chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 1 dose of moderna covid vaccine on 02/27/21 then the patient visited the pharmacy and requested 1 dose of pfizer covid vaccine and it was administered as if it were her first dose of covid 19 vaccine which this was on 05/08/21. Then patient went to the pharmacy for her second covid pfizer dose and it was administered on 05/29/21. patient received a total of 3 doses of covid 19 vaccine, she was instructed not to request the booster.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Patient received 1 dose of Moderna COVID-19 on 02/23/21 then patient visited pharmacy and requested 1 dose of COVID-19 Pfizer was administered as if it was his first dose of COVID-19 on 05/08/21. Then patient goes to the pharmacy for his second dose of COVID-19 Pfizer and it was administered on 05/29/21. patient received a total of 3 doses of COVID-19. 02/23/21 Moderna, 05/8/21 Pfizer, 05/29/21 Pfizer. Patient was advised not to request the booster.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Paraesthesia, Throat irritation, Throat tightness, Tongue disorder
Clinical narrative: Tested Positive for Covid
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Pruritus, Swelling face, Urticaria
Clinical narrative: Patient reports that she received the first Moderna COVID-19 vaccine in February 2021 and 4 weeks later received her second dose in the beginning of March 2021. Patient reports that 2 weeks after receiving her second vaccine, she broke out in severe hives from head to toe and had to be hospitalized for 2 nights due to hives being  uncontrollable and throat swelling and glands swelling. Patient reports that since the hives started she has been in the ER or urgent care 8 times for hives and needing a steroid shot. Patient denies  changes to environment, topical products, diet changes, or medications that may have been the cause. Patient has since been put on Xolair to help with the hives but is consistently still breaking out in hives and is having to take prednisone, Benadryl, and Zyrtec at least every couple of weeks to manage the hives along with trialing the Xolair. Patient also mentions that one of her coworkers received the same "batch" of the vaccine and has suffered similar symptoms. Patient did not have vaccine card with dates of injections and lots and expiration dates of vaccines on hand but stated she would try to call back to follow up.   Please note: **I am a pharmacist reporting from a specialty pharmacy who is not associated with where patient received COVID-19 vaccine**
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test negative, Lymphadenopathy, Pharyngeal swelling, Skin test, Urticaria
Clinical narrative: Patient reports that she received the first Moderna COVID-19 vaccine in February 2021 and 4 weeks later received her second dose in the beginning of March 2021. Patient reports that 2 weeks after receiving her second vaccine, she broke out in severe hives from head to toe and had to be hospitalized for 2 nights due to hives being  uncontrollable and throat swelling and glands swelling. Patient reports that since the hives started she has been in the ER or urgent care 8 times for hives and needing a steroid shot. Patient denies  changes to environment, topical products, diet changes, or medications that may have been the cause. Patient has since been put on Xolair to help with the hives but is consistently still breaking out in hives and is having to take prednisone, Benadryl, and Zyrtec at least every couple of weeks to manage the hives along with trialing the Xolair. Patient also mentions that one of her coworkers received the same "batch" of the vaccine and has suffered similar symptoms. Patient did not have vaccine card with dates of injections and lots and expiration dates of vaccines on hand but stated she would try to call back to follow up.   Please note: **I am a pharmacist reporting from a specialty pharmacy who is not associated with where patient received COVID-19 vaccine**
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Computerised tomogram thorax abnormal, Cough, Dyspnoea
Clinical narrative: Not LTCF. PCR(+) 05/24/2021. Fully vaccinated (J&J): 03/17/2021. DR survey: "NO OTHER RECORDS OBTAINED". Hospitalized, ICU,  05/23/2021. DC support covid-19 and (+)PCR is within 6 weeks of DOD. Intubated. S/S: chills, myalgia, rhinorrhea, SOA, Loss of appetite. C/M: Acid Reflux; sinus problems, former smoker.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lung opacity, SARS-CoV-2 test positive
Clinical narrative: Not LTCF. PCR(+) 05/24/2021. Fully vaccinated (J&J): 03/17/2021. DR survey: "NO OTHER RECORDS OBTAINED". Hospitalized, ICU,  05/23/2021. DC support covid-19 and (+)PCR is within 6 weeks of DOD. Intubated. S/S: chills, myalgia, rhinorrhea, SOA, Loss of appetite. C/M: Acid Reflux; sinus problems, former smoker.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Not LTCF. PCR(+) 05/24/2021. Fully vaccinated (J&J): 03/17/2021. DR survey: "NO OTHER RECORDS OBTAINED". Hospitalized, ICU,  05/23/2021. DC support covid-19 and (+)PCR is within 6 weeks of DOD. Intubated. S/S: chills, myalgia, rhinorrhea, SOA, Loss of appetite. C/M: Acid Reflux; sinus problems, former smoker.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chills, Death, Decreased appetite, Dyspnoea
Clinical narrative: Not LTCF. PCR(+) 05/24/2021. Fully vaccinated (J&J): 03/17/2021. DR survey: "NO OTHER RECORDS OBTAINED". Hospitalized, ICU,  05/23/2021. DC support covid-19 and (+)PCR is within 6 weeks of DOD. Intubated. S/S: chills, myalgia, rhinorrhea, SOA, Loss of appetite. C/M: Acid Reflux; sinus problems, former smoker.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Intensive care, Myalgia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Not LTCF. PCR(+) 05/24/2021. Fully vaccinated (J&J): 03/17/2021. DR survey: "NO OTHER RECORDS OBTAINED". Hospitalized, ICU,  05/23/2021. DC support covid-19 and (+)PCR is within 6 weeks of DOD. Intubated. S/S: chills, myalgia, rhinorrhea, SOA, Loss of appetite. C/M: Acid Reflux; sinus problems, former smoker.
Age: 82.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death, SARS-CoV-2 test positive
Clinical narrative: LTCF:  Colonial Center. (+) Ag 7/10/2021. DX: COVID-19, pressure ulcers on bilateral hips and coccyx. S/S: fever (101.6F), subjective fever, cough, SOA, difficulty breathing. C/M: DM 2, mononeuropathy, HTN,COPD,GERD, atherosclerotic heart disease of coronary artery, dementia, mood disorder, thypothyroidism, DVT, asthma, HLD, heart disease, prostate disorder, major depressive disorder, h/o TIA and cerebral infarction, cerebral infarction, hemiplegia, hemiparesis. LTCF exposure.    Pfizer: 1/5/2021 & 1/26/2021.
Age: 82.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Decubitus ulcer, Dyspnoea, Exposure to SARS-CoV-2
Clinical narrative: LTCF:  Colonial Center. (+) Ag 7/10/2021. DX: COVID-19, pressure ulcers on bilateral hips and coccyx. S/S: fever (101.6F), subjective fever, cough, SOA, difficulty breathing. C/M: DM 2, mononeuropathy, HTN,COPD,GERD, atherosclerotic heart disease of coronary artery, dementia, mood disorder, thypothyroidism, DVT, asthma, HLD, heart disease, prostate disorder, major depressive disorder, h/o TIA and cerebral infarction, cerebral infarction, hemiplegia, hemiparesis. LTCF exposure.    Pfizer: 1/5/2021 & 1/26/2021.
Age: 82.0
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: LTCF:  Colonial Center. (+) Ag 7/10/2021. DX: COVID-19, pressure ulcers on bilateral hips and coccyx. S/S: fever (101.6F), subjective fever, cough, SOA, difficulty breathing. C/M: DM 2, mononeuropathy, HTN,COPD,GERD, atherosclerotic heart disease of coronary artery, dementia, mood disorder, thypothyroidism, DVT, asthma, HLD, heart disease, prostate disorder, major depressive disorder, h/o TIA and cerebral infarction, cerebral infarction, hemiplegia, hemiparesis. LTCF exposure.    Pfizer: 1/5/2021 & 1/26/2021.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Fatigue, Myalgia, Myocarditis
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Troponin increased
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature increased, Chest pain, Coxsackie virus test, Cytomegalovirus test, Echocardiogram
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST-T change, Epstein-Barr virus antibody negative, HIV antibody negative, HIV antigen negative, Hepatitis C antibody negative
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mycobacterium tuberculosis complex test negative, Myocarditis, Pyrexia, Streptococcus test, Streptococcus test negative
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Chest pain, Echocardiogram, Electrocardiogram, Laboratory test
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Movement disorder, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: Day after vaccine he had a fever and couldn't move.  3 days after vaccine, chest pain and was see at the ER but then admitted to the hospital for Myocarditis with high levels of triponin.  He had an overnight stay in the hospital, sent home with meds and asked to do labs twice that week before coming in to see Infectious diseases Specialist .  Saw Cardio for a follow up on 8/24. Was cleared for sports with an echo and stress test on 10/28.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Chest X-ray abnormal, Computerised tomogram abnormal, Death, Dyspnoea
Clinical narrative: Patient is in a Retirement Community. Neg COVID-19 lab results. Had COVID-19 vaccine (Pfizer) on 12/23/2020 & 01/13/2021. Admitted at Hospital on 05/19/2021 and died on 05/23/2021. Patient was in the ICU from 05/19/2021 to 05/23/2021. S/S: Cough, SOA, diff breathing. PNA, ARDS, abn CXR. C/M: HTN, Hypothyroidism. Dx: Viral PNA; Acute on chronic hypoxemic resp failure. Meets clinical criteria AND epidemiological evidence with no confirmatory lab testing.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Intensive care, SARS-CoV-2 test negative
Clinical narrative: Patient is in a Retirement Community. Neg COVID-19 lab results. Had COVID-19 vaccine (Pfizer) on 12/23/2020 & 01/13/2021. Admitted at Hospital on 05/19/2021 and died on 05/23/2021. Patient was in the ICU from 05/19/2021 to 05/23/2021. S/S: Cough, SOA, diff breathing. PNA, ARDS, abn CXR. C/M: HTN, Hypothyroidism. Dx: Viral PNA; Acute on chronic hypoxemic resp failure. Meets clinical criteria AND epidemiological evidence with no confirmatory lab testing.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Chest X-ray abnormal, Cough, Death
Clinical narrative: Patient is in a Retirement Community. Neg COVID-19 lab results. Had COVID-19 vaccine (Pfizer) on 12/23/2020 & 01/13/2021. Admitted at Hospital on 05/19/2021 and died on 05/23/2021. Patient was in the ICU from 05/19/2021 to 05/23/2021. S/S: Cough, SOA, diff breathing. PNA, ARDS, abn CXR. C/M: HTN, Hypothyroidism. Dx: Viral PNA; Acute on chronic hypoxemic resp failure. Meets clinical criteria AND epidemiological evidence with no confirmatory lab testing.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypoxia, Intensive care, Pneumonia, Pneumonia viral
Clinical narrative: Patient is in a Retirement Community. Neg COVID-19 lab results. Had COVID-19 vaccine (Pfizer) on 12/23/2020 & 01/13/2021. Admitted at Hospital on 05/19/2021 and died on 05/23/2021. Patient was in the ICU from 05/19/2021 to 05/23/2021. S/S: Cough, SOA, diff breathing. PNA, ARDS, abn CXR. C/M: HTN, Hypothyroidism. Dx: Viral PNA; Acute on chronic hypoxemic resp failure. Meets clinical criteria AND epidemiological evidence with no confirmatory lab testing.
Age: 89.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Patient is in a Retirement Community. Neg COVID-19 lab results. Had COVID-19 vaccine (Pfizer) on 12/23/2020 & 01/13/2021. Admitted at Hospital on 05/19/2021 and died on 05/23/2021. Patient was in the ICU from 05/19/2021 to 05/23/2021. S/S: Cough, SOA, diff breathing. PNA, ARDS, abn CXR. C/M: HTN, Hypothyroidism. Dx: Viral PNA; Acute on chronic hypoxemic resp failure. Meets clinical criteria AND epidemiological evidence with no confirmatory lab testing.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: pt brought to ED with c/o difficulty breathing and congested cough; states was diagnosed positive for COVID 2- 3 wks prior to coming to ED; positive COVID test in ED; pt experiencing A Fib while in ED; admitted to hospital and placed on BiPAP; PMH:  chronic AFib, DM2, CAD,  diverticulitis; pt unable to progress towards weaning from O2 without desaturation; comfort measures instituted with pt's failing condition; once weaning protocol was initiated, the pt died in the hosp
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, COVID-19, Condition aggravated, Cough, Death
Clinical narrative: pt brought to ED with c/o difficulty breathing and congested cough; states was diagnosed positive for COVID 2- 3 wks prior to coming to ED; positive COVID test in ED; pt experiencing A Fib while in ED; admitted to hospital and placed on BiPAP; PMH:  chronic AFib, DM2, CAD,  diverticulitis; pt unable to progress towards weaning from O2 without desaturation; comfort measures instituted with pt's failing condition; once weaning protocol was initiated, the pt died in the hosp
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Oxygen saturation decreased, Positive airway pressure therapy, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: pt brought to ED with c/o difficulty breathing and congested cough; states was diagnosed positive for COVID 2- 3 wks prior to coming to ED; positive COVID test in ED; pt experiencing A Fib while in ED; admitted to hospital and placed on BiPAP; PMH:  chronic AFib, DM2, CAD,  diverticulitis; pt unable to progress towards weaning from O2 without desaturation; comfort measures instituted with pt's failing condition; once weaning protocol was initiated, the pt died in the hosp
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acidosis, Acute kidney injury, Acute respiratory distress syndrome, Acute respiratory failure, Bacterial test positive
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bilevel positive airway pressure, Blood lactic acid, Blood pH decreased, COVID-19, COVID-19 pneumonia
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Convalescent plasma transfusion, Culture, Culture urine positive, Death
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Endotracheal intubation, Enterococcal infection, Glycosylated haemoglobin
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoxia, Intensive care, Laboratory test, Legionella test, Leukocytosis
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lung opacity, Mechanical ventilation, Metabolic function test, PCO2 increased, Paralysis
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Positive end-expiratory pressure, Productive cough, Respiratory failure, Respiratory viral panel, SARS-CoV-2 test positive
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sepsis, Shock, Streptococcus test, Urinary tract candidiasis, Wheezing
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Cough, Death
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Enterococcal infection, SARS-CoV-2 test positive, Wheezing
Clinical narrative: DC: COVID-19 PNEUMONIA____VRE BACTEREMIA____ACUTE RESPIRATORY FAILURE 7/28/2021 S/S SHORTNESS OF BREATH, COUGH, WHEEZING, DIFFICULTY BREATHING. HX OF DIABETES, HYPERTENSION, COPD, CURRENT SMOKER, SUBSTANCE ABUSE, ANXIETY/DEPRESSION, HYPERLIPIDEMIA. PATIENT DECEASED ON 7/26/2021. CRM Non-LTCF. PCR (+) 07/21/2021. S/S: SOA, Cough, Wheezing. PMH: DM, HTN, COPD, current smoker, Substance abuse disorder, Anxiety/depression, HLD.  Vaccinated (Pfizer): 03/10/2021, 03/31/2021.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Chest pain, Dyspnoea exertional, Fatigue, Presyncope
Clinical narrative: Low hemoglobin, anemia, palpitations, hospitalization by emergency.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tinnitus
Clinical narrative: Low hemoglobin, anemia, palpitations, hospitalization by emergency.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Haemoglobin decreased, Palpitations
Clinical narrative: Low hemoglobin, anemia, palpitations, hospitalization by emergency.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood test, Chest scan, Computerised tomogram, Electrocardiogram
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Inflammation, Influenza like illness, Injection site pain
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Nausea, Paraesthesia, SARS-CoV-2 test, Vomiting
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood electrolytes normal, Blood test normal, Borrelia test negative, Chest X-ray normal
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Computerised tomogram normal, Disturbance in attention, Dizziness, Ear discomfort
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Inflammation
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker increased, Influenza like illness, Injection site pain, Lumbar puncture, Magnetic resonance imaging normal
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Pain, Paraesthesia, Venogram normal
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting, West Nile virus test negative
Clinical narrative: 8/8-8/10-flulike symptoms, pain at the injection site, chills & sweating (no fever), fatigue, body aches, light headed * dizzy, and abdominal pain 8/10-9/20-Headache (constant low level pain to peaking at migraine), nausea with 3 occasions of vomiting, fatigue (constant low level to extreme), dizzy/lightheaded, brain fog/difficulty concentrating, and raw feeling in ears. 9/5-9/20-tingling (pins & needles) in both toes/feet and fingers/hands. Current-headaches, dizziness, & fatigue
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation, COVID-19, COVID-19 pneumonia, Condition aggravated
Clinical narrative: pt admitted to Hospital 8/7 - 8/19/21 and diagnosed with COVID pneumonia, started on dexamethasone; caregivers have COVID @ home and are unable to care for pt @ this time; pt admitted to Hospital 8/10/21 for physical therapy and worsening dyspnea and generalized weakness; treated with antibiotics, Lasix (CHF secondary to COVID pneumonia), breathing treatments; O2 OptiFlow and NRB with O2 sats in the 80s; condition continued to worsen and family put pt on comfort care measures only; pt died in the hospital
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dementia, Diabetes mellitus, Gait disturbance, Hypophagia
Clinical narrative: pt admitted to Hospital 8/7 - 8/19/21 and diagnosed with COVID pneumonia, started on dexamethasone; caregivers have COVID @ home and are unable to care for pt @ this time; pt admitted to Hospital 8/10/21 for physical therapy and worsening dyspnea and generalized weakness; treated with antibiotics, Lasix (CHF secondary to COVID pneumonia), breathing treatments; O2 OptiFlow and NRB with O2 sats in the 80s; condition continued to worsen and family put pt on comfort care measures only; pt died in the hospital
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Left ventricular failure, Lethargy, Muscular weakness
Clinical narrative: pt admitted to Hospital 8/7 - 8/19/21 and diagnosed with COVID pneumonia, started on dexamethasone; caregivers have COVID @ home and are unable to care for pt @ this time; pt admitted to Hospital 8/10/21 for physical therapy and worsening dyspnea and generalized weakness; treated with antibiotics, Lasix (CHF secondary to COVID pneumonia), breathing treatments; O2 OptiFlow and NRB with O2 sats in the 80s; condition continued to worsen and family put pt on comfort care measures only; pt died in the hospital
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Respiratory syncytial virus test, SARS-CoV-2 test positive, Slow response to stimuli
Clinical narrative: pt admitted to Hospital 8/7 - 8/19/21 and diagnosed with COVID pneumonia, started on dexamethasone; caregivers have COVID @ home and are unable to care for pt @ this time; pt admitted to Hospital 8/10/21 for physical therapy and worsening dyspnea and generalized weakness; treated with antibiotics, Lasix (CHF secondary to COVID pneumonia), breathing treatments; O2 OptiFlow and NRB with O2 sats in the 80s; condition continued to worsen and family put pt on comfort care measures only; pt died in the hospital
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Cardiac failure congestive, Death, Dyspnoea
Clinical narrative: pt admitted to Hospital 8/7 - 8/19/21 and diagnosed with COVID pneumonia, started on dexamethasone; caregivers have COVID @ home and are unable to care for pt @ this time; pt admitted to Hospital 8/10/21 for physical therapy and worsening dyspnea and generalized weakness; treated with antibiotics, Lasix (CHF secondary to COVID pneumonia), breathing treatments; O2 OptiFlow and NRB with O2 sats in the 80s; condition continued to worsen and family put pt on comfort care measures only; pt died in the hospital
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 5 days after receiving shot. Site of shot felt numb and muscle tightened up.. this is on going at random times .. happening today 11/15/21.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site hypoaesthesia, Muscle tightness
Clinical narrative: 5 days after receiving shot. Site of shot felt numb and muscle tightened up.. this is on going at random times .. happening today 11/15/21.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Feeling abnormal
Clinical narrative: Patient of 23 years comes to the vaccination center at 6:55 to be evaluated since she felt palpitations. Patient indicates after receiving her booster dose of Pfizer at 5:34 she went shopping and at 6:50 she started feeling unwell. Patient is taken to treatment and observation area to be evaluated by EMT and her vital signs were 11/70b/p 114 pulse and 122dxt Case was consulted with Dr and refers to transport patient.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Malaise, Palpitations
Clinical narrative: Patient of 23 years comes to the vaccination center at 6:55 to be evaluated since she felt palpitations. Patient indicates after receiving her booster dose of Pfizer at 5:34 she went shopping and at 6:50 she started feeling unwell. Patient is taken to treatment and observation area to be evaluated by EMT and her vital signs were 11/70b/p 114 pulse and 122dxt Case was consulted with Dr and refers to transport patient.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Decreased appetite
Clinical narrative: Pt received moderna vaccines on 01/05/2021 and 02/05/2021. Pt presented to the ED on 11/07/21 with complaints of respiratory distress and fever. Pt was found to be COVID positive. CXR showed COVID pneumonia. PT was intubated.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Endotracheal intubation, Inappropriate schedule of product administration
Clinical narrative: Pt received moderna vaccines on 01/05/2021 and 02/05/2021. Pt presented to the ED on 11/07/21 with complaints of respiratory distress and fever. Pt was found to be COVID positive. CXR showed COVID pneumonia. PT was intubated.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Pt received moderna vaccines on 01/05/2021 and 02/05/2021. Pt presented to the ED on 11/07/21 with complaints of respiratory distress and fever. Pt was found to be COVID positive. CXR showed COVID pneumonia. PT was intubated.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Immunisation, Off label use
Clinical narrative: pt stated he developed vertigo symptom's within 10 minutes after getting booster shot.  He had fatigue and was dizzy and physically disoriented.  These symptoms lasted about four weeks.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK, COVID19
Symptoms: Disorientation, Dizziness, Fatigue, Vertigo
Clinical narrative: pt stated he developed vertigo symptom's within 10 minutes after getting booster shot.  He had fatigue and was dizzy and physically disoriented.  These symptoms lasted about four weeks.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest pain, Electrocardiogram, Heart rate irregular, Human rhinovirus test positive
Clinical narrative: Patient with myocarditis. Hospitalized 10/20-11/1 in the ICU initially. Troponins peaked at  9.75.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Inflammation, Magnetic resonance imaging heart, Myocarditis, Nasopharyngitis
Clinical narrative: Patient with myocarditis. Hospitalized 10/20-11/1 in the ICU initially. Troponins peaked at  9.75.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test negative, Troponin increased, Ultrasound scan, Viral test
Clinical narrative: Patient with myocarditis. Hospitalized 10/20-11/1 in the ICU initially. Troponins peaked at  9.75.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Myocarditis, Troponin increased
Clinical narrative: Patient with myocarditis. Hospitalized 10/20-11/1 in the ICU initially. Troponins peaked at  9.75.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Computerised tomogram thorax, Cough, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Diagnosed with Interstitial Lung Disease. symptoms began with a cough 6 days after the first shot and then ended with being put in the hospital  due to being unable to breathe. Treated with steroids to reduce the inflammation.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lung infiltration, Lung opacity, Procalcitonin normal, Respiratory failure, Respiratory syncytial virus test negative
Clinical narrative: Diagnosed with Interstitial Lung Disease. symptoms began with a cough 6 days after the first shot and then ended with being put in the hospital  due to being unable to breathe. Treated with steroids to reduce the inflammation.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Staphylococcus test negative
Clinical narrative: Diagnosed with Interstitial Lung Disease. symptoms began with a cough 6 days after the first shot and then ended with being put in the hospital  due to being unable to breathe. Treated with steroids to reduce the inflammation.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Cough, Dyspnoea, Electrocardiogram
Clinical narrative: Diagnosed with Interstitial Lung Disease. symptoms began with a cough 6 days after the first shot and then ended with being put in the hospital  due to being unable to breathe. Treated with steroids to reduce the inflammation.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Interstitial lung disease
Clinical narrative: Diagnosed with Interstitial Lung Disease. symptoms began with a cough 6 days after the first shot and then ended with being put in the hospital  due to being unable to breathe. Treated with steroids to reduce the inflammation.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Hospitalized again (previous VAERS # 698455, now with pneumonia due to COVID and episodes of desaturations.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Oxygen saturation decreased
Clinical narrative: Hospitalized again (previous VAERS # 698455, now with pneumonia due to COVID and episodes of desaturations.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Amniocentesis, Chromosome analysis normal, Exposure during pregnancy, Foetal death
Clinical narrative: SPONTANEOUS ABORTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a physician concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total was administered on 27-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-SEP-2021, the patient was vaccinated with Janssen Covid-19 vaccine resulting in vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported.  Before receiving the vaccine the patient had ultra sound and genetic testing which was normal. On 01-OCT-2021, patient had another ultrasound test and it was normal. On 18-OCT-2021, the patient was 14 weeks and 6 days pregnant and she had an ultra sound test that showed that the baby passed away (fetal demise). On 18-OCT-2021, the pregnancy resulted in a spontaneous abortion. On 21-OCT-2021, she had genetic test again and which was normal.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114914-COVID-19 VACCINE AD26.COV2.S-spontaneous abortion. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY  20211114914-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound antenatal screen abnormal, Uterine dilation and curettage
Clinical narrative: SPONTANEOUS ABORTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a physician concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total was administered on 27-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 27-SEP-2021, the patient was vaccinated with Janssen Covid-19 vaccine resulting in vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported.  Before receiving the vaccine the patient had ultra sound and genetic testing which was normal. On 01-OCT-2021, patient had another ultrasound test and it was normal. On 18-OCT-2021, the patient was 14 weeks and 6 days pregnant and she had an ultra sound test that showed that the baby passed away (fetal demise). On 18-OCT-2021, the pregnancy resulted in a spontaneous abortion. On 21-OCT-2021, she had genetic test again and which was normal.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211114914-COVID-19 VACCINE AD26.COV2.S-spontaneous abortion. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY  20211114914-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS