chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Confusional state, Cough, Dizziness, Fatigue
Clinical narrative: Pain in left shoulder (injection site); Swollen lymph nodes in both armpits/Swollen glands in throat; Sore throat; Cough; Nasal congestion; Runny nose; Headaches; Pain in almost all joints; Shooting pains in arms, legs, and abdomen; Pain/pressure in sinus cavities; Pain/pressure in sinus cavities; Tiredness/fatigue; Dizziness; Confusion; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm left on 07Sep2021 at 15:30 as dose 2, single for covid-19 immunization at pharmacy or drug store. Patient medical history included high blood pressure and migraines which was treated from an unknown date and unknown if ongoing. The patient had no allergies. Patient concomitant medication(s) included lisinopril, amitriptyline, ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported for any. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 16Aug2021 15:30 as dose 1, SINGLE for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Sep2021 at 16:00, the patient experienced pain in left shoulder (injection site), swollen lymph nodes in both armpits/swollen glands in throat, sore throat, cough, nasal congestion, runny nose, headaches, pain in almost all joints, shooting pains in arms, legs, and abdomen, pain/pressure in sinus cavities, tiredness/fatigue, dizziness and had confusion. The patient reported that she expected some of these side effects for a day or so, but it has been 2 weeks as of yesterday and they are getting worse instead of better. Everything started with the second dose and has not ended yet. For reference, she was the person who normally just sucks it up and moves on, which is why she haven't reported until now. She expected some side effects and she don't just lay down and give in, but this seems a bit excessive after 2 weeks. The patient did not receive any treatment for the events. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lymphadenopathy, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: Pain in left shoulder (injection site); Swollen lymph nodes in both armpits/Swollen glands in throat; Sore throat; Cough; Nasal congestion; Runny nose; Headaches; Pain in almost all joints; Shooting pains in arms, legs, and abdomen; Pain/pressure in sinus cavities; Pain/pressure in sinus cavities; Tiredness/fatigue; Dizziness; Confusion; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm left on 07Sep2021 at 15:30 as dose 2, single for covid-19 immunization at pharmacy or drug store. Patient medical history included high blood pressure and migraines which was treated from an unknown date and unknown if ongoing. The patient had no allergies. Patient concomitant medication(s) included lisinopril, amitriptyline, ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported for any. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 16Aug2021 15:30 as dose 1, SINGLE for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Sep2021 at 16:00, the patient experienced pain in left shoulder (injection site), swollen lymph nodes in both armpits/swollen glands in throat, sore throat, cough, nasal congestion, runny nose, headaches, pain in almost all joints, shooting pains in arms, legs, and abdomen, pain/pressure in sinus cavities, tiredness/fatigue, dizziness and had confusion. The patient reported that she expected some of these side effects for a day or so, but it has been 2 weeks as of yesterday and they are getting worse instead of better. Everything started with the second dose and has not ended yet. For reference, she was the person who normally just sucks it up and moves on, which is why she haven't reported until now. She expected some side effects and she don't just lay down and give in, but this seems a bit excessive after 2 weeks. The patient did not receive any treatment for the events. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paranasal sinus discomfort, Rhinorrhoea, Sinus pain, Vaccination site pain
Clinical narrative: Pain in left shoulder (injection site); Swollen lymph nodes in both armpits/Swollen glands in throat; Sore throat; Cough; Nasal congestion; Runny nose; Headaches; Pain in almost all joints; Shooting pains in arms, legs, and abdomen; Pain/pressure in sinus cavities; Pain/pressure in sinus cavities; Tiredness/fatigue; Dizziness; Confusion; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm left on 07Sep2021 at 15:30 as dose 2, single for covid-19 immunization at pharmacy or drug store. Patient medical history included high blood pressure and migraines which was treated from an unknown date and unknown if ongoing. The patient had no allergies. Patient concomitant medication(s) included lisinopril, amitriptyline, ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]) and multivitamin, all were taken for an unspecified indication, start and stop date were not reported for any. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 16Aug2021 15:30 as dose 1, SINGLE for covid-19 immunization at pharmacy or drug store. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Sep2021 at 16:00, the patient experienced pain in left shoulder (injection site), swollen lymph nodes in both armpits/swollen glands in throat, sore throat, cough, nasal congestion, runny nose, headaches, pain in almost all joints, shooting pains in arms, legs, and abdomen, pain/pressure in sinus cavities, tiredness/fatigue, dizziness and had confusion. The patient reported that she expected some of these side effects for a day or so, but it has been 2 weeks as of yesterday and they are getting worse instead of better. Everything started with the second dose and has not ended yet. For reference, she was the person who normally just sucks it up and moves on, which is why she haven't reported until now. She expected some side effects and she don't just lay down and give in, but this seems a bit excessive after 2 weeks. The patient did not receive any treatment for the events. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: EMS brought pt to the hospital after a fall in her house; requiring  O2 @ 4LPM via NC; per family member pt only on O2 prn not 24/7; c/o SOB, N/V/D, decreased appetite x 3-4 days; in house with people who have had COVID; pt tested positive for COVID; no remdesivir treatment given due to transaminitis; completed 10 days of steroid therapy; pt's condition continued to worsened; placed on comfort care measures; pt expired in the hospital
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: EMS brought pt to the hospital after a fall in her house; requiring  O2 @ 4LPM via NC; per family member pt only on O2 prn not 24/7; c/o SOB, N/V/D, decreased appetite x 3-4 days; in house with people who have had COVID; pt tested positive for COVID; no remdesivir treatment given due to transaminitis; completed 10 days of steroid therapy; pt's condition continued to worsened; placed on comfort care measures; pt expired in the hospital
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, Fall, Nausea, SARS-CoV-2 test positive, Transaminases increased
Clinical narrative: EMS brought pt to the hospital after a fall in her house; requiring  O2 @ 4LPM via NC; per family member pt only on O2 prn not 24/7; c/o SOB, N/V/D, decreased appetite x 3-4 days; in house with people who have had COVID; pt tested positive for COVID; no remdesivir treatment given due to transaminitis; completed 10 days of steroid therapy; pt's condition continued to worsened; placed on comfort care measures; pt expired in the hospital
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: EMS brought pt to the hospital after a fall in her house; requiring  O2 @ 4LPM via NC; per family member pt only on O2 prn not 24/7; c/o SOB, N/V/D, decreased appetite x 3-4 days; in house with people who have had COVID; pt tested positive for COVID; no remdesivir treatment given due to transaminitis; completed 10 days of steroid therapy; pt's condition continued to worsened; placed on comfort care measures; pt expired in the hospital
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: pt tested positive for COVID on 9/9; went to get monoclonal antibodies the next day but O2 sats were in the 70s, was sent to ED; presented with increasing SOB, hypoxia, COVID pneumonia;; hx of asthma, DM, HTN, malignant neoplasm; placed on BiPAP, treated with remdisivir, decadron, baricitinib; condition continued to decline; placed on comfort measures; pt expired in the hospital; acute hypoxic respiratory failure due to COVID pneumonia
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Death, Dyspnoea
Clinical narrative: pt tested positive for COVID on 9/9; went to get monoclonal antibodies the next day but O2 sats were in the 70s, was sent to ED; presented with increasing SOB, hypoxia, COVID pneumonia;; hx of asthma, DM, HTN, malignant neoplasm; placed on BiPAP, treated with remdisivir, decadron, baricitinib; condition continued to decline; placed on comfort measures; pt expired in the hospital; acute hypoxic respiratory failure due to COVID pneumonia
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: General physical health deterioration, Hypoxia, Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: pt tested positive for COVID on 9/9; went to get monoclonal antibodies the next day but O2 sats were in the 70s, was sent to ED; presented with increasing SOB, hypoxia, COVID pneumonia;; hx of asthma, DM, HTN, malignant neoplasm; placed on BiPAP, treated with remdisivir, decadron, baricitinib; condition continued to decline; placed on comfort measures; pt expired in the hospital; acute hypoxic respiratory failure due to COVID pneumonia
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt diagnosed with COVID on 9/7; hx of DMT2, CKD,ARF, critical lower limb ischemia; admitted to hospital (9/21) from previous facility already intubated (9/19); transferred to hospital for possible dialysis and vascular surgery consult; pt made a DNAR; condition worsened; comfort case measures instituted and pt was extubated; he passed away in the hospital; AHRF due to COVID
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Condition aggravated, Death, Endotracheal intubation
Clinical narrative: pt diagnosed with COVID on 9/7; hx of DMT2, CKD,ARF, critical lower limb ischemia; admitted to hospital (9/21) from previous facility already intubated (9/19); transferred to hospital for possible dialysis and vascular surgery consult; pt made a DNAR; condition worsened; comfort case measures instituted and pt was extubated; he passed away in the hospital; AHRF due to COVID
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: was accidentally given a 4th Covid vaccine; was accidentally given a 4th Covid vaccine; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received fourth dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 30155BA, and Expiration date: 31Dec2021), via an unspecified route of administration on 28Sep2021 (at the age of 73-year-old) as dose 4, single for COVID-19 immunization, at pharmacy or drug store. The patient medical history was none (with no underlying medical conditions). Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201, and Expiration date: Unknown), Intramuscular, administered in arm right on 12Feb2021 at 11:00 AM as dose 1, single for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206, and Expiration date: Unknown), Intramuscular, administered in arm right on 05Mar2021 at 10:30 AM as dose 2, single for COVID-19 immunization. The patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3184, and Expiration date: Unknown), Intramuscular, administered in arm left on 06Sep2021 as dose 3 (booster), single for COVID-19 immunization. It was reported that, the patient "was accidentally given a 4th Covid vaccine" on 28Sep2021. This was 3 weeks after the patient received a booster shot. The patient had asked to get a flu shot and the technician made a mistake and accidently gave the patient a covid-19 shot. It was reported that he also gave the patient the flu shot. The patient reported, her arm was a little sore on an unspecified date in 2021, but she had no issues besides that. Relevant tests were none. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: was accidentally given a 4th Covid vaccine; was accidentally given a 4th Covid vaccine; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received fourth dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: 30155BA, and Expiration date: 31Dec2021), via an unspecified route of administration on 28Sep2021 (at the age of 73-year-old) as dose 4, single for COVID-19 immunization, at pharmacy or drug store. The patient medical history was none (with no underlying medical conditions). Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6201, and Expiration date: Unknown), Intramuscular, administered in arm right on 12Feb2021 at 11:00 AM as dose 1, single for COVID-19 immunization. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6206, and Expiration date: Unknown), Intramuscular, administered in arm right on 05Mar2021 at 10:30 AM as dose 2, single for COVID-19 immunization. The patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3184, and Expiration date: Unknown), Intramuscular, administered in arm left on 06Sep2021 as dose 3 (booster), single for COVID-19 immunization. It was reported that, the patient "was accidentally given a 4th Covid vaccine" on 28Sep2021. This was 3 weeks after the patient received a booster shot. The patient had asked to get a flu shot and the technician made a mistake and accidently gave the patient a covid-19 shot. It was reported that he also gave the patient the flu shot. The patient reported, her arm was a little sore on an unspecified date in 2021, but she had no issues besides that. Relevant tests were none. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time normal, Animal scratch, Blood fibrinogen normal, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gingival bleeding, Haematocrit normal, Haemoglobin normal, Haemophagocytic lymphohistiocytosis, Haemorrhage
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio increased, Platelet count decreased, Prothrombin time prolonged, Red blood cells urine, Thrombocytopenia
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Biopsy bone marrow, Blood lactic acid increased, Blood loss anaemia, Blood phosphorus increased
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coagulopathy, Dexamethasone suppression test, Dialysis, Echocardiogram normal, Ejection fraction normal
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Extubation, Haematocrit decreased, Haemoglobin decreased, Hypervolaemia
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Immunoglobulin therapy, Intensive care, Mechanical ventilation, Melaena
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Metabolic acidosis, Packed red blood cell transfusion, Plasmapheresis, Platelet count decreased
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet transfusion, Shock haemorrhagic, Splenectomy, Thrombocytopenia, Transfusion
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vitreous haemorrhage
Clinical narrative: Severe thrombocytopenia -  Patient developed altered mental status and hypotension. Patient was emergently endotracheally intubated due to acute hypoxic respiratory failure. MTP was initiated and patient was transfused 4 units packed red blood cells, 1 unit cryoprecipitate, 2 units platelets and patient was started on tranexamic acid every 8 hours 800 mg due to life-threatening coagulopathy. Patient was found to have life-threatening acute blood loss anemia with hemoglobin 2.3\hematocrit 7. Patient received transfusion of blood products.  Due to life-threatening hypotension and hemorrhagic shock patient required IV norepinephrine drip/vasopressin drip/and sodium bicarb drip due to profound metabolic acidosis with lactic acid 21.5. Echocardiogram was done on 9/18/2021 which showed EF 60/64%.  On 9/27 he remained sedated, orally intubated on mechanical ventilation.  Had an episode of melena. Transfused 6 units PRBCs 2 units platelets 2 units FFP 2 units cryoprecipitate overnight. On 9/28 Hematology recommended plasmapheresis. Patient had persistent melena and continued on IV PPI. 10/1 Patient initiated on dialysis on 9/30 due to volume overload and severely elevated phosphorus. Patient continued to have critically low platelet level and severe anemia. Platelets and PRBCs transfused. 10/2 Patient underwent plasmapheresis and HD, both of which he tolerated well.  Patient had severe anemia requiring 2u PRBC and persistently thrombocytopenic requiring platelet transfusion. Patient extubated 10/3. IVIG started 10/5 per Hematology. Transfused 1u platelets, ordered 2u pRBCs for worsening anemia. He received 1 unit PRBCs and 1 unit platelets overnight for hemoglobin of 6.5 and platelet of 3 10/10.  On 10/12 patient had repeat BM biopsy  with IR. Dexamethasone suppression test unsuccessful due to improper timing of lab collection. Patient received 1 unit pRBCs for hgb 6.2. Ophthalmology consulted for vitreous hemorrhage, rec reconsult in 2 weeks if unimproved, OP follow up.  Transferred out of ICU 10/13. Heme/onc following getting scheduled transfusions.  Intermittently requiring prbc transfusion as well. Surg onc consulted. S/p splenectomy 10/22. Hematology managing of Nplate and continuing cyclosporin, and continuing transfusion of platelets. Undergoing splenectomy vaccination with plt transfusions per hematology. Patient is still inpatient.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Albumin CSF increased, Back pain, Blood albumin increased, Blood calcium increased, Blood cholesterol increased
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered at right arm on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021, the patient experienced bilateral facial paralysis. low back pain and bilateral leg pain. Then, he was diagnosed with guillian barre syndrome. On 18-Oct-2021 the patient was hospitalized and had received treatment of unspecified immunoglobulin. He was hospitalized for 5 days and on 22-OCT-2021 the patient was discharged. The patient was seen a couple of different neurologists (physician's office visit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211046479 - covid-19 vaccine ad26.cov2.s  Guillain-Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin G normal, Blood test, Blood triglycerides increased, CSF immunoglobulin increased
Clinical narrative: GUILLAIN BARRE SYNDROME; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total administered at right arm on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAY-2021, the patient experienced bilateral facial paralysis. low back pain and bilateral leg pain. Then, he was diagnosed with guillian barre syndrome. On 18-Oct-2021 the patient was hospitalized and had received treatment of unspecified immunoglobulin. He was hospitalized for 5 days and on 22-OCT-2021 the patient was discharged. The patient was seen a couple of different neurologists (physician's office visit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from guillain barre syndrome. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211046479 - covid-19 vaccine ad26.cov2.s  Guillain-Barre Syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.