chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, Therapeutic product effect decreased, Tinnitus
Clinical narrative: Severe migraines started after receiving the first dose and despite the doctor's best efforts they are still ongoing. The first migraine was so severe it mimicked the effects of a stroke. Hearing loss/ tinnitus started after receiving the 2nd dose and became worse after receiving the booster. The booster also had the effect of removing the benefits of the medications I was on and therefore setting back my recovery. I have been out of work since August of last year, I tried returning to work in January of this year but suffered another setback after only 3 shifts and have been out again since the first week of February.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Incident occurred from possible inviable dose being administered to patient. We tried to reach the patient 3 times but no answer.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Alopecia Areata, sudden appearance, no prior or family history. Continuing to lose hair rapidly since.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiac discomfort, Chest X-ray normal, Chest pain, Electrocardiogram normal
Clinical narrative: Heart Palpatations, Arrythmia, fast heartbeat. Chest pains, very hard to sleep at night. Very aware of my heartbeat. Lying down makes the symptoms worse. Feels like something was just wrong with my heart.  Suspected myocarditis/pericarditis/costochondritis after online research + due to being in the risk group (young male)
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Palpitations
Clinical narrative: Heart Palpatations, Arrythmia, fast heartbeat. Chest pains, very hard to sleep at night. Very aware of my heartbeat. Lying down makes the symptoms worse. Feels like something was just wrong with my heart.  Suspected myocarditis/pericarditis/costochondritis after online research + due to being in the risk group (young male)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Incident occurred from possible inviable dose administered to the patient. We tried to reach the patient 3 times but no answer
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: GIVEN EXPIRED VACCINE. NO ADVERSE EFFECTS WE ARE KNOWN OF
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Incident occurred from possible inviable dose administered to the patient. We tried to reach the patient 3 times but no answer
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN EXPIRED VACCINE
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN EXPIRED VACCINE
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid-19 , had a bad cough, very stuffy nose, fatigue
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Incident occurred from possible inviable dose administered to the patient. We tried to reach the patient 3 times but no answer
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient came in for a booster dose of Pfizer on 3/16/22.  The date of birth in the system (10/29/2008) did not match the date of birth on the consent form for the booster.  After reviewing the patient's passport, we confirmed the correct date of birth was 10/29/2008.  We reviewed the consent forms and vaccine dose card for the first 2 vaccines and confirmed the patient's parents purposely put an incorrect date of birth of 10/29/2008 so that the patient could receive a vaccine, however, our facility does not administer pediatric doses and as a result, the child was administered 2 adult doses of pfizer.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN EXPIRED VACCINE
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN EXPIRED VACCINE
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Deafness, Headache, Lethargy, Nausea
Clinical narrative: The morning after booster vaccine, Patient fainted,  had ringing in ears,  and experienced hearing loss,.  She also vomited  and had a stomach ache.  She also had a headache.  She was very lethargic.  This evening she still has queasy stomach and some ringing in ears though improved since this morning.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tinnitus, Vomiting
Clinical narrative: The morning after booster vaccine, Patient fainted,  had ringing in ears,  and experienced hearing loss,.  She also vomited  and had a stomach ache.  She also had a headache.  She was very lethargic.  This evening she still has queasy stomach and some ringing in ears though improved since this morning.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Incident occurred from possible inviable dose administered to patient. We tried to reach the patient 3 times but no answer
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PFIZER SHOT GIVEN WAS EXPIRED 1 DAY BUT PATIENT HAS NO ADVERSE REACTION AT THE TIME OF REPORT.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PT WAS GIVEN PFIZER SHOT EXPIRED BY 1 DAY.  NO ADVERSE REACTION AT THE TIME OF REPORT.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PT WAS GIVEN PFIZER SHOT EXPIRED BY 2 DAYS.  NO ADVERSE EVENT BY THE TIME OF THIS REPORT.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Starting about 10 days after the booster I have been getting terribly itchy full body hives.  This has been ongoing for about two months and though the hives are starting to lessen, they are still horribly itchy.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PT WAS GIVEN PFIZER SHOT EXPIRED BY 2 DAYS.  NO ADVERSE EVENT BY THE TIME OF THIS REPORT.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: I?ve had three shots now with all three shots I experienced a slight headache the night after the shot. But after the first shot I have ringing in the ears at has been persistent for the last year and a half.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: PT WAS GIVEN PFIZER SHOT EXPIRED BY 2 DAYS.  NO ADVERSE EVENT BY THE TIME OF THIS REPORT.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Skin irritation, Urticaria
Clinical narrative: Narrative: Patient received COVID booster in October 2021. Twelve days later developed rash. He contacted primary care team and reported rash originated at back of neck down to chest, lower back and right foot. Denies obvious allergens or recent changes to routines or diet. Tried over the counter Benadryl and hydrocortisone ointment. He presented to urgent care the following day. He received injections of Benadryl and depo-medrol and prescription for prednisone. His symptoms decreased in intensity but were still present and bothersome. After his prednisone course was completed, he had flare ups. He continued taking Benadryl every 6-8 hours that seemed to be helping. He reported even minor irritations result in skin flare up (hives). At that time (12/1/2021), they were occurring but less frequent and less widespread. He presented in January (1/7/2022) for routine follow up. Symptoms had improved. Providers notes indicate previous symptoms were worse with hot and warm showers. Chart updated to reflect delayed type IV hypersensitivity reaction to COVID-19 vaccine. Provider advised patient to defer future immunizations.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Urticaria
Clinical narrative: Narrative: Patient received second Moderna vaccine approximately October 2021 and had blisters and hives on both forearms for three months. The patient was treated with diphenhydramine.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Benign prostatic hyperplasia, Blood creatine phosphokinase, Cancer screening
Clinical narrative: Narrative:  H&P Hospital 11/28 and 11/29/2021 Admitted with Bilateral PE. COVID-19 vaccine #1 - 9/13 COVID-19 vaccine #2 - 10/11. Within 7 days of the second injection, he had a rash on left side of body. Had steroid injection from urgent care but rash did not resolve. Second visit with rash and dyspnea on exertion approx 10-14 days after 2nd COVID-19 dose. Prolonged course of steroids with some improvement in itching but SOB still present and he, again, went to urgen tcare. Treated with another prescription. Today SOB and slightly worse and experienced syncope when was thinking of coming to ER. EMS called - came to hospital. Hx GERD, HTN, PTSD, HLD. \ CXR. EKG RSR, PAC's, Left axis deviation and ST segment depression in leads 1, aVL, V4, V5, V6, D-dimer 11 INR 1 ProoBNP 56 CK CTA PE multiple b/l peripheral PE's. Mild right heart strain. No chest pain. High sensitivity troponin 110 Repeat High sensitivity troponin 505 Admit to inpatient status. PE - given timing, appears to be mRNA vaccine inflammatory  related hypercoagulable state. Lovenox 1 mg/kg Transition to Eliquis 10mg BID x 7 days course Recommended course of treatment 3-6 months. Up to date on age appropriate cancer screenings. No FH of hypercoagulable disorde.r Check Echo. High Troponin - likely related to PE, no CP, consider non-STEMI Trend troponin Trend EKG ASA daily Continue statin Weight based Lovenox Lymphadenopathy vs normal variant for ptt. /L US of axillary lymph nodes to assess for possible Anatomic abnormality. Generalized rash - appears urticarial - itchy folliculitis LLE. No evidence of infection, no petechiae. Multiple courses fo steroids over past several weeks w/o improvement. ?Autoimmune - ANA, CRP, ESR Loratadine 10mg BOD Hydroxy 25mg QID PRN Pepcid 20mg BID Doxycycline 100mg BID x 7 days Complication due to vaccination Unless another diagnosis sdor possible underlying malignancy is found, the ptt is likely experiencing mRNA vaccine hypercoagulable state post vaccination status. BPH w/o outflow obstruction Continue current medical management. HLD - statin Essential HTN - antihypertensive regimen adjust meds as needed. GERD - PPI Chronic depression - anti-depressant Plan - Lovenox AS above
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Condition aggravated, Dyspnoea, Dyspnoea exertional, Electrocardiogram
Clinical narrative: Narrative:  H&P Hospital 11/28 and 11/29/2021 Admitted with Bilateral PE. COVID-19 vaccine #1 - 9/13 COVID-19 vaccine #2 - 10/11. Within 7 days of the second injection, he had a rash on left side of body. Had steroid injection from urgent care but rash did not resolve. Second visit with rash and dyspnea on exertion approx 10-14 days after 2nd COVID-19 dose. Prolonged course of steroids with some improvement in itching but SOB still present and he, again, went to urgen tcare. Treated with another prescription. Today SOB and slightly worse and experienced syncope when was thinking of coming to ER. EMS called - came to hospital. Hx GERD, HTN, PTSD, HLD. \ CXR. EKG RSR, PAC's, Left axis deviation and ST segment depression in leads 1, aVL, V4, V5, V6, D-dimer 11 INR 1 ProoBNP 56 CK CTA PE multiple b/l peripheral PE's. Mild right heart strain. No chest pain. High sensitivity troponin 110 Repeat High sensitivity troponin 505 Admit to inpatient status. PE - given timing, appears to be mRNA vaccine inflammatory  related hypercoagulable state. Lovenox 1 mg/kg Transition to Eliquis 10mg BID x 7 days course Recommended course of treatment 3-6 months. Up to date on age appropriate cancer screenings. No FH of hypercoagulable disorde.r Check Echo. High Troponin - likely related to PE, no CP, consider non-STEMI Trend troponin Trend EKG ASA daily Continue statin Weight based Lovenox Lymphadenopathy vs normal variant for ptt. /L US of axillary lymph nodes to assess for possible Anatomic abnormality. Generalized rash - appears urticarial - itchy folliculitis LLE. No evidence of infection, no petechiae. Multiple courses fo steroids over past several weeks w/o improvement. ?Autoimmune - ANA, CRP, ESR Loratadine 10mg BOD Hydroxy 25mg QID PRN Pepcid 20mg BID Doxycycline 100mg BID x 7 days Complication due to vaccination Unless another diagnosis sdor possible underlying malignancy is found, the ptt is likely experiencing mRNA vaccine hypercoagulable state post vaccination status. BPH w/o outflow obstruction Continue current medical management. HLD - statin Essential HTN - antihypertensive regimen adjust meds as needed. GERD - PPI Chronic depression - anti-depressant Plan - Lovenox AS above
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram ST segment depression, Essential hypertension, Fibrin D dimer increased, Folliculitis, Hypercoagulation
Clinical narrative: Narrative:  H&P Hospital 11/28 and 11/29/2021 Admitted with Bilateral PE. COVID-19 vaccine #1 - 9/13 COVID-19 vaccine #2 - 10/11. Within 7 days of the second injection, he had a rash on left side of body. Had steroid injection from urgent care but rash did not resolve. Second visit with rash and dyspnea on exertion approx 10-14 days after 2nd COVID-19 dose. Prolonged course of steroids with some improvement in itching but SOB still present and he, again, went to urgen tcare. Treated with another prescription. Today SOB and slightly worse and experienced syncope when was thinking of coming to ER. EMS called - came to hospital. Hx GERD, HTN, PTSD, HLD. \ CXR. EKG RSR, PAC's, Left axis deviation and ST segment depression in leads 1, aVL, V4, V5, V6, D-dimer 11 INR 1 ProoBNP 56 CK CTA PE multiple b/l peripheral PE's. Mild right heart strain. No chest pain. High sensitivity troponin 110 Repeat High sensitivity troponin 505 Admit to inpatient status. PE - given timing, appears to be mRNA vaccine inflammatory  related hypercoagulable state. Lovenox 1 mg/kg Transition to Eliquis 10mg BID x 7 days course Recommended course of treatment 3-6 months. Up to date on age appropriate cancer screenings. No FH of hypercoagulable disorde.r Check Echo. High Troponin - likely related to PE, no CP, consider non-STEMI Trend troponin Trend EKG ASA daily Continue statin Weight based Lovenox Lymphadenopathy vs normal variant for ptt. /L US of axillary lymph nodes to assess for possible Anatomic abnormality. Generalized rash - appears urticarial - itchy folliculitis LLE. No evidence of infection, no petechiae. Multiple courses fo steroids over past several weeks w/o improvement. ?Autoimmune - ANA, CRP, ESR Loratadine 10mg BOD Hydroxy 25mg QID PRN Pepcid 20mg BID Doxycycline 100mg BID x 7 days Complication due to vaccination Unless another diagnosis sdor possible underlying malignancy is found, the ptt is likely experiencing mRNA vaccine hypercoagulable state post vaccination status. BPH w/o outflow obstruction Continue current medical management. HLD - statin Essential HTN - antihypertensive regimen adjust meds as needed. GERD - PPI Chronic depression - anti-depressant Plan - Lovenox AS above
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperlipidaemia, International normalised ratio normal, Lymphadenopathy, Myocardial injury, Prohormone brain natriuretic peptide
Clinical narrative: Narrative:  H&P Hospital 11/28 and 11/29/2021 Admitted with Bilateral PE. COVID-19 vaccine #1 - 9/13 COVID-19 vaccine #2 - 10/11. Within 7 days of the second injection, he had a rash on left side of body. Had steroid injection from urgent care but rash did not resolve. Second visit with rash and dyspnea on exertion approx 10-14 days after 2nd COVID-19 dose. Prolonged course of steroids with some improvement in itching but SOB still present and he, again, went to urgen tcare. Treated with another prescription. Today SOB and slightly worse and experienced syncope when was thinking of coming to ER. EMS called - came to hospital. Hx GERD, HTN, PTSD, HLD. \ CXR. EKG RSR, PAC's, Left axis deviation and ST segment depression in leads 1, aVL, V4, V5, V6, D-dimer 11 INR 1 ProoBNP 56 CK CTA PE multiple b/l peripheral PE's. Mild right heart strain. No chest pain. High sensitivity troponin 110 Repeat High sensitivity troponin 505 Admit to inpatient status. PE - given timing, appears to be mRNA vaccine inflammatory  related hypercoagulable state. Lovenox 1 mg/kg Transition to Eliquis 10mg BID x 7 days course Recommended course of treatment 3-6 months. Up to date on age appropriate cancer screenings. No FH of hypercoagulable disorde.r Check Echo. High Troponin - likely related to PE, no CP, consider non-STEMI Trend troponin Trend EKG ASA daily Continue statin Weight based Lovenox Lymphadenopathy vs normal variant for ptt. /L US of axillary lymph nodes to assess for possible Anatomic abnormality. Generalized rash - appears urticarial - itchy folliculitis LLE. No evidence of infection, no petechiae. Multiple courses fo steroids over past several weeks w/o improvement. ?Autoimmune - ANA, CRP, ESR Loratadine 10mg BOD Hydroxy 25mg QID PRN Pepcid 20mg BID Doxycycline 100mg BID x 7 days Complication due to vaccination Unless another diagnosis sdor possible underlying malignancy is found, the ptt is likely experiencing mRNA vaccine hypercoagulable state post vaccination status. BPH w/o outflow obstruction Continue current medical management. HLD - statin Essential HTN - antihypertensive regimen adjust meds as needed. GERD - PPI Chronic depression - anti-depressant Plan - Lovenox AS above
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Syncope, Troponin, Ultrasound lymph nodes
Clinical narrative: Narrative:  H&P Hospital 11/28 and 11/29/2021 Admitted with Bilateral PE. COVID-19 vaccine #1 - 9/13 COVID-19 vaccine #2 - 10/11. Within 7 days of the second injection, he had a rash on left side of body. Had steroid injection from urgent care but rash did not resolve. Second visit with rash and dyspnea on exertion approx 10-14 days after 2nd COVID-19 dose. Prolonged course of steroids with some improvement in itching but SOB still present and he, again, went to urgen tcare. Treated with another prescription. Today SOB and slightly worse and experienced syncope when was thinking of coming to ER. EMS called - came to hospital. Hx GERD, HTN, PTSD, HLD. \ CXR. EKG RSR, PAC's, Left axis deviation and ST segment depression in leads 1, aVL, V4, V5, V6, D-dimer 11 INR 1 ProoBNP 56 CK CTA PE multiple b/l peripheral PE's. Mild right heart strain. No chest pain. High sensitivity troponin 110 Repeat High sensitivity troponin 505 Admit to inpatient status. PE - given timing, appears to be mRNA vaccine inflammatory  related hypercoagulable state. Lovenox 1 mg/kg Transition to Eliquis 10mg BID x 7 days course Recommended course of treatment 3-6 months. Up to date on age appropriate cancer screenings. No FH of hypercoagulable disorde.r Check Echo. High Troponin - likely related to PE, no CP, consider non-STEMI Trend troponin Trend EKG ASA daily Continue statin Weight based Lovenox Lymphadenopathy vs normal variant for ptt. /L US of axillary lymph nodes to assess for possible Anatomic abnormality. Generalized rash - appears urticarial - itchy folliculitis LLE. No evidence of infection, no petechiae. Multiple courses fo steroids over past several weeks w/o improvement. ?Autoimmune - ANA, CRP, ESR Loratadine 10mg BOD Hydroxy 25mg QID PRN Pepcid 20mg BID Doxycycline 100mg BID x 7 days Complication due to vaccination Unless another diagnosis sdor possible underlying malignancy is found, the ptt is likely experiencing mRNA vaccine hypercoagulable state post vaccination status. BPH w/o outflow obstruction Continue current medical management. HLD - statin Essential HTN - antihypertensive regimen adjust meds as needed. GERD - PPI Chronic depression - anti-depressant Plan - Lovenox AS above
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Narrative:  H&P Hospital 11/28 and 11/29/2021 Admitted with Bilateral PE. COVID-19 vaccine #1 - 9/13 COVID-19 vaccine #2 - 10/11. Within 7 days of the second injection, he had a rash on left side of body. Had steroid injection from urgent care but rash did not resolve. Second visit with rash and dyspnea on exertion approx 10-14 days after 2nd COVID-19 dose. Prolonged course of steroids with some improvement in itching but SOB still present and he, again, went to urgen tcare. Treated with another prescription. Today SOB and slightly worse and experienced syncope when was thinking of coming to ER. EMS called - came to hospital. Hx GERD, HTN, PTSD, HLD. \ CXR. EKG RSR, PAC's, Left axis deviation and ST segment depression in leads 1, aVL, V4, V5, V6, D-dimer 11 INR 1 ProoBNP 56 CK CTA PE multiple b/l peripheral PE's. Mild right heart strain. No chest pain. High sensitivity troponin 110 Repeat High sensitivity troponin 505 Admit to inpatient status. PE - given timing, appears to be mRNA vaccine inflammatory  related hypercoagulable state. Lovenox 1 mg/kg Transition to Eliquis 10mg BID x 7 days course Recommended course of treatment 3-6 months. Up to date on age appropriate cancer screenings. No FH of hypercoagulable disorde.r Check Echo. High Troponin - likely related to PE, no CP, consider non-STEMI Trend troponin Trend EKG ASA daily Continue statin Weight based Lovenox Lymphadenopathy vs normal variant for ptt. /L US of axillary lymph nodes to assess for possible Anatomic abnormality. Generalized rash - appears urticarial - itchy folliculitis LLE. No evidence of infection, no petechiae. Multiple courses fo steroids over past several weeks w/o improvement. ?Autoimmune - ANA, CRP, ESR Loratadine 10mg BOD Hydroxy 25mg QID PRN Pepcid 20mg BID Doxycycline 100mg BID x 7 days Complication due to vaccination Unless another diagnosis sdor possible underlying malignancy is found, the ptt is likely experiencing mRNA vaccine hypercoagulable state post vaccination status. BPH w/o outflow obstruction Continue current medical management. HLD - statin Essential HTN - antihypertensive regimen adjust meds as needed. GERD - PPI Chronic depression - anti-depressant Plan - Lovenox AS above
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Nausea
Clinical narrative: Narrative: Patient received J&J vaccine on 6/2/2021@1251, went to ER later  that day with hypotension, dizziness, nausea. may have been related to J&J  vaccination as no other cause could be determined. Pt was checked by cardiology  due to hx of Afib but was not found to be having any acute episode.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Speech disorder
Clinical narrative: Narrative: He had CVA 2 weeks after 2nd pfizer vaccine. He is now on lipitor QHS and ASA 81MG . He lost his ability to speak for 24 hours. He has no permanent deficits. Clinical decision-making: Plan: 1) CVA: continue lipitor and ASA 81, given the timing of the administration of the COVID vaccine that may be possibility that it was triggered by the vaccine. Patient has already completed both shots. Patient counseled to hold off on the booster shot until there is more date to determine impact of booster on recurrence of vascular events
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Narrative: also mild tight upper chest - sxs resolved with benadryl 25 mg ivp, 500 ml saline and observation
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Epistaxis, Fatigue, Musculoskeletal pain
Clinical narrative: Angina mild-moderate arm pain, swelling, fatigue, sinus drainage,  sneezing, nose bleeds, R leg nerve pain, sensitive skin, back pain,  buttocks pain
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Sensitive skin, Sinus operation, Sneezing
Clinical narrative: Angina mild-moderate arm pain, swelling, fatigue, sinus drainage,  sneezing, nose bleeds, R leg nerve pain, sensitive skin, back pain,  buttocks pain
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Angina mild-moderate arm pain, swelling, fatigue, sinus drainage,  sneezing, nose bleeds, R leg nerve pain, sensitive skin, back pain,  buttocks pain
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Heart rate increased, Hyperhidrosis
Clinical narrative: HR 147, stayed 140s aprox 10 min; Not feeling well; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: FK5127) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM, Route of Administration: Intramuscular), administration date: 2021, for COVID-19 immunization, reaction(s): "Feeling "weird" in chest", "HR 140s", "Diaphoretic". The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "recovering", described as "HR 147, stayed 140s aprox 10 min"; MALAISE (non-serious) with onset 2021, outcome "recovering", described as "Not feeling well". The events "hr 147, stayed 140s aprox 10 min" and "not feeling well" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, malaise.  Additional information: patient took other vaccine in four weeks, no other medications the patient received within 2 weeks of vaccination, approx. 2 weeks after 1st dose, approx. 7 days of episodes 1-2 a day. On 3rd day of occurrence went to ED. D/c home, episode occurred for few more nights then stopped. Approx. 24 hrs. after 2nd dose (withheld) complained of, pulsox applied, No chest pain, no SOB, afebrile, nothing else remarkable. No Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Malaise, SARS-CoV-2 test negative
Clinical narrative: HR 147, stayed 140s aprox 10 min; Not feeling well; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the parent.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 (Lot number: FK5127) at the age of 9 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM, Route of Administration: Intramuscular), administration date: 2021, for COVID-19 immunization, reaction(s): "Feeling "weird" in chest", "HR 140s", "Diaphoretic". The following information was reported: HEART RATE INCREASED (non-serious) with onset 2021, outcome "recovering", described as "HR 147, stayed 140s aprox 10 min"; MALAISE (non-serious) with onset 2021, outcome "recovering", described as "Not feeling well". The events "hr 147, stayed 140s aprox 10 min" and "not feeling well" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, malaise.  Additional information: patient took other vaccine in four weeks, no other medications the patient received within 2 weeks of vaccination, approx. 2 weeks after 1st dose, approx. 7 days of episodes 1-2 a day. On 3rd day of occurrence went to ED. D/c home, episode occurred for few more nights then stopped. Approx. 24 hrs. after 2nd dose (withheld) complained of, pulsox applied, No chest pain, no SOB, afebrile, nothing else remarkable. No Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Rash
Clinical narrative: COVID mRNA vaccine reaction after first dose. Reported during office visit, allergy - rash, dyspnea
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given her 2nd Moderna vaccine 7 days before the recommended time between the 1st and 2nd dose.  Patient has been notified of the vaccine administration error.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fear, Heart rate increased, Hypoaesthesia
Clinical narrative: She notes having issues with 1st dose of Moderna 3/20/21. Se waited 30 minutes, went home.  Everything "seemed fine" but once she got home, she started itching all over really bad and then trouble breathing.  Tried Benadryl.  Tachycardia.  No improvement.  Felt like she was going to pass out and had trouble feeling.  She gave EpiPen and called 911.  Got better.  EMTs stayed with her until stabilized.  Once her heart rate came back down, she didn't have to go to the ER.  Was frightened.  Didn't want to take 2nd dose.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tachycardia
Clinical narrative: She notes having issues with 1st dose of Moderna 3/20/21. Se waited 30 minutes, went home.  Everything "seemed fine" but once she got home, she started itching all over really bad and then trouble breathing.  Tried Benadryl.  Tachycardia.  No improvement.  Felt like she was going to pass out and had trouble feeling.  She gave EpiPen and called 911.  Got better.  EMTs stayed with her until stabilized.  Once her heart rate came back down, she didn't have to go to the ER.  Was frightened.  Didn't want to take 2nd dose.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: rash on both her legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 33-year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on both her legs". The event "rash on both her legs" was evaluated at the physician office visit.  Additional information: Caller was a consumer who received both doses of the Pfizer Biontech COVID 19 vaccine adult formulation in Apr2021. She stated that 5 days after the first dose she presented a rash on both her legs and that 6 days to 1 week after receiving the second dose she started experiencing joint pain. Caller went to her Medical Doctor and Rheumatologist who after testing her, concluded this signs and symptoms as inconclusive, and that although they couldn't directly relate them to the vaccine, they might be a reaction that could happen after receiving it. Caller asked if these were reported adverse events. Caller provided she report the adverse reactions on the VAERS system but never got a follow up. Product was COMIRNATY. Caller asked how long does joint pain usually lasts after receiving the Pfizer Biontech COVID 19 vaccine. Caller asked if she could receive the booster dose after experiencing joint pain and a rash who were inconclusive to be related to the first two doses of the Pfizer BIontech COVID 19 vaccine adult formulation. Caller asked when does the protection begins to wear off after the first two doses of the Pfizer Biontech COVID 19 vaccine.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: rash on both her legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. A 33-year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on both her legs". The event "rash on both her legs" was evaluated at the physician office visit.  Additional information: Caller was a consumer who received both doses of the Pfizer Biontech COVID 19 vaccine adult formulation in Apr2021. She stated that 5 days after the first dose she presented a rash on both her legs and that 6 days to 1 week after receiving the second dose she started experiencing joint pain. Caller went to her Medical Doctor and Rheumatologist who after testing her, concluded this signs and symptoms as inconclusive, and that although they couldn't directly relate them to the vaccine, they might be a reaction that could happen after receiving it. Caller asked if these were reported adverse events. Caller provided she report the adverse reactions on the VAERS system but never got a follow up. Product was COMIRNATY. Caller asked how long does joint pain usually lasts after receiving the Pfizer Biontech COVID 19 vaccine. Caller asked if she could receive the booster dose after experiencing joint pain and a rash who were inconclusive to be related to the first two doses of the Pfizer BIontech COVID 19 vaccine adult formulation. Caller asked when does the protection begins to wear off after the first two doses of the Pfizer Biontech COVID 19 vaccine.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,single), administration date: Apr2021, for Covid-19 immunization, reaction(s): "rash on both her legs". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain".  Additional Information: After receiving the second dose she started experiencing joint pain. Patient went to her Medical Doctor and Rheumatologist who after testing her, concluded this signs and symptoms as inconclusive, and that although they couldn't directly relate them to the vaccine, they might be a reaction that could happen after receiving it. Question: Patient asked how long does joint pain usually lasts after receiving the Pfizer Biontech COVID 19 vaccine. Question: Patient asked if she could receive the booster dose after experiencing joint pain and a rash who were inconclusive to be related to the first two doses of the Pfizer BIontech COVID 19 vaccine adult formulation. Question: Patient asked when does the protection begins to wear off after the first two doses of the Pfizer Biontech COVID 19 vaccine.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 33 year-old female patient received bnt162b2 (COMIRNATY), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1,single), administration date: Apr2021, for Covid-19 immunization, reaction(s): "rash on both her legs". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain".  Additional Information: After receiving the second dose she started experiencing joint pain. Patient went to her Medical Doctor and Rheumatologist who after testing her, concluded this signs and symptoms as inconclusive, and that although they couldn't directly relate them to the vaccine, they might be a reaction that could happen after receiving it. Question: Patient asked how long does joint pain usually lasts after receiving the Pfizer Biontech COVID 19 vaccine. Question: Patient asked if she could receive the booster dose after experiencing joint pain and a rash who were inconclusive to be related to the first two doses of the Pfizer BIontech COVID 19 vaccine adult formulation. Question: Patient asked when does the protection begins to wear off after the first two doses of the Pfizer Biontech COVID 19 vaccine.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Dizziness, Drug ineffective, Dyspnoea
Clinical narrative: She tested positive for Covid; She tested positive for Covid; Allergic reaction; Heart rate dropped; Breathing dropped; difficulty breathing; Light headed; Chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Feb2022, outcome "unknown" and all described as "She tested positive for Covid"; HYPERSENSITIVITY (medically significant) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Allergic reaction"; HEART RATE DECREASED (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Heart rate dropped"; RESPIRATORY RATE DECREASED (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Breathing dropped"; DYSPNOEA (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "difficulty breathing"; DIZZINESS (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Light headed"; CHEST PAIN (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Chest pain". The events "allergic reaction", "heart rate dropped", "breathing dropped", "difficulty breathing", "light headed" and "chest pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (22Mar2021) dropped; respiratory rate: (22Mar2021) dropped; sars-cov-2 test: (28Feb2022) positive. Therapeutic measures were taken as a result of covid-19, hypersensitivity, respiratory rate decreased, dyspnoea.  Clinical course: It was reported, the patient had her first COVID vaccine on 22May2021, did not get any other vaccinations. She could not get the second COVID vaccine because she had an extreme reaction and an ambulance ride, doctor told her not to get the second. She stated, after she got the vaccine she could feel it, between 15 to 22 minutes of receiving the vaccine. Her heart rate dropped, breathing dropped, she had difficulty breathing, she was light headed, she experienced chest pain, states she did get an ambulance to take her to the emergency room, states they put her on an IV to help with an allergic reaction, an epinephrine drip. States she was crashing. She was not admitted to the hospital, stated she was there for about 5 hours, treated in the emergency room with a breathing treatment and the IV and then went home.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Hypersensitivity, Respiratory rate, Respiratory rate decreased
Clinical narrative: She tested positive for Covid; She tested positive for Covid; Allergic reaction; Heart rate dropped; Breathing dropped; difficulty breathing; Light headed; Chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Feb2022, outcome "unknown" and all described as "She tested positive for Covid"; HYPERSENSITIVITY (medically significant) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Allergic reaction"; HEART RATE DECREASED (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Heart rate dropped"; RESPIRATORY RATE DECREASED (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Breathing dropped"; DYSPNOEA (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "difficulty breathing"; DIZZINESS (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Light headed"; CHEST PAIN (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Chest pain". The events "allergic reaction", "heart rate dropped", "breathing dropped", "difficulty breathing", "light headed" and "chest pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (22Mar2021) dropped; respiratory rate: (22Mar2021) dropped; sars-cov-2 test: (28Feb2022) positive. Therapeutic measures were taken as a result of covid-19, hypersensitivity, respiratory rate decreased, dyspnoea.  Clinical course: It was reported, the patient had her first COVID vaccine on 22May2021, did not get any other vaccinations. She could not get the second COVID vaccine because she had an extreme reaction and an ambulance ride, doctor told her not to get the second. She stated, after she got the vaccine she could feel it, between 15 to 22 minutes of receiving the vaccine. Her heart rate dropped, breathing dropped, she had difficulty breathing, she was light headed, she experienced chest pain, states she did get an ambulance to take her to the emergency room, states they put her on an IV to help with an allergic reaction, an epinephrine drip. States she was crashing. She was not admitted to the hospital, stated she was there for about 5 hours, treated in the emergency room with a breathing treatment and the IV and then went home.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: She tested positive for Covid; She tested positive for Covid; Allergic reaction; Heart rate dropped; Breathing dropped; difficulty breathing; Light headed; Chest pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Feb2022, outcome "unknown" and all described as "She tested positive for Covid"; HYPERSENSITIVITY (medically significant) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Allergic reaction"; HEART RATE DECREASED (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Heart rate dropped"; RESPIRATORY RATE DECREASED (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Breathing dropped"; DYSPNOEA (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "difficulty breathing"; DIZZINESS (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Light headed"; CHEST PAIN (non-serious) with onset 22Mar2021, outcome "recovered" (22Mar2021), described as "Chest pain". The events "allergic reaction", "heart rate dropped", "breathing dropped", "difficulty breathing", "light headed" and "chest pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (22Mar2021) dropped; respiratory rate: (22Mar2021) dropped; sars-cov-2 test: (28Feb2022) positive. Therapeutic measures were taken as a result of covid-19, hypersensitivity, respiratory rate decreased, dyspnoea.  Clinical course: It was reported, the patient had her first COVID vaccine on 22May2021, did not get any other vaccinations. She could not get the second COVID vaccine because she had an extreme reaction and an ambulance ride, doctor told her not to get the second. She stated, after she got the vaccine she could feel it, between 15 to 22 minutes of receiving the vaccine. Her heart rate dropped, breathing dropped, she had difficulty breathing, she was light headed, she experienced chest pain, states she did get an ambulance to take her to the emergency room, states they put her on an IV to help with an allergic reaction, an epinephrine drip. States she was crashing. She was not admitted to the hospital, stated she was there for about 5 hours, treated in the emergency room with a breathing treatment and the IV and then went home.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, Alcohol use, COVID-19, Endotracheal intubation, Gait disturbance
Clinical narrative: Presented to the ED with worsening tremors and difficulty walking. In the ED, she develop hallucinations, tachycardia, and agitation. She has a history of heavy alcohol use and abruptly stopped drinking 3 days prior. She received multiple doses of benzodiazepines and ultimately required intubation for airway protection. She was admitted to the ICU for concern for alcohol withdrawal. She was found to be covid positive on admission
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hallucination, Intensive care, Muscular weakness, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: Presented to the ED with worsening tremors and difficulty walking. In the ED, she develop hallucinations, tachycardia, and agitation. She has a history of heavy alcohol use and abruptly stopped drinking 3 days prior. She received multiple doses of benzodiazepines and ultimately required intubation for airway protection. She was admitted to the ICU for concern for alcohol withdrawal. She was found to be covid positive on admission