chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Feeling abnormal, Feeling cold, Feeling drunk
Clinical narrative: Approx 15mins after having the shot administered I sat in my car and felt the medication coming on by it clouding my vision then causing me to faint (and by description from my fiancé) I had what appeared to be a mild seizure. I was out for a minute or two and when I was conscious again my vision was blurry and I felt very drunk for the next 45mins - hour. I also felt like I could taste the chemicals from the vaccine when I became conscious again.  The drunk/vertigo feeling subsided slowly over time but I was given a Benadryl from the pharmacist so I?m not sure when the dizziness stopped but I definitely could not drive home. My fainting was not due to any anxiety due to having a shot or anything, I was perfectly fine for approx 10-15 mins after the vaccine then I felt a cold feeling coming on from my right shoulder then up my neck then I got foggy and dizzy and passed out
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Syncope, Vertigo, Vision blurred
Clinical narrative: Approx 15mins after having the shot administered I sat in my car and felt the medication coming on by it clouding my vision then causing me to faint (and by description from my fiancé) I had what appeared to be a mild seizure. I was out for a minute or two and when I was conscious again my vision was blurry and I felt very drunk for the next 45mins - hour. I also felt like I could taste the chemicals from the vaccine when I became conscious again.  The drunk/vertigo feeling subsided slowly over time but I was given a Benadryl from the pharmacist so I?m not sure when the dizziness stopped but I definitely could not drive home. My fainting was not due to any anxiety due to having a shot or anything, I was perfectly fine for approx 10-15 mins after the vaccine then I felt a cold feeling coming on from my right shoulder then up my neck then I got foggy and dizzy and passed out
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Muscle spasms, Pain
Clinical narrative: Widespread muscle spasms, pain and weakness over about 1/2 hour. I had a similar, yet more severe reaction to chemo and neulasta.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: I started my symptoms on third but only morning on the fourth I started to get bleeding through my nose I woke up and somebody was coming out from the liquid was coming out from my nose so I went to the bathroom and signed a glass of wine with the bleeding and then I cleaned it out I put some ice I took a Tylenol and then I?m gonna contact the city is the Pfizer . Pfizer customer service representative took down my details what happened and all the symptoms and he told me that one of their medical team will call me to discuss about it but nobody called me so afterwords I call the CDC and ask them if this is normal they told me that it is all listed on the list which they have of the side effects then I called the nurse helpline and she told me that I was the second third patient who?s complaining about a nose bleeding she asked me whether I had any allergies or in anything like that but I don?t have no allergies at this the first time it started and since then my nose is bleeding at least twice but rice a day deal dated and I?m off from work from there
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anger
Clinical narrative: Rage for about 30 minutes. This happens about 2 days following flu vaccines as well
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphagia, Fatigue, Hyperhidrosis
Clinical narrative: 1st Day - 15 Apr 2021: Scratchy throat, sneezing  2nd Day - 16 Apr 2021: Sore throat (difficult to swallow), post-nasal drainage, nausea, fatigue, body aches, hard to get out of bed. 3rd Day - 17 Apr 2021: Same as day 2 plus chills, periods of sweating, stayed in bed most of day. 4th Day - 18 Apr 2021: Fatigue, nausea, slight cough, body aches.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: 1st Day - 15 Apr 2021: Scratchy throat, sneezing  2nd Day - 16 Apr 2021: Sore throat (difficult to swallow), post-nasal drainage, nausea, fatigue, body aches, hard to get out of bed. 3rd Day - 17 Apr 2021: Same as day 2 plus chills, periods of sweating, stayed in bed most of day. 4th Day - 18 Apr 2021: Fatigue, nausea, slight cough, body aches.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing, Throat irritation
Clinical narrative: 1st Day - 15 Apr 2021: Scratchy throat, sneezing  2nd Day - 16 Apr 2021: Sore throat (difficult to swallow), post-nasal drainage, nausea, fatigue, body aches, hard to get out of bed. 3rd Day - 17 Apr 2021: Same as day 2 plus chills, periods of sweating, stayed in bed most of day. 4th Day - 18 Apr 2021: Fatigue, nausea, slight cough, body aches.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dry mouth, Dyspnoea, Hypoaesthesia oral
Clinical narrative: After I arrived home I started having swelling burning numbness on my tongue,  extreme dry mouth 3 months later and after much tests and treatment it?s still ongoing. I also had dizziness and shortness of breath for about 3 weeks.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue discomfort
Clinical narrative: After I arrived home I started having swelling burning numbness on my tongue,  extreme dry mouth 3 months later and after much tests and treatment it?s still ongoing. I also had dizziness and shortness of breath for about 3 weeks.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Agitation, Cardiac failure, Chest pain, Condition aggravated
Clinical narrative: Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 2/13/21. Patient then presented to the ED on 2/15/21 for chest pain and shortness of breath. In the ED, he was noted to be agitated and have altered mental status. He was intubated in the ED for airway protection and started on Propofol for sedation. Patient was also found to be hypervolemic on admission, consistent with heart failure exacerbation. During his hospitalization, he underwent diuresis, but also developed acute renal failure requiring hemodialysis x2, and continues to have persistent encephalopathy despite cessation of sedation on 2/23/21. Patient was also treated for cavitating pneumonia with 7 days of cefepime. He had a tracheostomy done on 3/1. He has not received his 2nd dose of the COVID-19 vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Encephalopathy, Endotracheal intubation, Haemodialysis, Hypervolaemia
Clinical narrative: Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 2/13/21. Patient then presented to the ED on 2/15/21 for chest pain and shortness of breath. In the ED, he was noted to be agitated and have altered mental status. He was intubated in the ED for airway protection and started on Propofol for sedation. Patient was also found to be hypervolemic on admission, consistent with heart failure exacerbation. During his hospitalization, he underwent diuresis, but also developed acute renal failure requiring hemodialysis x2, and continues to have persistent encephalopathy despite cessation of sedation on 2/23/21. Patient was also treated for cavitating pneumonia with 7 days of cefepime. He had a tracheostomy done on 3/1. He has not received his 2nd dose of the COVID-19 vaccine.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Mental status changes, Pneumonia, Polyuria, Pulmonary cavitation, Tracheostomy
Clinical narrative: Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 2/13/21. Patient then presented to the ED on 2/15/21 for chest pain and shortness of breath. In the ED, he was noted to be agitated and have altered mental status. He was intubated in the ED for airway protection and started on Propofol for sedation. Patient was also found to be hypervolemic on admission, consistent with heart failure exacerbation. During his hospitalization, he underwent diuresis, but also developed acute renal failure requiring hemodialysis x2, and continues to have persistent encephalopathy despite cessation of sedation on 2/23/21. Patient was also treated for cavitating pneumonia with 7 days of cefepime. He had a tracheostomy done on 3/1. He has not received his 2nd dose of the COVID-19 vaccine.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Anticoagulant therapy, Basophil count decreased, Basophil percentage, Blood albumin normal
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood cholesterol increased
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood triglycerides normal, Blood urea decreased, Carbon dioxide normal, Eosinophil percentage, Glomerular filtration rate decreased
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin normal, Haematocrit normal, Haemoglobin normal, High density lipoprotein increased, Immunoglobulins
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Low density lipoprotein decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Mesenteric vein thrombosis, Neutrophil count normal, Pain, Platelet count normal, Protein total normal
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal, Thrombectomy
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Very low density lipoprotein normal, White blood cell count normal
Clinical narrative: VTE legs, large intestine, & lungs  Narrative:  Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Skin discolouration
Clinical narrative: Moderna COVID-19 Vaccine EUA. Round, pink spots on torso. Growing in size and number since first appearance about two weeks after shot. Start as small dot. Largest now several inches across (on back). Flat surface, no scaling, no iching, no pain. No treatment.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Dyspnoea at rest, Dyspnoea exertional, Fatigue
Clinical narrative: #1 post vaccine low BP in post 30 minutes 48 hs of pain local, tired/headache/aches  #2 Internal local pain followed by 48-72 of tired, HA, chills fever- continued fatigue since then. congestion for past 10 day- onset Dyspnea at activity/rest since 4/16/2021.  sent to emergency room.  T= 97.7 PO=100% BP 110/64 P= 72 R= 18
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Pain, Pyrexia, Respiratory tract infection
Clinical narrative: #1 post vaccine low BP in post 30 minutes 48 hs of pain local, tired/headache/aches  #2 Internal local pain followed by 48-72 of tired, HA, chills fever- continued fatigue since then. congestion for past 10 day- onset Dyspnea at activity/rest since 4/16/2021.  sent to emergency room.  T= 97.7 PO=100% BP 110/64 P= 72 R= 18
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: #1 post vaccine low BP in post 30 minutes 48 hs of pain local, tired/headache/aches  #2 Internal local pain followed by 48-72 of tired, HA, chills fever- continued fatigue since then. congestion for past 10 day- onset Dyspnea at activity/rest since 4/16/2021.  sent to emergency room.  T= 97.7 PO=100% BP 110/64 P= 72 R= 18
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Multiple sclerosis, Neuralgia, Pain
Clinical narrative: Approximately 24 hours after 2nd vaccine, I woke with excruciating, neuropathic pain along front and back torso that felt like a burning, stabbing and squeezing pain known to me as "multiple sclerosis hug." There was no itching, only pain. This lasted for approximately 48 hours.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood thyroid stimulating hormone, Fatigue, Myalgia
Clinical narrative: Fatigue, joint pain, myalgias x weeks, lot TSH, being evaluated by specialist
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: ON 4/16/21 @ 6:28 PM, PHARMacist completing this  FoRM IMMUNIZED patient with MODERNA Vaccine. At 6:32 pm, patient Complained oF FeeLing OF Swelling OF Lips. At 6:33 p.m. patient Received 25 mg po DipHenhyDRamine LiQuid. OBserved x; 40 Minutes, At Which time patient claimed to Be Feelin Well. I RECOMMENDED THAT SHE aRRaNge FOR TRANSPORTATION HOMe. Additional information: ADViseD tHAt ADMINIStRAted DiPHeNhyDRamine Could Likely Cause Drowsiness ADVised to Follow-up with pharmacist ON Duty THe Following Day (4-17-21) with ANy Concerns OR Questions-
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest pain, Dizziness, Feeling hot, Heart rate increased
Clinical narrative: Patient reported intermittent dizziness, light-headedness and tightness in throat approximately 20 minutes after vaccination was administered. Oral benadryl 50 mg and famotidine 20 mg were given on site. Patient was able to maintain conversation and normal breathing rate. Out of precaution, patient was taken to ED for further evaluation where she was given a prescription for methylprednisone 4 mg dose pack.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pharyngeal swelling, Swelling, Throat tightness
Clinical narrative: Patient reported intermittent dizziness, light-headedness and tightness in throat approximately 20 minutes after vaccination was administered. Oral benadryl 50 mg and famotidine 20 mg were given on site. Patient was able to maintain conversation and normal breathing rate. Out of precaution, patient was taken to ED for further evaluation where she was given a prescription for methylprednisone 4 mg dose pack.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Throat tightness
Clinical narrative: Patient reported intermittent dizziness, light-headedness and tightness in throat approximately 20 minutes after vaccination was administered. Oral benadryl 50 mg and famotidine 20 mg were given on site. Patient was able to maintain conversation and normal breathing rate. Out of precaution, patient was taken to ED for further evaluation where she was given a prescription for methylprednisone 4 mg dose pack.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pelvic venous thrombosis, Thrombectomy, Ultrasound Doppler abnormal
Clinical narrative: DVT (Phlegm Asia Cerulean Dolmens); This is a spontaneous report from a contactable health care professional (patient). This 30-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) at single dose via an unknown route in left arm on 27Jan2021 12:00 PM for Covid-19 immunization. Medical history included urinary tract infection. Family history included chronic kidney disease (CKD). No other vaccine in four weeks. No Covid prior vaccination. Other medications in two weeks included spironolactone 50 mg, daily. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route in left arm on 06Jan2021 17:30 for Covid-19 immunization.  The patient experienced DVT (Phlegm Asia Cerulean Dolans) on 29Jan2021 05:00 AM. AE resulted in Emergency room/department or urgent care, and was serious due to hospitalization and life threatening illness (immediate risk of death from the event). The event resulted in 2-day hospitalization. Known allergies included and had reaction (hives) to apixaban (ELIQUIS) upon discharge from hospital after thrombectomy. Covid tested (saliva) post vaccination on 13Feb2021was negative. The event treatment included thrombolysis, thrombectomy. Outcome of the event was resolved with sequel (reported as recovered with lasting effects).; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event deep vein thrombosis occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, SARS-CoV-2 test
Clinical narrative: DVT (Phlegm Asia Cerulean Dolmens); This is a spontaneous report from a contactable health care professional (patient). This 30-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262) at single dose via an unknown route in left arm on 27Jan2021 12:00 PM for Covid-19 immunization. Medical history included urinary tract infection. Family history included chronic kidney disease (CKD). No other vaccine in four weeks. No Covid prior vaccination. Other medications in two weeks included spironolactone 50 mg, daily. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3248) at single dose via an unknown route in left arm on 06Jan2021 17:30 for Covid-19 immunization.  The patient experienced DVT (Phlegm Asia Cerulean Dolans) on 29Jan2021 05:00 AM. AE resulted in Emergency room/department or urgent care, and was serious due to hospitalization and life threatening illness (immediate risk of death from the event). The event resulted in 2-day hospitalization. Known allergies included and had reaction (hives) to apixaban (ELIQUIS) upon discharge from hospital after thrombectomy. Covid tested (saliva) post vaccination on 13Feb2021was negative. The event treatment included thrombolysis, thrombectomy. Outcome of the event was resolved with sequel (reported as recovered with lasting effects).; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event deep vein thrombosis occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Committees and Investigators, as appropriate.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Confusional state, Transient ischaemic attack
Clinical narrative: Stroke(s), death
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: Stroke(s), death
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Discomfort, Feeling hot, Muscle spasms
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Arthralgia, Balance disorder, Blood creatine phosphokinase normal, Blood folate normal
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium normal, Blood thyroid stimulating hormone normal, Burning sensation, C-reactive protein normal, Differential white blood cell count normal
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dyskinesia, Dysphemia, Dyspnoea, Fatigue
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Headache, Hypoaesthesia, Inflammatory marker test, Magnetic resonance imaging head abnormal
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal abnormal, Magnetic resonance imaging thoracic normal, Metabolic function test, Muscle spasms, Muscle twitching
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Procalcitonin normal, Skin tightness, Speech disorder, Vision blurred, Vitamin B12 normal
Clinical narrative: 01/12/21 Brief pricking pain in left hip with mild cramping in left foot. 01/16/21  4 days later I experienced discomfort with burning,tingling radiating sensations in both knees,lower legs and feet for a few minutes. 01/22/21 symptoms returned and remained or more than 24 hours. After subsiding for several hours they returned 01/24/21 but progressed overnight up thighs to buttocks with 4 soft BM during night.01/25/21 I walked in to see PCP to report symptoms,exam and lab work drawn.01/27/21 tingling was experienced to upper thighs buttocks,perineum ,scapulae ,and fingers bilaterally,lasted briefly. 01/29/21 tingling in face. 02/01/21 pain in both arms. 02/02/21 weakness in legs,burning and cramping in both feet.02/04/21buttocks and thighs feeling heavy,tightness,numbness around nose,eyes and ear lobes,fatigue. 02/10/21 burning and tingling in 4th and 5th fingers of both hands radiating to elbows,hands unsteady. 02/12/21 MRI of brain and spine done,admitted to Hospital for worsening of symptoms including unsteadiness on feet, discharged 02/13/21. 02/14/21 Tingling in lips,tongue,speech halting and stuttering,head jerking,face twitching,shortness of breath,pounding heart. Speech abnormality returned on at least 6 different occasions. Mild headache,blurred vision,tightness in face,around eyes are occasional and transient since 03/22/21.Tingling and burning in feet and lower extremities and sporadic joint pain continue on and off with unsteadiness on feet and fatigue
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Nausea, Vomiting
Clinical narrative: small allergic reaction at injection site - pink area around site nausea alleviated after taking anti- nausea med Benadryl taken  Symptoms alleviated that evening next day - severe neck, hip, low back pain.  Difficulty walking Pain in joints still present - more hip, low back, knees - not constant but intermittent- especially after sitting for more than 20 minutes
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Injection site erythema, Loss of personal independence in daily activities
Clinical narrative: small allergic reaction at injection site - pink area around site nausea alleviated after taking anti- nausea med Benadryl taken  Symptoms alleviated that evening next day - severe neck, hip, low back pain.  Difficulty walking Pain in joints still present - more hip, low back, knees - not constant but intermittent- especially after sitting for more than 20 minutes
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain
Clinical narrative: small allergic reaction at injection site - pink area around site nausea alleviated after taking anti- nausea med Benadryl taken  Symptoms alleviated that evening next day - severe neck, hip, low back pain.  Difficulty walking Pain in joints still present - more hip, low back, knees - not constant but intermittent- especially after sitting for more than 20 minutes
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Rash pruritic
Clinical narrative: Several days after the vaccination I developed pulsatile tinnitus. No apparent hearing loss. It seems to be resolving in that the tinnitus is less loud and somewhat less frequent.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Several days after the vaccination I developed pulsatile tinnitus. No apparent hearing loss. It seems to be resolving in that the tinnitus is less loud and somewhat less frequent.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Acute myocardial infarction, Antiphospholipid syndrome, Atrial fibrillation, Biliary dilatation
Clinical narrative: Patient died on 2/27/2021 of Catastrophic Antiphospholipid syndrome at the Medical Center. She had no history of blood clots or of an autoimmune syndrome in Medical records. After the shot on 1/29/2021 patient self reported on 02/02/2021 "aches and palpitations in pelvis" Next day she noted "felt gastritus,,soreness under ribs and could not get a deep breath". Her condition continued to deteriorate and when she got diarrhea she called her doctor who recommended a Covid-19 test. Patient got that test on 02/10/2021 (negative result). Her condition continued to worsen adding new symptoms of vomiting and extreme tiredness. such that she got a doctors appointment for 02/15/2021.   On 02/15/2021 patient's condition deteriorated rapidly in the early afternoon before her appointment such that she was mentally disoriented and unable to concentrate; and was physically so weak and unsteady that she had to be assisted in her walking and needed a wheel chair by the time of the appointment. Patient was sent to the emergency room at Hospital and later transferred to Medical Center. Her admission notes at Medical Center list the first Assessment as Thrombus (pages of Electronic records). "Patient presents with concern for thrombus in both venous (splenic, SMV, portal vein) and arterial supplies (renal). --" Further on in paragraph entitled "Assessment and Plan" of the ER report at hospital the record says in part" "This is a 77 y.o. female with fatigue, nausea, vomiting. Found to have abdominal discomfort on examination. Labs and CT scans show multiple derangements. Etiology is uncertain. Most likely represents an embolic phenomenon of some kind." (Note that phenomenon can involve an autoimmune response.)   Patient had gone to the hospital ER on 10/20/2020. The medical records for that visit start including all lab tests. Essentially this all dealt with her lightheadedness and tachycardia. She had follow up visits on 10/23/2020; 11/17/2020 and finally on 01/26/2021. The doctor's report on that last visit noted with regard to the tachycardia that patient has been asymptomatic since using metoprolol succinate and noted any fatigue and lightheadedness may be due to medication and suggested cutting the dose in half. The hypertension was strongly suspected to be "white coat hypertension"; Osteopenia was stable and the cyst benign. There were no other medical conditions noted.   These facts prove that it is more likely than not that the Moderna Vaccine is the most likely cause of patient's embolic phenomenon or that the vaccine triggered an asymptomatic reaction causing the embolic phenomenon.  Please add a warning to Moderna Fact sheet for patients and providers to save a life!  SEEK IMMEDIATE MEDICAL ATTENTION IF YOU DEVELOP PERSISTENT ABDOMINAL PAIN; DIARRHEA; SHORTNESS OF BREATH; VOMITING; EXHAUSTION; OR MENTAL DISORIENTATION  TWO WEEKS after vaccination!