chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gingival swelling, Headache, Injection site bruising, Injection site rash, Metabolic function test
Clinical narrative: First 3-4 days, fever, sore arm, fatigue , aches, cough, rash around injection site, gums inflamed, purple bruising below injection site on arm  Fever, headaches, fatigue, lack of concentration for past four weeks
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Polymerase chain reaction positive, Pyrexia, SARS-CoV-2 antibody test positive
Clinical narrative: First 3-4 days, fever, sore arm, fatigue , aches, cough, rash around injection site, gums inflamed, purple bruising below injection site on arm  Fever, headaches, fatigue, lack of concentration for past four weeks
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electromyogram, Hypoaesthesia, Loss of control of legs, Magnetic resonance imaging
Clinical narrative: Paralysis of left leg; numbness; Tingling; spasms; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown, expiration date unknown), via an unspecified route of administration on 26Jan2021 at 16:30 (age at vaccination of 61-years-old) at single dose on right arm for COVID-19 immunisation.  Medical history included Charcot-Marie-Tooth (CMT) disease type 1A , sarcoidosis and thyroid disorder, all from an unknown date and unknown if ongoing; egg allergy and drug allergy to Ampicillin. The patient was not pregnant and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.   The patient experienced paralysis of left leg on 10Feb2021 (at 12:15), lasting numbness of upper quad and lower leg on 10Feb2021 (at 12:15), tingling on 10Feb2021 (at 12:15) and muscle spasms on 10Feb2021 (at 12:15); the events resulted in emergency room visit and patient was hospitalized for 3 days; the event paralysis of left leg was also serious as disability. The patient was tested for COVID post vaccination on 10Feb2021 and result of Nasal Swab was negative. Treatment for the events includes unspecified medication, PT (as reported), MRI, CT, Bloodwork, Ultrasound (results unknown). The patient was not recovered from the events.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Neurological examination, Pain, Paraesthesia, Paralysis
Clinical narrative: Paralysis of left leg; numbness; Tingling; spasms; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown, expiration date unknown), via an unspecified route of administration on 26Jan2021 at 16:30 (age at vaccination of 61-years-old) at single dose on right arm for COVID-19 immunisation.  Medical history included Charcot-Marie-Tooth (CMT) disease type 1A , sarcoidosis and thyroid disorder, all from an unknown date and unknown if ongoing; egg allergy and drug allergy to Ampicillin. The patient was not pregnant and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.   The patient experienced paralysis of left leg on 10Feb2021 (at 12:15), lasting numbness of upper quad and lower leg on 10Feb2021 (at 12:15), tingling on 10Feb2021 (at 12:15) and muscle spasms on 10Feb2021 (at 12:15); the events resulted in emergency room visit and patient was hospitalized for 3 days; the event paralysis of left leg was also serious as disability. The patient was tested for COVID post vaccination on 10Feb2021 and result of Nasal Swab was negative. Treatment for the events includes unspecified medication, PT (as reported), MRI, CT, Bloodwork, Ultrasound (results unknown). The patient was not recovered from the events.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: Paralysis of left leg; numbness; Tingling; spasms; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown, expiration date unknown), via an unspecified route of administration on 26Jan2021 at 16:30 (age at vaccination of 61-years-old) at single dose on right arm for COVID-19 immunisation.  Medical history included Charcot-Marie-Tooth (CMT) disease type 1A , sarcoidosis and thyroid disorder, all from an unknown date and unknown if ongoing; egg allergy and drug allergy to Ampicillin. The patient was not pregnant and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.   The patient experienced paralysis of left leg on 10Feb2021 (at 12:15), lasting numbness of upper quad and lower leg on 10Feb2021 (at 12:15), tingling on 10Feb2021 (at 12:15) and muscle spasms on 10Feb2021 (at 12:15); the events resulted in emergency room visit and patient was hospitalized for 3 days; the event paralysis of left leg was also serious as disability. The patient was tested for COVID post vaccination on 10Feb2021 and result of Nasal Swab was negative. Treatment for the events includes unspecified medication, PT (as reported), MRI, CT, Bloodwork, Ultrasound (results unknown). The patient was not recovered from the events.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Hypoaesthesia, Magnetic resonance imaging, Monoplegia
Clinical narrative: Paralysis of left leg; numbness; Tingling; spasms; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown, expiration date unknown), via an unspecified route of administration on 26Jan2021 at 16:30 (age at vaccination of 61-years-old) at single dose on right arm for COVID-19 immunisation.  Medical history included Charcot-Marie-Tooth (CMT) disease type 1A , sarcoidosis and thyroid disorder, all from an unknown date and unknown if ongoing; egg allergy and drug allergy to Ampicillin. The patient was not pregnant and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.   The patient experienced paralysis of left leg on 10Feb2021 (at 12:15), lasting numbness of upper quad and lower leg on 10Feb2021 (at 12:15), tingling on 10Feb2021 (at 12:15) and muscle spasms on 10Feb2021 (at 12:15); the events resulted in emergency room visit and patient was hospitalized for 3 days; the event paralysis of left leg was also serious as disability. The patient was tested for COVID post vaccination on 10Feb2021 and result of Nasal Swab was negative. Treatment for the events includes unspecified medication, PT (as reported), MRI, CT, Bloodwork, Ultrasound (results unknown). The patient was not recovered from the events.  Information on the lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Paraesthesia, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Paralysis of left leg; numbness; Tingling; spasms; This is a spontaneous report from a contactable consumer (patient).  A 61-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown, expiration date unknown), via an unspecified route of administration on 26Jan2021 at 16:30 (age at vaccination of 61-years-old) at single dose on right arm for COVID-19 immunisation.  Medical history included Charcot-Marie-Tooth (CMT) disease type 1A , sarcoidosis and thyroid disorder, all from an unknown date and unknown if ongoing; egg allergy and drug allergy to Ampicillin. The patient was not pregnant and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported.   The patient experienced paralysis of left leg on 10Feb2021 (at 12:15), lasting numbness of upper quad and lower leg on 10Feb2021 (at 12:15), tingling on 10Feb2021 (at 12:15) and muscle spasms on 10Feb2021 (at 12:15); the events resulted in emergency room visit and patient was hospitalized for 3 days; the event paralysis of left leg was also serious as disability. The patient was tested for COVID post vaccination on 10Feb2021 and result of Nasal Swab was negative. Treatment for the events includes unspecified medication, PT (as reported), MRI, CT, Bloodwork, Ultrasound (results unknown). The patient was not recovered from the events.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Application site haemorrhage, Full blood count normal, Gingival bleeding, Haemoglobin normal, Immunoglobulin therapy
Clinical narrative: 15Feb at platelet count was at 2,000/Repeat blood work on 19Feb showed platelet count at 22,000/Repeat blood work on 24Feb showed platelet count at 300,000; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received bnt162b2 (BNT162B2, Lot number: EL9261) first dose, via an unspecified route of administration on 11Feb2021 15:45 at SINGLE DOSE at right arm for Covid-19 immunisation.  Medical history included Celiac Disease, Auto Immune Anemia and ITP.  There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient previously took gluten and experienced allergies. Patient had a history of ITP and auto immune anemia. He detected gum bleeding and petechiae forming at right arm injection site on 14Feb. Met with hematologist on 15Feb at platelet count was at 2,000. Started 60mg of prednisone on 15Feb. Repeat blood work on 19Feb showed platelet count at 22,000. Received one 70g IVIG blood plasma treatment on 19Feb after blood work. Repeat blood work on 24Feb showed platelet count at 300,000. At this time, tapering prednisone and will repeat blood work weekly to see if blood levels hold. All events with onset date of 14Feb2021, 11:00PM with outcome of recovering. The patient underwent lab test which included platelet count: 2000 on 15Feb2021, 22,000 on 19Feb2021, 300,000 on 24Feb2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The treatment received included Prednisone and IVIG. No COVID prior vaccination. No COVID tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site haemorrhage, Platelet count decreased
Clinical narrative: 15Feb at platelet count was at 2,000/Repeat blood work on 19Feb showed platelet count at 22,000/Repeat blood work on 24Feb showed platelet count at 300,000; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received bnt162b2 (BNT162B2, Lot number: EL9261) first dose, via an unspecified route of administration on 11Feb2021 15:45 at SINGLE DOSE at right arm for Covid-19 immunisation.  Medical history included Celiac Disease, Auto Immune Anemia and ITP.  There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient previously took gluten and experienced allergies. Patient had a history of ITP and auto immune anemia. He detected gum bleeding and petechiae forming at right arm injection site on 14Feb. Met with hematologist on 15Feb at platelet count was at 2,000. Started 60mg of prednisone on 15Feb. Repeat blood work on 19Feb showed platelet count at 22,000. Received one 70g IVIG blood plasma treatment on 19Feb after blood work. Repeat blood work on 24Feb showed platelet count at 300,000. At this time, tapering prednisone and will repeat blood work weekly to see if blood levels hold. All events with onset date of 14Feb2021, 11:00PM with outcome of recovering. The patient underwent lab test which included platelet count: 2000 on 15Feb2021, 22,000 on 19Feb2021, 300,000 on 24Feb2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The treatment received included Prednisone and IVIG. No COVID prior vaccination. No COVID tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Application site haemorrhage, Gingival bleeding, Platelet count, Platelet count decreased
Clinical narrative: 15Feb at platelet count was at 2,000/Repeat blood work on 19Feb showed platelet count at 22,000/Repeat blood work on 24Feb showed platelet count at 300,000; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received bnt162b2 (BNT162B2, Lot number: EL9261) first dose, via an unspecified route of administration on 11Feb2021 15:45 at SINGLE DOSE at right arm for Covid-19 immunisation.  Medical history included Celiac Disease, Auto Immune Anemia and ITP.  There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient previously took gluten and experienced allergies. Patient had a history of ITP and auto immune anemia. He detected gum bleeding and petechiae forming at right arm injection site on 14Feb. Met with hematologist on 15Feb at platelet count was at 2,000. Started 60mg of prednisone on 15Feb. Repeat blood work on 19Feb showed platelet count at 22,000. Received one 70g IVIG blood plasma treatment on 19Feb after blood work. Repeat blood work on 24Feb showed platelet count at 300,000. At this time, tapering prednisone and will repeat blood work weekly to see if blood levels hold. All events with onset date of 14Feb2021, 11:00PM with outcome of recovering. The patient underwent lab test which included platelet count: 2000 on 15Feb2021, 22,000 on 19Feb2021, 300,000 on 24Feb2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The treatment received included Prednisone and IVIG. No COVID prior vaccination. No COVID tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: 15Feb at platelet count was at 2,000/Repeat blood work on 19Feb showed platelet count at 22,000/Repeat blood work on 24Feb showed platelet count at 300,000; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; I have a history of ITP and auto immune anemia.  I detected gum bleeding and petechiae forming at right arm injection site on 14Feb.; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received bnt162b2 (BNT162B2, Lot number: EL9261) first dose, via an unspecified route of administration on 11Feb2021 15:45 at SINGLE DOSE at right arm for Covid-19 immunisation.  Medical history included Celiac Disease, Auto Immune Anemia and ITP.  There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient previously took gluten and experienced allergies. Patient had a history of ITP and auto immune anemia. He detected gum bleeding and petechiae forming at right arm injection site on 14Feb. Met with hematologist on 15Feb at platelet count was at 2,000. Started 60mg of prednisone on 15Feb. Repeat blood work on 19Feb showed platelet count at 22,000. Received one 70g IVIG blood plasma treatment on 19Feb after blood work. Repeat blood work on 24Feb showed platelet count at 300,000. At this time, tapering prednisone and will repeat blood work weekly to see if blood levels hold. All events with onset date of 14Feb2021, 11:00PM with outcome of recovering. The patient underwent lab test which included platelet count: 2000 on 15Feb2021, 22,000 on 19Feb2021, 300,000 on 24Feb2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The treatment received included Prednisone and IVIG. No COVID prior vaccination. No COVID tested post vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Application site haemorrhage, Full blood count normal, Gingival bleeding, Haemoglobin normal, Immunoglobulin therapy
Clinical narrative: Thrombocytopenia caused petechiae.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site haemorrhage, Platelet count decreased
Clinical narrative: Thrombocytopenia caused petechiae.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Application site haemorrhage, Gingival bleeding, Platelet count, Platelet count decreased
Clinical narrative: Thrombocytopenia caused petechiae.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia caused petechiae.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Confusional state, Nausea, Vomiting
Clinical narrative: Weakness, dizziness, nausea, vomiting started 17 hours after 2nd moderna vaccine.  He was dizzy and had some vomiting.  In the ER he was tachypneic (RR as high as 27, fever of 101.3 and elevated procalcitonin, elevated WBC (chronic w CLL), and dehydration, creatinine of 1.8, baseline creatinine of 1.5.   Imaging (cxr) unremarkable.  UA unremarkable.  Seen by infectious disease specialist who diagnosed him with profound weakness secondary to vaccine reactogenic in nature.  Was placed on empiric ceftriaxone.  Covid test was negative.   had hypoglycemia episodes 2/2 poor oral intake.  Started on maintenance fluids w dextrose.  Later found to have ileus.  As of this reports patient is day 7 hospitalization, still with profound weakness.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood creatinine increased, Chest X-ray normal, Dehydration, Dizziness
Clinical narrative: Weakness, dizziness, nausea, vomiting started 17 hours after 2nd moderna vaccine.  He was dizzy and had some vomiting.  In the ER he was tachypneic (RR as high as 27, fever of 101.3 and elevated procalcitonin, elevated WBC (chronic w CLL), and dehydration, creatinine of 1.8, baseline creatinine of 1.5.   Imaging (cxr) unremarkable.  UA unremarkable.  Seen by infectious disease specialist who diagnosed him with profound weakness secondary to vaccine reactogenic in nature.  Was placed on empiric ceftriaxone.  Covid test was negative.   had hypoglycemia episodes 2/2 poor oral intake.  Started on maintenance fluids w dextrose.  Later found to have ileus.  As of this reports patient is day 7 hospitalization, still with profound weakness.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoglycaemia, Hypophagia, Ileus, Nausea, Procalcitonin increased
Clinical narrative: Weakness, dizziness, nausea, vomiting started 17 hours after 2nd moderna vaccine.  He was dizzy and had some vomiting.  In the ER he was tachypneic (RR as high as 27, fever of 101.3 and elevated procalcitonin, elevated WBC (chronic w CLL), and dehydration, creatinine of 1.8, baseline creatinine of 1.5.   Imaging (cxr) unremarkable.  UA unremarkable.  Seen by infectious disease specialist who diagnosed him with profound weakness secondary to vaccine reactogenic in nature.  Was placed on empiric ceftriaxone.  Covid test was negative.   had hypoglycemia episodes 2/2 poor oral intake.  Started on maintenance fluids w dextrose.  Later found to have ileus.  As of this reports patient is day 7 hospitalization, still with profound weakness.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Reactogenicity event, SARS-CoV-2 test negative, Tachypnoea, Urine analysis normal
Clinical narrative: Weakness, dizziness, nausea, vomiting started 17 hours after 2nd moderna vaccine.  He was dizzy and had some vomiting.  In the ER he was tachypneic (RR as high as 27, fever of 101.3 and elevated procalcitonin, elevated WBC (chronic w CLL), and dehydration, creatinine of 1.8, baseline creatinine of 1.5.   Imaging (cxr) unremarkable.  UA unremarkable.  Seen by infectious disease specialist who diagnosed him with profound weakness secondary to vaccine reactogenic in nature.  Was placed on empiric ceftriaxone.  Covid test was negative.   had hypoglycemia episodes 2/2 poor oral intake.  Started on maintenance fluids w dextrose.  Later found to have ileus.  As of this reports patient is day 7 hospitalization, still with profound weakness.
Age: 95.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Weakness, dizziness, nausea, vomiting started 17 hours after 2nd moderna vaccine.  He was dizzy and had some vomiting.  In the ER he was tachypneic (RR as high as 27, fever of 101.3 and elevated procalcitonin, elevated WBC (chronic w CLL), and dehydration, creatinine of 1.8, baseline creatinine of 1.5.   Imaging (cxr) unremarkable.  UA unremarkable.  Seen by infectious disease specialist who diagnosed him with profound weakness secondary to vaccine reactogenic in nature.  Was placed on empiric ceftriaxone.  Covid test was negative.   had hypoglycemia episodes 2/2 poor oral intake.  Started on maintenance fluids w dextrose.  Later found to have ileus.  As of this reports patient is day 7 hospitalization, still with profound weakness.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: soon after injection, face started getting red around mask, continued turning red and spreading across face, after several hours extended onto upper chest.  Over several days turned deeper red then purple.  Sought care from PCP who  rx's 7 days of steroids.  During time say allergist who said rash was probably due to some agent in the vaccine and not the rna component.  Pt has contacted pfizer and cdc about issue and is irate that was told no one would call her back.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Rash
Clinical narrative: soon after injection, face started getting red around mask, continued turning red and spreading across face, after several hours extended onto upper chest.  Over several days turned deeper red then purple.  Sought care from PCP who  rx's 7 days of steroids.  During time say allergist who said rash was probably due to some agent in the vaccine and not the rna component.  Pt has contacted pfizer and cdc about issue and is irate that was told no one would call her back.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergic reaction to excipient
Clinical narrative: soon after injection, face started getting red around mask, continued turning red and spreading across face, after several hours extended onto upper chest.  Over several days turned deeper red then purple.  Sought care from PCP who  rx's 7 days of steroids.  During time say allergist who said rash was probably due to some agent in the vaccine and not the rna component.  Pt has contacted pfizer and cdc about issue and is irate that was told no one would call her back.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cerebrovascular accident, Drug ineffective, Dysphagia, Facial paralysis
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Stroke-Severe
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Laboratory test, Magnetic resonance imaging brain, Malaise, Speech disorder
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Stroke-Severe
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Stroke-Severe
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: On 2/4 patient recieved 1st dose of COVID vaccination and experienced headache and arm pain. On 2/23 patient received 2nd dose of COVID vaccination at 12:47 p.m. Noticed headache at base of head and took Ibuprofen for relief. On 2/26 at 1:30 pm patient noticed that her right eye was not closing well. Had to force eye closed. On 2/27 early in the morning patient's eyebrows were not moving and it was still hard to close right eye. Stated that the right side of her face was 'not working'. Presented  Emergency Department around 8:30 a.m. with complaints of facial numbness. Full workup led to diagnosis of Bell's Palsy. Initiated Acyclovir and Prednisone and discharged to home.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram normal, Eyelid function disorder, Facial paresis, Headache
Clinical narrative: On 2/4 patient recieved 1st dose of COVID vaccination and experienced headache and arm pain. On 2/23 patient received 2nd dose of COVID vaccination at 12:47 p.m. Noticed headache at base of head and took Ibuprofen for relief. On 2/26 at 1:30 pm patient noticed that her right eye was not closing well. Had to force eye closed. On 2/27 early in the morning patient's eyebrows were not moving and it was still hard to close right eye. Stated that the right side of her face was 'not working'. Presented  Emergency Department around 8:30 a.m. with complaints of facial numbness. Full workup led to diagnosis of Bell's Palsy. Initiated Acyclovir and Prednisone and discharged to home.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: On 2/4 patient recieved 1st dose of COVID vaccination and experienced headache and arm pain. On 2/23 patient received 2nd dose of COVID vaccination at 12:47 p.m. Noticed headache at base of head and took Ibuprofen for relief. On 2/26 at 1:30 pm patient noticed that her right eye was not closing well. Had to force eye closed. On 2/27 early in the morning patient's eyebrows were not moving and it was still hard to close right eye. Stated that the right side of her face was 'not working'. Presented  Emergency Department around 8:30 a.m. with complaints of facial numbness. Full workup led to diagnosis of Bell's Palsy. Initiated Acyclovir and Prednisone and discharged to home.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Hepatic enzyme abnormal, Rash, Rash maculo-papular, White blood cell count
Clinical narrative: Progressive pruritic papular erythematous initially vesicular now coalescing rash (head, trunk, back, arms) with mucocutaneous involvement. Biopsies as below, c/w Erythema Multiforme. Pt presented to the hospital on 2/18, initially treated for disseminated dx/VZV, but microbiology workup largely negative (see below).  Rheumatological workup negative (see below). Biopsy results as below.  Pt was initiated on Prednisone 80 on 2/26 which halted progression of rash.  Discharged on prednisone taper with close Dermatology f/u.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin abnormal, Blister, Eczema, Eosinophil count, Erythema multiforme
Clinical narrative: Progressive pruritic papular erythematous initially vesicular now coalescing rash (head, trunk, back, arms) with mucocutaneous involvement. Biopsies as below, c/w Erythema Multiforme. Pt presented to the hospital on 2/18, initially treated for disseminated dx/VZV, but microbiology workup largely negative (see below).  Rheumatological workup negative (see below). Biopsy results as below.  Pt was initiated on Prednisone 80 on 2/26 which halted progression of rash.  Discharged on prednisone taper with close Dermatology f/u.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperkeratosis, Lymphocyte count, Mucocutaneous rash, Necrosis, Neutrophil count
Clinical narrative: Progressive pruritic papular erythematous initially vesicular now coalescing rash (head, trunk, back, arms) with mucocutaneous involvement. Biopsies as below, c/w Erythema Multiforme. Pt presented to the hospital on 2/18, initially treated for disseminated dx/VZV, but microbiology workup largely negative (see below).  Rheumatological workup negative (see below). Biopsy results as below.  Pt was initiated on Prednisone 80 on 2/26 which halted progression of rash.  Discharged on prednisone taper with close Dermatology f/u.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular, Rash pruritic, Rash vesicular
Clinical narrative: Progressive pruritic papular erythematous initially vesicular now coalescing rash (head, trunk, back, arms) with mucocutaneous involvement. Biopsies as below, c/w Erythema Multiforme. Pt presented to the hospital on 2/18, initially treated for disseminated dx/VZV, but microbiology workup largely negative (see below).  Rheumatological workup negative (see below). Biopsy results as below.  Pt was initiated on Prednisone 80 on 2/26 which halted progression of rash.  Discharged on prednisone taper with close Dermatology f/u.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Erythema multiforme, Investigation, Rash
Clinical narrative: Progressive pruritic papular erythematous initially vesicular now coalescing rash (head, trunk, back, arms) with mucocutaneous involvement. Biopsies as below, c/w Erythema Multiforme. Pt presented to the hospital on 2/18, initially treated for disseminated dx/VZV, but microbiology workup largely negative (see below).  Rheumatological workup negative (see below). Biopsy results as below.  Pt was initiated on Prednisone 80 on 2/26 which halted progression of rash.  Discharged on prednisone taper with close Dermatology f/u.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Chronic obstructive pulmonary disease, Dyspnoea, Dyspnoea exertional, Interstitial lung disease
Clinical narrative: Patient presented to the ED with increased SOB. During his admission he was noted to likely have diastolic HF (to follow up with cardiologist for stress test), COPD and suggested pulmonary HTN, as well as cirrhosis of unclear etiology. Patient was treated with diuretics, steroids, and antibiotics and was later discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary oedema, Right ventricular failure
Clinical narrative: Patient presented to the ED with increased SOB. During his admission he was noted to likely have diastolic HF (to follow up with cardiologist for stress test), COPD and suggested pulmonary HTN, as well as cirrhosis of unclear etiology. Patient was treated with diuretics, steroids, and antibiotics and was later discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Hepatic cirrhosis, Left ventricular failure
Clinical narrative: Patient presented to the ED with increased SOB. During his admission he was noted to likely have diastolic HF (to follow up with cardiologist for stress test), COPD and suggested pulmonary HTN, as well as cirrhosis of unclear etiology. Patient was treated with diuretics, steroids, and antibiotics and was later discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary hypertension
Clinical narrative: Patient presented to the ED with increased SOB. During his admission he was noted to likely have diastolic HF (to follow up with cardiologist for stress test), COPD and suggested pulmonary HTN, as well as cirrhosis of unclear etiology. Patient was treated with diuretics, steroids, and antibiotics and was later discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall
Clinical narrative: "It wasn't that bad. Not joint, just muscles."; "I was stiff"; fell on ice; next day, lower back pain plus legs; I had lower back pain; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of an unspecified age (reported as 84, unit unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number and expiry date not reported) via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I had lower back pain on 27Jan2021, next day, lower back pain plus legs on 28Jan2021 and "It wasn't that bad. Not joint, just muscles", "I was stiff" on unspecified date. It was reported that the patient received 1st dose on 27Jan2021. Reporter fell on ice and asking if he can take Tylenol between the vaccine doses. After information given to reporter about his initial inquiry, reporter states, "I am surprised how least I had a reaction. 1st day of vaccine, that evening, I had lower back pain. The next day, lower back pain plus legs. On the 3rd day, pain receding. Right now everything is fine". "It wasn't that bad. Not joint, just muscles." "I was stiff". The outcome of the events I had lower back pain and next day, lower back pain plus legs was recovered on 01Feb2021. Outcome of "It wasn't that bad. Not joint, just muscles", "I was stiff" and "fell on ice" was unknown.    Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Fall, Muscle disorder, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: "It wasn't that bad. Not joint, just muscles."; "I was stiff"; fell on ice; next day, lower back pain plus legs; I had lower back pain; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A male patient of an unspecified age (reported as 84, unit unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number and expiry date not reported) via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported I had lower back pain on 27Jan2021, next day, lower back pain plus legs on 28Jan2021 and "It wasn't that bad. Not joint, just muscles", "I was stiff" on unspecified date. It was reported that the patient received 1st dose on 27Jan2021. Reporter fell on ice and asking if he can take Tylenol between the vaccine doses. After information given to reporter about his initial inquiry, reporter states, "I am surprised how least I had a reaction. 1st day of vaccine, that evening, I had lower back pain. The next day, lower back pain plus legs. On the 3rd day, pain receding. Right now everything is fine". "It wasn't that bad. Not joint, just muscles." "I was stiff". The outcome of the events I had lower back pain and next day, lower back pain plus legs was recovered on 01Feb2021. Outcome of "It wasn't that bad. Not joint, just muscles", "I was stiff" and "fell on ice" was unknown.    Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Dyspnoea, Palpitations
Clinical narrative: Chest pain, shortness of breath, palpitations, tachycardia, facial swelling   Emergency Department IV Benadryl and solumedrol
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Full blood count, Metabolic function test, Palpitations
Clinical narrative: Chest pain, shortness of breath, palpitations, tachycardia, facial swelling   Emergency Department IV Benadryl and solumedrol
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Tachycardia, Troponin
Clinical narrative: Chest pain, shortness of breath, palpitations, tachycardia, facial swelling   Emergency Department IV Benadryl and solumedrol
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID antigen positive 2/26/2021; asymptomatic, but recent known community exposure
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Vertigo, Vision blurred
Clinical narrative: Dizziness,,blurred vision, head ache and rise in blood pressure.  Blood pressure rose over 210 and rising.  Treated with meds until BP was reduced to 147. Released from ER approximately 2PM.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Headache, Vision blurred
Clinical narrative: Dizziness,,blurred vision, head ache and rise in blood pressure.  Blood pressure rose over 210 and rising.  Treated with meds until BP was reduced to 147. Released from ER approximately 2PM.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthenia, Blood pressure increased, Chest discomfort, Cough
Clinical narrative: Received Moderna then in 10 minutes she had near syncope, Lip swollen, lip numbness and tongue swelling, with dizziness. Then patient got Benadryl  and got 2 shots of epinephrine prior to arrival, BP recorded at 177/92 but it was after patient got Epinephrine.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disorientation, Dysphonia, Dyspnoea, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: Received Moderna then in 10 minutes she had near syncope, Lip swollen, lip numbness and tongue swelling, with dizziness. Then patient got Benadryl  and got 2 shots of epinephrine prior to arrival, BP recorded at 177/92 but it was after patient got Epinephrine.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Pruritus, Respiratory rate increased, Somnolence
Clinical narrative: Received Moderna then in 10 minutes she had near syncope, Lip swollen, lip numbness and tongue swelling, with dizziness. Then patient got Benadryl  and got 2 shots of epinephrine prior to arrival, BP recorded at 177/92 but it was after patient got Epinephrine.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Throat irritation, Throat tightness
Clinical narrative: Received Moderna then in 10 minutes she had near syncope, Lip swollen, lip numbness and tongue swelling, with dizziness. Then patient got Benadryl  and got 2 shots of epinephrine prior to arrival, BP recorded at 177/92 but it was after patient got Epinephrine.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia oral, Lip swelling, Presyncope, Swollen tongue
Clinical narrative: Received Moderna then in 10 minutes she had near syncope, Lip swollen, lip numbness and tongue swelling, with dizziness. Then patient got Benadryl  and got 2 shots of epinephrine prior to arrival, BP recorded at 177/92 but it was after patient got Epinephrine.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Injection site reaction, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: Patient called primary care office on 3/1/21 stating she had a local reaction to the COVID vaccine that started a week after getting it. It started as a rash and reported it being very itchy. She took Benadryl and iced her arm and that was helping.  She called on 3/4/21 stating the rash started to spread down her arm and her home treatments were no longer working so she was scheduled for an appointment in clinic with her provider.  Provider did take a picture and prescribed a steroid cream and Zyrtec to take.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient called primary care office on 3/1/21 stating she had a local reaction to the COVID vaccine that started a week after getting it. It started as a rash and reported it being very itchy. She took Benadryl and iced her arm and that was helping.  She called on 3/4/21 stating the rash started to spread down her arm and her home treatments were no longer working so she was scheduled for an appointment in clinic with her provider.  Provider did take a picture and prescribed a steroid cream and Zyrtec to take.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune system disorder, Joint swelling, Musculoskeletal discomfort, Off label use, Product use issue
Clinical narrative: had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; This is a spontaneous report from a contactable consumer.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation.  Medical history included Graves' disease.  The patient's concomitant medications were not reported.  The patient experienced had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body on an unspecified date. The outcome of events was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; This is a spontaneous report from a contactable consumer.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation.  Medical history included Graves' disease.  The patient's concomitant medications were not reported.  The patient experienced had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body on an unspecified date. The outcome of events was unknown.    Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune disorder, Rash, Urticaria
Clinical narrative: had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body; This is a spontaneous report from a contactable consumer.  A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation.  Medical history included Graves' disease.  The patient's concomitant medications were not reported.  The patient experienced had an "autoimmune response" and reported to have experienced hives (on left leg) and dots that go "off and on" in different parts of the body on an unspecified date. The outcome of events was unknown.    Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Feeling cold, Rash pruritic
Clinical narrative: Had CSection in Feb. Cord around neck. Merconium in amniotic sac. Not breathing when born. Pushed for 4 hours. Labor  over 36 hours. Newborn continues to have oxygen unstable levels. In neonatal unit for over 9 days.  Birth weight of 6 lbs 8 oz. 3 days early. Mother hemorrhages. Hives on mother worsening. All over body. Photos available. Will speak to hospital today.   Full body hives. Not lessened with benydryl. Every 4 hours. Worsening symptoms
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Had CSection in Feb. Cord around neck. Merconium in amniotic sac. Not breathing when born. Pushed for 4 hours. Labor  over 36 hours. Newborn continues to have oxygen unstable levels. In neonatal unit for over 9 days.  Birth weight of 6 lbs 8 oz. 3 days early. Mother hemorrhages. Hives on mother worsening. All over body. Photos available. Will speak to hospital today.   Full body hives. Not lessened with benydryl. Every 4 hours. Worsening symptoms
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: temperature excurtion for PROQUAD and VARIVAX / vaccines were administered to patients prior to having them evaluated; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 25-JAN-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA)(PROQUAD) 0.5 ml for 1 dose, lot # T013540, expiration date 17-OCT-2021, for prophylaxis (strength, route and frequency were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  The cumulative and complete temperature excursion was unknown. It was  also unknown if a digital data logger was involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller was reporting a temperature excursion for GARDASIL 9; This spontaneous report was received from a clinical coordinator referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, and anatomical location date were unknown) with lot # 1687291 and expiration date 11-SEP-2022.   The information regarding the temperature excursion and if it a data logger was involved was not reported. No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability