chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: ER care, spent 5-7 hours under treatment of lactic acid, saline IV, ivsoln IV and ceftriaxone vial after receiving multiple imaging tests, EKG, and other tests. He started feeling bad in the evening, went to sleep, and woke up around 11pm that night shaking uncontrollably, unable to see, had an extreme headache and was throwing up. His heart rate was close to 180 while sitting down and he could not stand up. Was taken to the ER and seen immediately. Afterwards for about 2 weeks he had bad chest pains and extreme shortness of breath. He could not exert himself at all.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph nodes in multiple locations including armpits, groin, collarbone, neck, side of breast. Lasted for over a week and still not completely gone
Age: 36.0
Sex: F
Vaccine: UNK
Symptoms: Vaginal haemorrhage
Clinical narrative: 2.5 months constant of vaginal Bleeding since vaccine initial dose
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash, Rash erythematous
Clinical narrative: Large red, painful rash at imjection site. Covid arm
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: 2 days after the vaccine, my left eye became swollen and red. No pain, itching or other noticeable changes. Disappeared after 3 days onset, gradually getting better.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Paraesthesia
Clinical narrative: Moderately severe burning type paresthesias in feet and hands. Painful tingling lasted 45-60 minutes then would resolve spontaneously. The painful symptoms would recur 3-8 times per day and are ongoing at the time of this report. Medical attention has not been sought due to symptoms resolving for hours at a time. Will likely contact neurologist next week if symptoms persist.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Blood urine present, Focal dyscognitive seizures, Pain in extremity, Pyrexia
Clinical narrative: Simple partial seizures started almost 8 days after 1st Moderna shot, and have continued ever since.  I have grand-mal, and never simple partial. I'm taking antiseizure medicine, which was increased, but they continue.  A low grade fever of 99.0, the highest was 99.4, for two weeks. Rashes, red, itchy and raised, on my wrists started after 2nd shot, alternating on and off. One time on my neck and onto face. Then a rash on my right upper arm,  had stopped about 5 days ago. but today a new one on my wrist started. Pain in my arms on and off, and new pain started today in my left arm , before the rash started.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic, Urine analysis abnormal
Clinical narrative: Simple partial seizures started almost 8 days after 1st Moderna shot, and have continued ever since.  I have grand-mal, and never simple partial. I'm taking antiseizure medicine, which was increased, but they continue.  A low grade fever of 99.0, the highest was 99.4, for two weeks. Rashes, red, itchy and raised, on my wrists started after 2nd shot, alternating on and off. One time on my neck and onto face. Then a rash on my right upper arm,  had stopped about 5 days ago. but today a new one on my wrist started. Pain in my arms on and off, and new pain started today in my left arm , before the rash started.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Sore at injection site, fever, chills, body aches, headache
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site rash, Rash, Skin discolouration, Sleep disorder
Clinical narrative: Very itchy rash that began near the injection site and grew to spots all over abdomen, legs, feet, hands, and neck. Was not helped by benadryl, had to have prednisone prescribed. The rash lasted for a little over a week and interfered with sleep and comfort. The rash did not interfere with breathing, vision, mobility, etc. I still have some discolored skin from the rash over a month later.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dyspnoea
Clinical narrative: Patient complaints of dizziness and shortness of breathing. Provider on-site assessed the condition of the patient and was experiencing cold clammy skin. Provider recommended to give EPIPEN 0.3 and called 911
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Blood fibrinogen, Blood thyroid stimulating hormone, C-reactive protein, Full blood count
Clinical narrative: LE edema, purpura, and pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio, Metabolic function test, Oedema peripheral, Pain in extremity, Prothrombin time
Clinical narrative: LE edema, purpura, and pain.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Purpura, Red blood cell count, Ultrasound Doppler
Clinical narrative: LE edema, purpura, and pain.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Rhinorrhoea, Throat irritation
Clinical narrative: Client arrived on 5/27/21 to the Health Center to get his second dose of Pfizer. Client reports that after her first dose on 5/6/21 of Pfizer lot #EW0179 she experienced itchy throat on only the left side, runny nostril on the left side and watery left eye 5 hours after receiving dose.  Client reports she was vaccinated on the left arm. Client reports it resolved on its own after 4 days.  Client approved lead PHN to administer 2nd dose with a 30 minute wait and no reaction occurred.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Muscle spasms, Pain
Clinical narrative: Body ache, fever, chills, headache, diarrhea, muscle spasm hip
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body ache, fever, chills, headache, diarrhea, muscle spasm hip
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Pyrexia, Rash, Vomiting
Clinical narrative: Had chills and hot flashes. Fever got up to 101.4. I couldn't keep any food or liquid down for 48 hours. This all began 12 hours after getting the shot. A week later my face began breaking out. It's either pimples or rosacea.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Dizziness, Fall, Pneumonia
Clinical narrative: SEPTIC SHOCK, BILATERAL PNEUMONIA, DIZZINESS, REPEATED FALLS, POSSIBLE STROKE.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Septic screen, Septic shock
Clinical narrative: SEPTIC SHOCK, BILATERAL PNEUMONIA, DIZZINESS, REPEATED FALLS, POSSIBLE STROKE.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram, Exercise electrocardiogram normal, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: Pt presented with chest pain, 4 days post vaccine, Elevated troponin noted (over 3.) 2nd troponin value climbing.  Of note, patient got the vaccine the day after returning from a trip out of state.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Slight headache, chills, left arm soare, tired
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody increased, Laboratory test, Ocular hyperaemia, White blood cell count increased
Clinical narrative: Noticed redness in left eye corner and went to eye doctor. Doctor gave me an eye drop prednisolone 1% and when it did not work, She gave me Prednisone 20 MG tablet and refer to primary Physician. When Primary Physician tested blood my ANA came at positive 1:80. They advise me to go to Rheumatology for further evaluation of an autoimmune disease. Blood test in December 2020 was normal with WBC in normal range but when I did the test on May 12th, it came as High.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Arthralgia, Headache, Scleritis, White blood cell count
Clinical narrative: Noticed redness in left eye corner and went to eye doctor. Doctor gave me an eye drop prednisolone 1% and when it did not work, She gave me Prednisone 20 MG tablet and refer to primary Physician. When Primary Physician tested blood my ANA came at positive 1:80. They advise me to go to Rheumatology for further evaluation of an autoimmune disease. Blood test in December 2020 was normal with WBC in normal range but when I did the test on May 12th, it came as High.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Injection site pain, Pain, Pain in extremity
Clinical narrative: Burning at injection, soreness at injection5 to 9 hourafter injection, I feel some shotting pain down arm occasionally. Slight pressure in head but not full on headache within 2 hours of headache.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac monitoring, Palpitations, Tremor
Clinical narrative: After 3 minutes,,I felt palpitations-weak-shaking. I went to the ER  right away. for the first dose..I felt the same and I went to urgent care right away.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: After 3 minutes,,I felt palpitations-weak-shaking. I went to the ER  right away. for the first dose..I felt the same and I went to urgent care right away.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Swelling face
Clinical narrative: 20 minutes post vaccination Pt felt tingling in throat, swelling of the cheeks, and heaviness in the chest. Pt was escorted to lie on cot and vitals were obtained: B/P - 122/70, P - 88, Resp - 24, O2 - 99%. EMS was called and Fire Dept arrived on scene at 1650. Pt released by Fire Dept at site at approximately 1720.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: Within 6 hours ? headache Within 12 hours ? extreme nausea, chills, fatigue, body aches, mild arm soreness, mild shortness of breath 12-24 hours ? mild nausea, chills, fatigue, body aches, slight cough, more intense arm soreness at injection site
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain, Pain in extremity
Clinical narrative: Within 6 hours ? headache Within 12 hours ? extreme nausea, chills, fatigue, body aches, mild arm soreness, mild shortness of breath 12-24 hours ? mild nausea, chills, fatigue, body aches, slight cough, more intense arm soreness at injection site
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Cardiovascular evaluation, Chest discomfort, Echocardiogram, Fibrin D dimer normal
Clinical narrative: Patient began to experience palpitations and left-sided chest discomfort approximately 1-2 weeks after the second vaccine dose on 4/22/2021 was received.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Troponin normal
Clinical narrative: Patient began to experience palpitations and left-sided chest discomfort approximately 1-2 weeks after the second vaccine dose on 4/22/2021 was received.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test abnormal, Cardiac valve disease, Chest discomfort, Computerised tomogram coronary artery normal, Echocardiogram
Clinical narrative: There was a thumping and tightness in my chest centered around my heart, as well as pain in my left arm that traveled, fulfilling the textbook definition of a heart attack. I went to the ER, got an EKG and it looked normal. The tightness lasted for the next few days, and occasionally persists to today (March 27th). After two blood tests, X ray, and blood pressure they determined my troponin levels were not only measurable, they were increasing, so I was admitted to the hospital. I was given aspirin for 30 days, and told to leave caffeine alone for that time, but I was cleared of the daily aspirin doses and allowed to consume caffeine again after approximately two weeks. Furthermore, I was prescribed nitroglycerin pills incase it should happen again. Doctors concluded that one of my heart valves had a spasm, triggering the event.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Palpitations, Scan with contrast normal, Troponin increased, X-ray
Clinical narrative: There was a thumping and tightness in my chest centered around my heart, as well as pain in my left arm that traveled, fulfilling the textbook definition of a heart attack. I went to the ER, got an EKG and it looked normal. The tightness lasted for the next few days, and occasionally persists to today (March 27th). After two blood tests, X ray, and blood pressure they determined my troponin levels were not only measurable, they were increasing, so I was admitted to the hospital. I was given aspirin for 30 days, and told to leave caffeine alone for that time, but I was cleared of the daily aspirin doses and allowed to consume caffeine again after approximately two weeks. Furthermore, I was prescribed nitroglycerin pills incase it should happen again. Doctors concluded that one of my heart valves had a spasm, triggering the event.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Arthropathy, Condition aggravated, Dyspnoea, Fatigue
Clinical narrative: Immediate dizzyness followed by headache.  Next day slight fever, fatigue, flare up of arthritis, swelling in ankles and by 3rd or 4th day, diarreha.  2nd dose had consult with on site doctor about my lingering symptoms.  Doctor asked me a few questions.  I already had Covid-19 back in January 14th, 2021.  Doctor determined i should be fine.  It got worse.   I honestly felt like i had Covid-19 all over again, only worse beccause I was vomiting the next morninng. I had all the same exact symptoms that I had originally in January, only worse, besides vometing, arthritis flare up, feel like I have carpal tunnel syndrom, couldn't do anything with my right hand for 2 days, and the swelling of ankles/feet and hands. Do not let me forget about the fatigue and shortness of breath.  I feel like i have been hit by a truck.  I even had the fever for 1 day.  It was only around 99, however, I naturally run at 97.7, so 99 is high for me.  Personally, I feel like I received the vaccine too soon after actually having Covid-19.  I am just praying that this arthritis and carpal tunnel symptoms go away.  Oh and the random shooting pains all through out my body.  I am still having that as well and it has been 8 days since my 2nd dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Joint swelling, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Immediate dizzyness followed by headache.  Next day slight fever, fatigue, flare up of arthritis, swelling in ankles and by 3rd or 4th day, diarreha.  2nd dose had consult with on site doctor about my lingering symptoms.  Doctor asked me a few questions.  I already had Covid-19 back in January 14th, 2021.  Doctor determined i should be fine.  It got worse.   I honestly felt like i had Covid-19 all over again, only worse beccause I was vomiting the next morninng. I had all the same exact symptoms that I had originally in January, only worse, besides vometing, arthritis flare up, feel like I have carpal tunnel syndrom, couldn't do anything with my right hand for 2 days, and the swelling of ankles/feet and hands. Do not let me forget about the fatigue and shortness of breath.  I feel like i have been hit by a truck.  I even had the fever for 1 day.  It was only around 99, however, I naturally run at 97.7, so 99 is high for me.  Personally, I feel like I received the vaccine too soon after actually having Covid-19.  I am just praying that this arthritis and carpal tunnel symptoms go away.  Oh and the random shooting pains all through out my body.  I am still having that as well and it has been 8 days since my 2nd dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Immediate dizzyness followed by headache.  Next day slight fever, fatigue, flare up of arthritis, swelling in ankles and by 3rd or 4th day, diarreha.  2nd dose had consult with on site doctor about my lingering symptoms.  Doctor asked me a few questions.  I already had Covid-19 back in January 14th, 2021.  Doctor determined i should be fine.  It got worse.   I honestly felt like i had Covid-19 all over again, only worse beccause I was vomiting the next morninng. I had all the same exact symptoms that I had originally in January, only worse, besides vometing, arthritis flare up, feel like I have carpal tunnel syndrom, couldn't do anything with my right hand for 2 days, and the swelling of ankles/feet and hands. Do not let me forget about the fatigue and shortness of breath.  I feel like i have been hit by a truck.  I even had the fever for 1 day.  It was only around 99, however, I naturally run at 97.7, so 99 is high for me.  Personally, I feel like I received the vaccine too soon after actually having Covid-19.  I am just praying that this arthritis and carpal tunnel symptoms go away.  Oh and the random shooting pains all through out my body.  I am still having that as well and it has been 8 days since my 2nd dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Lower respiratory tract infection, Troponin
Clinical narrative: Chest pain a month after second dose and following a chest cold
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Since having my second vaccine administered on February 3rd of this year. A few weeks after I have had issues with pain in my pinky and joints in my pinky and outer hand. I had never experienced any problems until the vaccine
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Tinnitus
Clinical narrative: I felt fine immediately after the shot and had no physical pain or discomfort other than mild soreness at the injection site.  The next morning I woke up and noticed a loud ringing in both ears.  That ringing has not diminished or gone away since then.  When surrounded by loud ambient noise I don't notice it unless I concentrate on doing so.  Otherwise, it is quite loud and constant.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody, Antinuclear antibody, Arthralgia, Asthenia, Blood immunoglobulin G
Clinical narrative: First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after vaccination I came down with flu like symptoms including: muscle aches, fever, chills, severe headache, and extremely tired which last for five days. 3. No medication would relieve the symptoms including the headache. 4. Had to stay in bed or on couch entire weekend. Second Dose 3/19/2021: 1. Five hours after vaccination, I cam down with the same flu like systems including: muscle aches, fever, chills and severe headache, which lasted for another five days.  This time it also kicked off my Graves eye disease. 2. Shot made the arm feel very heavy and hard to use. 3. No medication would relieve the symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Blood thyroid stimulating hormone, Blood uric acid, Chills, DNA antibody
Clinical narrative: First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after vaccination I came down with flu like symptoms including: muscle aches, fever, chills, severe headache, and extremely tired which last for five days. 3. No medication would relieve the symptoms including the headache. 4. Had to stay in bed or on couch entire weekend. Second Dose 3/19/2021: 1. Five hours after vaccination, I cam down with the same flu like systems including: muscle aches, fever, chills and severe headache, which lasted for another five days.  This time it also kicked off my Graves eye disease. 2. Shot made the arm feel very heavy and hard to use. 3. No medication would relieve the symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Enzyme activity assay, Fatigue, Full blood count, Headache, Hypokinesia
Clinical narrative: First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after vaccination I came down with flu like symptoms including: muscle aches, fever, chills, severe headache, and extremely tired which last for five days. 3. No medication would relieve the symptoms including the headache. 4. Had to stay in bed or on couch entire weekend. Second Dose 3/19/2021: 1. Five hours after vaccination, I cam down with the same flu like systems including: muscle aches, fever, chills and severe headache, which lasted for another five days.  This time it also kicked off my Graves eye disease. 2. Shot made the arm feel very heavy and hard to use. 3. No medication would relieve the symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Legionella test, Limb discomfort, Lyme disease, Metabolic function test
Clinical narrative: First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after vaccination I came down with flu like symptoms including: muscle aches, fever, chills, severe headache, and extremely tired which last for five days. 3. No medication would relieve the symptoms including the headache. 4. Had to stay in bed or on couch entire weekend. Second Dose 3/19/2021: 1. Five hours after vaccination, I cam down with the same flu like systems including: muscle aches, fever, chills and severe headache, which lasted for another five days.  This time it also kicked off my Graves eye disease. 2. Shot made the arm feel very heavy and hard to use. 3. No medication would relieve the symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Red blood cell sedimentation rate, Rheumatoid factor
Clinical narrative: First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after vaccination I came down with flu like symptoms including: muscle aches, fever, chills, severe headache, and extremely tired which last for five days. 3. No medication would relieve the symptoms including the headache. 4. Had to stay in bed or on couch entire weekend. Second Dose 3/19/2021: 1. Five hours after vaccination, I cam down with the same flu like systems including: muscle aches, fever, chills and severe headache, which lasted for another five days.  This time it also kicked off my Graves eye disease. 2. Shot made the arm feel very heavy and hard to use. 3. No medication would relieve the symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Urine analysis
Clinical narrative: First Dose 2/26/2021: 1. sore arm where shot was administered for about 5 days. 2. Two weeks after vaccination I came down with flu like symptoms including: muscle aches, fever, chills, severe headache, and extremely tired which last for five days. 3. No medication would relieve the symptoms including the headache. 4. Had to stay in bed or on couch entire weekend. Second Dose 3/19/2021: 1. Five hours after vaccination, I cam down with the same flu like systems including: muscle aches, fever, chills and severe headache, which lasted for another five days.  This time it also kicked off my Graves eye disease. 2. Shot made the arm feel very heavy and hard to use. 3. No medication would relieve the symptoms.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chest X-ray, Chest pain, Differential white blood cell count, Electrocardiogram
Clinical narrative: 1. Severe chest pain (stabbing) 15 hrs later that woke me up in the middle of the night. Went to emergency room around 11am (day after vaccine).  2. No menstral cycle for 7 weeks  after the first injection. Visited OB/GYN
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Full blood count, Menstruation delayed, Metabolic function test, Sleep disorder
Clinical narrative: 1. Severe chest pain (stabbing) 15 hrs later that woke me up in the middle of the night. Went to emergency room around 11am (day after vaccine).  2. No menstral cycle for 7 weeks  after the first injection. Visited OB/GYN
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test normal
Clinical narrative: 1. Severe chest pain (stabbing) 15 hrs later that woke me up in the middle of the night. Went to emergency room around 11am (day after vaccine).  2. No menstral cycle for 7 weeks  after the first injection. Visited OB/GYN
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I'm not sure if this is from my vaccine.  I started getting hives well over 2 months from receiving it. I went to my ER twice with severe hives the second time was given Hydroxyzine 50MG that cleared my hives up with in 2 hours. This was Sunday 5/23 night at about 3 am I stayed hive clear till Thru 5/27 at about 5 PM. Now the Hydroxyzine is no longer working.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Confusional state, Depression, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath, numbness is hand, sweats, blurred vision, headache, muscle aches, swelling, dizziness, confusion, worsened depression
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Myalgia, Swelling, Vision blurred
Clinical narrative: Shortness of breath, numbness is hand, sweats, blurred vision, headache, muscle aches, swelling, dizziness, confusion, worsened depression
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Shortness of breath and wheezing for three days - albuterol, IV Mag and prednisone given with improvement.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Back pain, Blood test abnormal, Blood urine present, Decreased appetite
Clinical narrative: first night very high fever, headache, chill, body ache, sweating, no appetite. however specifically the pain was very intense in the lower back and sides almost like back labor and some lower abdominal and with nausea . then next morning the back pain was the same and still nauseous from pain and noticed a full on rash all over chest neck, back and stomach. called my doctor and they asked to go in and check with blood test and Urine sample.  most items were normal on the test except blood in urine and low white blood cell counts which I have to follow up with a second test a week later bec my doctor want to make sure it is not due to vaccine. not sure if these are related. rash is still on , went down a little but not complete with Claritin however it looks like it has come back at the night time. and that is up to now so will see the rest later.  ( very healthy normally , no issue before getting the vaccine ) also want to here mention first dose gave me horrible anxiety and depression and paranoia for few days starting few days after which I was told was due to hormone imbalance.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Hyperhidrosis, Nausea, Pain
Clinical narrative: first night very high fever, headache, chill, body ache, sweating, no appetite. however specifically the pain was very intense in the lower back and sides almost like back labor and some lower abdominal and with nausea . then next morning the back pain was the same and still nauseous from pain and noticed a full on rash all over chest neck, back and stomach. called my doctor and they asked to go in and check with blood test and Urine sample.  most items were normal on the test except blood in urine and low white blood cell counts which I have to follow up with a second test a week later bec my doctor want to make sure it is not due to vaccine. not sure if these are related. rash is still on , went down a little but not complete with Claritin however it looks like it has come back at the night time. and that is up to now so will see the rest later.  ( very healthy normally , no issue before getting the vaccine ) also want to here mention first dose gave me horrible anxiety and depression and paranoia for few days starting few days after which I was told was due to hormone imbalance.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urine analysis abnormal, White blood cell count decreased
Clinical narrative: first night very high fever, headache, chill, body ache, sweating, no appetite. however specifically the pain was very intense in the lower back and sides almost like back labor and some lower abdominal and with nausea . then next morning the back pain was the same and still nauseous from pain and noticed a full on rash all over chest neck, back and stomach. called my doctor and they asked to go in and check with blood test and Urine sample.  most items were normal on the test except blood in urine and low white blood cell counts which I have to follow up with a second test a week later bec my doctor want to make sure it is not due to vaccine. not sure if these are related. rash is still on , went down a little but not complete with Claritin however it looks like it has come back at the night time. and that is up to now so will see the rest later.  ( very healthy normally , no issue before getting the vaccine ) also want to here mention first dose gave me horrible anxiety and depression and paranoia for few days starting few days after which I was told was due to hormone imbalance.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Mental impairment, Tinnitus
Clinical narrative: 5/26: fatigue, difficulty with thought, insomnia, headache 5/27: awakened with loud screeching sound, constant. About 11khz. Appears to be tinnitus. Headache, less fatigue but still difficulty with thought.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Headache, Insomnia
Clinical narrative: I almost immediately started getting soar in my arm.  After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy.  Headaches were present most of the first day.  That night, around supper time I felt nauseous and then had some severe stomach cramps.  I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head.  Most of the symptoms were gone after 48 hrs.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity
Clinical narrative: I almost immediately started getting soar in my arm.  After a few hours my arm down to my elbow was VERY soar, my back around my shoulder blade became soar, and over my shoulder up to my neck into the left side of my head was very soar and achy.  Headaches were present most of the first day.  That night, around supper time I felt nauseous and then had some severe stomach cramps.  I didn?t sleep well and woke up with the same bad pain from my elbow to my shoulder and also my shoulder blade to my neck and head.  Most of the symptoms were gone after 48 hrs.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Dyspnoea, Fatigue
Clinical narrative: 1st day - very sore arm of injection, dizziness, and fatigue.  2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm.  At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce.  I was unable to sleep well for the first 3 days after the vaccine.  3rd day -  sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous.  4th day - fatigued and somewhat dizzy from time to time.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Muscle fatigue, Nausea, Neck pain
Clinical narrative: 1st day - very sore arm of injection, dizziness, and fatigue.  2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm.  At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce.  I was unable to sleep well for the first 3 days after the vaccine.  3rd day -  sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous.  4th day - fatigued and somewhat dizzy from time to time.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st day - very sore arm of injection, dizziness, and fatigue.  2nd day - very sore arm, dizziness, extreme muscle fatigue, headache, nauseous, shortness of breath, and chest pains radiating to my left shoulder/arm.  At one point late in the evening of the 2nd day after the vaccine, I considered calling for medical assistnce.  I was unable to sleep well for the first 3 days after the vaccine.  3rd day -  sore arm, dizziness, extreme muscle fatigue, neck pain, headache, and nauseous.  4th day - fatigued and somewhat dizzy from time to time.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Breast tenderness, Chills, Culture, Dizziness
Clinical narrative: Started to get a migraine with dizziness (atypical of when I usually get migraines) which then went Into mastitis, chronic dizziness and a second bout of mastisis, I?ve breastfed two other children and never had mastitis,. There have been many reports in my moms groups of women getting mastitis after receiving the vaccine. Currently still ill with fever body aches chills dizziness and breast tenderness
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Mastitis, Migraine, Pain, Pyrexia
Clinical narrative: Started to get a migraine with dizziness (atypical of when I usually get migraines) which then went Into mastitis, chronic dizziness and a second bout of mastisis, I?ve breastfed two other children and never had mastitis,. There have been many reports in my moms groups of women getting mastitis after receiving the vaccine. Currently still ill with fever body aches chills dizziness and breast tenderness
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Mobility decreased, Musculoskeletal discomfort, Myalgia
Clinical narrative: I haven?t stopped coughing two months in. Also, about 2 weeks after my upper back became extremely knotted up. The muscles are balled up and I can barely move my neck.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: loss of muscle strength, low temperature, headache
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Epistaxis, Vaccination complication
Clinical narrative: INTERMITTENT NASAL BLEEDING; VACCINATION ADVERSE REACTION; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 180 pounds, and height was 66 inches. The patient's concurrent conditions included rheumatoid arthritis and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 09-APR-2021 for covid-19 vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number: 1127007 expiry: UNKNOWN) dose and frequency were not reported from 12-MAR-2021 for rheumatoid arthritis. Concomitant medications included duloxetine hydrochloride, folic acid, gabapentin, hydroxychloroquine phosphate, methotrexate, prednisone, sulfasalazine, and tramadol. On 10-APR-2021, the subject experienced intermittent nasal bleeding. On 10-APR-2021, the subject experienced vaccination adverse reaction. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from intermittent nasal bleeding, and vaccination adverse reaction. This report was non-serious.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Medical asistant called in a temperature excursion on Varivax; No additional AE/PQC reported at this time; This spontaneous report was received from a medical assistant regarding a patient of unknown gender, who at the time of the report was 12-months-old. The, the patient's concurrent medications, pertinent medical history, drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously,  lot # T021826, expiration date was provided and also validated as 25-JUN-2022 (dose, strength, vaccination scheme frequency and anatomical location were not reported) for prophylaxis (improper storage of product in use). The vaccines were exposed to a temperature excursion of, the temperature frame was from -58 degrees Fahrenheit (F) to +5 F and the vaccine was at 6.3 F for 6 hours 0 minutes and 30 seconds, another temperature excursion at 10.9 F for 0 hours 7 minutes and 30 seconds, which were detected by the Digital Data Logger. It was reported there was a previous temperature excursion. No additional adverse event (AE) was reported.  This is one of the five linked reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA008255: US-009507513-2104USA008185: US-009507513-2104USA008081: US-009507513-2104USA008342:
Age: 0.42
Sex: F
Vaccine: DTAP, IPV, PNC13, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired ROTATEQ was administered; This spontaneous report was received from a medical assistant who refers to a 5-month-old female patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and her pertinent medical history was not provided. The patient's birth weight was reported as 3.629 kg. On 11-MAY-2021, the patient was vaccinated with following vaccines (concomitant therapies):diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), polio vaccine inact (IPV) and pneumococcal vaccine conj 13v (crm197)(PREVENAR 13). On the same date, she received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 ml tube, 2 ml, once, orally, for prophylaxis, lot # 1660998, expiry date 03-MAY-2021 (dose number was not reported). No additional adverse event was reported. There was no prescription drug treatment required. There was a plan to re-vaccinate the patient in 4 weeks. The suspect vaccine had no prior temperature excursions.
Sex: F
Vaccine: HPV4
Symptoms: Coeliac disease, Genital lesion, Papilloma viral infection
Clinical narrative: celiac disease; genital things, little lesions maybe, on my privates; I may have had it [Human Papilloma Virus].; This spontaneous report refers to a 83-year old-female patient reporting on herself. Her concurrent conditions and medical history was not reported. She had no allergies. Concomitant medication included "a lot of vitamin".   On an unknown date (reported as a long time ago), the patient was vaccinated with a single dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection, 0.5 milliliter, route of administration was reported as injection, (anatomical location, lot # and expiration date were not reported) for prevention of Human Papilloma Virus (HPV).  On an unknown date (reported as a long time ago, but might have been when the patient was a senior), the patient experienced genital things, little lesions maybe, on her privates. She thought she might have had HPV. It was unclear what age the patient received quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), and whether it was received prior or subsequent to the development of genital lesions. She sought seeing a skin doctor and being given an antibiotic- doxycycline (reported as "DOXYCYCLINEN or something like that") which made the genital lesions went away without relapse or recurrence. She also had celiac disease (date of diagnosis was unknown, celiac disease was also reported as the patient's pertinent medical history). The patient accepted offer to send the prescribing information. No additional adverse events or product quality complaints were reported. No further information was provided. The outcome of genital lesion was reported as recovered, the outcome of on an unknown date human papilloma virus infection and celiac disease was unknown.   The causal relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) was not reported.  Upon internal review, celiac disease was determined to be medically significant (MS).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Rash
Clinical narrative: painful rash on his upper back that spread around left side and was diagnosed with acute herpes zoster neuropathy; painful rash on his upper back that spread around left side and was diagnosed with acute herpes zoster neuropathy; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 28-MAY-2017, the pt. was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration was not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) by an unknown health care provider (HCP).  On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt. experienced a painful rash on his upper back that spread around left side and was diagnosed with acute herpes zoster neuropathy.  As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt. had resulted in physical limitations not presented prior to the use of the vaccine. Pt. also experienced mental and emotional distress due to resulting in physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt. sustained severe and permanent personal injuries. The pt. suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life; physical impairment and injury; and other damages including medical expenses, the loss of accumulations, and other economic and non-economic damages.  At the reporting time, he was not recovered of acute herpes zoster neuropathy.  The reporter considered the event of acute herpes zoster neuropathy to be related to zoster vaccine live (ZOSTAVAX). The reporter considered the acute herpes zoster neuropathy to be disabling.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pneumococcal vaccine administered in 2007 and on 15-OCT-2007; This spontaneous report has been received from a healthcare provider via medical records and from a lawyer from a case in litigation for zoster vaccine live (ZOSTAVAX) (1803USA004717), concerning a 73-year-old male patient.  On 03-DEC-1999, the patient was vaccinated with the first dose (reported as series 1) of pneumococcal vaccine (manufacturer unknown) (dose, route od administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date in 2007, the patient received the second dose (reported as series 2) of pneumococcal vaccine (manufacturer unknown) and on 15-OCT-2007, he received his third dose (reported as series 3) (dose, route od administration, anatomical location, lot # and expiration date were not provided for both) for prophylaxis (inappropriate schedule). On 01-DEC-2014, he received his fourth dose (reported as series 4) of pneumococcal vaccine (manufacturer unknown).  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-1803USA004717:
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patient had no side effects associated with the vaccination/ No additional AE information provided; received her second dose of VAQTA one week early; This spontaneous report was received from a bachelor of science in nursing and refers to a female patient of unknown age. There was no information regarding her medical history, concurrent conditions nor concomitant therapies provided.  On 09-DEC-2020, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 24-MAY-2021 (reported as today), one week too early, she received the second dose of the vaccine (0.5 mL, lot # T035720, expiration date 15-APR-2022; route of administration and anatomical location were not provided) (inappropriate schedule of vaccine administered). The reporter stated that the patient had no side effects associated with the vaccination and no adverse event (AE) information was provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Therapeutic product effect decreased
Clinical narrative: was having longer RA flares than usual; wasn't sure if this fell under potentially decreasing efficacy; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASP2021077167), license party for etanercept (ENBREL).  This serious spontaneous report (USASP2021077167) was reported to Amgen on 15/MAY/2021 by a consumer and involves an adult female patient who was having longer RA (rheumatoid arthritis) flares than usual [PT: rheumatoid arthritis], was not sure if this fell under potentially decreasing efficacy [PT: therapeutic product effect decreased] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included Adderall (amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate) and Covid-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient stated that she was having longer rheumatoid arthritis flares than usual even though she was still taking Enbrel as prescribed. The patient stated that this might or might not have anything to do with her recent COVID-19 vaccine or from an increase in Adderall (amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate) dosage. The patient also stated that she was not sure if this fell under potentially decreasing efficacy. No treatment information was received. The outcome of the event rheumatoid arthritis was reported as not recovered/not resolved. The outcome of the event therapeutic product effect decreased was reported as unknown. Action taken with Enbrel was continued for the events rheumatoid arthritis and therapeutic product effect decreased. The consumer reported that the event therapeutic product effect decreased was possibly related to Enbrel. The causal relationship between the event rheumatoid arthritis and Enbrel was not provided by the consumer. Follow up has been requested for the lot number only.  Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept caused or contributed to the adverse events reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.