chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Positive airway pressure therapy, Pulmonary fibrosis, Rhonchi, Sepsis
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope, Tachypnoea, Transaminases increased, Ultrasound Doppler normal, Visual impairment
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Blood lactic acid, Blood sodium decreased, Blood urea increased, Brain natriuretic peptide increased
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breath sounds abnormal, C-reactive protein increased, COVID-19 pneumonia, Cardiac failure acute, Cardiac failure chronic
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Computerised tomogram thorax normal, Condition aggravated, Dyspnoea, Dyspnoea at rest
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Emphysema, Fibrin D dimer, Gait disturbance, Glomerular filtration rate decreased, Hypertransaminasaemia
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ischaemic hepatitis, Nausea, Oedema peripheral, Orthostatic hypotension, Pain in extremity
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Positive airway pressure therapy, Pulmonary fibrosis, Refusal of examination, Rhonchi, Sepsis
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope, Tachypnoea, Ultrasound Doppler normal, Visual impairment, White blood cell count increased
Clinical narrative: 11/30/21:  Patient went to PCP with complaints of increasing SOB for weeks, nausea, syncopal events, increased edema and pain bilater lower extremities.  PCP diagnosed high suspicion for DVT/PE and recommended patient go to ER for evaluation.  Patient refused. 12/1/21:  Patient called EMS due to increased dyspnea and tachypnea, inability to ambulate without syncope.  Arrived to ER with noted SOB at rest requiring 6L NC to sat 90%.  RR 32-40, HR 110, +3 bilateral LE pitting edema, coarse rhonchi on auscultation throughout.  Orthostatic hypotension in ER with BP 104/71 at rest then 75/49 upon standing with complaints of vision changes.  During evaluation patient became suddenly unable to maintain oxygenation over 80% despite increase in oxygen to 10L via HFNC.  Placed on BiPAP 10/5 FiO2 40% sat 98% with improved dyspnea.  CXR shows emphysema and diffuse pulmonary fibrosis.  NA 132, K5.5, eGFR 36 BUN/Creatine 34/2.5, AST 3214, ALT 1827, WBC 27.5, CRP 2.7, Lactic acid 8.7, d-dimer 856.  Admit with acute hypoxic respiratory failure and sepsis in the setting of COVID 19 PNA, new acute kidney injury with transaminitis, acute on chronic heart failure exacerbation, shocked liver.  Started on IV Lasix, rocephin, azythromycin, IV solumedrol, Lovenox, and home dulera, spiriva.  Remdesivir and baricitinib held due to AKI. 12/2/21:  CT negative for PE, dopplar negative for DVT.  RR 22-30, afebrile, HR 80, sat 93% on 6L via NC using BiPap at night 10/5 FiO2 40%.  BNP 2580 12/4/21:  ambulating in room on 4L NC sat 90%.  Sat 98% at rest.  RR 16-20, afebrile, SBP 90-110s.  No distress noted with speaking or ambulating.  BUN/Creating 42/1.2 eGFR >60, AST 332, ALT 1006. 12/5/21:  Patient to be discharged home on baseline home O2 of 4L.  Continue long steroid taper and have sleep study outpatient for new home CPAP at night.  WBC 14.7, BUN/Creating 22/0.9, ALT 711, AST 160.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 4/1/21, 4/22/21, 11/13/21. Positive on 5/20/22
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: I have had the same reaction to the 2nd, 3rd and 4th vaccination. On April 9th, my arm began to swell with silver dollar size red marks. Within 3 hours later, the swelling increased by another silver dollar size. The injection site was very red, swollen, painful. I had red marks under my arm too. On April 10th, the injection site was very big and angry. April 11th, I started taking Benadryl and using ice to relieve the swelling/pain/irritation. April 12th  - 14th my symptoms got better. April 15th, I felt much better with all symptoms gone.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site irritation, Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: I have had the same reaction to the 2nd, 3rd and 4th vaccination. On April 9th, my arm began to swell with silver dollar size red marks. Within 3 hours later, the swelling increased by another silver dollar size. The injection site was very red, swollen, painful. I had red marks under my arm too. On April 10th, the injection site was very big and angry. April 11th, I started taking Benadryl and using ice to relieve the swelling/pain/irritation. April 12th  - 14th my symptoms got better. April 15th, I felt much better with all symptoms gone.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: I have had the same reaction to the 2nd, 3rd and 4th vaccination. On April 9th, my arm began to swell with silver dollar size red marks. Within 3 hours later, the swelling increased by another silver dollar size. The injection site was very red, swollen, painful. I had red marks under my arm too. On April 10th, the injection site was very big and angry. April 11th, I started taking Benadryl and using ice to relieve the swelling/pain/irritation. April 12th  - 14th my symptoms got better. April 15th, I felt much better with all symptoms gone.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection. Cough noted. Symptom onset not clear
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Influenza A virus test, Influenza B virus test, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID infection. Cough noted. Symptom onset not clear
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection. Cough noted. Symptom onset not clear
Sex: F
Vaccine: HEPA, RAB, TYP, VARZOS
Symptoms: Malaise, Product administered to patient of inappropriate age, Underdose
Clinical narrative: the patient is "not feeling the best today" as she received multiple vaccines yesterday; adult patient was administered a pediatric dose of VAQTA yesterday, 21-APR-2022; adult patient was administered a pediatric dose of VAQTA yesterday, 21-APR-2022; This spontaneous report has been received from a registered nurse and refers to an adult female patient.  The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 21-APR-2022, the adult patient was administered a 0.5 milliliters (ml) pediatric dose of hepatitis a vaccine, inactivated (VAQTA) for hepatitis A prophylaxis (valid lot number U012525 for vial formulation, with expiration date 06-FEB-2023) (product administered to patient of inappropriate age and underdose). On the same date, the patient received varicella zoster vaccine rge (cho) (SHINGRIX) and unspecified rabies and typhoid vaccines (formulation, dose, indication, lot number, and expiration date were not reported). The dose number, vaccination scheme, route of administration, and anatomical location were not provided for any of the suspect vaccines.   On 22-APR-2022, the patient was not feeling the best (malaise), unresolved by reporting time.   The nurse reported that the patient was not feeling the best as she received multiple vaccines.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: A pediatric dose of VAQTA was given to an adult; No additional AE information; This spontaneous report was received from a medical assistant referring to an adult patient of unspecified gender whose medical history, concurrent conditions, previous adverse drug reaction, or family adverse drug reactions were not provided.  On an unknown date, a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, for prophylaxis (strength, lot number, expiration date, route of administration, anatomical location, and vaccine scheme were not provided) was not confirmed by the reporter whether it was given to an adult patient (incorrect dose administered). No additional adverse event (AE) information was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: VAQTA that had undergone temperature excursion was administered to a patient before calling; no adverse event; This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of hepatitis a vaccine, inactivated(VAQTA) for prophylaxis (lot number U026782 was an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX). Lot number U026782 does not match any Company product as confirmed by Lot Verification team) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 49.6° Fahrenheit (F) for 32 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Zoster like rash/Herpes zoster (not diseminated); An immunocompromised patient; This spontaneous report was received from a pediatrician concerning an 8 years-old male patient. The patient's concurrent conditions included an immunocompromised status, his pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On an unspecified date between 2015 and 2018, the patient who was inmmunocompromised was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (contraindicated product administered) administered subcutaneously (formulation, strength, dose, frequency, anatomical injection site, lot number, and expiration date were not provided) for varicella prevention.  On an unknown date, the patient had a Zoster like rash herpes zoster (not disseminated) and sought medical attention. The pediatrician requested to participate in the varicella-zoster virus identification program (VZVIP). It was not reported if the patient received treatment, At the time of the report, the patient had not recovered from the event herpes zoster.   The causal relationship between the event herpes zoster with the suspect therapy was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; The nurse reported an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report has been received from a nurse concerning a patient of unreported age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, or allergies, and concomitant medications were not provided.  On 13-MAY-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, vial (valid lot number U024220 [expiration date 04-AUG-2023]) for prophylaxis, after a temperature excursion of 32.9 degrees Fahrenheit (F) for 24 hours (h) 30 minutes (min) and 0 seconds (sec) (product storage error) (dose, dose number, vaccination scheme frequency, route, and anatomical location of vaccination were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature; This spontaneous report has been received from an office manager and refers to a patient of an unknown age and gender.  The patient's medical history, current conditions, concomitant therapies, allergies and drugs reactions were not provided.  On an unknown date in 2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, dose reported as 1 (units not reported), lot number U017138, expiration date: 28-NOV-2022, administered for prophylaxis (strength, route of administration and anatomical location were not provided). On 20-JAN-2022 a temperature excursion occurred at a temperature of -14 degrees Celsius for 7 hours (product storage error). No previous temperature excursion was reported. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004990:Case number: 02167746 US-009507513-2205USA005067:Case number: 02167784 US-009507513-2205USA005084:Case number: 02167789 US-009507513-2205USA005023:Case number: 02167763 US-009507513-2205USA005071:Case number: 02167774 US-009507513-2205USA005002:Case number: 02167802 US-009507513-2205USA005130:Case number: 02167643 US-009507513-2205USA005126:Case number: 02167756 US-009507513-2205USA005229:Case number: 02167797
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: First dose received at 14 years old and second dose received at 17 years old/Pharmacist confirmed patient received dose 1 at age 13 and dose 2 at age 17; Caller did not provide any additional AE information at this time/No additional AE/PQC reported at time of call; This spontaneous report was received from a pharmacist concerning a 17 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On an unknown date  (reported as when the patient was 13 years old), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).         On an unknown date (reported as when the patient was 17 years old), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  No adverse event reported.
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Supraventricular tachycardia
Clinical narrative: TACHYCARDIA (SUPRAVENTRICULAR); AIR BUBBLE IN THE CHEST; This spontaneous report received from a consumer or other non-health professional (Johnson and Johnson) concerned a 52 year old male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 21-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that on 21-JUL-2021, the patient began complaining if episodes of tachycardia (supraventricular) that have prompted admission to the hospital at least half a dozen of times ever since. The patient had also complained of having an air bubble in the chest on 21-JUL-2021. The patient was hospitalized on 21-JUL-2021 and it was not reported if the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia (supraventricular) and air bubble in the chest. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220533119-Covid-19 vaccine ad26.cov2.s. tachycardia (supraventricular), air bubble in the chest.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Age at time of vaccination 56 years old. No concomitant medications were reported. On 09-SEP-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of refrozen vaccine and vaccine was refrozen was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538890, 20220540611, 20220541180, 20220537683, 20220540524, 20220540570, 20220540688, 20220541506, 20220541401, 20220541085, 20220540853, 20220540816, 20220540642, 20220540536, 20220540474, 20220540435, 20220540420, 20220540324, 20220539045, 20220538693, 20220538347, 20220538146, 20220537507, 20220537341, 20220537356, 20220537444, 20220537532, 20220537548, 20220537688, 20220538149, 20220538210, 20220538238, 20220538292, 20220538297, 20220538316, 20220538379, 20220538411, 20220538425, 20220538428, 20220538437, 20220538758, 20220538666, 20220538627, 20220538573, 20220540814 and 20220538480.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Got really sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got really sick). At the time of the report, ILLNESS (Got really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-568296, MOD-2022-568298, MOD-2021-024069, MOD-2022-571305 (Patient Link).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got really sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Got really sick) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got really sick). At the time of the report, ILLNESS (Got really sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-568296, MOD-2022-568298, MOD-2021-571297, MOD-2021-024069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Patient demographic details were updated.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022); 2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) and PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 014F21A, 030A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included BICALUTAMIDE from 14-Mar-2022 to an unknown date, LISINOPRIL from 17-Jan-2022 to an unknown date and AMLODIPINE from 06-Feb-2020 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) and PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 10-May-2022,  MOD-2022-560476 became Invalid as one criteria was missing for valid case that was identifiable patient(2 patients). Hence processed this case as invalid only.  The vial was initially stored in the refrigerator on 05-May-2022 The vial did not undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up received contains no new information. On 19-May-2022: Follow up received on 19/May/2022: Upon follow up the case was became valid. Follow up received includes Patient details, Dose details, Dose expiration date, Concomitant medications, Case Narrative updated
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Rebound infection after Paxlovid; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Rebound infection after Paxlovid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Rebound infection after Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-Apr-2022 to 05-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound infection after Paxlovid) was resolving.            No concomitant medication information was reported.  The device date was reported as 11-May-2022.  Company Comment: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected AESI non-serious event of Covid-19. The event occurred on an unknown date after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on an unknown date. Patient was treated with Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event were reported as resolving at time of event. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a patient of unknown age and gender with no reported medical history, who experienced the unexpected AESI non-serious event of Covid-19. The event occurred on an unknown date after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on an unknown date. Patient was treated with Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event were reported as resolving at time of event. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: His arm was pretty sore after his 2nd shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (His arm was pretty sore after his 2nd shot.) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (His arm was pretty sore after his 2nd shot.). At the time of the report, VACCINATION SITE PAIN (His arm was pretty sore after his 2nd shot.) had resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pruritus, Swelling of eyelid, Urticaria
Clinical narrative: Lips swelling; eye lid swelling; Itching; Hives; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Lips swelling), SWELLING OF EYELID (eye lid swelling), PRURITUS (Itching) and URTICARIA (Hives) in a 48-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included MONTELUKAST, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced LIP SWELLING (Lips swelling), SWELLING OF EYELID (eye lid swelling), PRURITUS (Itching) and URTICARIA (Hives). At the time of the report, LIP SWELLING (Lips swelling), SWELLING OF EYELID (eye lid swelling), PRURITUS (Itching) and URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received an expired dose of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. Number of doses or vials reported as 1 dose but there may be more. Date the vial was initially stored in the refrigerator was unknown by the hcp. Vial did not undergoes any temperature excursions. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was left out for 48 hours and was administered; Vaccine was left out for 48 hours and was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was left out for 48 hours and was administered) and PRODUCT STORAGE ERROR (Vaccine was left out for 48 hours and was administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was left out for 48 hours and was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was left out for 48 hours and was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was left out for 48 hours and was administered) and PRODUCT STORAGE ERROR (Vaccine was left out for 48 hours and was administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  It was reported that number of doses is 1 dose. On 17-MAY-2022 vial was initially stored in the refrigerator. Vial did not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) is a little less than 48 hours.