the injection site. I only noticed them because I felt my arm warmer than usual. The texture of the rash is a bit different than my regular skin, mildly reddish in color, 1 patch is 2 inches in diameter, the others are smaller. I called in to vaccination team and the nurse took my statement and directed me to report it here.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Ocular discomfort, Paraesthesia
Clinical narrative: Received shot on 5/17/2021 at 1:00...Within 20 to 30 minutes upon receiving the Pfizer COVID-19 vaccine, I experienced numbness on the right side of my entire body where the vaccine was given, also and pressure behind my right eye. Along with tingling on the right side of my body, headache, fatigue.  Called pharmacy and was advised by a man that it?s fairly common and that it would go away in 24-48 hours and if it didn?t then to seek medical care.   As of 12:40AM on 05/22/2021 it is better but still not back to fully 100%.  It is now been 4 days going on 5 and I still have loss of sensation on the right side of my body of approximately 5% (tingling).  Have not taken anything nor sought medical care. Even thought a visit to the ER was recommended, Patient said he could still mostly function.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: Received shot on 5/17/2021 at 1:00...Within 20 to 30 minutes upon receiving the Pfizer COVID-19 vaccine, I experienced numbness on the right side of my entire body where the vaccine was given, also and pressure behind my right eye. Along with tingling on the right side of my body, headache, fatigue.  Called pharmacy and was advised by a man that it?s fairly common and that it would go away in 24-48 hours and if it didn?t then to seek medical care.   As of 12:40AM on 05/22/2021 it is better but still not back to fully 100%.  It is now been 4 days going on 5 and I still have loss of sensation on the right side of my body of approximately 5% (tingling).  Have not taken anything nor sought medical care. Even thought a visit to the ER was recommended, Patient said he could still mostly function.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache
Clinical narrative: Headaches, Bell's Palsy
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling cold, Feeling hot, Injection site pain
Clinical narrative: 101 F temperature, Higher temperature chest/stomach area, joint/muscle pain, chills, nausea, injection site pain.  Started about 1:15am, woke up with severe chills, fever and the pain.  Took Advil for fever and pain.  Went from chill to hot and back again throughout the night.  By morning, even drinking water was generating nausea.  Symptoms decreased in the late even, but second night still had chills but much reduced.  Next day, only the soreness in arm has remained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 101 F temperature, Higher temperature chest/stomach area, joint/muscle pain, chills, nausea, injection site pain.  Started about 1:15am, woke up with severe chills, fever and the pain.  Took Advil for fever and pain.  Went from chill to hot and back again throughout the night.  By morning, even drinking water was generating nausea.  Symptoms decreased in the late even, but second night still had chills but much reduced.  Next day, only the soreness in arm has remained.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Ear infection, Malaise, Oropharyngeal pain, Respiratory symptom
Clinical narrative: Patient began to experience symptoms consistent with an upper respiratory infection one day after getting 1st dose of COVID-19 vaccine. By day four, she developed an ear infection and began antibiotics. It is now exactly one week after the shot and 3 days after starting antibiotics and she still feels miserable. She?s losing her voice, throat is sore, and both ears feel infected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Nausea, Pain
Clinical narrative: Chest pains, nausea, soreness
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Rash developed on arm around injection site about a day after injection.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: On 5/20 I began to notice my arm was really itchy at the sight of injection. I thought it was a mosquito bite at first because it felt bumpy. After a few hours I noticed a big red mark all around the sight of injection. It was swollen and itchy. It was a ring but more akin to a red patch right at the sight of injection. Then around that patch was a ring.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: On 5/20 I began to notice my arm was really itchy at the sight of injection. I thought it was a mosquito bite at first because it felt bumpy. After a few hours I noticed a big red mark all around the sight of injection. It was swollen and itchy. It was a ring but more akin to a red patch right at the sight of injection. Then around that patch was a ring.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Pulmonary embolism, Respiratory failure, Ultrasound Doppler, Ventilation/perfusion scan
Clinical narrative: onset of respiratory failure on 05/14/2021 to be eventually diagnosed with pulmonary embolism.  hospitalized at facility .
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy - left side of face  Treated with prednisone and anti viral medication
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Bruxism, Dyskinesia, Eye movement disorder, Fall, Hyperhidrosis
Clinical narrative: After administering the shot, patient was very quiet. As I was filling out the rest of her paperwork, I asked her a question that she did not respond to, I noticed her sweating and start to fall forward. I was able to catch her, guard her head and lie her down, but she seemed to be seizing (clenching and unclenching her arms and feet, her eyes had rolled back, with teeth clenching ). She did not acknowledge when I called her name, but was making small noises. It lasted for a little over a minute before her vision was able to focus on me. I asked if she was alright, told her that she passed out and may have had a seizure; then I asked if she would like me to call an ambulance. She declined multiple time and stated that she fainted sometimes when she was scared (although never before with an immunization and no history of seizure, as was listed on the VAR). I offered her water (she declined) and to take her blood pressure (she declined) and told her to wait in the waiting room for at least 15 minutes while we monitored her. Patient was joined by her aunt (who was waiting for her outside) and I suggested that they make an appointment with patient's regular doctor, which patient again declined.  I settled them in, then checked on her at minute 5 and minute 10, she stated that she was "feeling fine" at both checks (no sweating or seizure signs either). When I went back to check at minute 15, they were already gone. Patient did not return my phone calls for follow-up later in the day.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure, Unresponsive to stimuli
Clinical narrative: After administering the shot, patient was very quiet. As I was filling out the rest of her paperwork, I asked her a question that she did not respond to, I noticed her sweating and start to fall forward. I was able to catch her, guard her head and lie her down, but she seemed to be seizing (clenching and unclenching her arms and feet, her eyes had rolled back, with teeth clenching ). She did not acknowledge when I called her name, but was making small noises. It lasted for a little over a minute before her vision was able to focus on me. I asked if she was alright, told her that she passed out and may have had a seizure; then I asked if she would like me to call an ambulance. She declined multiple time and stated that she fainted sometimes when she was scared (although never before with an immunization and no history of seizure, as was listed on the VAR). I offered her water (she declined) and to take her blood pressure (she declined) and told her to wait in the waiting room for at least 15 minutes while we monitored her. Patient was joined by her aunt (who was waiting for her outside) and I suggested that they make an appointment with patient's regular doctor, which patient again declined.  I settled them in, then checked on her at minute 5 and minute 10, she stated that she was "feeling fine" at both checks (no sweating or seizure signs either). When I went back to check at minute 15, they were already gone. Patient did not return my phone calls for follow-up later in the day.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Deafness unilateral, Decreased appetite, Ear discomfort
Clinical narrative: Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little appetite felt very very bad after 2nd dose on April 27. Awoke sweating profusely bed damp pajamas damn at 6:30 on Thursday, April 29 to loud ringing buzzing whining in both ears. Pressure in ears soreness in ears deep where ears meet brain. Feels as if ears will burst if I lean over. Headache in forehead. Fever 99.0 -99.4.  Ear pressure aching ringing has continued since. At times, left ear feels like a void like I can?t hear. Right ear like it hears too well too loud. Music songs sound different. Like not blended. Like missing a part. When 2 many sounds happening, I can?t distinguish detail. It?s all blurred. An ambulance went by. I couldn?t hear with my left ear. Seatbelt beeping in car is faint and does not bother me now.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Ear, nose and throat examination normal, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little appetite felt very very bad after 2nd dose on April 27. Awoke sweating profusely bed damp pajamas damn at 6:30 on Thursday, April 29 to loud ringing buzzing whining in both ears. Pressure in ears soreness in ears deep where ears meet brain. Feels as if ears will burst if I lean over. Headache in forehead. Fever 99.0 -99.4.  Ear pressure aching ringing has continued since. At times, left ear feels like a void like I can?t hear. Right ear like it hears too well too loud. Music songs sound different. Like not blended. Like missing a part. When 2 many sounds happening, I can?t distinguish detail. It?s all blurred. An ambulance went by. I couldn?t hear with my left ear. Seatbelt beeping in car is faint and does not bother me now.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Fever 100.8 x 30 hours chills headache in nape of neck. unsteady arm soreness weak no sleep little appetite felt very very bad after 2nd dose on April 27. Awoke sweating profusely bed damp pajamas damn at 6:30 on Thursday, April 29 to loud ringing buzzing whining in both ears. Pressure in ears soreness in ears deep where ears meet brain. Feels as if ears will burst if I lean over. Headache in forehead. Fever 99.0 -99.4.  Ear pressure aching ringing has continued since. At times, left ear feels like a void like I can?t hear. Right ear like it hears too well too loud. Music songs sound different. Like not blended. Like missing a part. When 2 many sounds happening, I can?t distinguish detail. It?s all blurred. An ambulance went by. I couldn?t hear with my left ear. Seatbelt beeping in car is faint and does not bother me now.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia
Clinical narrative: extreme headaches chills and fever 36 hours  thought i was dying
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Muscle spasms, Pregnancy, Vaginal haemorrhage
Clinical narrative: I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal bleeding and crumping, had miscarriage next day.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Body temperature normal, Chills
Clinical narrative: 5/19/21 -- Blurred vision, headache, nausea, lightheaded, stomach ache, disoriented, sweating, right ear plugged, temp 98.9, legs feel heavy. Felt like I was going to pass out several times. 5/20/21 -- Temp 98.4, nausea, dizzy, sluggish, oximeter 96%, joint pain, blurred vision, weak, chills. Went home early from work. 5/21/21 -- Nausea, blurred vision started around 2 pm, headache, fatigue, stomach ache, dizzy, Taking pepto bismol & Ibuprofen
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Ear discomfort, Headache, Hyperhidrosis
Clinical narrative: 5/19/21 -- Blurred vision, headache, nausea, lightheaded, stomach ache, disoriented, sweating, right ear plugged, temp 98.9, legs feel heavy. Felt like I was going to pass out several times. 5/20/21 -- Temp 98.4, nausea, dizzy, sluggish, oximeter 96%, joint pain, blurred vision, weak, chills. Went home early from work. 5/21/21 -- Nausea, blurred vision started around 2 pm, headache, fatigue, stomach ache, dizzy, Taking pepto bismol & Ibuprofen
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Limb discomfort, Nausea, Sluggishness, Vision blurred
Clinical narrative: 5/19/21 -- Blurred vision, headache, nausea, lightheaded, stomach ache, disoriented, sweating, right ear plugged, temp 98.9, legs feel heavy. Felt like I was going to pass out several times. 5/20/21 -- Temp 98.4, nausea, dizzy, sluggish, oximeter 96%, joint pain, blurred vision, weak, chills. Went home early from work. 5/21/21 -- Nausea, blurred vision started around 2 pm, headache, fatigue, stomach ache, dizzy, Taking pepto bismol & Ibuprofen
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dysmenorrhoea, Fatigue, Gastrointestinal disorder
Clinical narrative: dizziness and vertigo on and off since 5/18; evening of 5/18 had intense digestive issues and diarrhea; period started suddenly at this time as well and extremely heavy with clots, very intense cramping, period will be like this for about 8 hours and then stop and start again about 8-12 hours later; fatigued but can't sleep
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Insomnia, Vertigo
Clinical narrative: dizziness and vertigo on and off since 5/18; evening of 5/18 had intense digestive issues and diarrhea; period started suddenly at this time as well and extremely heavy with clots, very intense cramping, period will be like this for about 8 hours and then stop and start again about 8-12 hours later; fatigued but can't sleep
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site bruising, Injection site erythema, Injection site rash
Clinical narrative: Tuesday night: Insomnia Wednesday morning: noticed bruising at injection site about the size of a quarter Wednesday night around 10PM: insomnia, also developed chills & fever to 101.4F, achy knees Thursday: mild itching on left arm below injection site Friday night: developed large red rash about six inches below the injection site, swollen and hot to the touch
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Pruritus, Pyrexia
Clinical narrative: Tuesday night: Insomnia Wednesday morning: noticed bruising at injection site about the size of a quarter Wednesday night around 10PM: insomnia, also developed chills & fever to 101.4F, achy knees Thursday: mild itching on left arm below injection site Friday night: developed large red rash about six inches below the injection site, swollen and hot to the touch
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral artery embolism, Cerebrovascular accident, Death, Intensive care, Loss of consciousness
Clinical narrative: Massive stroke from huge clot right of brain. Never regained con..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombectomy
Clinical narrative: Massive stroke from huge clot right of brain. Never regained con..
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, COVID-19, Menstruation delayed, SARS-CoV-2 test positive
Clinical narrative: Missed menstrual cycle.  Severe burning joint pain
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Fatigue six hours after injection. Chills and fever started ten hours after injection, lasted for three hours. Pain, swelling, hardness and redness began next day near injection site (left arm) and lasted for a few days. Headache also began the day after vaccination and lasted for a few hours. Symptoms were treated with Tylenol.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fatigue six hours after injection. Chills and fever started ten hours after injection, lasted for three hours. Pain, swelling, hardness and redness began next day near injection site (left arm) and lasted for a few days. Headache also began the day after vaccination and lasted for a few hours. Symptoms were treated with Tylenol.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Exercise tolerance decreased, Fatigue
Clinical narrative: Swollen arm with redness, POTS (fatigue,, dizziness, lightheadedness, blurry vision, increased heart rate upon standing, shortness of breath, exercise intolerance, nausea)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Nausea, Peripheral swelling, Postural orthostatic tachycardia syndrome, Tilt table test positive
Clinical narrative: Swollen arm with redness, POTS (fatigue,, dizziness, lightheadedness, blurry vision, increased heart rate upon standing, shortness of breath, exercise intolerance, nausea)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Swollen arm with redness, POTS (fatigue,, dizziness, lightheadedness, blurry vision, increased heart rate upon standing, shortness of breath, exercise intolerance, nausea)
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right shoulder and upper arm is red, swollen and hot. Entire area is extremely painful requiring ice pack and antiinflammatories. Sleep is difficult due to pain and swelling.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia
Clinical narrative: Right shoulder and upper arm is red, swollen and hot. Entire area is extremely painful requiring ice pack and antiinflammatories. Sleep is difficult due to pain and swelling.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal uterine bleeding, Uterine haemorrhage
Clinical narrative: Abnormal and heavy uterine bleeding
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nightmare
Clinical narrative: I?ve had continuous headaches for 2 weeks now that come and go during the day of the moderate severity type. Difficulty sleeping and nightmares from time to time.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Minor muscle twitches multiple times a day
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Started feeling pains and feverish on Tuesday the 18th around 1:30 pm with an increasing body temperature  around 104. something around 12:00 am on Wednesday even after haven taken Tylenol at the onset. Pains and feverish feelings continued to stay above 100 of body temperature per my wife's readings. Attempt to reach Teledoc was unsuccessful until  Wednesday around 10:00am.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus ringing in both ears - left side stronger/louder than right
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Myalgia, Nausea, Pain
Clinical narrative: So it happened later when I got home, but I suffered from extreme body and muscle pain, heavy fatigue, severe naseua, a fever at about 100 degrees Fahrenheit, and severe migraines. This continued till about 8 am the next morning when my fever finally broke, and the other symptoms have gradually lessened over the period of today.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: So it happened later when I got home, but I suffered from extreme body and muscle pain, heavy fatigue, severe naseua, a fever at about 100 degrees Fahrenheit, and severe migraines. This continued till about 8 am the next morning when my fever finally broke, and the other symptoms have gradually lessened over the period of today.
Age: 39.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Chest pain, Myocardial necrosis marker increased, Myocarditis, Pericarditis
Clinical narrative: Pt received covid 19 vaccine appx 3 weeks prior to severe  Chest pain and elevated cardiac enzymes. Cardiologist notes believes to be myocarditis or pericarditis
Age: 39.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Cardiac disorder, Myocarditis, Pericarditis
Clinical narrative: Pt received covid 19 vaccine appx 3 weeks prior to severe  Chest pain and elevated cardiac enzymes. Cardiologist notes believes to be myocarditis or pericarditis
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Chills, Headache, Hyperhidrosis, Myalgia
Clinical narrative: The JANSSEN COVID-19 vaccine. Fever of 38.5 degrees C. Strong pain in ovaries. Shaking chills. Muscle pain in lower limbs. Sweats. Headache.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: The JANSSEN COVID-19 vaccine. Fever of 38.5 degrees C. Strong pain in ovaries. Shaking chills. Muscle pain in lower limbs. Sweats. Headache.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Fibrin D dimer
Clinical narrative: ACUTE LEFT LEG DVT WITHOUT PE
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: My arm was sore and tender for 2 days after the vaccine which is considered normal but then 8 days after my arm became sore and tender again, hot to the touch and there's a bit of swelling. It is now Saturday May 22 and my arm is red, tender, swollen a bit and quite itchy.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mastitis, Pyrexia
Clinical narrative: I am breastfeeding and on the second day after vaccine I developed a serious mastitis in my right breast. I had fever of 38,5, which beaded after a day and a half of intense sweating.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest X-ray, Dyspnoea, Orthopnoea, Wheezing
Clinical narrative: ACUTE ASTHMA, DYSPNEA, ORTHOPNEA, WHEEZING
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Erythema, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Day of vaccine at approximately 11:45AM I noticed that my entire throat area, and upper portion of my chest was really bright red so I took a dose of OTC benadryl and when it subsided I didn't think about it any further. After that day I was good for the following 4 or 5 days, and then woke up with tummy cramps and just did not feel good at all, I thought maybe I needed to eat something because I didn't eat with the previous nights bed time meds. About 30 minutes of still not feeling well I had watery stools immediately followed by vomiting, hot and cold flashes, and profusely sweating all over. The only comfort I could experience was when I slept. That all lasted about 36 hours and the crampy discomfort another 2 or 3 days passed that. I am now fine.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Malaise, Vomiting
Clinical narrative: Day of vaccine at approximately 11:45AM I noticed that my entire throat area, and upper portion of my chest was really bright red so I took a dose of OTC benadryl and when it subsided I didn't think about it any further. After that day I was good for the following 4 or 5 days, and then woke up with tummy cramps and just did not feel good at all, I thought maybe I needed to eat something because I didn't eat with the previous nights bed time meds. About 30 minutes of still not feeling well I had watery stools immediately followed by vomiting, hot and cold flashes, and profusely sweating all over. The only comfort I could experience was when I slept. That all lasted about 36 hours and the crampy discomfort another 2 or 3 days passed that. I am now fine.
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No other AEs; a temperature excursion on ROTATEQ that was administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions, allergies and concomitant medications.   On 22-APR-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 time dose, route defaulted to oral, lot # T033812, has been confirmed to be a valid lot #, expiration date 29-DEC-2021) (exact dose, route of administration and anatomical location were not provided), for prophylaxis. Administered dose of vaccine experienced temperature excursion of 48.2 degrees Fahrenheit (above 47 degrees Fahrenheit) for 2 hours. There was no adverse event reported. Data logger was not involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA007516: US-009507513-2104USA007568: US-009507513-2105USA003675:
Sex: U
Vaccine: PPV, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AEs.; The patient the received the first PNEUMOVAX 23 on 11/29/2016. The patient then received a second PNEUMOV AX 23 vaccination on 3/26/2021; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-NOV-2016, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 26-MAR-2021, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, 0.5 milliliter, lot # T028093, expiration date 24-APR-2022 (injection site and route of administration were not provided) (Inappropriate schedule of vaccine administered). No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: adult VAQT A and it was administered to three 15 month old patients; Physicians's office accidently ordered adult VAQTA; adult VAQT A and it was administered to three 15 month old patients; no adverse reactions were reported; This spontaneous report as received from an unspecified reporter concerning a 15-month-old patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  The practice accidently ordered adult hepatitis a vaccine, inactivated (VAQTA) instead of pediatric dose (Product prescribing error).    On an unknown date, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) instead of pediatric dose  for prophylaxis ( dose, route of administration, lot number and expiration date were not reported) (Product administered to patient of inappropriate age, Accidental overdose) .  No adverse reactions were reported per caller.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA004310: US-009507513-2105USA004309:
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient who was previously administered the 1st GARDASIL 9 dose in 2013 experienced an interruption in completing GARDASIL 9 schedule and had never received 2nd GARDASIL 9 dose.; No additional AE; This spontaneous report was received from a pharmacist and refers to a currently 25-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in 2013, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. The patient experienced an interruption in completing hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) schedule and had never received the second dose. The pharmacist requested medical information.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; a consumer received a dose of PNEUMOV AX 23 on June 24, 2019 and a second dose on September 21st, 2020; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-JUN-2019, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 21-SEP-2020, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) (Inappropriate schedule of vaccine administered). No additional adverse event was reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported.; A temperature excursion on VAQTA. Excursions occurred on 04/09/2021 and 04/23/2021. Company made aware of excursions on 05/12/2021. Doses were administered on 4/14/2021 and 05/07/2021.; Information has been received from an administrator, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unspecified date in 2021 (reported between 14-APR-2021 and 07-MAY-2021), the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T017179, with expiration date on 26-OCT-2021 or lot # T014835, with expiration date on 17-JUL-2021 (dose, adminstration route and anatomical location were not reported) 1 "time dose" for prophylaxis. No signs or symptoms were reported, nor product quality complaints.  The vaccine had a temperature excursions of 49.0 Fahrenheit (F) and 48.7F on 09-APR-2021 and 23-APR-2021, respectively. The excursion last 1 hour and 15 minutes.It was confirmed that no previous temperature excursions occurred and no digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: v; expirationdate: 26-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 01-MAR-2021, the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines for Children (VFC) program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543: