chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram head, Tinnitus
Clinical narrative: tinnitus; loud enough to stop sleep; This case was reported by a consumer and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On 22nd June 2021, the patient received the 2nd dose of Shingrix. On 22nd June 2021, less than a day after receiving Shingrix, the patient experienced tinnitus and difficulty sleeping. On an unknown date, the outcome of the tinnitus and difficulty sleeping were unknown.   It was unknown if the reporter considered the tinnitus and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received dose of Shingrix and 4 to 5 hours later, the patient had tinnitus and loud enough to stop sleep. The patient wanted GlaxoSmithKline to stop selling product as it was hurting people lives. The patient went to his/her physician for only high blood pressure and they were pushing this Shingrix vaccine. The patient reported he/she foolishly chose to take the vaccine and imagine the health network, he/she belonged to and was pushed by their GlaxoSmithKline salesman to push that troubling product Shingrix, called off the Shingrix salesman.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR164697:same reporter, (invalid case)
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Insomnia, Tinnitus
Clinical narrative: tinnitus; loud enough to stop sleep; This case was reported by a consumer and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high.   On 22nd June 2021, the patient received the 2nd dose of Shingrix. On 22nd June 2021, less than a day after receiving Shingrix, the patient experienced tinnitus and difficulty sleeping. On an unknown date, the outcome of the tinnitus and difficulty sleeping were unknown.   It was unknown if the reporter considered the tinnitus and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received dose of Shingrix and 4 to 5 hours later, the patient had tinnitus and loud enough to stop sleep. The patient wanted GlaxoSmithKline to stop selling product as it was hurting people lives. The patient went to his/her physician for only high blood pressure and they were pushing this Shingrix vaccine. The patient reported he/she foolishly chose to take the vaccine and imagine the health network, he/she belonged to and was pushed by their GlaxoSmithKline salesman to push that troubling product Shingrix, called off the Shingrix salesman.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR164697:same reporter, (invalid case)
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient had already had a Johnson and Johnson vaccine on 3/19/21.  At the clinic, which was a large public event, he did not disclose that he had already had a vaccine, and the setting did not allow for complete checking of medical records prior to administering the Pfizer vaccines
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Patient had already had a Johnson and Johnson vaccine on 3/19/21.  At the clinic, which was a large public event, he did not disclose that he had already had a vaccine, and the setting did not allow for complete checking of medical records prior to administering the Pfizer vaccines
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: feeling dizzy; This is a spontaneous report received from a Pfizer-sponsored program. A contactable pharmacist reported for a 30-year-old female patient received bnt162b2 (BNT162B2; Formulation: Solution for injection, Batch/Lot Number: EW0181; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 24Jun2021 (at the age 30-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient stated feeling dizzy on an unspecified date. She reports the patient received her first Covid 19 vaccine on 24Jun2021 and the patient reported feeling dizzy after she received the first Covid 19 vaccine. First Covid 19 vaccine information is in the suspect product field. Outcome of the event was unknown.  No further information was available at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia
Clinical narrative: feeling dizzy; This is a spontaneous report received from a Pfizer-sponsored program. A contactable pharmacist reported for a 30-year-old female patient received bnt162b2 (BNT162B2; Formulation: Solution for injection, Batch/Lot Number: EW0181; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 24Jun2021 (at the age 30-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient stated feeling dizzy on an unspecified date. She reports the patient received her first Covid 19 vaccine on 24Jun2021 and the patient reported feeling dizzy after she received the first Covid 19 vaccine. First Covid 19 vaccine information is in the suspect product field. Outcome of the event was unknown.  No further information was available at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: feeling dizzy; This is a spontaneous report received from a Pfizer-sponsored program. A contactable pharmacist reported for a 30-year-old female patient received bnt162b2 (BNT162B2; Formulation: Solution for injection, Batch/Lot Number: EW0181; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 24Jun2021 (at the age 30-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient stated feeling dizzy on an unspecified date. She reports the patient received her first Covid 19 vaccine on 24Jun2021 and the patient reported feeling dizzy after she received the first Covid 19 vaccine. First Covid 19 vaccine information is in the suspect product field. Outcome of the event was unknown.  No further information was available at the time of this report.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: next morning getting out of bed and fell and tried to get up but became weak in the legs, had no strength in legs, fatigue, couldn't stand stayed in bed about 10 days, she felt like she had COVID again. couldn't hold anything on her stomach
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral normal, Computerised tomogram head normal, Fall, Fatigue, Guillain-Barre syndrome
Clinical narrative: next morning getting out of bed and fell and tried to get up but became weak in the legs, had no strength in legs, fatigue, couldn't stand stayed in bed about 10 days, she felt like she had COVID again. couldn't hold anything on her stomach
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: next morning getting out of bed and fell and tried to get up but became weak in the legs, had no strength in legs, fatigue, couldn't stand stayed in bed about 10 days, she felt like she had COVID again. couldn't hold anything on her stomach
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Dysstasia, Fall, Fatigue, Magnetic resonance imaging
Clinical narrative: next morning getting out of bed and fell and tried to get up but became weak in the legs, had no strength in legs, fatigue, couldn't stand stayed in bed about 10 days, she felt like she had COVID again. couldn't hold anything on her stomach
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioplasty, Arteriogram abnormal, Catheter directed thrombolysis, Catheter placement, Leg amputation
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral artery thrombosis, Peripheral ischaemia, Platelet count normal, Platelet factor 4
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombectomy, Ultrasound Doppler normal
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Activated partial thromboplastin time, Adrenal haematoma, Adrenal haemorrhage, Anaemia
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram abnormal, Ankle brachial index abnormal, Anticoagulant therapy, Antiphospholipid syndrome, Arterial catheterisation abnormal
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cerebral haemorrhage, Computerised tomogram head abnormal, Computerised tomogram thorax abnormal, Discomfort
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin, Headache, Heparin-induced thrombocytopenia, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infarction, Laboratory test normal, Leg amputation, Neuropsychological test abnormal, Pain in extremity
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Peripheral artery occlusion, Peripheral artery thrombosis, Plasmapheresis, Platelet count
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Superior sagittal sinus thrombosis, Tarsal tunnel syndrome, Thrombectomy, Thrombolysis, Transverse sinus thrombosis
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan normal, Vascular test abnormal, Venogram abnormal, Venous thrombosis
Clinical narrative: Mid 3/2021: received the J&J COVID vaccine. 2 weeks later she developed LLE paresthesias and mild discomfort. 5/5/2021: ER visit for LLE pain. Reported she had a DVT ultrasound without arterial imaging that was reportedly normal.  6/2/2021: saw her PCP for progressive LLE symptoms. Obtained blood work  7/8/2021: presented to Hospital with severe LLE pain and diagnosed with L Popliteal artery thrombus s/p catheter-directed thrombolysis. Platelets 218. 7/10/2021: open thrombectomy of L popliteal artery and started on IV heparin. Platelets 144.  7/11/2021: platelets 182  7/12/2021: platelets 203 7/13/2021: L BKA, platelets 131 7/14/2021: platelets 144, HITT Ab positive (0.780 by OD). Unclear if AC changed at this time. 7/15/21: platelets 159  7/16/2021: platelets 132 7/17/2021: platelets 107 7/18/2021: platelets 108 7/19/2021: Developed abdominal pain with worsening anemia. Right adrenal hematoma found on CT. Anticoagulation was discontinued. Platelets 112  7/20/2021: platelets 127 7/25/2021: CT a/p showed the L adrenal hematoma at 4 cm x 2.5 cm. Started IV solumedrol (unclear dose) for possible adrenal insufficiency.  7/27/2021: Argatroban started. IVIG x1 for TTS 7/28/2021: IVIG 2nd dose  7/29/2021: CNS imaging done for headache, showed superior saggital sinus and bilateral partial transverse sinus thrombosis. Platelets 228  7/31/21: PLEX 1st  8/1/21: PLEX 2nd day  8/2/2021: arrived at our institution for further evaluation. Argatroban continued.     8/3/2021:  -CT head/neck venogram: Extensive dural venous thrombosis and associated venous infarctions with petechial hemorrhage have not significantly changed from prior examinations.  -DVT u/s BLE: No ultrasound evidence of deep venous thrombosis. -Vascular lab ABIs: L sided occluded distal Superficial Femoral and Popliteal artery throughout via thrombus. R side patent.  -CTA Thrombotic occlusion of the distal Left femoral artery and left popliteal artery. B/l adrenal hemorrhages -Initial hematology consult. Noted ddx includes HITT vs TTS vs APS. Thought the normal platelets were unusual for HITT or TTS, but favored treating as such given no other plausible explanation. Gave back IVIG and deferred PLEX. -S/p IVIG 1gm/kg Day 1    8/4/2021: Platelets 460 -- > 504, PTT 54, Hgb 9.1 -- > 8.2, APS panel negative. IVIG 1 gm/kg Day 2
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle disorder, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Pt. states that after receiving the J&J 1st dose 06/25/2021, started experiencing symptoms 07/04/2021 of weakness in the left arm, pain radiating to the neck, dizziness, brain fog, head tingling, and confusion. Primary visit resulted in steroid shot. Symptoms still continuing. Primary follow-up scheduled for 08/09/2021.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Pt. states that after receiving the J&J 1st dose 06/25/2021, started experiencing symptoms 07/04/2021 of weakness in the left arm, pain radiating to the neck, dizziness, brain fog, head tingling, and confusion. Primary visit resulted in steroid shot. Symptoms still continuing. Primary follow-up scheduled for 08/09/2021.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Feeling abnormal, Muscular weakness, Pain
Clinical narrative: Pt. states that after receiving the J&J 1st dose 06/25/2021, started experiencing symptoms 07/04/2021 of weakness in the left arm, pain radiating to the neck, dizziness, brain fog, head tingling, and confusion. Primary visit resulted in steroid shot. Symptoms still continuing. Primary follow-up scheduled for 08/09/2021.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Pt. states that after receiving the J&J 1st dose 06/25/2021, started experiencing symptoms 07/04/2021 of weakness in the left arm, pain radiating to the neck, dizziness, brain fog, head tingling, and confusion. Primary visit resulted in steroid shot. Symptoms still continuing. Primary follow-up scheduled for 08/09/2021.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Joint stiffness, Lip swelling, Paraesthesia, Paraesthesia oral, Pruritus
Clinical narrative: I started having little itchiness around the whole area;  the itching started getting worse, my hands were itching, my right ear was itching; About 45 minutes or hour after there were two little nodules like little nodes that appeared on my left arm but they looked like round Rosea type; I had hives, like on my right arm; I had tingling in my face, my back, my arms were tingling; My lips swelled up; This is a spontaneous report from a contactable consumer.   A patient (demographics unknown) received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EW0180), via an unspecified route in the left arm, on 24Jul2021 at 05:24 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. About 15 to 20 minutes after the vaccination the patient had hives, like on right arm, the patient had tingling in face, back, arms were tingling. Then, the patient started having little itchiness around the whole area, lips swelled up for 30 minutes. After the patient had got itching, the itching started getting worse, hands were itching, right ear was itching then about 45 minutes or hour after there were two little nodules like little nodes that appeared on left arm but they looked like round Rosea type and after that the patient  took diphenhydramine hydrochloride (BENADRYL), just two tea spoon. No seriousness criterion was provided by reporter. The outcome of the events was unknown.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Skin mass, Skin tightness, Urticaria
Clinical narrative: I started having little itchiness around the whole area;  the itching started getting worse, my hands were itching, my right ear was itching; About 45 minutes or hour after there were two little nodules like little nodes that appeared on my left arm but they looked like round Rosea type; I had hives, like on my right arm; I had tingling in my face, my back, my arms were tingling; My lips swelled up; This is a spontaneous report from a contactable consumer.   A patient (demographics unknown) received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EW0180), via an unspecified route in the left arm, on 24Jul2021 at 05:24 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. About 15 to 20 minutes after the vaccination the patient had hives, like on right arm, the patient had tingling in face, back, arms were tingling. Then, the patient started having little itchiness around the whole area, lips swelled up for 30 minutes. After the patient had got itching, the itching started getting worse, hands were itching, right ear was itching then about 45 minutes or hour after there were two little nodules like little nodes that appeared on left arm but they looked like round Rosea type and after that the patient  took diphenhydramine hydrochloride (BENADRYL), just two tea spoon. No seriousness criterion was provided by reporter. The outcome of the events was unknown.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia, Pruritus, Urticaria
Clinical narrative: I started having little itchiness around the whole area;  the itching started getting worse, my hands were itching, my right ear was itching; About 45 minutes or hour after there were two little nodules like little nodes that appeared on my left arm but they looked like round Rosea type; I had hives, like on my right arm; I had tingling in my face, my back, my arms were tingling; My lips swelled up; This is a spontaneous report from a contactable consumer.   A patient (demographics unknown) received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EW0180), via an unspecified route in the left arm, on 24Jul2021 at 05:24 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. About 15 to 20 minutes after the vaccination the patient had hives, like on right arm, the patient had tingling in face, back, arms were tingling. Then, the patient started having little itchiness around the whole area, lips swelled up for 30 minutes. After the patient had got itching, the itching started getting worse, hands were itching, right ear was itching then about 45 minutes or hour after there were two little nodules like little nodes that appeared on left arm but they looked like round Rosea type and after that the patient  took diphenhydramine hydrochloride (BENADRYL), just two tea spoon. No seriousness criterion was provided by reporter. The outcome of the events was unknown.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia, Pain, Pain of skin
Clinical narrative: pain on his Right-side torso on 7-27-2021; Fever on 7-24-2021; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th July 2021, 1 days after receiving Shingrix, the patient experienced fever. On 27th July 2021, the patient experienced pain. The patient was treated with gabapentin and naproxen (Naprosyn). On 25th July 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were reported as follows: The patient reported that he received first dose of shingrix vaccine. The patient experienced fever the next day at 5pm and it resolved at 3 am. The patient began to get pain on his right side torso. The HCP prescribed Gabapentin and Naprosyn for the pain. For pain in right side torso and another fever episode refer second case id US2021AMR166287 same reporter for second episode.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166287:same patient/reporter
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Axillary pain, Back pain, Breast pain, Herpes zoster, Pain
Clinical narrative: pain on his Right-side torso on 7-27-2021; Fever on 7-24-2021; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th July 2021, 1 days after receiving Shingrix, the patient experienced fever. On 27th July 2021, the patient experienced pain. The patient was treated with gabapentin and naproxen (Naprosyn). On 25th July 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were reported as follows: The patient reported that he received first dose of shingrix vaccine. The patient experienced fever the next day at 5pm and it resolved at 3 am. The patient began to get pain on his right side torso. The HCP prescribed Gabapentin and Naprosyn for the pain. For pain in right side torso and another fever episode refer second case id US2021AMR166287 same reporter for second episode.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166287:same patient/reporter
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: pain on his Right-side torso on 7-27-2021; Fever on 7-24-2021; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th July 2021, 1 days after receiving Shingrix, the patient experienced fever. On 27th July 2021, the patient experienced pain. The patient was treated with gabapentin and naproxen (Naprosyn). On 25th July 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were reported as follows: The patient reported that he received first dose of shingrix vaccine. The patient experienced fever the next day at 5pm and it resolved at 3 am. The patient began to get pain on his right side torso. The HCP prescribed Gabapentin and Naprosyn for the pain. For pain in right side torso and another fever episode refer second case id US2021AMR166287 same reporter for second episode.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166287:same patient/reporter
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: pain on his Right-side torso on 7-27-2021; Fever on 7-24-2021; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 24th July 2021, 1 days after receiving Shingrix, the patient experienced fever. On 27th July 2021, the patient experienced pain. The patient was treated with gabapentin and naproxen (Naprosyn). On 25th July 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were reported as follows: The patient reported that he received first dose of shingrix vaccine. The patient experienced fever the next day at 5pm and it resolved at 3 am. The patient began to get pain on his right side torso. The HCP prescribed Gabapentin and Naprosyn for the pain. For pain in right side torso and another fever episode refer second case id US2021AMR166287 same reporter for second episode.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR166287:same patient/reporter