chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthropod bite, Blood test, Henoch-Schonlein purpura, Lymphadenopathy, Purpura
Clinical narrative: The evening of 6/4 she came home from outside noticed mosquitos lower leg. On the next day the bumps became bigger,darker in appearance she took Benadryl. The following Monday the appearance looked purple color and lot more spots had occurred. Then on 6/8 becoming larger almost big as Mom palm. She was taken to Urgent Care after observation taken to ER. The medical staff confirmed that it was Purpura and doctor in the ER diagnosed with HSP(typically you see that after having viral or vaccine) was given pain injection. Also she had swollen under her left arm. She was prescribed Prednisone and Diclofenac.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Skin discolouration, Urine analysis
Clinical narrative: The evening of 6/4 she came home from outside noticed mosquitos lower leg. On the next day the bumps became bigger,darker in appearance she took Benadryl. The following Monday the appearance looked purple color and lot more spots had occurred. Then on 6/8 becoming larger almost big as Mom palm. She was taken to Urgent Care after observation taken to ER. The medical staff confirmed that it was Purpura and doctor in the ER diagnosed with HSP(typically you see that after having viral or vaccine) was given pain injection. Also she had swollen under her left arm. She was prescribed Prednisone and Diclofenac.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Incorrect Reconstitution
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Headache, Mobility decreased, Muscular weakness, Pain
Clinical narrative: Pt stated that she had her Moderna covid vaccine on Thursday and woke up the next morning extremely weak. She said her legs were so weak she couldn't stand and had to be helped back to bed. She was also very tired. This lasted for 2 days, until Sunday. She was feeling better by Monday. She contacted the doctor and is to call them again in a few days with an update.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Pt stated that she had her Moderna covid vaccine on Thursday and woke up the next morning extremely weak. She said her legs were so weak she couldn't stand and had to be helped back to bed. She was also very tired. This lasted for 2 days, until Sunday. She was feeling better by Monday. She contacted the doctor and is to call them again in a few days with an update.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dysstasia, Fatigue, Muscular weakness
Clinical narrative: Pt stated that she had her Moderna covid vaccine on Thursday and woke up the next morning extremely weak. She said her legs were so weak she couldn't stand and had to be helped back to bed. She was also very tired. This lasted for 2 days, until Sunday. She was feeling better by Monday. She contacted the doctor and is to call them again in a few days with an update.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bundle branch block right, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram repolarisation abnormality
Clinical narrative: Chest pain, went to ER. DX with Myocarditis. Treated with pain medications in the hospital. He was then transfer to  Hospital were again dx was Acute idiopathic myocarditis and elevated Troponin level. Was given discharge instructions to Follow up in 1 week with Cardiology, lab draws to repeat Troponin levels before Cardiology visit. No heavy lifting or physical activity until after visit with cardiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Chest pain, went to ER. DX with Myocarditis. Treated with pain medications in the hospital. He was then transfer to  Hospital were again dx was Acute idiopathic myocarditis and elevated Troponin level. Was given discharge instructions to Follow up in 1 week with Cardiology, lab draws to repeat Troponin levels before Cardiology visit. No heavy lifting or physical activity until after visit with cardiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Laboratory test, Myocarditis
Clinical narrative: Chest pain, went to ER. DX with Myocarditis. Treated with pain medications in the hospital. He was then transfer to  Hospital were again dx was Acute idiopathic myocarditis and elevated Troponin level. Was given discharge instructions to Follow up in 1 week with Cardiology, lab draws to repeat Troponin levels before Cardiology visit. No heavy lifting or physical activity until after visit with cardiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram, Malaise, Myocarditis
Clinical narrative: Chest pain, went to ER. DX with Myocarditis. Treated with pain medications in the hospital. He was then transfer to  Hospital were again dx was Acute idiopathic myocarditis and elevated Troponin level. Was given discharge instructions to Follow up in 1 week with Cardiology, lab draws to repeat Troponin levels before Cardiology visit. No heavy lifting or physical activity until after visit with cardiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Chest pain, went to ER. DX with Myocarditis. Treated with pain medications in the hospital. He was then transfer to  Hospital were again dx was Acute idiopathic myocarditis and elevated Troponin level. Was given discharge instructions to Follow up in 1 week with Cardiology, lab draws to repeat Troponin levels before Cardiology visit. No heavy lifting or physical activity until after visit with cardiology.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Electrocardiogram normal, Myocarditis
Clinical narrative: Pt reported epigastric burning and chest pain.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Pt reported epigastric burning and chest pain.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspepsia, Troponin
Clinical narrative: Pt reported epigastric burning and chest pain.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Epistaxis, Thrombosis
Clinical narrative: Patient states that 2-3 days after receiving first Pfizer vaccine, she has been having significant nosebleeds. She reports having about 14 nosebleeds, at least 1 a day. She denies changing any medications or lifestyle changes
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: Patient states that 2-3 days after receiving first Pfizer vaccine, she has been having significant nosebleeds. She reports having about 14 nosebleeds, at least 1 a day. She denies changing any medications or lifestyle changes
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: My daughter had a 40-1 minute seizure 40 minutes post vaccine shot. Not prior seizures to this one.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Neurological examination, Seizure
Clinical narrative: My daughter had a 40-1 minute seizure 40 minutes post vaccine shot. Not prior seizures to this one.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Troponin
Clinical narrative: Myocarditis - patient has chest pain, elevated troponins, ST elevation on EKG, normal Echo.  Symptoms started 4 days after second dose of Pfizer Covid vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Myocarditis - patient has chest pain, elevated troponins, ST elevation on EKG, normal Echo.  Symptoms started 4 days after second dose of Pfizer Covid vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis - patient has chest pain, elevated troponins, ST elevation on EKG, normal Echo.  Symptoms started 4 days after second dose of Pfizer Covid vaccine.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Electrocardiogram ST segment elevation, Pyrexia, Troponin T increased
Clinical narrative: Myocarditis - patient has chest pain, elevated troponins, ST elevation on EKG, normal Echo.  Symptoms started 4 days after second dose of Pfizer Covid vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: After second dose, menstrual periods became longer and heavier.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cluster headache, Computerised tomogram abnormal, Disturbance in attention, Echocardiogram
Clinical narrative: Chronic cluster and migraine headache with vision changes, joint pain, short term memory and concentration issues - onset after vaccine to current date.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Magnetic resonance imaging abnormal, Memory impairment, Migraine, Red blood cell sedimentation rate increased
Clinical narrative: Chronic cluster and migraine headache with vision changes, joint pain, short term memory and concentration issues - onset after vaccine to current date.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Chronic cluster and migraine headache with vision changes, joint pain, short term memory and concentration issues - onset after vaccine to current date.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Headache, Pain, Pyrexia
Clinical narrative: Fever (101.2), generalized body aches, headache, ear pain
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Liver function test increased, Metabolic function test, Urine analysis, Vomiting
Clinical narrative: Patient developed persistent vomiting. 10 times. Seen in ER. Received IV fluids, zofran.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Headache, Nausea, Pain
Clinical narrative: After receiving the vaccine I startedfeelng naseated, running fever, body started aching really bad. I had chills and a very bad headache for days. The fever and chills lasted 3 days. My temps was 102.4.Also, I couldn't write, it seems like i couldn't remember how.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: After receiving the vaccine I startedfeelng naseated, running fever, body started aching really bad. I had chills and a very bad headache for days. The fever and chills lasted 3 days. My temps was 102.4.Also, I couldn't write, it seems like i couldn't remember how.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pain
Clinical narrative: described a painful, silver dollar-sized blister popping up on his left calf approximately one week after his second COVID-19 vaccine. Then a second blister appeared on the right calf within a few days. He went to his primary care provider and they treated it but did not make a connection to the vaccine. It wasn't until a couple weeks later when his (adult) son got his second COVID-19 vaccine and had the exact same large blister appear on one of his calves that they made the connection to the vaccine. Obviously a genetic component here that someone needs to look at.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Chest pain, Chills, Headache, Hyperhidrosis
Clinical narrative: Pain in my entire left side. Left ovary aching, chest pain. Low grade fever, headaches,  violent chills and sweats for 2 days
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pain in my entire left side. Left ovary aching, chest pain. Low grade fever, headaches,  violent chills and sweats for 2 days
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Dizziness, Ear infection, Middle ear inflammation, Paraesthesia
Clinical narrative: Vertigo and dizziness the weeks following second dose, acute sialadenitis (resolved with Augmentin), tingling, ear infection and loss of hearing in left ear for 48 hours (treated with antibiotic)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sialoadenitis, Vertigo
Clinical narrative: Vertigo and dizziness the weeks following second dose, acute sialadenitis (resolved with Augmentin), tingling, ear infection and loss of hearing in left ear for 48 hours (treated with antibiotic)
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Disruption in menstrual cycle.   Multiple periods in one month.  Extremely heavy menstruation with cramping.  All out of character of usual cycle.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Fatigue
Clinical narrative: Extreme fatigue and terrible depression., 3 weeks after 1st shot.   Lasted over 3 months especially fatigue.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Mammogram abnormal, Ultrasound scan
Clinical narrative: DVT (arm) follow by abnormal mammogram
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Injection site mass, Injection site rash, Injection site warmth, Pruritus
Clinical narrative: mass below injection site that was warm and then devolved into a minor rash in addition on the date mentioned (June 11th, 2021) both palms have ichy blisters that are under the skin much like a contact dermatitis. - No formal diagnosis at this time
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Later Sunday June 13th arm was sore and was very tired. In the middle of the night of Sunday/ early Monday morning he woke up feeling horrible. Dizzy, nauseated, body hurt, sweating then the chills. No fever. All Monday he slept on and off waking up feeling nauseous, weak, dizzy, having chills to sweating. Monday evening started throwing up fluids. Has had no appetite. Tried to eat a piece of bread, threw it up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis, Nausea, Pain, Pain in extremity
Clinical narrative: Later Sunday June 13th arm was sore and was very tired. In the middle of the night of Sunday/ early Monday morning he woke up feeling horrible. Dizzy, nauseated, body hurt, sweating then the chills. No fever. All Monday he slept on and off waking up feeling nauseous, weak, dizzy, having chills to sweating. Monday evening started throwing up fluids. Has had no appetite. Tried to eat a piece of bread, threw it up.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Vomiting
Clinical narrative: Later Sunday June 13th arm was sore and was very tired. In the middle of the night of Sunday/ early Monday morning he woke up feeling horrible. Dizzy, nauseated, body hurt, sweating then the chills. No fever. All Monday he slept on and off waking up feeling nauseous, weak, dizzy, having chills to sweating. Monday evening started throwing up fluids. Has had no appetite. Tried to eat a piece of bread, threw it up.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Computerised tomogram, Eye disorder, Facial spasm, Head discomfort
Clinical narrative: Severe shaking that begin immediately along with spasm and anxiety.lower face and mouth spasm.neck very strong.arms woukd not stop shaking.hypertension.vision change not eyesfront of head brain pressure
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Hypertension, Immediate post-injection reaction, Muscle spasms, Tremor, Visual impairment
Clinical narrative: Severe shaking that begin immediately along with spasm and anxiety.lower face and mouth spasm.neck very strong.arms woukd not stop shaking.hypertension.vision change not eyesfront of head brain pressure
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Grip strength decreased, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Ever since receiving the vaccine, two months ago now, my left arm has had chronic pain usually radiating out from the injection site but sometimes spreading across my entire shoulder and down to my elbow. I also have quite a bit of pain depending on the motion I try to take and a fairly regular (and worsening) throbbing sensation around where the injection was. - I also regularly feel like I have no strength in my left arm/grip and it?s gotten to the point where it?s now affecting daily life.  Some days, the area around the site swells up and I feel a burning sensation instead of a painful pulsing or throbbing  Painkillers (ibuprofen) don?t seem to help very much though and sometimes I?ll wake up in the middle of the night from rolling onto my left arm and causing the pain to intensify.  I?m not sure if the pain is truly a side effect of the vaccine or if the volunteer performing the vaccine did something wrong when administering it.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Sleep disorder
Clinical narrative: Ever since receiving the vaccine, two months ago now, my left arm has had chronic pain usually radiating out from the injection site but sometimes spreading across my entire shoulder and down to my elbow. I also have quite a bit of pain depending on the motion I try to take and a fairly regular (and worsening) throbbing sensation around where the injection was. - I also regularly feel like I have no strength in my left arm/grip and it?s gotten to the point where it?s now affecting daily life.  Some days, the area around the site swells up and I feel a burning sensation instead of a painful pulsing or throbbing  Painkillers (ibuprofen) don?t seem to help very much though and sometimes I?ll wake up in the middle of the night from rolling onto my left arm and causing the pain to intensify.  I?m not sure if the pain is truly a side effect of the vaccine or if the volunteer performing the vaccine did something wrong when administering it.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Mobility decreased
Clinical narrative: Severe fatigue and weakness, headache, general muscle ache, fever, lack of appetite Unable to function -  5 days in duration
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Severe fatigue and weakness, headache, general muscle ache, fever, lack of appetite Unable to function -  5 days in duration
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration
Clinical narrative: 20 minutes after getting my 2nd vaccine my left arm and hand began hurting and my left hand and fingers turned  blue for  about 40 minutes and it was very painful. I took pictures of it and after when my hand went back to normal
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hypertension
Clinical narrative: high blood pressure averaging 170/100 constantly daily with chest pain, prior to vaccine average 130/76.  Placed on Losartan 25 mg, 2t Qam and 1 t pm - not working
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Lymph node pain, Lymphadenopathy, Muscular weakness, Pain
Clinical narrative: Swollen and painful axillary lymph nodes- swollen to size of a quarter. Muscle weakness and loss of mobility in vaccinated arm. Joint pain. Shooting pain. Spinal pain.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain
Clinical narrative: Swollen and painful axillary lymph nodes- swollen to size of a quarter. Muscle weakness and loss of mobility in vaccinated arm. Joint pain. Shooting pain. Spinal pain.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Deep Vein Thrombosis, left leg
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Balance disorder, Blood folate normal, Blood magnesium normal, Blood test
Clinical narrative: Paraesthesia, in the form of prickling sensations on the skin, began one week after injection (04/25/2021). It occurred randomly and sporadically across my whole body, but most commonly in the legs. This symptom has continued (intermittently) up to the time of this reporting.  Roughly two weeks after injection (05/01/2021), intermittent muscle weakness and vertigo began. The muscle weakness was primarily in my legs and arms, on both sides, and created a sensation that the limbs were limp/floppy or that the hand/foot was unusually heavy. What I describe as vertigo was not dizziness or the perception of spinning, but rather a sensation of being off-balance or having an unsteady head. When present, the vertigo was triggered by motion of the head (e.g. the motions caused by walking). The muscle weakness is generally worse at night. The vertigo had ceased by 05/30; muscle weakness eventually became persistent, and continues up to the time of this reporting.  An additional symptom that eventually appeared is occasional tensing and soreness of various muscle groups in the legs and arms, as if they have been intensely exercised (but they have in fact not been exercised). This also continues up to the time of this reporting.  On the night of 05/14 through the morning of 05/15, I experienced exceptionally serious muscle weakness and vertigo. The vertigo made it nearly impossible to go to sleep, because the beginning of sleep would trigger a sensation of falling that would cause me to immediately awaken. In the morning, my calf muscles were so weak that it could be difficult to stand up for more than a few minutes at a time, and they would sometimes shake with the effort. These symptoms gradually improved over the course of the following day.  I had additional "attacks" on the night of 5/20 through the morning of 05/21, and the night of 05/29 through the morning of 05/30. Again, these led to serious leg weakness that improved gradually during the subsequent day. A persistent low level of leg muscle weakness eventually developed.  On 06/14 I began an attempted treatment with a 10-day prednisone course. Outcome still future and therefore unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Computerised tomogram normal, Discomfort, Dysstasia, Hypotonia
Clinical narrative: Paraesthesia, in the form of prickling sensations on the skin, began one week after injection (04/25/2021). It occurred randomly and sporadically across my whole body, but most commonly in the legs. This symptom has continued (intermittently) up to the time of this reporting.  Roughly two weeks after injection (05/01/2021), intermittent muscle weakness and vertigo began. The muscle weakness was primarily in my legs and arms, on both sides, and created a sensation that the limbs were limp/floppy or that the hand/foot was unusually heavy. What I describe as vertigo was not dizziness or the perception of spinning, but rather a sensation of being off-balance or having an unsteady head. When present, the vertigo was triggered by motion of the head (e.g. the motions caused by walking). The muscle weakness is generally worse at night. The vertigo had ceased by 05/30; muscle weakness eventually became persistent, and continues up to the time of this reporting.  An additional symptom that eventually appeared is occasional tensing and soreness of various muscle groups in the legs and arms, as if they have been intensely exercised (but they have in fact not been exercised). This also continues up to the time of this reporting.  On the night of 05/14 through the morning of 05/15, I experienced exceptionally serious muscle weakness and vertigo. The vertigo made it nearly impossible to go to sleep, because the beginning of sleep would trigger a sensation of falling that would cause me to immediately awaken. In the morning, my calf muscles were so weak that it could be difficult to stand up for more than a few minutes at a time, and they would sometimes shake with the effort. These symptoms gradually improved over the course of the following day.  I had additional "attacks" on the night of 5/20 through the morning of 05/21, and the night of 05/29 through the morning of 05/30. Again, these led to serious leg weakness that improved gradually during the subsequent day. A persistent low level of leg muscle weakness eventually developed.  On 06/14 I began an attempted treatment with a 10-day prednisone course. Outcome still future and therefore unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Intervertebral disc degeneration, Magnetic resonance imaging, Mean cell haemoglobin, Mean cell volume abnormal, Metabolic function test normal
Clinical narrative: Paraesthesia, in the form of prickling sensations on the skin, began one week after injection (04/25/2021). It occurred randomly and sporadically across my whole body, but most commonly in the legs. This symptom has continued (intermittently) up to the time of this reporting.  Roughly two weeks after injection (05/01/2021), intermittent muscle weakness and vertigo began. The muscle weakness was primarily in my legs and arms, on both sides, and created a sensation that the limbs were limp/floppy or that the hand/foot was unusually heavy. What I describe as vertigo was not dizziness or the perception of spinning, but rather a sensation of being off-balance or having an unsteady head. When present, the vertigo was triggered by motion of the head (e.g. the motions caused by walking). The muscle weakness is generally worse at night. The vertigo had ceased by 05/30; muscle weakness eventually became persistent, and continues up to the time of this reporting.  An additional symptom that eventually appeared is occasional tensing and soreness of various muscle groups in the legs and arms, as if they have been intensely exercised (but they have in fact not been exercised). This also continues up to the time of this reporting.  On the night of 05/14 through the morning of 05/15, I experienced exceptionally serious muscle weakness and vertigo. The vertigo made it nearly impossible to go to sleep, because the beginning of sleep would trigger a sensation of falling that would cause me to immediately awaken. In the morning, my calf muscles were so weak that it could be difficult to stand up for more than a few minutes at a time, and they would sometimes shake with the effort. These symptoms gradually improved over the course of the following day.  I had additional "attacks" on the night of 5/20 through the morning of 05/21, and the night of 05/29 through the morning of 05/30. Again, these led to serious leg weakness that improved gradually during the subsequent day. A persistent low level of leg muscle weakness eventually developed.  On 06/14 I began an attempted treatment with a 10-day prednisone course. Outcome still future and therefore unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Muscular weakness, Myalgia, Myoclonus, Paraesthesia
Clinical narrative: Paraesthesia, in the form of prickling sensations on the skin, began one week after injection (04/25/2021). It occurred randomly and sporadically across my whole body, but most commonly in the legs. This symptom has continued (intermittently) up to the time of this reporting.  Roughly two weeks after injection (05/01/2021), intermittent muscle weakness and vertigo began. The muscle weakness was primarily in my legs and arms, on both sides, and created a sensation that the limbs were limp/floppy or that the hand/foot was unusually heavy. What I describe as vertigo was not dizziness or the perception of spinning, but rather a sensation of being off-balance or having an unsteady head. When present, the vertigo was triggered by motion of the head (e.g. the motions caused by walking). The muscle weakness is generally worse at night. The vertigo had ceased by 05/30; muscle weakness eventually became persistent, and continues up to the time of this reporting.  An additional symptom that eventually appeared is occasional tensing and soreness of various muscle groups in the legs and arms, as if they have been intensely exercised (but they have in fact not been exercised). This also continues up to the time of this reporting.  On the night of 05/14 through the morning of 05/15, I experienced exceptionally serious muscle weakness and vertigo. The vertigo made it nearly impossible to go to sleep, because the beginning of sleep would trigger a sensation of falling that would cause me to immediately awaken. In the morning, my calf muscles were so weak that it could be difficult to stand up for more than a few minutes at a time, and they would sometimes shake with the effort. These symptoms gradually improved over the course of the following day.  I had additional "attacks" on the night of 5/20 through the morning of 05/21, and the night of 05/29 through the morning of 05/30. Again, these led to serious leg weakness that improved gradually during the subsequent day. A persistent low level of leg muscle weakness eventually developed.  On 06/14 I began an attempted treatment with a 10-day prednisone course. Outcome still future and therefore unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Scoliosis, Sleep disorder, Thyroxine normal, Tremor, Vertigo
Clinical narrative: Paraesthesia, in the form of prickling sensations on the skin, began one week after injection (04/25/2021). It occurred randomly and sporadically across my whole body, but most commonly in the legs. This symptom has continued (intermittently) up to the time of this reporting.  Roughly two weeks after injection (05/01/2021), intermittent muscle weakness and vertigo began. The muscle weakness was primarily in my legs and arms, on both sides, and created a sensation that the limbs were limp/floppy or that the hand/foot was unusually heavy. What I describe as vertigo was not dizziness or the perception of spinning, but rather a sensation of being off-balance or having an unsteady head. When present, the vertigo was triggered by motion of the head (e.g. the motions caused by walking). The muscle weakness is generally worse at night. The vertigo had ceased by 05/30; muscle weakness eventually became persistent, and continues up to the time of this reporting.  An additional symptom that eventually appeared is occasional tensing and soreness of various muscle groups in the legs and arms, as if they have been intensely exercised (but they have in fact not been exercised). This also continues up to the time of this reporting.  On the night of 05/14 through the morning of 05/15, I experienced exceptionally serious muscle weakness and vertigo. The vertigo made it nearly impossible to go to sleep, because the beginning of sleep would trigger a sensation of falling that would cause me to immediately awaken. In the morning, my calf muscles were so weak that it could be difficult to stand up for more than a few minutes at a time, and they would sometimes shake with the effort. These symptoms gradually improved over the course of the following day.  I had additional "attacks" on the night of 5/20 through the morning of 05/21, and the night of 05/29 through the morning of 05/30. Again, these led to serious leg weakness that improved gradually during the subsequent day. A persistent low level of leg muscle weakness eventually developed.  On 06/14 I began an attempted treatment with a 10-day prednisone course. Outcome still future and therefore unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vitamin B12 abnormal
Clinical narrative: Paraesthesia, in the form of prickling sensations on the skin, began one week after injection (04/25/2021). It occurred randomly and sporadically across my whole body, but most commonly in the legs. This symptom has continued (intermittently) up to the time of this reporting.  Roughly two weeks after injection (05/01/2021), intermittent muscle weakness and vertigo began. The muscle weakness was primarily in my legs and arms, on both sides, and created a sensation that the limbs were limp/floppy or that the hand/foot was unusually heavy. What I describe as vertigo was not dizziness or the perception of spinning, but rather a sensation of being off-balance or having an unsteady head. When present, the vertigo was triggered by motion of the head (e.g. the motions caused by walking). The muscle weakness is generally worse at night. The vertigo had ceased by 05/30; muscle weakness eventually became persistent, and continues up to the time of this reporting.  An additional symptom that eventually appeared is occasional tensing and soreness of various muscle groups in the legs and arms, as if they have been intensely exercised (but they have in fact not been exercised). This also continues up to the time of this reporting.  On the night of 05/14 through the morning of 05/15, I experienced exceptionally serious muscle weakness and vertigo. The vertigo made it nearly impossible to go to sleep, because the beginning of sleep would trigger a sensation of falling that would cause me to immediately awaken. In the morning, my calf muscles were so weak that it could be difficult to stand up for more than a few minutes at a time, and they would sometimes shake with the effort. These symptoms gradually improved over the course of the following day.  I had additional "attacks" on the night of 5/20 through the morning of 05/21, and the night of 05/29 through the morning of 05/30. Again, these led to serious leg weakness that improved gradually during the subsequent day. A persistent low level of leg muscle weakness eventually developed.  On 06/14 I began an attempted treatment with a 10-day prednisone course. Outcome still future and therefore unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test normal, Differential white blood cell count normal, Dyspnoea, Electrocardiogram normal
Clinical narrative: 1 week after shot. Sore chest muscles, ear ringing, severe anxiety, winded easily, racing heart, heart palpitations, fast pulse with minimal activity. Waking in night with rapid pulse 140BPM, resting pulse between 90-110.  Headache, severe muscle aches and night sweats.  These severe symptoms lasted two weeks. Symptoms slowly have been subsiding, but it took nearly two months. Still have a slightly elevated resting heart rate. Other than that, feel fully recovered. Very scary experience! Grateful to be vaccinated though.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Headache, Heart rate increased, Metabolic function test, Myalgia
Clinical narrative: 1 week after shot. Sore chest muscles, ear ringing, severe anxiety, winded easily, racing heart, heart palpitations, fast pulse with minimal activity. Waking in night with rapid pulse 140BPM, resting pulse between 90-110.  Headache, severe muscle aches and night sweats.  These severe symptoms lasted two weeks. Symptoms slowly have been subsiding, but it took nearly two months. Still have a slightly elevated resting heart rate. Other than that, feel fully recovered. Very scary experience! Grateful to be vaccinated though.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Palpitations, Tinnitus, Vitamin D
Clinical narrative: 1 week after shot. Sore chest muscles, ear ringing, severe anxiety, winded easily, racing heart, heart palpitations, fast pulse with minimal activity. Waking in night with rapid pulse 140BPM, resting pulse between 90-110.  Headache, severe muscle aches and night sweats.  These severe symptoms lasted two weeks. Symptoms slowly have been subsiding, but it took nearly two months. Still have a slightly elevated resting heart rate. Other than that, feel fully recovered. Very scary experience! Grateful to be vaccinated though.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Vertigo with occasional headache
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Hypoaesthesia
Clinical narrative: Heart flutters, chest discomfort, and numbness left side of face
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound breast
Clinical narrative: Developed a Mondor's cord in the left breast on the same side as the shot as well as swollen lymph nodes in the left armpit. After palpation, doctor ordered a diagnostic mammogram and ultrasound to confirm the suspected thrombophlebitis diagnosis. Given topical NSAID for a month. Ultrasound repeated and cord and node swelling had resolved.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: Early periods, heavy flow and tiredness because of that
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Headache, Migraine
Clinical narrative: headaches after my 2nd dose which would not respond to Tylenol or ibuprofen; Heart pain and ocular migraine; Heart pain; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Latex allergy and Drug allergy (Allergy to Bactrim (Sulfamethoxazole And Trimethoprim)).   On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGINA PECTORIS (Heart pain) (seriousness criterion medically significant). On 25-May-2021, the patient experienced MIGRAINE (Heart pain and ocular migraine). On an unknown date, the patient experienced HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 31-May-2021, ANGINA PECTORIS (Heart pain) had resolved. At the time of the report, MIGRAINE (Heart pain and ocular migraine) was resolving and HEADACHE (headaches after my 2nd dose which would not respond to Tylenol or ibuprofen) outcome was unknown.            No concomitant medicines were reported. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; VARlVAX by the intramuscular route instead of subcutaneous; This non-valid spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 29-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T012552, expiration date 10-APR-2021 for prophylaxis. The vaccine was administered intramuscularly instead of subcutaneously (incorrect route of product administration). No adverse event was reported.  This is a non-valid case due to the lack of patient identifiers.  Follow-up information was received from a nurse on 12-MAY-2021. The patient's identifiers were provided: the patient was a 21-year-old male. He was vaccinated in the right deltoid.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion on PROQUAD; This spontaneous report has been received from a medical assistant referring to a 12 months old patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported.    On 10-MAY-2021, the patient was vaccinated with temperature excursion dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, route of administration and anatomical location were not provided, lot number U002535 has been verified to be a valid lot number, expiration date reported as 24-JUL-2022) for prophylaxis (product storage error). The vaccine underwent temperature excursion at -10.8 degree Celsius (C) for 1 hours 45 minutes. It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2105USA003786: US-009507513-2105USA004015: US-009507513-2106USA001126:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE/ PQC reported at this time.; Improper storage of product in use; This spontaneous report was received from other health care professional and refers to a 6-week-old patient of unknown gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.     On 24-MAY-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1741376, which has been verified to be valid, the expiration date was reported and validated 06-MAR-2022), as prophylaxis (product storage error) (strength, dose, dose number, and route of administration were not provided).    The suspect vaccine was exposed to a temperature of 36 to 46 degrees Fahrenheit (F) (48.2 degrees F) for a time frame of 0 hours 15 minutes 0 seconds, as recorded by digital data logger. There was a previous temperature excursion reported of 36 to 46 degrees Fahrenheit (F) (46.2 degrees F) for a time frame of 0 hours 15 minutes 0 seconds. No additional adverse event were reported.  This is one of several report received from the same reporter.; Sender's Comments:  US-009507513-2106USA000988:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; During the temperature excursion evaluation it was discovered that V ARlV AX had been administered to a patient on; This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. Pertinent information regarding the patient's concurrent conditions, medical history or concomitant medications was not provided.  On 28-MAY-2021 the patient was administered improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot number T028306 and expiration date 20-AUG-2022) (dose number, route of administration, anatomical location, vaccination scheme was not reported) as prophylaxis. The involved vaccine underwent a temperature excursion of -12.3 degrees Celsius (°C) for 56 minutes. There was no previous temperature excursion reported.  This information was due to a data logger. No additional adverse events were reported. The outcome of the events was unknown.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other AE.; The customer said the patient will come back "soon" to receive the 3rd dose of GARDASIL 9, but the dose was not given yesterday as scheduled.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On an unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (formulation, exact dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).  On 02-JUN-2021 (reported as "yesterday"), the patient was supposed to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), but the dose was not given as scheduled because just received the COVID 19 vaccine 1 week ago, so the patient said that would come back "soon" to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No other adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose schedule was interrupted / The patient received first dose of GARDASIL 9 on 12/12/2020 and the patient is in the pharmacy now to get the second dose but did not get the dose yet.; This spontaneous report was received from a pharmacist referring to a patient of unspecified age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 12-DEC-2020, 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) (strength, dose, route of administration, lot number, and expiration date was not reported) for prophylaxis.  The reporter mentioned that the patient's hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose schedule was interrupted and that on 07-JUN-2021, also reported as "now", the patient was in the pharmacy to get the second dose but did not get the dose yet. No product quality complaint and no further information was available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO additional AE; adverse event of expired VAQTA, with an expiration date of 6/4/2021, which was inadvertently administered on 6/7/2021; This spontaneous report was received from a medical assistant, referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 07-JUN-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml injection (route of administration and anatomical location were not reported; lot number T008698 has been verified to be a valid lot number, expiration date 04-JUN-2021) for prophylaxis. The hepatitis a vaccine, inactivated (VAQTA) did not undergone any temperature excursion. No additional adverse effect was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: An MMR vaccine was administered to a patient today, and she received her Variax 24 hours ago; This spontaneous report was received from a pharmacist regarding a 30-year-old female patient.  Information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was unknown by the reporter.  On 06-JUN-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), and on 07-JUN-2021, she was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), both of them subcutaneously for prophylaxis (dose, lot number and expiration date were unknown by the reporter; vaccination scheme and anatomical location of administration were not reported) (inappropriate schedule of product administration).