chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Night sweats, Tension
Clinical narrative: hot flashes; night sweats; Missed menstrual periods; tension; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Physical & mental fatigue lasting daily for 14 days/physical exhaustion; Muscle cramping; Severe migraines; The initial safety information received was reporting only non-serious adverse drug reactions, upon receipt of follow-up information on 25Oct2021, this case now contains serious adverse reactions. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received bnt162b2, dose 1 intramuscular, administered in left arm on 03Sep2021 14:30 (Lot Number: FC3184; Expiration Date: 31Oct2021) as single for COVID-19 immunization at the age of 30 years old. Medical history included attention deficit hyperactivity disorder (ADHD) from 15May2011 and ongoing, generalized anxiety from 01Apr2011 and ongoing, premenstrual dysphoric disorder (PMDD) from 01Feb2012 and ongoing, Herpes Simplex Type 1 from 12Feb2012 and ongoing, birthcontrol from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, and genital herpes from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control from 2018 and ongoing; alprazolam taken for anxiety from 2016 and ongoing; and valaciclovir hydrochloride (VALTREX) taken for genital herpes from 2012 and ongoing. The patient experienced severe hot flashes 4-8x daily (persisting issue since 1st dose of vaccine), severe night sweats 1-4x per night (persisting issue since 1st dose of vaccine) and missed menstrual periods (persisting issue since 1st dose of vaccine) - 2 menstrual cycles with missed period to date on 04Sep2021 09:45 with outcome of not recovered. Events reported as serious important medical event. The patient also experienced tension, physical & mental fatigue lasting daily for 14 days/physical exhaustion in both left & right legs (from upper thighs to both feet) lasting daily for 3 days, muscle cramping, and severe migraines 3-5x/week for 2 weeks on 04Sep2021 09:45 with outcome of recovered with sequelae. All events required Doctor or other healthcare professional office/clinic visit. No treatment needed for the events nor hospitalization. The patient received the second dose (lot no. - FF2589) on 25Sep2021 15:00, intramuscular in the left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt had previous hospitalization (9/26 - 9/28/21) for positive COVID test and hypoxia, treated with steroids and antibiotics, illness was improving and pt was sent home; presents to ED with increasing weakness and SOB past 2 days; fell yesterday and hurt back; O2 sats on RA in 70s and low 80s; did not tolerate BiPAP, placed on HF NC; pt requested comfort care; condition worsened and pt died in the hospital
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back injury, COVID-19, Death, Dyspnoea
Clinical narrative: pt had previous hospitalization (9/26 - 9/28/21) for positive COVID test and hypoxia, treated with steroids and antibiotics, illness was improving and pt was sent home; presents to ED with increasing weakness and SOB past 2 days; fell yesterday and hurt back; O2 sats on RA in 70s and low 80s; did not tolerate BiPAP, placed on HF NC; pt requested comfort care; condition worsened and pt died in the hospital
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Hypoxia, Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: pt had previous hospitalization (9/26 - 9/28/21) for positive COVID test and hypoxia, treated with steroids and antibiotics, illness was improving and pt was sent home; presents to ED with increasing weakness and SOB past 2 days; fell yesterday and hurt back; O2 sats on RA in 70s and low 80s; did not tolerate BiPAP, placed on HF NC; pt requested comfort care; condition worsened and pt died in the hospital
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Migraine
Clinical narrative: 2nd covid vaccine 9/24/2021 (pfizer)- headaches since. No issues with headaches prior to this. No prior h/o headaches at all.   Top front of head, severe sense of pressure, head being pushed on- pain strong, heavy, feels like pushing down into body.   headache started 9/28/2021 to 9/30/2021. All day long headache. Headaches did not wake pt from sleep.  Sleep feels super heavy when sleeps- like she won't wake up. Overall increased fatigue. 10/3-10/4, 10/7,10/8, 10/12, 10/13, 10/14- full days with ha (8 hr in duration) 10/22, 10/28- 8 hr ha with severe vertigo 10/18, 10/19, 10/21, 10/25, 10/26, 10/30, 11/2, 11/3, 11/7, 11/8- headaches not as severe, 2 hr in length  when HA severe- dizziness, at times full room moving, can't walk, can't do things, needing to go down stairs on butt d/t unsteadiness.  HA often occur after eating. 11/3- went to dinner with friend. Started to feel not good, start of HA. By time got home- increased dizziness, incoherent speech (denies any alcohol intake). Spouse worried. Went to sleep, woke up fine.   LMP- 10/28- 11/2/2021. Periods normal timing, but symptoms of period different since vaccination. Periods very heavy for 3 days (lots of clots), then spotting last 2.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Blood iron, Blood magnesium, Blood thyroid stimulating hormone, Dizziness
Clinical narrative: 2nd covid vaccine 9/24/2021 (pfizer)- headaches since. No issues with headaches prior to this. No prior h/o headaches at all.   Top front of head, severe sense of pressure, head being pushed on- pain strong, heavy, feels like pushing down into body.   headache started 9/28/2021 to 9/30/2021. All day long headache. Headaches did not wake pt from sleep.  Sleep feels super heavy when sleeps- like she won't wake up. Overall increased fatigue. 10/3-10/4, 10/7,10/8, 10/12, 10/13, 10/14- full days with ha (8 hr in duration) 10/22, 10/28- 8 hr ha with severe vertigo 10/18, 10/19, 10/21, 10/25, 10/26, 10/30, 11/2, 11/3, 11/7, 11/8- headaches not as severe, 2 hr in length  when HA severe- dizziness, at times full room moving, can't walk, can't do things, needing to go down stairs on butt d/t unsteadiness.  HA often occur after eating. 11/3- went to dinner with friend. Started to feel not good, start of HA. By time got home- increased dizziness, incoherent speech (denies any alcohol intake). Spouse worried. Went to sleep, woke up fine.   LMP- 10/28- 11/2/2021. Periods normal timing, but symptoms of period different since vaccination. Periods very heavy for 3 days (lots of clots), then spotting last 2.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Gait inability, Head discomfort, Headache
Clinical narrative: 2nd covid vaccine 9/24/2021 (pfizer)- headaches since. No issues with headaches prior to this. No prior h/o headaches at all.   Top front of head, severe sense of pressure, head being pushed on- pain strong, heavy, feels like pushing down into body.   headache started 9/28/2021 to 9/30/2021. All day long headache. Headaches did not wake pt from sleep.  Sleep feels super heavy when sleeps- like she won't wake up. Overall increased fatigue. 10/3-10/4, 10/7,10/8, 10/12, 10/13, 10/14- full days with ha (8 hr in duration) 10/22, 10/28- 8 hr ha with severe vertigo 10/18, 10/19, 10/21, 10/25, 10/26, 10/30, 11/2, 11/3, 11/7, 11/8- headaches not as severe, 2 hr in length  when HA severe- dizziness, at times full room moving, can't walk, can't do things, needing to go down stairs on butt d/t unsteadiness.  HA often occur after eating. 11/3- went to dinner with friend. Started to feel not good, start of HA. By time got home- increased dizziness, incoherent speech (denies any alcohol intake). Spouse worried. Went to sleep, woke up fine.   LMP- 10/28- 11/2/2021. Periods normal timing, but symptoms of period different since vaccination. Periods very heavy for 3 days (lots of clots), then spotting last 2.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Incoherent, Loss of personal independence in daily activities, Lyme disease, Magnetic resonance imaging head
Clinical narrative: 2nd covid vaccine 9/24/2021 (pfizer)- headaches since. No issues with headaches prior to this. No prior h/o headaches at all.   Top front of head, severe sense of pressure, head being pushed on- pain strong, heavy, feels like pushing down into body.   headache started 9/28/2021 to 9/30/2021. All day long headache. Headaches did not wake pt from sleep.  Sleep feels super heavy when sleeps- like she won't wake up. Overall increased fatigue. 10/3-10/4, 10/7,10/8, 10/12, 10/13, 10/14- full days with ha (8 hr in duration) 10/22, 10/28- 8 hr ha with severe vertigo 10/18, 10/19, 10/21, 10/25, 10/26, 10/30, 11/2, 11/3, 11/7, 11/8- headaches not as severe, 2 hr in length  when HA severe- dizziness, at times full room moving, can't walk, can't do things, needing to go down stairs on butt d/t unsteadiness.  HA often occur after eating. 11/3- went to dinner with friend. Started to feel not good, start of HA. By time got home- increased dizziness, incoherent speech (denies any alcohol intake). Spouse worried. Went to sleep, woke up fine.   LMP- 10/28- 11/2/2021. Periods normal timing, but symptoms of period different since vaccination. Periods very heavy for 3 days (lots of clots), then spotting last 2.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Metabolic function test, Serum ferritin, Sleep disorder, Thyroxine
Clinical narrative: 2nd covid vaccine 9/24/2021 (pfizer)- headaches since. No issues with headaches prior to this. No prior h/o headaches at all.   Top front of head, severe sense of pressure, head being pushed on- pain strong, heavy, feels like pushing down into body.   headache started 9/28/2021 to 9/30/2021. All day long headache. Headaches did not wake pt from sleep.  Sleep feels super heavy when sleeps- like she won't wake up. Overall increased fatigue. 10/3-10/4, 10/7,10/8, 10/12, 10/13, 10/14- full days with ha (8 hr in duration) 10/22, 10/28- 8 hr ha with severe vertigo 10/18, 10/19, 10/21, 10/25, 10/26, 10/30, 11/2, 11/3, 11/7, 11/8- headaches not as severe, 2 hr in length  when HA severe- dizziness, at times full room moving, can't walk, can't do things, needing to go down stairs on butt d/t unsteadiness.  HA often occur after eating. 11/3- went to dinner with friend. Started to feel not good, start of HA. By time got home- increased dizziness, incoherent speech (denies any alcohol intake). Spouse worried. Went to sleep, woke up fine.   LMP- 10/28- 11/2/2021. Periods normal timing, but symptoms of period different since vaccination. Periods very heavy for 3 days (lots of clots), then spotting last 2.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vitamin B12
Clinical narrative: 2nd covid vaccine 9/24/2021 (pfizer)- headaches since. No issues with headaches prior to this. No prior h/o headaches at all.   Top front of head, severe sense of pressure, head being pushed on- pain strong, heavy, feels like pushing down into body.   headache started 9/28/2021 to 9/30/2021. All day long headache. Headaches did not wake pt from sleep.  Sleep feels super heavy when sleeps- like she won't wake up. Overall increased fatigue. 10/3-10/4, 10/7,10/8, 10/12, 10/13, 10/14- full days with ha (8 hr in duration) 10/22, 10/28- 8 hr ha with severe vertigo 10/18, 10/19, 10/21, 10/25, 10/26, 10/30, 11/2, 11/3, 11/7, 11/8- headaches not as severe, 2 hr in length  when HA severe- dizziness, at times full room moving, can't walk, can't do things, needing to go down stairs on butt d/t unsteadiness.  HA often occur after eating. 11/3- went to dinner with friend. Started to feel not good, start of HA. By time got home- increased dizziness, incoherent speech (denies any alcohol intake). Spouse worried. Went to sleep, woke up fine.   LMP- 10/28- 11/2/2021. Periods normal timing, but symptoms of period different since vaccination. Periods very heavy for 3 days (lots of clots), then spotting last 2.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss/shedding starting approximately one week after the first dose; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0162) via an unspecified route of administration in the left arm on 17Apr2021 at 09:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) 150 mcg for an unspecified indication from an unknown date and unknown if ongoing. On 24Apr2021 at 09:00, approximately one week after the first dose, the patient experienced hair loss/shedding. The hair shedding was evenly distributed over entire scalp. Shedding occurred every day with most hair falling out in the shower and when combing. She had lost approximately 50% of her hair. Six months after the first dose, her hair was still falling out. The event resulted in doctor/other health care professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hair loss/shedding starting approximately one week after the first dose was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 08May2021 at 09:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Parotitis
Clinical narrative: Patient developed a 3x3 cm submandibular mass that began within 48-72h of his Pfizer covid booster. Tender, no fevers or other symptoms (sore throat, nasal congestion, cough). Had US yesterday followed by CT showing asymmetric enlargement of the L parotid with overlying induration of the SQ fat and thickening of platysma muscle, consistent with parotitis. No evidence of collection or obstruction/stone or lymphadenopathy. Swelling goes down with ibuprofen then recurs.   He found some case reports of covid causing parotitis so got a covid test (negative)   We discussed the possibility of a post vaccination inflammatory response, which is now 17 days out from his vaccination. NSAIDS are a reasonable approach.   He is about to travel to a conference in State tomorrow. I prescribed Augmentin in the event that he develops fever or drainage while away, but we agreed to observe for now.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram neck, Induration, Mandibular mass, Parotid gland enlargement, Parotitis
Clinical narrative: Patient developed a 3x3 cm submandibular mass that began within 48-72h of his Pfizer covid booster. Tender, no fevers or other symptoms (sore throat, nasal congestion, cough). Had US yesterday followed by CT showing asymmetric enlargement of the L parotid with overlying induration of the SQ fat and thickening of platysma muscle, consistent with parotitis. No evidence of collection or obstruction/stone or lymphadenopathy. Swelling goes down with ibuprofen then recurs.   He found some case reports of covid causing parotitis so got a covid test (negative)   We discussed the possibility of a post vaccination inflammatory response, which is now 17 days out from his vaccination. NSAIDS are a reasonable approach.   He is about to travel to a conference in State tomorrow. I prescribed Augmentin in the event that he develops fever or drainage while away, but we agreed to observe for now.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Tenderness, Ultrasound Doppler abnormal, Ultrasound scan abnormal
Clinical narrative: Patient developed a 3x3 cm submandibular mass that began within 48-72h of his Pfizer covid booster. Tender, no fevers or other symptoms (sore throat, nasal congestion, cough). Had US yesterday followed by CT showing asymmetric enlargement of the L parotid with overlying induration of the SQ fat and thickening of platysma muscle, consistent with parotitis. No evidence of collection or obstruction/stone or lymphadenopathy. Swelling goes down with ibuprofen then recurs.   He found some case reports of covid causing parotitis so got a covid test (negative)   We discussed the possibility of a post vaccination inflammatory response, which is now 17 days out from his vaccination. NSAIDS are a reasonable approach.   He is about to travel to a conference in State tomorrow. I prescribed Augmentin in the event that he develops fever or drainage while away, but we agreed to observe for now.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood glucose normal, Chest X-ray normal, Chest pain
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Full blood count, Hyperhidrosis, Inappropriate schedule of product administration
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Intensive care, Metabolic function test, Monocyte count increased, Myocarditis, Nausea
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count normal, SARS-CoV-2 test negative, Sinus bradycardia, Troponin increased, White blood cell count normal
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase increased, Blood cholesterol decreased, Blood creatine phosphokinase, Blood triglycerides normal, Brain natriuretic peptide normal
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment abnormal
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeding disorder, Haematocrit increased, Haemoglobin normal, Headache, Hyperhidrosis
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Monocyte percentage increased, Nausea, Platelet count normal, QRS axis abnormal, Red blood cell sedimentation rate normal
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sinus arrhythmia, Sinus bradycardia, Sleep disorder, Troponin I increased
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased, White blood cell count normal
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Patient started having acute sharp chest pain the day after he received his 2nd covid vaccine dose, Patient complained about chest pain, nausea and sweating. At ED patient was afebrile HR 68, BP112/70 SATS 97%.  CBC Showed WBC 7.5 with Monocytes elevated at 11.4% H/ H 15.1/44.6 plt 218. CMP remarkable for glucose 113, AST elevated to 43 CK 197. COVID Negative, Chest Xray no acute process. Initial Tropononin 1.190 EKG sinus brady w/ RAD no ST elevation. Given 30ml of Mal Al suspension, 0.125mg hyoscyamine, 15mg Toradol and 324mg of Aspirin. Patient was transferred and admitted to PICU for Myocarditis. Initial Troponin was 4.38. Cardiology was consulted and recommended trops q 8 hours, repeated EKG and ECHO were WNL.  Troponins trended down 2.85,2.69,3.58, then final 1.85.  Patient was placed on Ibuprofen 400mg q8gh, Aspirin 81mg qday and GI prophylaxis with Famotidine 20mg BID.  Patient stayed in the hospital 2 days from 10/23/21 to 10/25/21 Cardiology followed patient a week later after discharged from Hospital, his troponin levels were normal <0.012 on 10/29/21, was doing better and did not have any recurrent pains, EKG on 11/1/21 showed sinus rhythm with normal intervals and forces for age, ECHO on 11/1/21 showed structurally normal heart.  Patient was continued on Ibuprofen for 6 more days the stopped.  Aspirin also was stopped.  No physical activity until further notice. Follow up visit in 4 weeks with another troponin level and fasting lipid profile .  Patient Received his first covid vaccine aprox 2 months prior second dose on 8/23/21 and consulted to PCP a week later for 4 days symptoms of diarrhea, headaches, body aches, pruritus and rash, patient states symptoms started 2 days after the vaccine but also ate fish that he thinks was spoiled. 20 days After first covid vaccine patient received MenB vaccine Bexero   Note: Previously before both vaccine doses patient was being treated with antibiotics due to infectious processes ( one to 2 weeks prior to doses)
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Muscle spasms, Muscle twitching
Clinical narrative: twitching in both legs; twitching and spasms in both eyelids; leg spasms/calf cramps; This is a spontaneous report from a contactable consumer (patient reported for self). A 34-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, administered in arm right on 18Oct2021 as (at the age of 34 years old) dose 1, single for COVID-19 immunization. Medical history reported was none. Concomitant medication(s) included the patient received other vaccines within 4 weeks prior to the COVID vaccine influenza vaccine (FLU)/ Flu shot taken for immunisation on 27Sep2021 administered in right arm. The other medications patient received within 2 weeks of vaccination omeprazole 40 mg, vitamin c [ascorbic acid], ergocalciferol (VITAMIN D), cetirizine hydrochloride (ZYRTEC) all taken for unspecified indications and date(s). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not having any known allergies. The patient is not pregnant at time of vaccination. The patient reported stating, she received first dose of Pfizer vaccine on Monday, 18Oct2021. Beginning Wednesday morning, 20Oct2021 07:00 patient began to experience leg spasms and twitching in both legs and twitching and spasms in both eyelids. Patient reported stating, as of today, Monday, 25Oct2021 was still experiencing all adverse effects listed. The patient did not receive any treatment for the events. The events did not result in prolonged hospitalization. The patient had experienced the calf cramps and muscle twitching/spasms for one week now (started 2 days after first shot). Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as not recovered. Device Date: 25Oct2021.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Decreased activity, Headache, Impaired work ability, Magnetic resonance imaging
Clinical narrative: massive headache 24/7; life has turned to shit cant do any thing; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient got the Pfizer vaccine second shot on 28Sep2021 and have had a massive headache 24/7 since. Patient had MRI done, CAT scans on an unspecified date in 2021, any idea of this or a way to get rid of it. Patient stated that he can't take it no more, his life has turned to shit and can't do anything from an unspecified date in 2021. Patient wanted to know if there was a cure for this, patient never had headaches before now this one never goes away stays all day all night. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mental impairment
Clinical narrative: massive headache 24/7; life has turned to shit cant do any thing; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historically received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient got the Pfizer vaccine second shot on 28Sep2021 and have had a massive headache 24/7 since. Patient had MRI done, CAT scans on an unspecified date in 2021, any idea of this or a way to get rid of it. Patient stated that he can't take it no more, his life has turned to shit and can't do anything from an unspecified date in 2021. Patient wanted to know if there was a cure for this, patient never had headaches before now this one never goes away stays all day all night. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.