chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Patient is a 76 years old male patient with history of CVA, hypertension, hyperlipidemia, neuropathy, and GERD who presented to Hospital with worsened right sided weakness.   Sepsis, and Acute Hypoxic Respiratory Failure, due to: COVID 19 Pneumonia Tachycardic and febrile on presentation to ED Some desaturations on RA prompted NC to be placed. Currently on room air since yesterday Personally reviewed chest xray with bibasilar atelectasis UA not suggestive of infection Urine and blood cultures pending COVID positive Discontinue remdesivir, plan to complete 10 days of steroids Patient has been on room air for the last 48 hoursStroke Like Symptoms Past CV Stroke Like Symptoms Past CVA with Right Sided Weakness NSTEMI, likely type 2 Hypertension Hyperlipidemia Has had worsening right sided weakness the last couple days Wife having a hard time assisting with ambulation CT head with evidence of prior infarct, seen on previous MRI, and other chronic changes Suspect symptoms are due to recrudescence in the setting of sepsis from COVID as above Troponin 24, no chest pain, likely type 2 in the setting of COVID. Right hemiparesis as a long-term effect of stroke chronic with acute exacerbation since resolved by neurology Cleared for discharge   Chronic Normocytic Anemia Hemoglobin 11.3 on admission Baseline around 12 No evidence of bleeding Continue to monitor with daily CBC's   Neuropathy Continue home Lyrica   GERD Continue home PPI
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthritis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain at injection site from date of injection persisting continually for more than 2 1/2 months pain causing difficulty, lifting the arm where the injection happened. So severe that it has seriously  limited range of motion and use of the left arm. Joint inflammation and arthritis like symptoms are new and also present since the time of injection in both hands.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Acute respiratory failure, Biopsy bladder, Biopsy colon, Blood culture negative
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Colonoscopy abnormal, Coma scale, Computerised tomogram abdomen abnormal, Condition aggravated
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Culture urine positive, Cystoscopy, Depressed level of consciousness, Diverticulum, Endotracheal intubation
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal oedema, Glycosylated haemoglobin, Haemorrhoids, Hepatic encephalopathy, Hydronephrosis
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Insulin therapy, Intensive care, Klebsiella test, Lower gastrointestinal haemorrhage, Nephrolithiasis
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Non-alcoholic steatohepatitis, Oesophagogastroduodenoscopy, Pneumatosis, Rectal haemorrhage, Respiratory failure
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis, Type 2 diabetes mellitus, Ureteral stent insertion, Urinary tract infection
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Varices oesophageal
Clinical narrative: Patient is a 75 y.o. female with a history of AFIB on Eliquis, HFpEF, Aortic Stenosis (TAVR 2020) COPD on 2L NC, NASH Cirrhosis, Kidney tones, Recurrent UTIs who presented to Emergency Department on 11/27/23 with rectal bleeding and obtunded state. OLH course complicated by grade-4 hepatic encephalopathy (intubated), CT A/P: pneumatosis of cecum, ascending colon, 7 mm R renal stone, 1.7 cm L renal stone with bilateral hydronephrosis. Transferred to another hospital SICU on 11/27/23. SICU course complicated by emergent cystoscopy and bilateral ureteral stent placement 11/28/23, +COVID test, persistent hepatic encephalopathy. Transferred to another hospital MICU On 11/29/23 with complex medical issues. MICU course complicated by respiratory failure (extubated 12/1/23). Facility consulted 12/3/23 to assume care. Discharged to home w/ HHC 12/4/23.   1. Acute on Chronic Hypoxic Respiratory Failure: On 2L NC baseline due to COPD, intubated at ED 11/27/23 for grade-4 hepatic encephalopathy and COVID-19 infection. Extubated 12/1/23 weaned to home 2L NC by 12/3/23 2. COVID-19 Infection: with numerous comorbid conditions, +Test 11/28/23, completed 5 days of Remdesivir on 12/3/23 and 10 days of Decadron end date 12/9/23 3. Bilateral Obstructive Renal Stones: CT A/P 11/27/23 bilateral hydronephrosis with kidney stones, s/p Cystoscopy and Bilateral ureteral stents placement with bladder biopsy 11/28/23 with Dr. (Urology)  4. Sepsis from Complicated UTI: with infected bilateral kidney stones. Recent Urine culture 11/21/23: 50K Klebsiella and 50k VRE. Blood Cultures 11/28/23 negative, urine culture 11/29/23 negative Remains on empric IV Zosyn since admit, end date TBD   5. Decompensated NASH Cirrhosis: with prior esophageal varices, hepatic hydrothorax (s/p TIPS 2019 at CCF) and recurrent hepatic encephalopathy. S/p EGD 11/29/23: nonbleeding grade-1 EV, reduced home diuretics. Hepatology followed 6. Recurrent Hepatic Encephalopathy: prior hx of same with recurrent admits, initially had grade-4 HE (near-comatose state) with GCS score-6 on 11/27/23 and intubated for airway protection. Caregiver reports 99% compliance with Rifaxamin and Lactulose TID prior to admit. Continued Rifaximin and lactulose. 7. Colonic Distension: CT A/P (11/27/23) Pneumatosis in the cecum and ascending colon without surrounding inflammatory changes. General surgery evaluated and signed off 11/28/23 with no plans for OR and no further workup indicated 8. Lower GI Bleeding: likely 2/2 diverticulosis, s/p colonoscopy 11/30/23: widely edematous colon with appendiceal lesion (biopsied) with internal hemorrhoids.  9. T2DM On Insulin: Last A1c 6.3% 11/2023. Reduced lantus dose
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Dyspnoea, Oropharyngeal pain
Clinical narrative: The patient was admitted 11/12/23 - 11/17/23 with shortness of breath, sore throat, and generalized weakness. She tested positive for COVID via PCR on 11/12/23. Discharge diagnoses included acute hypoxemic respiratory failure likely due to COVID infection and severe sepsis due to COVID-19 infection and UTI, among other diagnoses. Patient was treated with Decadron, supplemental oxygen, cough medicine, and incentive spirometer. She was able to wean off oxygen prior to discharge. Of note, the patient has received four doses of the COVID vaccine - the Pfizer Monovalent COVID vaccine (given 3/6/21; 3/28/21; 10/20/21; 4/6/22) and the Pfizer Bivalent COVID Vaccine (given 10/13/22).
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sepsis, Urinary tract infection
Clinical narrative: The patient was admitted 11/12/23 - 11/17/23 with shortness of breath, sore throat, and generalized weakness. She tested positive for COVID via PCR on 11/12/23. Discharge diagnoses included acute hypoxemic respiratory failure likely due to COVID infection and severe sepsis due to COVID-19 infection and UTI, among other diagnoses. Patient was treated with Decadron, supplemental oxygen, cough medicine, and incentive spirometer. She was able to wean off oxygen prior to discharge. Of note, the patient has received four doses of the COVID vaccine - the Pfizer Monovalent COVID vaccine (given 3/6/21; 3/28/21; 10/20/21; 4/6/22) and the Pfizer Bivalent COVID Vaccine (given 10/13/22).
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient received x1 Covid Moderna vaccine on 12/26.  The vaccine was deemed expired by x4d per due to it being pulled out of the freezer x30d prior.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Headache, Loss of consciousness, Vomiting
Clinical narrative: Felt dizzy then lost consciousness for approximately 30 seconds.  Once he "came to" promptly vomited once and complained of a headache.  Mom was a witness to the event and called 911.  Ambulance arrived, checked him out, and stated he was in good health, and did not need to go to the ER.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine 5 days after BUD date.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine 5 days past BUD date.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given vaccine after BUD date. No adverse effects reported.
Age: 12.0
Sex: M
Vaccine: COVID19, FLU4, HPV9
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Patient was seen by an LPN for the HPV, COVID, and Flu vaccines. Patient reported to parent and staff that he was feeling lightheaded. Parent stated the patient had "glazed eyes" and "swayed". Parent caught the patient and staff instructed parent to put patient in a chair. Nursing was alerted via intercom. Nurse arrived at patient's side. Patient was pallor and perspiring. RN, took the patients BP: 89/55 P:114. Dr. was notified of the event and recommended blood pressure to be taken twice in the next 30 minutes. Nurse preformed blood pressure: 110/70 and Pulse: 106. Patients color was returning in his face. After the thirty minutes his final average Blood pressure: 109/74 and pulse: 87. Patient reported no dizziness or lightheadedness. Patient checked out per Providers recommendations.
Age: 74.0
Sex: M
Vaccine: COVID19, FLUX, RSV
Symptoms: Asthenia, Erythema, Fall, Myalgia, Paraesthesia
Clinical narrative: This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 74-year-old male patient who received Arexvy (batch number 2CY74, expiry date 30-MAR-2025). Co-suspect products included Influenza vaccine for prophylaxis and Elasomeran (Spikevax) for prophylaxis. On 27-DEC-2023, the patient received Arexvy, Influenza vaccine and Spikevax. On 28-DEC-2023, 1 days after receiving Arexvy and Influenza vaccine, the patient experienced rash (Verbatim: Rash down both legs), tingling (Verbatim: Tingling in toes), erythema of extremities (Verbatim: Redness in arms), weakness (Verbatim: weakness), fall (Verbatim: Fall/fell) and myalgia (Verbatim: Myalgia). The outcome of the rash, tingling, weakness, fall and myalgia were not resolved and the outcome of the erythema of extremities was resolving. It was unknown if the reporter considered the rash, tingling, erythema of extremities, weakness, fall and myalgia to be related to Arexvy. It was unknown if the company considered the rash, tingling, erythema of extremities, weakness, fall and myalgia to be related to Arexvy. Additional Information: GSK receipt date:29-DEC-2023. The reporter reported that a patient received Arexvy, Flu vaccine(unspecified) and Spikevax on 27th December 2023. Pharmacist reported that the patient began experiencing events last night, 28Dec2023, and into this morning, 29th Dec 2023. The redness in both arms had already stated go down. The patient was fell because he was weak. No additional details provided. It was unknown if the reporter considered the rash, tingling, erythema of extremities, weakness, fall and myalgia to be related to Spikevax and flu vaccine. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: COVID19, FLUX, RSV
Symptoms: Rash
Clinical narrative: This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a 74-year-old male patient who received Arexvy (batch number 2CY74, expiry date 30-MAR-2025). Co-suspect products included Influenza vaccine for prophylaxis and Elasomeran (Spikevax) for prophylaxis. On 27-DEC-2023, the patient received Arexvy, Influenza vaccine and Spikevax. On 28-DEC-2023, 1 days after receiving Arexvy and Influenza vaccine, the patient experienced rash (Verbatim: Rash down both legs), tingling (Verbatim: Tingling in toes), erythema of extremities (Verbatim: Redness in arms), weakness (Verbatim: weakness), fall (Verbatim: Fall/fell) and myalgia (Verbatim: Myalgia). The outcome of the rash, tingling, weakness, fall and myalgia were not resolved and the outcome of the erythema of extremities was resolving. It was unknown if the reporter considered the rash, tingling, erythema of extremities, weakness, fall and myalgia to be related to Arexvy. It was unknown if the company considered the rash, tingling, erythema of extremities, weakness, fall and myalgia to be related to Arexvy. Additional Information: GSK receipt date:29-DEC-2023. The reporter reported that a patient received Arexvy, Flu vaccine(unspecified) and Spikevax on 27th December 2023. Pharmacist reported that the patient began experiencing events last night, 28Dec2023, and into this morning, 29th Dec 2023. The redness in both arms had already stated go down. The patient was fell because he was weak. No additional details provided. It was unknown if the reporter considered the rash, tingling, erythema of extremities, weakness, fall and myalgia to be related to Spikevax and flu vaccine. The reporter consented to follow up.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Non-approved diluent used for reconstitution and administration; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received MMR (Priorix) (batch number 75S93, expiry date 11-MAY-2024) for prophylaxis.   On 18-DEC-2023, the patient received Priorix. On 18-DEC-2023, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Non-approved diluent used for reconstitution and administration) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-JAN-2024 Registered pharmacist reported that on 18-DEC-2023 a medical assistant administered Priorix to a patient that was reconstituted with sterile diluent (used for reconstitution of live vaccines) not provided with Priorix, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. They discovered the error last Thursday (28-DEC-2023). The reporter consented to follow up.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Priorix were put in the freezer instead of the fridge, being exposed to the temperature of -23.4°C.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Priorix were put in the freezer instead of the fridge, being exposed to the temperature of -23.4°C.). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:03-JAN-2024 The reporter was informed (on the day of reporting) that doses of Priorix were put in the freezer instead of fridge, being exposed to the temperature of minus 23.4 degree Celsius, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received just the adjuvant component of Shingrix, and not the reconstituted vaccine; received just the adjuvant component of Shingrix, and not the reconstituted vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received just the adjuvant component of Shingrix, and not the reconstituted vaccine) and inappropriate dose of vaccine administered (Verbatim: received just the adjuvant component of Shingrix, and not the reconstituted vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-JAN-2024 The reporter was a clinical pharmacist, called because one clinic member (patient) received just the adjuvant component of Shingrix and not the reconstituted vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had no information about the dose given, no lot number, expiry date, whether it was the 1st or 2nd dose, date administered, and does not know which clinic member (patient) was involved. Consent to follow-up granted.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: He experienced several strokes. This is the second time he's had a reaction to your Moderna Covid vaccine.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (He experienced several strokes. This is the second time he's had a reaction to your Moderna Covid vaccine.) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Fibrillation atrial since 2017.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (He experienced several strokes. This is the second time he's had a reaction to your Moderna Covid vaccine.) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (He experienced several strokes. This is the second time he's had a reaction to your Moderna Covid vaccine.) outcome was unknown.            No relevant concomitant medications were reported. End of Oct 2023 patient received vaccine. No treatment medication reported. Company comment: This spontaneous case concerns a 68-year-old male patient, with medical history of atrial fibrillation and stroke reported, who experienced the unexpected serious (medically significant) event of Cerebrovascular accident (AESI)(reported as He experienced several strokes. This is the second time he's had a reaction to your Moderna Covid vaccine.) which occurred in context of vaccination with SPIKEVAX 2023-2024 which was unspecified dose in Covid-19 vaccination schedule. Medical history of atrial fibrillation and previous occurrence of stroke remain as confounders in the case. No further clinical information or details about course of the event and treatment was provided for medical review. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 Vaccine is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Erythema, Malaise
Clinical narrative: Aches/body aches; Arm swollen and red; Arm swollen and red; General malaise; pvc's; Fever; chills; Axilla pain; Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aches/body aches), PERIPHERAL SWELLING (Arm swollen and red), ERYTHEMA (Arm swollen and red), MALAISE (General malaise) and VENTRICULAR EXTRASYSTOLES (pvc's) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 26-Dec-2023, the patient experienced PAIN (Aches/body aches), PERIPHERAL SWELLING (Arm swollen and red), ERYTHEMA (Arm swollen and red), MALAISE (General malaise), VENTRICULAR EXTRASYSTOLES (pvc's), PYREXIA (Fever), CHILLS (chills), AXILLARY PAIN (Axilla pain) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, PAIN (Aches/body aches), PERIPHERAL SWELLING (Arm swollen and red), ERYTHEMA (Arm swollen and red), MALAISE (General malaise), VENTRICULAR EXTRASYSTOLES (pvc's), PYREXIA (Fever), CHILLS (chills), AXILLARY PAIN (Axilla pain) and VACCINATION SITE PAIN (Injection site pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were provided. The patient had fever up to 102 f. No treatment medications were provided. Company comment This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced the unexpected non-serious AESI of Ventricular extrasystoles that occurred on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) and was resolving at the time of the last observation. It was reported that the patient experienced fever up to 102 F, chills, body aches, arm swollen and red injection site pain, axilla pain and general malaise. No further clinical information was provided. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine in not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Vaccination site pain, Ventricular extrasystoles
Clinical narrative: Aches/body aches; Arm swollen and red; Arm swollen and red; General malaise; pvc's; Fever; chills; Axilla pain; Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aches/body aches), PERIPHERAL SWELLING (Arm swollen and red), ERYTHEMA (Arm swollen and red), MALAISE (General malaise) and VENTRICULAR EXTRASYSTOLES (pvc's) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 26-Dec-2023, the patient experienced PAIN (Aches/body aches), PERIPHERAL SWELLING (Arm swollen and red), ERYTHEMA (Arm swollen and red), MALAISE (General malaise), VENTRICULAR EXTRASYSTOLES (pvc's), PYREXIA (Fever), CHILLS (chills), AXILLARY PAIN (Axilla pain) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, PAIN (Aches/body aches), PERIPHERAL SWELLING (Arm swollen and red), ERYTHEMA (Arm swollen and red), MALAISE (General malaise), VENTRICULAR EXTRASYSTOLES (pvc's), PYREXIA (Fever), CHILLS (chills), AXILLARY PAIN (Axilla pain) and VACCINATION SITE PAIN (Injection site pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were provided. The patient had fever up to 102 f. No treatment medications were provided. Company comment This spontaneous case concerns a 69-year-old female patient, with no medical history reported, who experienced the unexpected non-serious AESI of Ventricular extrasystoles that occurred on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) and was resolving at the time of the last observation. It was reported that the patient experienced fever up to 102 F, chills, body aches, arm swollen and red injection site pain, axilla pain and general malaise. No further clinical information was provided. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine in not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pain in extremity, Panic attack, Rash
Clinical narrative: increased number of panic attacks; day after the shot, with sore arm; hot to touch; rash on the shot arm; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (increased number of panic attacks), PAIN IN EXTREMITY (day after the shot, with sore arm), FEELING HOT (hot to touch) and RASH (rash on the shot arm) in a 71-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031048) for COVID-19 prophylaxis.   No Medical History information was reported.  On 29-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 30-Dec-2023, the patient experienced PANIC ATTACK (increased number of panic attacks), PAIN IN EXTREMITY (day after the shot, with sore arm), FEELING HOT (hot to touch) and RASH (rash on the shot arm). At the time of the report, PANIC ATTACK (increased number of panic attacks), PAIN IN EXTREMITY (day after the shot, with sore arm), FEELING HOT (hot to touch) and RASH (rash on the shot arm) was resolving.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   Concomitant product use was not provided by the reporter.  Events started Saturday, day after the shot, with sore arm and increased number of panic attacks. This lasted for two days with the addition of a rash on the shot arm, halfway between the shot site and my elbow. Area remained hot to touch, sore and bright rash until day four when the rash was receding.  It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Overdose
Clinical narrative: strokes/paralyzed on left side and partially on right side; Patient received 1mL of Moderna COVID-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (strokes/paralyzed on left side and partially on right side) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no medical history, concomitant disease or risk factor.     On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 milliliter. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Patient received 1mL of Moderna COVID-19 Vaccine). On 30-Aug-2023, the patient experienced CEREBROVASCULAR ACCIDENT (strokes/paralyzed on left side and partially on right side) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes/paralyzed on left side and partially on right side) had not resolved and OVERDOSE (Patient received 1mL of Moderna COVID-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Patient's age was reported as 82 years.  No concomitant medication was reported.  Reportedly, patient had 2 strokes, paralyzed on left side and partially on right side.  The patient did not experience any additional symptoms/events. There were no lab data/results available.  No treatment information was provided. Company comment This spontaneous case concerns a 79-year-old female patient, with no medical history, concomitant disease or risk factor reported, who experienced the unexpected, serious (medically significant) AESI of Cerebrovascular accident (AESI), that occurred approximately 2 years after a dose of mRNA-1273. Overdose was considered as an additional event because it was reported that the patient received 1mL of Moderna COVID-19 Vaccine. As reported, the patient experienced 2 Strokes, was paralyzed on left side and partially on right side. No further clinical information was provided. Cerebrovascular accident was assessed as not related due to long latency (about 2 years) after the vaccine. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: that their son got the vaccines and had side effects after; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (that their son got the vaccines and had side effects after) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (that their son got the vaccines and had side effects after). At the time of the report, IMMUNISATION REACTION (that their son got the vaccines and had side effects after) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.   Reporter did not allow further contact