chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: PASSED OUT; TIGHTNESS IN CHEST; SWELLING IN RIGHT LEG AND RIGHT CALF; DIZZINESS; NAUSEA; STOMACH PAIN; LEG CRAMPS; FOOT PINS AND NEEDLES; LEG PAIN; CHILLS; FEVER; NIGHT SWEATS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, one total, administered to the left arm on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced night sweats, chills, fever and leg pain. On 30-MAR-2021, the patient experienced leg cramps, stomach pain and foot pins and needles. On 08-APR-2021, the patient experienced swelling in right leg and right calf, tightness in chest, dizziness, nausea and patient passed out The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 08-APR-2021, and night sweats, chills, and fever on 26-MAR-2021, and had not recovered from leg pain, stomach pain, foot pins and needles, swelling in right leg and right calf, tightness in chest, dizziness, nausea, and leg cramps. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s -Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Musculoskeletal discomfort, Musculoskeletal stiffness, Pain
Clinical narrative: Started having Stiff neck and Stiff shoulder since 4/22/2021. Unable to work or manage pain. Not able to sleep because of pain and unable to find a posture that can help relive pain. Was taking Advil and Tylenol continuously, but of no use. Started taking the TiZANdine 2mg from 4/23/2021 but no change in pain. Been to Physician's office on 4/27/2021. Doctor tried to change prescription to GABAPENTIN 100mg.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Fatigue, Headache, Injection site pain
Clinical narrative: Sore arm at site of the injection, extreme nausea, loss of appetite, feeling feverish, coughing, headache, sore throat, nasal congestion, achy, fatigue, and generally not feeling well for  5 days so far.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Sore arm at site of the injection, extreme nausea, loss of appetite, feeling feverish, coughing, headache, sore throat, nasal congestion, achy, fatigue, and generally not feeling well for  5 days so far.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm at site of the injection, extreme nausea, loss of appetite, feeling feverish, coughing, headache, sore throat, nasal congestion, achy, fatigue, and generally not feeling well for  5 days so far.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Tinnitus
Clinical narrative: Dizziness/Body swaying/nausea/Tinnitus.  I have been dizzy for over a week now with occasional nausea and I have mild ringing in my ears as well. Ringing hasn't stopped. Dizziness/nausea comes and goes, but happens daily.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain and a redness at injection site that has spread down the better part of my upper arm. My doctor requested to see me  I was seen at on 4/27-they said it was Covid arm. I was told to ice it, take tylenol or advil for the pain and to monitor my symptoms. I was advised to call or go to urgent care if it gets worse, doesn't get better or I develop anymore symptoms such as a fever, chills etc
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin
Clinical narrative: Patient received vaccination on 4/22 and started developing chest pain on 4/24. patient presented to the Emergency Department on 4/25 and was evaluated and found to have a troponin of 1500 and was diagnosed with myocarditis. The source is unknown at this point but may be related to the vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Cardiac imaging procedure abnormal, Chest pain, Echocardiogram, Electrocardiogram ST segment elevation
Clinical narrative: Patient received vaccination on 4/22 and started developing chest pain on 4/24. patient presented to the Emergency Department on 4/25 and was evaluated and found to have a troponin of 1500 and was diagnosed with myocarditis. The source is unknown at this point but may be related to the vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Myocarditis, Pyrexia, Troponin T increased, Ventricular extrasystoles
Clinical narrative: Patient received vaccination on 4/22 and started developing chest pain on 4/24. patient presented to the Emergency Department on 4/25 and was evaluated and found to have a troponin of 1500 and was diagnosed with myocarditis. The source is unknown at this point but may be related to the vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Patient received vaccination on 4/22 and started developing chest pain on 4/24. patient presented to the Emergency Department on 4/25 and was evaluated and found to have a troponin of 1500 and was diagnosed with myocarditis. The source is unknown at this point but may be related to the vaccine.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Deep vein thrombosis
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Headache, Hypoaesthesia
Clinical narrative: I had a rash from the shot and an immediate headache in my temple right above my eye. I started to get Migraines which became very painful four days after the vaccine. I had to go to the ER because the pain was so bad one day that I almost passed out. It is a much different pain than my normal Migraines my left arm and leg were numb. I have been getting Migraines daily for five weeks now. I have been trying to control my diet and switched medication in an effort to control the Migraines. The medication helps a little if I take it early. I also still get a little of the numbness in the left side of my body. All services provided by insurance company.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Migraine, Rash
Clinical narrative: I had a rash from the shot and an immediate headache in my temple right above my eye. I started to get Migraines which became very painful four days after the vaccine. I had to go to the ER because the pain was so bad one day that I almost passed out. It is a much different pain than my normal Migraines my left arm and leg were numb. I have been getting Migraines daily for five weeks now. I have been trying to control my diet and switched medication in an effort to control the Migraines. The medication helps a little if I take it early. I also still get a little of the numbness in the left side of my body. All services provided by insurance company.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Red swollen arm , warm to touch
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Pyrexia
Clinical narrative: headache, chest pain, fever/chills
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: chills, fatigue, weak, nausea, vomit, diarrhea
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills, fatigue, weak, nausea, vomit, diarrhea
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Magnetic resonance imaging, Tinnitus, Ultrasound scan, Weight decreased
Clinical narrative: SEVERE TINNITUS ATTACK OF RIGHT EAR; LOST 15-20 LBS IN TWO WEEKS; DID NOT SLEEP FOR THREE WEEKS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included tinnitus, and hearing loss.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced severe tinnitus attack of right ear. On an unspecified date, the subject experienced lost 15-20 lbs in two weeks, and did not sleep for three weeks. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) Negative, and MRI (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost 15-20 lbs in two weeks, had not recovered from severe tinnitus attack of right ear, and the outcome of did not sleep for three weeks was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue
Clinical narrative: Vaccinator informed lead PHN  vaccine had spilled when administering  Moderna COVID vaccine (lot # 016C21A, expires 5/22/2021) to client. Per LVN , vaccine spilled from needle hub where it connects to syringe when she had already penetrated client's left arm. Vaccine spilled down clients arm. LVN   disposed  of sharp. PHN contacted supervisor authorized to give new dose on right arm.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Paraesthesia, Tinnitus
Clinical narrative: Noticed ringing in my ear the second day following the 2nd dose. It has continued at the same level since.  Only notice when room quiet or I think about it.  I also experienced arm pain at the injection site and was extremely tired for 3 days following both doses.  I also had a few instances of dizziness that were mild and tingling in my hand fingers in the arm of the injection.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1ST DOSE TO 2ND DOSE PFIZERS 14 DAYS APART
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Pallor
Clinical narrative: 5 minutes after vaccination, flushing/sweating, pallor, diaphoretic, dizziness. Patient stable, released from vaccination site.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, Swelling, Urticaria
Clinical narrative: Developed a rash/hives on the right inside and outside elbow area within the first 24 hrs approximately. By Sunday evening, I also had a rash on the back of my right bicep area. The rash is raised bumps which appear to be similar to a blister. On Monday, the rash became more severe on my inner elbow area with severe itching. On Tuesday morning, I also had a small rash/blisters on my left inner forearm. On Tuesday, 4/27 I did go to my family doctor and was diagnosed with hives and being treated with Famotidine and Zyrtec.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site infection, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelled, became warm to touch.  The swelling and red spread across my whole arm. 4/9 was diagnosed with an infection at the injection site. Was put on antibiotics- Cephalex 500mg ever 12 hours for 10 days.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: Moderna Vac on a thursday .. 4 days later woke up enlarged lymph nodes on right side of body. Neck, under arm.... 5 days after that I had red bulging lymph on my groin..  uncomfortable for over 10 days now much better. Reported to my Doc n then went to urgent care ... neither of them could produce any explanation..
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes virus test, Vulval ulceration
Clinical narrative: LABIAL ULCERS; This spontaneous report received from a health care professional concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included Covid, and concurrent conditions included alcohol user, non smoker, and marijuana abuse, and other pre-existing medical conditions included the patient had no known drug allergy. the patient was not pregnant at time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A,expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced labial ulcers. Laboratory data included: Herpes virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from labial ulcers. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chest X-ray, Chest pain, Fibrin D dimer, Full blood count
Clinical narrative: Patient is 44-year-old Male, to the emergency department for evaluation of left sided chest/rib pain.  Onset: Last night. Aggravated with movement and deep inspiration.  No other associated symptoms.  Saw primary doctor today in which she had a chest x-ray notable for trace left pleural effusion.  In addition had blood work notable for nonelevated dimer
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Liver function test, Musculoskeletal chest pain, Pleural effusion
Clinical narrative: Patient is 44-year-old Male, to the emergency department for evaluation of left sided chest/rib pain.  Onset: Last night. Aggravated with movement and deep inspiration.  No other associated symptoms.  Saw primary doctor today in which she had a chest x-ray notable for trace left pleural effusion.  In addition had blood work notable for nonelevated dimer
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray abnormal, Chest pain, Computerised tomogram normal, Electrocardiogram
Clinical narrative: Patient is 44-year-old Male, to the emergency department for evaluation of left sided chest/rib pain.  Onset: Last night. Aggravated with movement and deep inspiration.  No other associated symptoms.  Saw primary doctor today in which she had a chest x-ray notable for trace left pleural effusion.  In addition had blood work notable for nonelevated dimer
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pleural effusion
Clinical narrative: Patient is 44-year-old Male, to the emergency department for evaluation of left sided chest/rib pain.  Onset: Last night. Aggravated with movement and deep inspiration.  No other associated symptoms.  Saw primary doctor today in which she had a chest x-ray notable for trace left pleural effusion.  In addition had blood work notable for nonelevated dimer
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Feeling abnormal, Headache
Clinical narrative: Flu-like.  Extreme fatigue, headache, no appetite, intestinal distress, brain fog
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like.  Extreme fatigue, headache, no appetite, intestinal distress, brain fog
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Limb discomfort, Nausea
Clinical narrative: nausea, diarrhea, fever, severe stomach cramping that lasted a 8 days, 3 weeks later had tingling neuropathy return to my legs, fatigue
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral, Paraesthesia, Pyrexia
Clinical narrative: nausea, diarrhea, fever, severe stomach cramping that lasted a 8 days, 3 weeks later had tingling neuropathy return to my legs, fatigue
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Irritability, Malaise
Clinical narrative: I received my vaccine in the left arm in the mid-afternoon on Sunday and experienced little discomfort the rest of the day with some soreness in the arm before bed.  The following morning i felt unwell and my arm was extremely sore.  It took some focus and energy to move.  I took 500 mg acetaminophen 3x  and Ondansetron 1x over the day due to feeling nauseous, low-grade headache, tiredness and a general feeling of being unwell.  I felt noticeably irritable.  My arm was sore to the touch and in the late afternoon i noticed i had a mild rash across the back of my arm  starting below my deltoid muscle and spread out and down close to my elbow.  It was not a bright red but the area was remarkably sensitive, so much so that i felt i should report the reaction because ive never had a noticeable reaction to a vaccine so i became mildly alarmed.   I put no creams on the rash nor did i take additional meds.  The following day (today) it has decreased significantly in sensitivity and has faded so much so that if you don't look for it, you cant easily see it.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: I received my vaccine in the left arm in the mid-afternoon on Sunday and experienced little discomfort the rest of the day with some soreness in the arm before bed.  The following morning i felt unwell and my arm was extremely sore.  It took some focus and energy to move.  I took 500 mg acetaminophen 3x  and Ondansetron 1x over the day due to feeling nauseous, low-grade headache, tiredness and a general feeling of being unwell.  I felt noticeably irritable.  My arm was sore to the touch and in the late afternoon i noticed i had a mild rash across the back of my arm  starting below my deltoid muscle and spread out and down close to my elbow.  It was not a bright red but the area was remarkably sensitive, so much so that i felt i should report the reaction because ive never had a noticeable reaction to a vaccine so i became mildly alarmed.   I put no creams on the rash nor did i take additional meds.  The following day (today) it has decreased significantly in sensitivity and has faded so much so that if you don't look for it, you cant easily see it.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Swelling
Clinical narrative: Pt reports red rash with swelling and itching starting 10 days after shot.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Eyelid disorder
Clinical narrative: Drooping eyelid
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Mobility decreased, Pain
Clinical narrative: Extremely fatigued, body aching all over & headache for 2 & 1/2 days. Felt terribly sick & couldn?t get out of bed for the 2 & 1/2 days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Differential white blood cell count normal, Dyspnoea, Eye infection
Clinical narrative: Symptoms appeared after leaving vaccination clinic, on the 3 hour drive home. Headache, shortness of breath, and severely bloodshot eyes, with eye pain. Fever spiked at 102.7 with body aches, nausea, diarrhea. Severely bloodshot eyes and eye pain did not resolve. I presented 4/11/2021 at a Urgent Care. Diagnosed with sinus and bilateral eye infections. Prescriptions  for antibiotic, 10 day course and Cipro0.3% eye drops. Completed a 10 day course of both, but the eye symptoms and headache did not resolve. Wednesday, April 21  seen in-person by eye specialist Dr. Diagnosed with eye inflammation, and prescribed prednisone 1% eye drops. After two doses the eye pain and headache began to resolve. On April 22, I hand an in-person appointment with my endocrinologist. He told me I had had an unusual allergic reaction to the vaccination. After 1st vaccination, I also had mild bloodshot and painful  eye symptoms which resolved on their own after 3 days.  Eyes are now back to normal. I am concerned about the possibility of another adverse reaction if I were to receive a COVID-19 booster shot.   No contact lenses or glasses.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Eye pain, Full blood count normal, Glycosylated haemoglobin, Headache
Clinical narrative: Symptoms appeared after leaving vaccination clinic, on the 3 hour drive home. Headache, shortness of breath, and severely bloodshot eyes, with eye pain. Fever spiked at 102.7 with body aches, nausea, diarrhea. Severely bloodshot eyes and eye pain did not resolve. I presented 4/11/2021 at a Urgent Care. Diagnosed with sinus and bilateral eye infections. Prescriptions  for antibiotic, 10 day course and Cipro0.3% eye drops. Completed a 10 day course of both, but the eye symptoms and headache did not resolve. Wednesday, April 21  seen in-person by eye specialist Dr. Diagnosed with eye inflammation, and prescribed prednisone 1% eye drops. After two doses the eye pain and headache began to resolve. On April 22, I hand an in-person appointment with my endocrinologist. He told me I had had an unusual allergic reaction to the vaccination. After 1st vaccination, I also had mild bloodshot and painful  eye symptoms which resolved on their own after 3 days.  Eyes are now back to normal. I am concerned about the possibility of another adverse reaction if I were to receive a COVID-19 booster shot.   No contact lenses or glasses.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Metabolic function test, Nausea, Ocular hyperaemia, Pain
Clinical narrative: Symptoms appeared after leaving vaccination clinic, on the 3 hour drive home. Headache, shortness of breath, and severely bloodshot eyes, with eye pain. Fever spiked at 102.7 with body aches, nausea, diarrhea. Severely bloodshot eyes and eye pain did not resolve. I presented 4/11/2021 at a Urgent Care. Diagnosed with sinus and bilateral eye infections. Prescriptions  for antibiotic, 10 day course and Cipro0.3% eye drops. Completed a 10 day course of both, but the eye symptoms and headache did not resolve. Wednesday, April 21  seen in-person by eye specialist Dr. Diagnosed with eye inflammation, and prescribed prednisone 1% eye drops. After two doses the eye pain and headache began to resolve. On April 22, I hand an in-person appointment with my endocrinologist. He told me I had had an unusual allergic reaction to the vaccination. After 1st vaccination, I also had mild bloodshot and painful  eye symptoms which resolved on their own after 3 days.  Eyes are now back to normal. I am concerned about the possibility of another adverse reaction if I were to receive a COVID-19 booster shot.   No contact lenses or glasses.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, Sinusitis
Clinical narrative: Symptoms appeared after leaving vaccination clinic, on the 3 hour drive home. Headache, shortness of breath, and severely bloodshot eyes, with eye pain. Fever spiked at 102.7 with body aches, nausea, diarrhea. Severely bloodshot eyes and eye pain did not resolve. I presented 4/11/2021 at a Urgent Care. Diagnosed with sinus and bilateral eye infections. Prescriptions  for antibiotic, 10 day course and Cipro0.3% eye drops. Completed a 10 day course of both, but the eye symptoms and headache did not resolve. Wednesday, April 21  seen in-person by eye specialist Dr. Diagnosed with eye inflammation, and prescribed prednisone 1% eye drops. After two doses the eye pain and headache began to resolve. On April 22, I hand an in-person appointment with my endocrinologist. He told me I had had an unusual allergic reaction to the vaccination. After 1st vaccination, I also had mild bloodshot and painful  eye symptoms which resolved on their own after 3 days.  Eyes are now back to normal. I am concerned about the possibility of another adverse reaction if I were to receive a COVID-19 booster shot.   No contact lenses or glasses.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Acute hepatic failure, Alanine aminotransferase increased, Aspartate aminotransferase increased, Biopsy bone marrow normal, Blood alkaline phosphatase increased
Clinical narrative: Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Death, Fatigue, Fibrin D dimer increased, Haemoglobin decreased
Clinical narrative: Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Haemophagocytic lymphohistiocytosis, Hyperferritinaemia, Platelet count decreased, Pneumonia legionella, Pruritus
Clinical narrative: Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Serum ferritin increased, Sleep disorder, T-lymphocyte count increased, Transaminases increased
Clinical narrative: Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyelonephritis
Clinical narrative: Patient admitted for pyelonephritis 2 months after her COVID vaccine.  Likely unrelated
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Fatigue, Headache, Nausea
Clinical narrative: HEADACHE; ANXIETY ATTACK; VOMITING; CHILLS; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included radioactive iodine, and concurrent conditions included penicillin allergy, graves disease, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced anxiety attack. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety attack on 12-APR-2021, vomiting, chills, and nausea on 10-APR-2021, and fatigue on 11-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: MAC; V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: HEADACHE; ANXIETY ATTACK; VOMITING; CHILLS; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included radioactive iodine, and concurrent conditions included penicillin allergy, graves disease, and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced anxiety attack. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety attack on 12-APR-2021, vomiting, chills, and nausea on 10-APR-2021, and fatigue on 11-APR-2021, and had not recovered from headache. This report was non-serious.; Sender's Comments: MAC; V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Dyspnoea, Heart rate, Nausea
Clinical narrative: She started having the following symptoms about 30 minutes after the vaccine administration: Anxiety, shortness of breath, nausea. Her blood pressure was at 118/70 and pulse of 74 bpm. Her FSBS was at 375. The vitals were taken by Fire department EMTs who came on site. They recommended her to go to the hospital and she agreed.  Her symptoms had subsided by the time they were leaving the facility. We have no further information from her status at this time.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: She started having the following symptoms about 30 minutes after the vaccine administration: Anxiety, shortness of breath, nausea. Her blood pressure was at 118/70 and pulse of 74 bpm. Her FSBS was at 375. The vitals were taken by Fire department EMTs who came on site. They recommended her to go to the hospital and she agreed.  Her symptoms had subsided by the time they were leaving the facility. We have no further information from her status at this time.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Blood uric acid, Computerised tomogram, Condition aggravated, Full blood count
Clinical narrative: I woke up with neck pain on the right side of the back of my neck on Sat 4/24. Thinking I just "slept wrong", I ignored this symptom initially.  Over the course of Sunday and Monday, this neck pain worsened culminating in severe pain by Monday afternoon with significant decreased ROM (inability to turn my head from side).  At approx 1800, while inactive and sitting, I lost vision in my left eye.  Since I am fairly recently post partum (delivered 3/20/21), I took my blood pressure as a precaution.  My initial reading was 161/108 with repeat 5min later 156/106.  I was instructed to go to the nearest ER.  My BPs there were 171/86 and 166/96.  Labs and diagnostic imaging were performed and I rec'd IV fluids, Reglan, and IV Tylenol.  I was discharged around 0045 with a diagnosis of Migraine Headache.  I woke up on Tuesday 4/27 with a worsening headache.  My BP was 148/91, 141/100 and 130/100 throughout the morning.  I was seen by my chiropractor in an attempt to resolve the neck pain around noon, my BP afterwards was 149/99 142/97-No resolution of headache.  At this point I was instructed to go to Medical Facility for further testing and admission to the women?s services unit.  My BP just prior to admission was 146/107.  I was admitted, given an IV infusion of magnesium sulfate and am currently inpatient with plans to be discharged tomorrow.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Metabolic function test, Migraine, Musculoskeletal stiffness, Neck pain
Clinical narrative: I woke up with neck pain on the right side of the back of my neck on Sat 4/24. Thinking I just "slept wrong", I ignored this symptom initially.  Over the course of Sunday and Monday, this neck pain worsened culminating in severe pain by Monday afternoon with significant decreased ROM (inability to turn my head from side).  At approx 1800, while inactive and sitting, I lost vision in my left eye.  Since I am fairly recently post partum (delivered 3/20/21), I took my blood pressure as a precaution.  My initial reading was 161/108 with repeat 5min later 156/106.  I was instructed to go to the nearest ER.  My BPs there were 171/86 and 166/96.  Labs and diagnostic imaging were performed and I rec'd IV fluids, Reglan, and IV Tylenol.  I was discharged around 0045 with a diagnosis of Migraine Headache.  I woke up on Tuesday 4/27 with a worsening headache.  My BP was 148/91, 141/100 and 130/100 throughout the morning.  I was seen by my chiropractor in an attempt to resolve the neck pain around noon, my BP afterwards was 149/99 142/97-No resolution of headache.  At this point I was instructed to go to Medical Facility for further testing and admission to the women?s services unit.  My BP just prior to admission was 146/107.  I was admitted, given an IV infusion of magnesium sulfate and am currently inpatient with plans to be discharged tomorrow.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis, Urine protein/creatinine ratio
Clinical narrative: I woke up with neck pain on the right side of the back of my neck on Sat 4/24. Thinking I just "slept wrong", I ignored this symptom initially.  Over the course of Sunday and Monday, this neck pain worsened culminating in severe pain by Monday afternoon with significant decreased ROM (inability to turn my head from side).  At approx 1800, while inactive and sitting, I lost vision in my left eye.  Since I am fairly recently post partum (delivered 3/20/21), I took my blood pressure as a precaution.  My initial reading was 161/108 with repeat 5min later 156/106.  I was instructed to go to the nearest ER.  My BPs there were 171/86 and 166/96.  Labs and diagnostic imaging were performed and I rec'd IV fluids, Reglan, and IV Tylenol.  I was discharged around 0045 with a diagnosis of Migraine Headache.  I woke up on Tuesday 4/27 with a worsening headache.  My BP was 148/91, 141/100 and 130/100 throughout the morning.  I was seen by my chiropractor in an attempt to resolve the neck pain around noon, my BP afterwards was 149/99 142/97-No resolution of headache.  At this point I was instructed to go to Medical Facility for further testing and admission to the women?s services unit.  My BP just prior to admission was 146/107.  I was admitted, given an IV infusion of magnesium sulfate and am currently inpatient with plans to be discharged tomorrow.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Mild arm soreness - about four hours later; about 5 1/2 hours later a mild headache. I did take Tylenol which helped the symptoms. I had mild nausea and in the middle of the night and I took a Zofran - which helped with my nausea. I still had a mild headache the next morning and I took another Tylenol - but the end of that day I was totally fine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Lymphadenopathy
Clinical narrative: I have a lymph node that is right below my left clavicle that is as hard as an uncooked green pea.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Pruritus, Rash
Clinical narrative: Tiny "bumps" covering both arms, both legs below the knee, collarbone area, back, and shoulders. Bumps are extremely itchy. I have unknowingly itched my arms until the bumps begin to bleed. Best described as hundreds of small mosquito bites.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Client reported they were 16 and received Pfizer dose even though they are 15 years old.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Erythema, Peripheral swelling, Ultrasound Doppler
Clinical narrative: Left leg DVT.    I am a nephrologist practicing in my area.  10 days or so  after receiving Pfizer vaccine I started noticing left leg swelling and some redness. I didn't pay attention to it because I thought this could be a muscle or tendon issues because of my exercise. But the swelling did not go away, however, it decreased overtime with leg elevation, etc but when I checked my leg I found out that I have a DVT.   I am a healthy 39 ( when I received the vaccine but I am 40  now). I don't smoke. No family history.  I am on a blood thinner now.   I need to report this as I think that it is important to be reported.   I read in the news that a 40 year-old man was diagnosed with DVT after Pfizer vaccine  Please call or email if you need further info
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Pain, SARS-CoV-2 test negative
Clinical narrative: Fever, chills, headache and body ache starting 3 2-3 days after vaccine was received. Headache and chills has resolved, but fever is still reaching 100.0 without the use of Tylenol accompanied by bodyaches.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyskinesia, Muscle twitching, Pain
Clinical narrative: Within 15 min of vaccine injection pt states "Its starting, and left arm starting twitching, pt began rocking back and forth and then rest of body followed with 'involuntary movements' including her trunk and head.  Pt states unable to control movements and body is in 'pain'.   Pt transferred to emergency department - given Ativan and Benadryl and discharged home.  Pt states this is not unusal for her post some medications.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Feeling hot, Peripheral swelling, Systemic lupus erythematosus
Clinical narrative: 8 days post vaccination developed "COVID" arm: localized swelling, redness and warm to touch. On Day 9, developed generalized hives trunk, arms and legs which required a 2 1/2 week prednisone burst. Resolved slowly over a month duration. 3 weeks out experienced joint pain/lupus flare which again required prednisone. PCP recommended to refrain from Dose 2. Rheumatologist did not advise.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 8 days post vaccination developed "COVID" arm: localized swelling, redness and warm to touch. On Day 9, developed generalized hives trunk, arms and legs which required a 2 1/2 week prednisone burst. Resolved slowly over a month duration. 3 weeks out experienced joint pain/lupus flare which again required prednisone. PCP recommended to refrain from Dose 2. Rheumatologist did not advise.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Allergic reaction throat started closed
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Unusual and extremely heavy Menstrual cycle with many clots.  The menstrual cycle was heaviest and has had most clots that I have ever experienced.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Angina pectoris, Aphasia, Blood pressure decreased, Cold sweat
Clinical narrative: Dr consult EMS called to assess via 911 Dr visit in person Urgent Care  Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue  Onset at time of vaccine administration  Labeled NOT anaphylaxis
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Coordination abnormal, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Dr consult EMS called to assess via 911 Dr visit in person Urgent Care  Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue  Onset at time of vaccine administration  Labeled NOT anaphylaxis
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Hypotonia, Muscle spasms, Paraesthesia
Clinical narrative: Dr consult EMS called to assess via 911 Dr visit in person Urgent Care  Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue  Onset at time of vaccine administration  Labeled NOT anaphylaxis
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary hypertension, Restlessness, Tremor, Vision blurred
Clinical narrative: Dr consult EMS called to assess via 911 Dr visit in person Urgent Care  Trouble breathing, dizziness, heart pain, numbness and tingling in extremities, blurred vision, muscle spasms, poor muscle tone, rapid heart rate, drop in blood pressure, elevated heart pressure, trouble talking, brain fog, intestinal upset, cold sweats, tremor, poor coordination, restlessness, fatigue  Onset at time of vaccine administration  Labeled NOT anaphylaxis
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Employee told employee health "got fever on Wednesday evening was off and on till Friday at 3pm, and Wednesday evening got: really tired, bad body aches, chills and headache and those all lasted till Friday at 3pm. I got the vaccine Wednesday morning/midday."
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Sore point inside my armpit. I had heard that a symptom is an inflamed or swollen lymph node.   That seems to be the issue. But, it feels like a small sore spot in my armpit.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram head, Embolic stroke, Hemiparesis, Implantable defibrillator insertion
Clinical narrative: Sudden onset embolic stroke requiring embolectomy two days following first dose of moderna vaccine. Successful clot removal, but residual small stroke causing left-sided weakness.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Thromboembolectomy
Clinical narrative: Sudden onset embolic stroke requiring embolectomy two days following first dose of moderna vaccine. Successful clot removal, but residual small stroke causing left-sided weakness.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: 1 day after vaccines, pt had hives on both sides of trunk, pt took benadryl and symptoms went away
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Decreased appetite, Dehydration, Diarrhoea, Dizziness
Clinical narrative: 1st shot - Severe diarrhea and nausea for 1 month. Lost 10 lbs, severely dehydrated, light headed, loss balance, weak lost two week off work.  2nd shot - felt vaccine go in my groin, begin experiencing severe pain and a limp, ache in left calf, left knee begin to swell, could not lift my left leg, lost appetite, nausea, loss time from work due to weakness and nausea.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Groin pain, Joint swelling, Loss of personal independence in daily activities, Movement disorder, Muscular weakness
Clinical narrative: 1st shot - Severe diarrhea and nausea for 1 month. Lost 10 lbs, severely dehydrated, light headed, loss balance, weak lost two week off work.  2nd shot - felt vaccine go in my groin, begin experiencing severe pain and a limp, ache in left calf, left knee begin to swell, could not lift my left leg, lost appetite, nausea, loss time from work due to weakness and nausea.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Weight decreased
Clinical narrative: 1st shot - Severe diarrhea and nausea for 1 month. Lost 10 lbs, severely dehydrated, light headed, loss balance, weak lost two week off work.  2nd shot - felt vaccine go in my groin, begin experiencing severe pain and a limp, ache in left calf, left knee begin to swell, could not lift my left leg, lost appetite, nausea, loss time from work due to weakness and nausea.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Oropharyngeal pain, Pain
Clinical narrative: Body aches, chills, sore throat