chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Erythema, Pain, Platelet count decreased, Pyrexia
Clinical narrative: on 5/19, patient with no significant past medical history presented to ED for evaluation of abnormal labs onset. Patient states he had his second dose of Pfizer covid vaccine on 5/18 and felt achy with low subjective fever the night before. On the morning of 5/19, he noticed that he had red spots on his legs so went to Urgent Care where bloodwork was done. The results showed patient's platelet levels at 2, so was sent to ED.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event following immunisation, Chills, Haemoglobin normal, Haptoglobin normal, Headache
Clinical narrative: on 5/19, patient with no significant past medical history presented to ED for evaluation of abnormal labs onset. Patient states he had his second dose of Pfizer covid vaccine on 5/18 and felt achy with low subjective fever the night before. On the morning of 5/19, he noticed that he had red spots on his legs so went to Urgent Care where bloodwork was done. The results showed patient's platelet levels at 2, so was sent to ED.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Lethargy, Night sweats, Petechiae
Clinical narrative: on 5/19, patient with no significant past medical history presented to ED for evaluation of abnormal labs onset. Patient states he had his second dose of Pfizer covid vaccine on 5/18 and felt achy with low subjective fever the night before. On the morning of 5/19, he noticed that he had red spots on his legs so went to Urgent Care where bloodwork was done. The results showed patient's platelet levels at 2, so was sent to ED.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Prothrombin time prolonged, Pyrexia, Thrombocytopenia
Clinical narrative: on 5/19, patient with no significant past medical history presented to ED for evaluation of abnormal labs onset. Patient states he had his second dose of Pfizer covid vaccine on 5/18 and felt achy with low subjective fever the night before. On the morning of 5/19, he noticed that he had red spots on his legs so went to Urgent Care where bloodwork was done. The results showed patient's platelet levels at 2, so was sent to ED.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: on 5/19, patient with no significant past medical history presented to ED for evaluation of abnormal labs onset. Patient states he had his second dose of Pfizer covid vaccine on 5/18 and felt achy with low subjective fever the night before. On the morning of 5/19, he noticed that he had red spots on his legs so went to Urgent Care where bloodwork was done. The results showed patient's platelet levels at 2, so was sent to ED.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiomyopathy, Catheterisation cardiac abnormal, Chest discomfort, Congestive cardiomyopathy, Coronary artery stenosis
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dizziness postural, Echocardiogram, Ejection fraction decreased, Electrocardiogram abnormal
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, General physical health deterioration, Heart rate irregular, Intensive care
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Left ventricular dysfunction, Malaise, Right ventricular dysfunction, Ventricular extrasystoles, Ventricular hypokinesia
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Asthenia, Biopsy heart, Biopsy lung, Cardiac failure
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Catheterisation cardiac, Echocardiogram, Electrocardiogram, Feeling abnormal, Heart rate
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myocarditis, Positron emission tomogram, Ventricular tachycardia
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: PROBABLE MYOCARDITIS.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Erythema, Heart rate increased, Muscle tightness
Clinical narrative: She states that within 5 minutes of receiving the vaccine she developed numbness and tingling and swelling in 3 fingers of her hand as well as they began to turn blue.  She then noted the feeling that someone was strangling her.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: She states that within 5 minutes of receiving the vaccine she developed numbness and tingling and swelling in 3 fingers of her hand as well as they began to turn blue.  She then noted the feeling that someone was strangling her.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Choking sensation, Cyanosis, Hypoaesthesia, Paraesthesia, Peripheral swelling
Clinical narrative: She states that within 5 minutes of receiving the vaccine she developed numbness and tingling and swelling in 3 fingers of her hand as well as they began to turn blue.  She then noted the feeling that someone was strangling her.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: She states that within 5 minutes of receiving the vaccine she developed numbness and tingling and swelling in 3 fingers of her hand as well as they began to turn blue.  She then noted the feeling that someone was strangling her.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Big red circle about 2 inches  UNDER injection sight. Circle is sore to touch but not itchy.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Hallucination, Headache, Myalgia
Clinical narrative: Fever, Chills, Headache, Severe Muscle Ache, Sore Throat, Cold Sweats, Hallucinations for 8 days.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Streptococcus test negative
Clinical narrative: Fever, Chills, Headache, Severe Muscle Ache, Sore Throat, Cold Sweats, Hallucinations for 8 days.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: I had reached menopause (confirmed through blood test) and starting menstruating two days after my first COVID vaccine.  I started menstruating again the day after my 2nd shot (given on 4/21/21).  I just started bleeding heavily again this morning (5/20/21).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: pt was nervous 15 minutes after vaccination.  bp was taken as a precaution. bp was 141/77. pt was asked to sit, sip water and have a low sodium snack.  at 8:56p.m. bp was  121/76, pt was feeling better and smiling.  pt's morale had improved and pt was ready to leave.  Advised if any other side effects, to advise employer of needing time off
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: During administration of vaccine, the needle became detached from the syringe resulting in little to no vaccine being administered to the patient, and resulting in spillage of vaccine. It was determined by the pharmacist that the patient likely did not even receive half of the dose, and per previous direction from Moderna, warranted another dose be administered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Missed period, about a month late. Received second dose about 5 days before expected period.  Pms symptoms the entire time. Confirmation not pregnant.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Head injury, Syncope, Vomiting
Clinical narrative: Patient experienced syncope about 5 minutes after recieving vaccine.  he fainted fell to the floor bumped his head then got up immediately later and reported to pharmacist around 7:40.  Patient was asked to sit down, given water and powerade for fluids and electrolytes.  after 20-30 minutes patient vomited.  911 was called immediately after.  first responders came in 10 minutes around 8pm and took vital signs and questioned patient.  patient refused to go with them stating he felt better.  patient left pharmacy around 8:30 pm 5/12
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed and dizzy without fainting. Patient laid flat with legs elevated approximately 30 minutes, was then able to travel home in personal vehicle with driver.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Unresponsive to stimuli
Clinical narrative: Had a stroke on May 12, 2021. Found unresponsive while at work, while at work and sent to ER at Hospital. Hospital sent him to Hospital, due to Stroke on the same day. On 5-15-21 sent to Acute Rehabilitation. Still in Rehab doing PT, OT and speech therapy. Many test completed and unknown to how stroke happened. Health prior to vaccine was healthy with no concerns.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe vertigo decreasing as time goes on
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Induration, Pain
Clinical narrative: 18 hours after my second vaccine (moderna) I woke up with a low grade fever, chills, headache, and body aches. That lasted for about a day. The next day I looked at my arm and there was a raised, red, oval shaped mark. It was hard and warm to the touch. I put ice on it and hydrocortisone cream. It was bigger the following day, but seems to be gone now.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: 18 hours after my second vaccine (moderna) I woke up with a low grade fever, chills, headache, and body aches. That lasted for about a day. The next day I looked at my arm and there was a raised, red, oval shaped mark. It was hard and warm to the touch. I put ice on it and hydrocortisone cream. It was bigger the following day, but seems to be gone now.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Swelling
Clinical narrative: Patient developed significant and tender left axillary lymph node swelling and left upper chest swelling
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Muscle twitching
Clinical narrative: Severe twitching and jerking of neck hands and head. And trouble breathing with chest tightness
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Deafness, Vertigo
Clinical narrative: 4 days after each dose of series started having vestibular symptoms. First dose resulted in disequilibrium that was positional (up and down movements of the head) at first and the progressed to persistent the next day and ended with a migraine headache that night. Better during the weekend and then took about 2 weeks to resolve. Had almost fully resolved (would still return with ingestion of antihistamine so had to stop taking it) but then got second dose and was initially ok,  but 4 days after dose started having rotator vertigo L sided. Vertigo and disequilibrium were never symptoms of known schwanomma. The schwanomma is small 3mm and intralabyrinthine. Negligible hearing loss at baseline of 25 dB at 4000 Hz. Both ENT physicians acknowledge temporal link but agree hard to tell because vaccine is so new and hard to conclude causation and none of the routine evaluation for the schwanomma fit the clinical picture.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 17 y/o at time of vaccination. He was under the age of recommendation set forth by the manufacturer.  No reaction to the vaccine observed or reported by the patient.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: Post second-vaccination, my menstrual period was much heavier, much more painful, and lasted longer than my 3-4 day average. The pain was barely treatable with ibuprofen, and taking that only took the pain from an 8 to a 6.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Biopsy breast, Heavy menstrual bleeding, Muscle spasms
Clinical narrative: Heavier and longer menstrual cycle. Prior to the vaccine, did not have a menstrual cycle since 2/2020 due to breastfeeding and birth control. Prior menstrual cycles lasted 4-5 days with few other symptoms. After the second dose of the vaccine on 2/2/21, my cycle returned on 2/19/21 despite still breastfeeding and no change in birth control. For the next 3 months, my period has been longer (8-9 days), heavier, and with new bloating, low back pain, and cramps.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Heavier and longer menstrual cycle. Prior to the vaccine, did not have a menstrual cycle since 2/2020 due to breastfeeding and birth control. Prior menstrual cycles lasted 4-5 days with few other symptoms. After the second dose of the vaccine on 2/2/21, my cycle returned on 2/19/21 despite still breastfeeding and no change in birth control. For the next 3 months, my period has been longer (8-9 days), heavier, and with new bloating, low back pain, and cramps.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: dermatologic reaction, multiple itchy erythematous patches on left leg (calf up to knee)
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was 17 y/o at the time she received her first dose of the Moderna vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Rash, Rash erythematous
Clinical narrative: Pain in left arm at injection site. Day after shot large swollen and painful rash that is raised. Noticed when I woke up that next morning on May 20, 2021
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Body temperature abnormal, Feeling abnormal, Headache, Insomnia
Clinical narrative: Currently suffering from symptoms indicative of brain damage, namely new anxiety, mood changes, some occasional headaches, mild brain fog, and insomnia (have not slept for more than 4-5 hours injection date.  Also have messed up sense of temperature, as well as occasional aches.  Also had soreness in jabbed arm as well as inflammation in said arm.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Mood altered, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Currently suffering from symptoms indicative of brain damage, namely new anxiety, mood changes, some occasional headaches, mild brain fog, and insomnia (have not slept for more than 4-5 hours injection date.  Also have messed up sense of temperature, as well as occasional aches.  Also had soreness in jabbed arm as well as inflammation in said arm.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Feeling cold, Hot flush, Nausea
Clinical narrative: Kidney Pain, chills, brain fog, shivering, hot and cold flashes, nausea, and body aches.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Renal pain
Clinical narrative: Kidney Pain, chills, brain fog, shivering, hot and cold flashes, nausea, and body aches.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Tingling and numbness in arm of injection
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Vaccine positive rechallenge
Clinical narrative: Ever since I got the Pfizer COVID19 vaccine, there's been something wrong with my heartbeat. It feels stronger, to the point where it keeps me up at night sometimes. At first it was subtle, and I thought it could have been indigestion (I have IBS which sometimes causes gastrointestinal distress), or anxiety. However, both of those conditions have been with me for many years, and this particular event began precisely when I got my first dose of the COVID19 vaccine - that night. The first time, it went away after a few days, but after my second dose, it came back (again, the same night the vaccine was administered) and hasn't gone away since. It's still subtle enough that I don't notice it during the day, but it's there quite clearly every single night now. I'm getting used to it, and it doesn't seem to be causing any other health problems or adverse effects, but something has definitely changed.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disorientation, Fatigue, Gait disturbance, Pain in extremity
Clinical narrative: I had to use my walker, from knee surgery 2 yrs ago, to get around. Still difficult- legs and knees hurt pretty bad. Husband said I was ?talking out of my head some?, was very tired. It passed after one day.  *Please make note that I did have Covid in January- in my lungs. I did not report to my dr- but I will
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Walking aid user
Clinical narrative: I had to use my walker, from knee surgery 2 yrs ago, to get around. Still difficult- legs and knees hurt pretty bad. Husband said I was ?talking out of my head some?, was very tired. It passed after one day.  *Please make note that I did have Covid in January- in my lungs. I did not report to my dr- but I will
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: A mild rash has appeared about 4.5 inches below injection site on my upper left arm. Strangely, the rash is rectangular in shape, about 4 inches long by 1 inch wide. The rash itched only once, is not painful, and is very warm to the touch. I have not treated the rash, as it has not been bothersome.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Tinnitus, ringing in my left ear and slight hearing loss
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Burning sensation, Chills, Dizziness
Clinical narrative: 5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: 5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Nausea, Pain in extremity, Tremor
Clinical narrative: 5-3-2021: at 11:54 am got J&J Covid-19 vaccine at Pharmacy. No anaphylaxis or other severe reactions within first four hours. By 8:00 pm began feeling fatigued and generally warm. No nausea or vomiting. By 11:00 pm developed diffuse soreness of left deltoid at injection site, mild chilling, muscle aches, T 98.8. Then developed severe shaking chills and profuse sweating, generalized, systemic burning sensation, nausea, light-headedness. This reaction lasted through the night, about 8 hrs. I spent 5-4-2021 in bed, and started feeling a bit better by 7:00 pm. By the next day felt very weak, light-headed and tired, and a little short of breath with movement. By 5-8-2021 felt pretty much back to normal, but tired. Arm soreness resolved. Reported reaction to my MD.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 infection
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: "COVID Arm" type of reaction on left arm. Includes redness, itching, swelling, heat and soreness.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in left hip - severe
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Syncope
Clinical narrative: (Vasovagal Response)  Fainted as walking to court yard.  Parent was able to assist w/o fall. Pt laid down and elevated feet. No additional treatment needed.  (Initial BP 80/62 ?  BP 96/68)
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Immediate post-injection reaction, Presyncope
Clinical narrative: (Vasovagal Response) Felt tired and ?felt like fainting? immediately after shot.  Pt laid down and elevated feet.    No additional treatment needed.  (Initial BP 87/58)
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Limb injury, Presyncope, Syncope
Clinical narrative: (Vasovagal Response) Fainted when standing up after getting vaccine.  Hit shoulder on table.  C/o of mild pain to shoulder, but no additional complaints.  Laid down and no additional treatment needed.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Syncope
Clinical narrative: (Vasovagal Response) Felt faint and wanted to lay down when walking to court yard.  Pt laid down and elevated leg.  No additional treatment needed. (Initial BP 86/48 ? 5 mins 86/68, ? 10 mins 90/60)
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Presyncope, Rash, Urticaria
Clinical narrative: (Vasovagal Response and Mild Urticaria) ? Felt faint, had very mild rash on both arms. Pt said he saw a flash of ?blue light?.  Possible to d/t laying out in the sun. Mom noted possible allergic reaction to cats at home. (Initial BP 100/62  ? 10 mins 118/68).  Treatment:  Diphenhydramine 50mg/ml injection on right arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Atrial fibrillation, Blood test, Chest X-ray
Clinical narrative: loss of taste and small April 18 - 24, 2021 Racing heart rate, significant weight/pressure on chest, difficulty catching breath: - first episode April 24, 2021 - second episode included cold sweats May 4, 2021. I called 911 and was transported to Emergency Department. ED team diagnosed issue as atrial fibrillation.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cold sweat, Dyspnoea, Electrocardiogram abnormal, Palpitations
Clinical narrative: loss of taste and small April 18 - 24, 2021 Racing heart rate, significant weight/pressure on chest, difficulty catching breath: - first episode April 24, 2021 - second episode included cold sweats May 4, 2021. I called 911 and was transported to Emergency Department. ED team diagnosed issue as atrial fibrillation.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: C/o Dizziness/ Headache ? Initial BP 89/62 ? 103/75
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Anuria, Back pain, Bilevel positive airway pressure
Clinical narrative: Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Blood lactic acid increased, Blood pH decreased, Blood urea increased, Chest X-ray abnormal
Clinical narrative: Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Circumoral swelling, Computerised tomogram abnormal, Dyspnoea, Endotracheal intubation, Hypocomplementaemia
Clinical narrative: Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Liver function test increased, Mastication disorder, Mobility decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myositis, Neck pain, Oropharyngeal pain, Pleural effusion, Renal replacement therapy
Clinical narrative: Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rhabdomyolysis, Swelling
Clinical narrative: Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Blood creatine phosphokinase, Computerised tomogram, Rhabdomyolysis
Clinical narrative: Patient received COVID vaccine approximately one week prior to admission.  Patient developed acute rhabdomyolysis requiring hospitalization.  She developed pain and stiffness in her neck which spread to her back and generalized muscles to the point where she had difficulty moving in the next 12 hours.  She did not have difficulty swallowing but she did have difficulty chewing and complained of throat pain.  Upon arrival to the emergency room she was unable to lift her legs to get out of the car.  In the emergency room she was found to have a CK of 130,000 along with a creatinine of 1.1 and potassium of 6.8 with a calcium of 7.0.  She was admitted to the hospital ward and given aggressive IVFs. The following am she was having trouble breathing and was started on BIPAP; the repeat CK level climbed to 543,500.  She continued to worsen, developing increased swelling around the mouth and neck.  She became anuric with acute kidney injury; and was subsequently transferred to CCC upon which she was intubated and initiated on CRRT.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Started feeling tenderness again, the next morning I woke up and had itchiness. By the evening I had seen raised thick lines about 3 inches long below the injection bruise. They are warm, raised, red, sore and itchy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Started feeling tenderness again, the next morning I woke up and had itchiness. By the evening I had seen raised thick lines about 3 inches long below the injection bruise. They are warm, raised, red, sore and itchy.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Tremor
Clinical narrative: 24 hours later, shaking chills, diarrhea, chest pain
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Injection site swelling
Clinical narrative: Other than perhaps a touch of fatigue, some mild soreness only at the injection site (left arm), and mild shoulder joint pain, I had no notable reaction to my first Moderna vaccine (April 20, 2021; Moderna Lot #047B21A).   On the evening of the day I received the second Moderna vaccine (injection around noon on May 18, 2021; Moderna Lot #017C21A) I experienced chills, fatigue, significant muscle aches (especially in entire left arm, shoulder, neck, and very significantly in my legs), as well as joint pain. The following day, May 19, the fatigue grew much worse, and the muscle aches and joint pain continued, but the chills subsided. The following day, May 20, an approximately 3" x 6" swath of my upper left arm began to painfully swell and was VERY hot to the touch; visually, it was very slightly red but not dramatically so. I was still fatigued and achey, with some joint pain. By today, May 21, the area remains very painful and weirdly hot to the touch, and in addition *has turned a bright angry red color*. The hot, swollen area begins exactly 4" below the injection site, as measured from the edge of the bandaid to the edge of the affected area. As the skin reaction grows worse, my other symptoms have improved. Other than the skin reaction, I have mild fatigue and very mild aches and joint pain.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity
Clinical narrative: Other than perhaps a touch of fatigue, some mild soreness only at the injection site (left arm), and mild shoulder joint pain, I had no notable reaction to my first Moderna vaccine (April 20, 2021; Moderna Lot #047B21A).   On the evening of the day I received the second Moderna vaccine (injection around noon on May 18, 2021; Moderna Lot #017C21A) I experienced chills, fatigue, significant muscle aches (especially in entire left arm, shoulder, neck, and very significantly in my legs), as well as joint pain. The following day, May 19, the fatigue grew much worse, and the muscle aches and joint pain continued, but the chills subsided. The following day, May 20, an approximately 3" x 6" swath of my upper left arm began to painfully swell and was VERY hot to the touch; visually, it was very slightly red but not dramatically so. I was still fatigued and achey, with some joint pain. By today, May 21, the area remains very painful and weirdly hot to the touch, and in addition *has turned a bright angry red color*. The hot, swollen area begins exactly 4" below the injection site, as measured from the edge of the bandaid to the edge of the affected area. As the skin reaction grows worse, my other symptoms have improved. Other than the skin reaction, I have mild fatigue and very mild aches and joint pain.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on extremities and trunk, occurred 1 day after vaccine, resolved with Benadryl, no other symptoms
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, SARS-CoV-2 test negative
Clinical narrative: Start having severe nasal congestion on the left side from day 5th (5/12).  Certirizine HCI, XClear Nasal spray, NeilMed Sinus rinse dose not help. Now it's day 14th. The nasal congestion still persist. The last time I have similar condition was Dec. 2019.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Developed Bell?s Palsy on left side of face
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness transient, Deafness, Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Dizzy, full body sweat, temporary loss of hearing and sight. Symptoms came on 1 minute after injection and lasted for 20 minutes. Lingering ringing and dizziness 24 hours after.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Dizzy, full body sweat, temporary loss of hearing and sight. Symptoms came on 1 minute after injection and lasted for 20 minutes. Lingering ringing and dizziness 24 hours after.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Extremely sore throat
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue started 3 hours after shot. Woke up with bad fatigue the next morning, muscle aches, and headache. Headache has persisted. Treating with Ibuprofen
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Insomnia
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body urticaria beginning on stomach and rapidly progressing to large area across stomach and back. Hives subsided and have resurfaced for several days across arms legs face torso . Over the counter antihistamine Allegra in combination with Benadryl at night and steroid pack initiated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node right clavicle
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms, all over body aches, fever of up to 103.2 which has been ongoing for about 5 days now, loss of appetite, symptoms are finally subsiding.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Tendon pain
Clinical narrative: First shot gave me a tight chest and swollen throat right away day one about 40 minutes after receiving shot. That night I was woken up with burning ligament and tendon pain in my legs. This subsided after two days. Pain in all joints of foot, ankle, knees and elbows have been ongoing but not constant. The day after second shot tendons in  thumbs on both hands became painful and popping.  This hasn't went away and is constantly painful.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache
Clinical narrative: severe joint pain, head aches, sweats
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Arthritis, Blood test, Inflammation, Polyarthritis
Clinical narrative: Severe systemic arthritic reaction to all joints. Severity lasted 8 weeks, and although lessened, is still strong. Most effects in both shoulders, left elbow, left hand, both hips, both knees.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Systemic lupus erythematosus
Clinical narrative: Severe systemic arthritic reaction to all joints. Severity lasted 8 weeks, and although lessened, is still strong. Most effects in both shoulders, left elbow, left hand, both hips, both knees.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Migraine, Nausea, Pyrexia
Clinical narrative: chills and fever, migraine, nausea, fatigue
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Severe painful and heavy period, above and beyond what has been usual
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Red Rash all over chest and neck
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Myalgia
Clinical narrative: Woke up the morning after receiving the shot & felt fine, so I went to work. As the day went on, I got muscle aches and pains all through my body (especially in my left arm - the injection site - of course) and fatigue. It continually worsened throughout the afternoon and evening, despite bedrest and proper hydration, and I could barely sleep.  However, the next morning I woke up just as I did the day before - no problems, feeling fine.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Swollen upper arm (below injection site) developed around 9 pm, Tuesday, May 18, 2021 and has not resolved. Large, pinkish, red patch developed around 5 am on Thursday, May 20, 2021 and has not resolved. I rested and took ibuprofen, with no results. Vaccine administrator stuck the needle at an angle, which likely caused much of the prolonged swelling.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
Clinical narrative: Menstrual cycle changed: I got my period ahead of time, with very heavy bleeding. My period was always normal, in terms of amount, time, etc. At first, I didn't think of it was related to vaccine.  However, after the second dose (on 4/11/2021) , same thing happened again: I got my period in shorter cycle, and the bleed was very heavy, running pure blood (didn't see tissue in) and drag for ~10 days, I basically had to bed rest to let it stop.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Panic attack, Syncope, Unresponsive to stimuli
Clinical narrative: pt received second dose of pfizer vaccine and within ten minutes started feeling dizzy and nauseated, sweating and feeling as though having a panic attack. Pt had syncope episode and ammonia inhalant used and pt non responsive. 911 called and pt monitored. Once pt placed on stretcher pt became more responsive and was able to state name and todays date,  bp 109/62 p73 @ 15:48 / bp 109/74 p 88 @ 15:52. Pt verbal and states he is feeling better, states he has not had much to drink today and has been mowing today. EMS on scene and pt leaves clinic with EMS.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest X-ray, Electrocardiogram, Vital signs measurement
Clinical narrative: Anaphylaxis
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE's or PQC's reported; a temperature excursion on GARDASIL 9 that was administered; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical condition, current condition and concomitant medication were not reported.  On 22-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot # S033308 with expiration date: 08-APR-2022, 1 dosage form (reported as 1 time dose) (route and strength were unknown) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or Product Quality Complaint (PQC) was reported.  Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) experienced the temperature excursion above 47 Fahrenheit degrees (F) (48.2F) for 2 hours 0 minutes and 0 seconds. There was no previous temperature excursions reported. The digital data logger was not involved to capture the temperature excursion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S033308; expirationdate: 08-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 and 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bradyphrenia, Dizziness, Feeling abnormal, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Urinated on herself-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Immediately after vaccination she started to feel "awful" and unable to describe exactly what was wrong. She was lightheaded, shaky and dizzy. She lost consciousness for about 1-2 minutes and paramedics were called. Once consciousness was regained, she lied down and started to feel better. She continued to lie down until paramedics showed up and assessed her. She was feeling better and was not taken to the hospital.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope, Tremor, Urinary incontinence
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Urinated on herself-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Immediately after vaccination she started to feel "awful" and unable to describe exactly what was wrong. She was lightheaded, shaky and dizzy. She lost consciousness for about 1-2 minutes and paramedics were called. Once consciousness was regained, she lied down and started to feel better. She continued to lie down until paramedics showed up and assessed her. She was feeling better and was not taken to the hospital.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: limited shoulder range of motion-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)