chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil percentage increased, Platelet count normal, Procalcitonin normal, Protein total decreased, Prothrombin time shortened
Clinical narrative: On 5/23 two days after vaccine  he was irritable, tired, fatigued, not sleeping well. He could not complete his track meet . He had abdominal pain, felt bloated, and he felt this nausea & discomfort. He thought he might be constipated, so he took MiraLAX and then he had diarrhea all day yesterday. on 5/26   he had a temperature of 99.2, he had acute chest pain retrosternal and feeling of compression on the chest, head fullness as if he is going to explode. He had nausea, insomnia. Ibuprofen was given to him by his mother and this helped a lot But  he woke up on  morning of 5/27 , but the chest pain returned with increased pressure, very nauseous, agitated, unable to be comfortable. No fever,,  the pain was a sharp pressure. He had no syncope or chest shortness of breath He was seen at Hospital ER where a chest x-ray was normal. Echocardiogram was done, ,noted to  have EKG changes. Troponin was elevated. He had a cardiac catheterization done emergently at hospital through the right radial artery and was noted to have normal coronaries.  He also had a chest x-ray done which was negative for pulmonary lesions, and his abdominal pain he says was relieved after the MiraLAX and the diarrhea. His  twin sister who received the vaccine 15 minutes after him is completely asymptomatic.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative, Serum ferritin increased
Clinical narrative: On 5/23 two days after vaccine  he was irritable, tired, fatigued, not sleeping well. He could not complete his track meet . He had abdominal pain, felt bloated, and he felt this nausea & discomfort. He thought he might be constipated, so he took MiraLAX and then he had diarrhea all day yesterday. on 5/26   he had a temperature of 99.2, he had acute chest pain retrosternal and feeling of compression on the chest, head fullness as if he is going to explode. He had nausea, insomnia. Ibuprofen was given to him by his mother and this helped a lot But  he woke up on  morning of 5/27 , but the chest pain returned with increased pressure, very nauseous, agitated, unable to be comfortable. No fever,,  the pain was a sharp pressure. He had no syncope or chest shortness of breath He was seen at Hospital ER where a chest x-ray was normal. Echocardiogram was done, ,noted to  have EKG changes. Troponin was elevated. He had a cardiac catheterization done emergently at hospital through the right radial artery and was noted to have normal coronaries.  He also had a chest x-ray done which was negative for pulmonary lesions, and his abdominal pain he says was relieved after the MiraLAX and the diarrhea. His  twin sister who received the vaccine 15 minutes after him is completely asymptomatic.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Troponin I increased, Troponin increased, White blood cell count increased
Clinical narrative: On 5/23 two days after vaccine  he was irritable, tired, fatigued, not sleeping well. He could not complete his track meet . He had abdominal pain, felt bloated, and he felt this nausea & discomfort. He thought he might be constipated, so he took MiraLAX and then he had diarrhea all day yesterday. on 5/26   he had a temperature of 99.2, he had acute chest pain retrosternal and feeling of compression on the chest, head fullness as if he is going to explode. He had nausea, insomnia. Ibuprofen was given to him by his mother and this helped a lot But  he woke up on  morning of 5/27 , but the chest pain returned with increased pressure, very nauseous, agitated, unable to be comfortable. No fever,,  the pain was a sharp pressure. He had no syncope or chest shortness of breath He was seen at Hospital ER where a chest x-ray was normal. Echocardiogram was done, ,noted to  have EKG changes. Troponin was elevated. He had a cardiac catheterization done emergently at hospital through the right radial artery and was noted to have normal coronaries.  He also had a chest x-ray done which was negative for pulmonary lesions, and his abdominal pain he says was relieved after the MiraLAX and the diarrhea. His  twin sister who received the vaccine 15 minutes after him is completely asymptomatic.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Chills, Insomnia, Lymphadenopathy, Pain
Clinical narrative: Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Chills, Headache
Clinical narrative: Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Insomnia, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram abnormal, Cough, Haemoptysis, Lymphangioleiomyomatosis
Clinical narrative: After 2days of vaccination, I started to cough. Then after one week, blood came out. I took a X-ray and CT scan and the CT specialist described I have LAM disease.  Currently I?m waiting to see lung specialist.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Dizziness, Headache, Malaise
Clinical narrative: Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All symptoms have not subsided since the day after the 2nd vaccination shot. It has been 10-days.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Renal function test, Temporomandibular joint syndrome, Vision blurred
Clinical narrative: Headache, Malaise, Confusion, Blurred Vision, Nausea, Joint Pain, Dizziness, and TMJ flare ups. All symptoms have not subsided since the day after the 2nd vaccination shot. It has been 10-days.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Vomiting
Clinical narrative: The events have been injection site pain, arm soreness, headaches, dizziness, nausea, diarrheas, swelling, and vomits.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Constant itchiness all over my body after 2nd dose of Moderna Covid-19 vaccine. Doctor prescribed steroids and steroid shot. Temporary relief from steroid shot. No change with steroid pill. 1st dose on 4/2/2021- itchiness only on palm and toes. Started 8 days after receiving vaccine. Bumps and pointy spots on palm and toes. Doctor prescribed steroid pills 20mg for 5 days.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Prolonged vaginal bleed/menstruation
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody negative, Brain natriuretic peptide increased, Campylobacter test positive, Chills, Diarrhoea
Clinical narrative: Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later.  He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%.  On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO.  Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Fatigue, Fibrin D dimer, Hypotension, Inflammatory marker increased
Clinical narrative: Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later.  He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%.  On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO.  Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukocytosis, Lung assist device therapy, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Nausea
Clinical narrative: Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later.  He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%.  On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO.  Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction positive, Pyrexia, Rash macular, Respiratory viral panel, Tachycardia
Clinical narrative: Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later.  He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%.  On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO.  Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin, Vomiting
Clinical narrative: Starting the day after the second dose of Pfizer mRNA, he developed prodrome with fever/chills, N/V/D, systemic macular rash, and fatigue that persisted until presenting to the ED 9 days later.  He was noted to be tachycardic and hypotensive with a severe leukocytosis, elevated inflammatory markers and + troponin, and an LVEF 35-40%. He was referred to tertiary care center, had a cardiac MRI that showed little inflammation but LVEF now 12%.  On 5/21/21 he was started on high dose steroids and placed on mechanical circulatory support with VA ECMO.  Cardiac function quickly improved and he is ready to come off VA ECMO 5/29 with an LVEF improved to > 40% during weaning trials.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Pt presents to clinic with c/o S/E to Pfizer Covid 1st Vac. to L delt 3 days ago, states since yesterday has felt drained/tired then today while at work was nauseated.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Vertigo
Clinical narrative: April 1 - first dose May 7 - second dose  May 8 - Headache, muscle soreness, fatigue May 17 - I thought I had a headache (I don't ever get headaches)... As the day progressed, I became incredibly dizzy and had to get on all fours at some points due to the dizziness.  I was told by provider that I was experiencing vertigo. May 18 - continued to experience vertigo symptoms.  May 19 - continued to experience vertigo symptoms, but less than the 2 previous days May 20 - mild dizziness  May 21 - no more dizziness
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 5/27/21 at approximately 7PM patient stated having  Pain, severe itching, tenderness and swelling (hardness) the size of a quarter to the right arm injection site noted.   5/28/2021 at approximately 6:30pm, call to notify infection preventionist about Reaction to vaccine. Patient advice to take Benadryl. Patient stated taking 50 mg of Benadryl by mouth. At approximately 10:00 PM, patient stated she no longer had further itching to the injection site however showed nurse a picture and noted still redness to site. Nurse advised to continue to monitor, and notified if any worsen reaction occurs. Patient voiced understanding.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Myocarditis, Troponin increased
Clinical narrative: Acute myopericarditis
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Hyperhidrosis, Neck pain
Clinical narrative: Within a minute or less of receiving the shot, I experienced a rapid and intense onset of blurred vision, lightheadedness, profuse sweating, and extreme numbness all over but especially in my hands and feet. I came close to losing consciousness and was instructed to lay down with my knees bent to increase blood flow. I slowly came to over the course of probably 10 minutes while laying on the ground, but my hands and especially my fingers remained numb for 30-45 minutes while I experienced chills. My left hand and fingers were extremely pale and bluish during this time. I also had minor pains on the left side of my neck and left shoulder blade. Color came back to my left hand and chills subsided around an hour after my shot.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration, Vision blurred
Clinical narrative: Within a minute or less of receiving the shot, I experienced a rapid and intense onset of blurred vision, lightheadedness, profuse sweating, and extreme numbness all over but especially in my hands and feet. I came close to losing consciousness and was instructed to lay down with my knees bent to increase blood flow. I slowly came to over the course of probably 10 minutes while laying on the ground, but my hands and especially my fingers remained numb for 30-45 minutes while I experienced chills. My left hand and fingers were extremely pale and bluish during this time. I also had minor pains on the left side of my neck and left shoulder blade. Color came back to my left hand and chills subsided around an hour after my shot.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain, Tinnitus
Clinical narrative: Constant sensation of fullness, ringing sound, and aching pain in both ears.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: So I puked both times offered each shot the next day after receiving it but the first time I was sick for a couple days just feeling lucky like puking nauseated the second one just the other day or yesterday I feel I puked and it lasted for about 5 hours and then today on the 29th I am really sore I'm on my whole body aches and I have not been to the doctor.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: Legs had a numbness/ tingling sensation then today I could barely walk
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness, tingling, and burning of extremities and eventually face.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever of 100F+ Body aches  Chills
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pruritus, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Swollen arm at site of injection and about 4.5" around. Warm and slightly itchy. Yesterday I was tired and slept alot but I felt OK by 3 pm. Then around 11 am today my arm started to swell.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Bipolar disorder, Condition aggravated, Mania
Clinical narrative: Went in to BiPolar Mania and Rage.  One of the worst events I have had.  I take my meds, and have not had a Mania event since 2014.  There were no triggers for this event.   I have had Rage events more recently, last one 11 months ago.  But never both of these together.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: Within 10 minutes of injection vasovagal syncope occurred in vehicle while parked in observation area. Due to being in seat was not able to prevent syncope and nurses had to treat for 15 minutes until symptoms subsided. Blood pressure was monitored and dropped to 50/20. Finger pulse oximeter would not register. Nurses provided ice packs, alcohol wipes for smelling, and water. Unable to lay flat and extend legs so episode lasted longer than expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Menstrual cycle  changes; periods started early and prolonged not stopping even after 20 days. Bleeding is not heavy bit it is continuous spotting. So for now have not yet consulted a gynecologist.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Blood test normal, Laboratory test normal, Photophobia, Retinal vein occlusion
Clinical narrative: On 04/02/2021, exactly 6 weeks after receiving my second dose of the Moderna vaccine, I went blind in my right eye suddenly and had extreme light sensitivity in my right eye. I was hospitalized for two days at medical center and bloodwork was completed due to right monocular vision changes. Bloodwork was normal for the most part. I am now under the care of doctor and I am diagnosed with Central Retinal Vein Occlusion (eye stroke). I am stull suffering with some peripheral vision loss in my right eye.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual field defect
Clinical narrative: On 04/02/2021, exactly 6 weeks after receiving my second dose of the Moderna vaccine, I went blind in my right eye suddenly and had extreme light sensitivity in my right eye. I was hospitalized for two days at medical center and bloodwork was completed due to right monocular vision changes. Bloodwork was normal for the most part. I am now under the care of doctor and I am diagnosed with Central Retinal Vein Occlusion (eye stroke). I am stull suffering with some peripheral vision loss in my right eye.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: Fainted twice. 2 minutes apart. Approx 5.5 hours after vaccinated. No other adverse reactions. Cannot ever remember fainting previously in 48 years, for any reason. Not concerned at this time, after reading information from cdc. Just wanted to contribute,  and not go unheard.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: After the normal fever symptoms the next two days after my second shot (limited nausea but lots of sinus pressure including a pretty bad tension headache at the beginning of the third day) concluded, I thought I was home free (the injection site is still a bit sore but now hardly noticeable, like a mild bruise). I had been consuming one ibuprofen every six hours starting immediately after my covid shot until mid way through the second day after. This evening, (around 10:00pm the third day after receiving the shot) I noticed a red rash had appeared on the front of the arm in which I had received my covid shot. It is red, hot to the touch, and stings when touched; it is an oblong shape approximately 4" in length, 1" wide at the bottom, and 3" wide at the top, ending about 2" above my elbow. So far all I've done about it is try not to touch it and put Aveeno Daily Moisturizing Lotion (fragrance free) on it. That seems to help with the burning, but when I stretch my arm up, the burning and slight stinging briefly intensify.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Paranasal sinus discomfort, Pyrexia, Tension headache
Clinical narrative: After the normal fever symptoms the next two days after my second shot (limited nausea but lots of sinus pressure including a pretty bad tension headache at the beginning of the third day) concluded, I thought I was home free (the injection site is still a bit sore but now hardly noticeable, like a mild bruise). I had been consuming one ibuprofen every six hours starting immediately after my covid shot until mid way through the second day after. This evening, (around 10:00pm the third day after receiving the shot) I noticed a red rash had appeared on the front of the arm in which I had received my covid shot. It is red, hot to the touch, and stings when touched; it is an oblong shape approximately 4" in length, 1" wide at the bottom, and 3" wide at the top, ending about 2" above my elbow. So far all I've done about it is try not to touch it and put Aveeno Daily Moisturizing Lotion (fragrance free) on it. That seems to help with the burning, but when I stretch my arm up, the burning and slight stinging briefly intensify.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Heart rate increased, Hyperhidrosis, Syncope
Clinical narrative: First I felt weak, difficult to breath, fast but weak heart beats, then I had sudden extensive sweating from all over my body, then I fainted for maybe half a minutes.  I started to regain consciousness after that.  My son helped me to lie down in the sofa, and I was able to recover slowly after that without treatment.  My heart beat also gradually slowed down after that event, but it was still about 108/minute when I was in bed at around 5pm that day (about 5 hours after I fainted).
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Magnetic resonance imaging, Tinnitus
Clinical narrative: Received the vaccine on Friday 1018/19 - monday morning 10/21 I woke up with no hearing in my right ear.  I saw my dr that day & was prescribed prednisone and valacyclovir.  She confirmed a sudden hearing loss and referred me to an ENT.  The ENT office scheduled an audio test on the 22nd with a follow up with the ENT Dr.   In addition to hearing loss I also developed tinnitus.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain in injection site, including redness around injection site.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Angiogram pulmonary normal, Arthralgia, Aspartate aminotransferase increased, Autoimmune disorder
Clinical narrative: Patient presented to urgent care with 3 days of pleuritic chest pain.  He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED.  Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago.  About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder.  No associated cough, dyspnea, sputum production, hemoptysis.  Chest pain is not associated with activity.  He does not describe chest pain with the positional change or laying down. no fever or chills.  He had 3 episodes of emesis this morning.  No abdominal pain, no diarrhea.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, Cardiac telemetry, Chest pain, Electrocardiogram T wave inversion
Clinical narrative: Patient presented to urgent care with 3 days of pleuritic chest pain.  He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED.  Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago.  About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder.  No associated cough, dyspnea, sputum production, hemoptysis.  Chest pain is not associated with activity.  He does not describe chest pain with the positional change or laying down. no fever or chills.  He had 3 episodes of emesis this morning.  No abdominal pain, no diarrhea.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer increased, Full blood count normal, Liver function test abnormal, Metabolic function test normal
Clinical narrative: Patient presented to urgent care with 3 days of pleuritic chest pain.  He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED.  Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago.  About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder.  No associated cough, dyspnea, sputum production, hemoptysis.  Chest pain is not associated with activity.  He does not describe chest pain with the positional change or laying down. no fever or chills.  He had 3 episodes of emesis this morning.  No abdominal pain, no diarrhea.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pain, Painful respiration, Pericarditis, Pleuritic pain
Clinical narrative: Patient presented to urgent care with 3 days of pleuritic chest pain.  He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED.  Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago.  About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder.  No associated cough, dyspnea, sputum production, hemoptysis.  Chest pain is not associated with activity.  He does not describe chest pain with the positional change or laying down. no fever or chills.  He had 3 episodes of emesis this morning.  No abdominal pain, no diarrhea.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Systemic immune activation, Troponin I increased, Vaccination complication, Vomiting
Clinical narrative: Patient presented to urgent care with 3 days of pleuritic chest pain.  He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED.  Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago.  About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder.  No associated cough, dyspnea, sputum production, hemoptysis.  Chest pain is not associated with activity.  He does not describe chest pain with the positional change or laying down. no fever or chills.  He had 3 episodes of emesis this morning.  No abdominal pain, no diarrhea.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Myocarditis, Troponin increased
Clinical narrative: Patient presented to urgent care with 3 days of pleuritic chest pain.  He had abnormal EKG with T wave inversions in V1 to V3, elevated D-dimer and elevated troponin. Sent to ED.  Patient received Pfizer Covid vaccine, first dose, approximately 2 weeks ago.  About 3 days ago he developed chest pain with breathing, located at the anterior chest and radiating to the left shoulder.  No associated cough, dyspnea, sputum production, hemoptysis.  Chest pain is not associated with activity.  He does not describe chest pain with the positional change or laying down. no fever or chills.  He had 3 episodes of emesis this morning.  No abdominal pain, no diarrhea.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody positive, Arthralgia, Blood test normal, C-reactive protein increased, Dizziness
Clinical narrative: Mild dizziness & muscle spasm in first 10 minutes of injections. On 4/24, muscle spasm returned & found rash on right arm. I began having joint/muscle pain mainly in knees and in my hands. On 5/3, I struggled with dizziness and nausea as well as the joint/muscle pain so I decided to go to urgent care. They ran some tests and I scheduled a follow up with my doctors office.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Muscle spasms, Myalgia, Nausea, Pain in extremity
Clinical narrative: Mild dizziness & muscle spasm in first 10 minutes of injections. On 4/24, muscle spasm returned & found rash on right arm. I began having joint/muscle pain mainly in knees and in my hands. On 5/3, I struggled with dizziness and nausea as well as the joint/muscle pain so I decided to go to urgent care. They ran some tests and I scheduled a follow up with my doctors office.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Red blood cell sedimentation rate normal
Clinical narrative: Mild dizziness & muscle spasm in first 10 minutes of injections. On 4/24, muscle spasm returned & found rash on right arm. I began having joint/muscle pain mainly in knees and in my hands. On 5/3, I struggled with dizziness and nausea as well as the joint/muscle pain so I decided to go to urgent care. They ran some tests and I scheduled a follow up with my doctors office.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Dyspnoea, Respiratory distress, Urticaria, Vomiting
Clinical narrative: The patient started vomiting about an hour after her second dose of Moderna.  She then got hives and took Benadryl.  Then she got short of breath and came to the ED.  She was in respiratory distress on arrival but not clear that this was asthma or anaphylaxis.  She was treated aggreassively with epi, solumedrol, albuterol, and epinephrine
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Runny nose, body aches, chills, bloating, kidney pain, sore arm, slight headache
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Rhinorrhoea
Clinical narrative: Runny nose, body aches, chills, bloating, kidney pain, sore arm, slight headache
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: approximately 24 hours post dose 2, patient suffered a witnessed syncopal event. He recovered relatively quickly and was brought in to clinic by bystanders. He is suffering no lingering effects 1 hour post event.
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired dose; This spontaneous report was received from a consumer and referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.     On 13-APR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 dose, lot # s024844, expiration date was 01-APR-2021) orally for prophylaxis.  Follow up information was received from a nurse on 04-MAY-2021. The details of the reporter and patient were updated. This was a 6-month-old (also reported as 7 months old) male patient. On 13-APR-2021, the patient was vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S024844) which was expired. The provider and the patient's mother were aware that. That dose remained effective. The patient was not reimmunized and remaining doses were removed from the office supply. No further vaccination needed. No digital data logger was involved.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic reaction, Breath sounds abnormal, Croup infectious, Throat tightness, Vaccination complication
Clinical narrative: anaphylactic reaction; Almost as he had croup; This spontaneous report was received from an unspecified reporter via Pfizer and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.   In 2010, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) (dose, vaccination site, route and lot# were not provided), for prophylaxis.    In 2010, the patient had a anaphylactic reaction to the MMR (measles, mumps, and rubella) vaccine. This reaction caused him to wound up in the emergency room 5 hours after having the vaccine, he received Epipen and breathing treatments as his throat was closing in and he had chest sounds, aImost as he had croup.  At the time of reporting, the outcome of anaphylactic reaction and croup infectious was unknown. The reporter considered anaphylactic reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown) but the reporter did not provided a causality assessment between croup and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown).  Upon internal review, croup and anaphylactic reaction were determined to be medically significant.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No other AE's reported; Customer reports administration of V ARlV AX and MMR II (stored in freezer) 19.3 F; This spontaneous report as received from a nurse and refers to a 12-month-old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medications provided. On 20-MAY-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, subcutaneously, lot # T027305, expiration date 12-AUG-2022 and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) 0.5 milliliter, subcutaneously, lot # S037497, expiration date 20-NOV-2021. Administered dose of vaccine experienced the temperature excursion of 19.3 degrees Fahrenheit for 1 hour 31 minutes. Data logger was involved. There were no previous excursions reported.
Age: 65.0
Sex: M
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Adverse reaction or side effect experienced: None; Pneumococcal vaccine administered on 23-MAY-2013 and on 03-AUG-2015; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for Zoster Vaccine Live (ZOSTAVAX) (MARRS# 2008USA002268), concerning a 67-year-old male patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 23-MAY-2013, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and on 03-AUG-2015, he received a dose of pneumococcal vaccine 13v (manufacturer unknown) (inappropriate schedule of product administration), both administered as prophylaxis (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported for both doses). No adverse effects were reported.; Sender's Comments:  US-009507513-2008USA002268:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; first dose of V AQT A on 12/2/2020 and the booster dose on 5/25/2021 which was a week sooner than 6 months; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 02-DEC-2021, the patient was vaccinated with the first dose of hepatitis A vaccine, inactivated (VAQTA) 0,5 milliliter, lot # T013546, expiration date 28-OCT-2021 (route of administration and anatomical location not provided). On 25-MAY-2021, the patient received second dose of hepatitis A vaccine, inactivated (VAQTA) 0,5 milliliter, lot # T013546, expiration date 28-OCT-2021 (route of administration and anatomical location not provided) (inappropriate schedule of vaccine administered). Both vaccines were administered for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Headache, Loss of consciousness, Nausea
Clinical narrative: Loss of consciousness; Dizziness; Ear discomfort; Pain; Headache; Nausea; This case was received via  VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Traumatic brain injury and Dizziness. Concurrent medical conditions included Allergy to grains, Fistula (TBI w bilateral perilymph fistula causing gluten issue was reported.) and Gluten intolerance (TBI w bilateral perilymph fistula causing gluten issue was reported.). Concomitant products included VIT D [VITAMIN D NOS].   On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), EAR DISCOMFORT (Ear discomfort), PAIN (Pain), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), EAR DISCOMFORT (Ear discomfort), PAIN (Pain), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided by the reported.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Patient passed out 8n bathroom from lain and nausea. She could left bed till 4pm that day due to body pain, chills and headache. 72 hours later still she had left ear full, very dizzy and slight nausea.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Loss of consciousness; Dizziness; Ear discomfort; Pain; Headache; Nausea; This case was received via  VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Traumatic brain injury and Dizziness. Concurrent medical conditions included Allergy to grains, Fistula (TBI w bilateral perilymph fistula causing gluten issue was reported.) and Gluten intolerance (TBI w bilateral perilymph fistula causing gluten issue was reported.). Concomitant products included VIT D [VITAMIN D NOS].   On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), EAR DISCOMFORT (Ear discomfort), PAIN (Pain), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), EAR DISCOMFORT (Ear discomfort), PAIN (Pain), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided by the reported.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Patient passed out 8n bathroom from lain and nausea. She could left bed till 4pm that day due to body pain, chills and headache. 72 hours later still she had left ear full, very dizzy and slight nausea.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site erythema, Pyrexia
Clinical narrative: Cellulitis; Injection site erythema; Pyrexia; This case was receivedon 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (Injection site erythema) and PYREXIA (Pyrexia). At the time of the report, CELLULITIS (Cellulitis) and INJECTION SITE ERYTHEMA (Injection site erythema) outcome was unknown and PYREXIA (Pyrexia) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other Meds :  Symptom Text : She had a fever 12 hours after 2nd dose of moderna vaccine and resolved after 2 days. She went to urgent care due to redness at injection site. She was told her had cellulitis and given antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Excessive eye blinking, Fall, Respiratory rate, Syncope
Clinical narrative: Syncope; Excessive eye blinking; Fall; This case was received via on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), EXCESSIVE EYE BLINKING (Excessive eye blinking) and FALL (Fall). At the time of the report, SYNCOPE (Syncope), EXCESSIVE EYE BLINKING (Excessive eye blinking) and FALL (Fall) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Respiratory rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pyrexia, Sepsis, White blood cell count
Clinical narrative: Sepsis; Pyrexia; This regulatory authority case was reported by an other health care professional and describes the occurrence of SEPSIS (Sepsis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Flu (seizure like activity). Past adverse reactions to the above products included Seizure with Flu. Concurrent medical conditions included Sulfonamide allergy (sulfa (Bactrim) facial swelling), Allergy (environmental allergies), Factor V Leiden mutation (TSVT) and Asthma. Concomitant products included METOPROLOL, WARFARIN and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced SEPSIS (Sepsis) (seriousness criterion medically significant) and PYREXIA (Pyrexia). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, SEPSIS (Sepsis) and PYREXIA (Pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Blood test: 1750 (Inconclusive) 1750. On 08-Feb-2021, White blood cell count: 2.4 (Inconclusive) 2.4. On 14-Feb-2021, Blood test: 26200 (Inconclusive) 26200. On 14-Feb-2021, White blood cell count: 5.82 (Inconclusive) 5.82.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded