chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue pruritus, Vital signs measurement, Wheezing
Clinical narrative: throat and tongue started swelling again and were very itchy; throat and tongue started swelling again and were very itchy; difficulty breathing; swallowing saliva; wheezing; noticeably lower than usual with a HR of ~60, BP of 100/70; feeling extreme itchiness and swelling in my tongue; itchiness in her tongue/throat and tongue started were very itchy/feeling extreme itchiness and swelling in her tongue; slight headache/ Headache got worse; felt fatigued; voice sounded weird/my throat was extremely hoarse; constantly cough; upset diarrhea; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left on 31Mar2021 16:45 at age of 34-year-old (Batch/Lot Number: ER8732) at single dose for COVID-19 immunization.  Medical history included Von Willebrands Type 1, and a family history of auto-immune issues like myasthenia gravis, lupus and Chronic inflammatory demyelinating polyradiculoneuropathy. Patient had known allergies to coconut, latex. Concomitant medications included norethindrone acetate and ethinyl estradiol. There was no other vaccine in four weeks. On 01Apr2021, the patient woke up at 08:00 with slight headache and felt fatigued but most noticeably her voice sounded weird and her throat was extremely hoarse while talking in work meeting and she had to constantly cough to clear it. Headache got worse in the afternoon and she had upset diarrhea. Around 19:45 she started feeling extreme itchiness and swelling in her tongue. This didn't improve, so she took 25mg diphenhydramine hydrochloride (BENADRYL)  at 20:20, at which time her vitals were normal, but noticeably lower than usual with a heart rate of 60, blood pressure of 100/70, O2 sat 99% and normal temperature. She also took another 1000 mg paracetamol (TYLENOL) at 21:30 and went to bed. 02Apr2021, 07: 30 woke up and her throat and tongue started swelling again and were very itchy. She then began had difficulty breathing and swallowing saliva. She also could not swallow a banana easily, stopped eating it. She also had some wheezing that would only go away with a cough. She took 25mg more of diphenhydramine hydrochloride and went to urgent care immediately because breathing was becoming increasingly difficult. The 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). Treatment for the events included diphenhydramine hydrochloride injection and prednisone. There was no COVID prior vaccination. There was no COVID tested post vaccination. The patient recovered from the events in Apr2021.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood pressure increased, Dizziness, Nausea, Paraesthesia
Clinical narrative: About 4-5 min after my dose was administered I got a warm rush up the back of my neck, a dull ache above my eyes that came and went super fast, then my heart started racing, I got really light-headed, nauseated and my face got hot and tingly. I let the pharmacist know and he had me prop up my feet, that didn't help, so he had me lie down and elevate my feet. My mouth at this point also went extremely dry.  At first, the pharmacist thought I was experiencing Syncopy, but because my face was hot, and my face and ears were tingling, he felt he should call 911. The paramedics arrived and check my vitals. My blood pressure was high, as was my pulse, but my oxygen levels were fine.  At this point my body legs and hands started to shake a bit, I am guessing from the adrenaline and my fingers got ice cold. I had not eaten a ton that day so they also checked my blood sugar which was normal, but on the low side.  After about 40  min they had me stand up and made sure I was ok.  I decided to go home and monitor the symptoms.  I was hot, dizzy, and nauseated for the next 3 hours. For 12 hours post-vaccine I was nauseous, then had a dull headache.  Today, one-week post-vaccine my injection site is very hot and red and a few little bumps have formed.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin warm, Tachycardia
Clinical narrative: About 4-5 min after my dose was administered I got a warm rush up the back of my neck, a dull ache above my eyes that came and went super fast, then my heart started racing, I got really light-headed, nauseated and my face got hot and tingly. I let the pharmacist know and he had me prop up my feet, that didn't help, so he had me lie down and elevate my feet. My mouth at this point also went extremely dry.  At first, the pharmacist thought I was experiencing Syncopy, but because my face was hot, and my face and ears were tingling, he felt he should call 911. The paramedics arrived and check my vitals. My blood pressure was high, as was my pulse, but my oxygen levels were fine.  At this point my body legs and hands started to shake a bit, I am guessing from the adrenaline and my fingers got ice cold. I had not eaten a ton that day so they also checked my blood sugar which was normal, but on the low side.  After about 40  min they had me stand up and made sure I was ok.  I decided to go home and monitor the symptoms.  I was hot, dizzy, and nauseated for the next 3 hours. For 12 hours post-vaccine I was nauseous, then had a dull headache.  Today, one-week post-vaccine my injection site is very hot and red and a few little bumps have formed.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood pressure increased, Dizziness, Dry mouth, Eye pain
Clinical narrative: About 4-5 min after my dose was administered I got a warm rush up the back of my neck, a dull ache above my eyes that came and went super fast, then my heart started racing, I got really light-headed, nauseated and my face got hot and tingly. I let the pharmacist know and he had me prop up my feet, that didn't help, so he had me lie down and elevate my feet. My mouth at this point also went extremely dry.  At first, the pharmacist thought I was experiencing Syncopy, but because my face was hot, and my face and ears were tingling, he felt he should call 911. The paramedics arrived and check my vitals. My blood pressure was high, as was my pulse, but my oxygen levels were fine.  At this point my body legs and hands started to shake a bit, I am guessing from the adrenaline and my fingers got ice cold. I had not eaten a ton that day so they also checked my blood sugar which was normal, but on the low side.  After about 40  min they had me stand up and made sure I was ok.  I decided to go home and monitor the symptoms.  I was hot, dizzy, and nauseated for the next 3 hours. For 12 hours post-vaccine I was nauseous, then had a dull headache.  Today, one-week post-vaccine my injection site is very hot and red and a few little bumps have formed.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: About 4-5 min after my dose was administered I got a warm rush up the back of my neck, a dull ache above my eyes that came and went super fast, then my heart started racing, I got really light-headed, nauseated and my face got hot and tingly. I let the pharmacist know and he had me prop up my feet, that didn't help, so he had me lie down and elevate my feet. My mouth at this point also went extremely dry.  At first, the pharmacist thought I was experiencing Syncopy, but because my face was hot, and my face and ears were tingling, he felt he should call 911. The paramedics arrived and check my vitals. My blood pressure was high, as was my pulse, but my oxygen levels were fine.  At this point my body legs and hands started to shake a bit, I am guessing from the adrenaline and my fingers got ice cold. I had not eaten a ton that day so they also checked my blood sugar which was normal, but on the low side.  After about 40  min they had me stand up and made sure I was ok.  I decided to go home and monitor the symptoms.  I was hot, dizzy, and nauseated for the next 3 hours. For 12 hours post-vaccine I was nauseous, then had a dull headache.  Today, one-week post-vaccine my injection site is very hot and red and a few little bumps have formed.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Paraesthesia, Peripheral coldness, Tremor
Clinical narrative: About 4-5 min after my dose was administered I got a warm rush up the back of my neck, a dull ache above my eyes that came and went super fast, then my heart started racing, I got really light-headed, nauseated and my face got hot and tingly. I let the pharmacist know and he had me prop up my feet, that didn't help, so he had me lie down and elevate my feet. My mouth at this point also went extremely dry.  At first, the pharmacist thought I was experiencing Syncopy, but because my face was hot, and my face and ears were tingling, he felt he should call 911. The paramedics arrived and check my vitals. My blood pressure was high, as was my pulse, but my oxygen levels were fine.  At this point my body legs and hands started to shake a bit, I am guessing from the adrenaline and my fingers got ice cold. I had not eaten a ton that day so they also checked my blood sugar which was normal, but on the low side.  After about 40  min they had me stand up and made sure I was ok.  I decided to go home and monitor the symptoms.  I was hot, dizzy, and nauseated for the next 3 hours. For 12 hours post-vaccine I was nauseous, then had a dull headache.  Today, one-week post-vaccine my injection site is very hot and red and a few little bumps have formed.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Product administered at inappropriate site
Clinical narrative: COVID-19 vaccine (Pfizer dose #2) on 4/13/2021. It was injected too high. The injection was given on the left bursae according to the patient's daughter who filed the complaint and is a nurse who also administers vaccines. He is complaining of neck pain. It could be a side effect or as a result of the poor IM injection placement (SIRVA).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Shoulder injury related to vaccine administration, Wrong technique in product usage process
Clinical narrative: COVID-19 vaccine (Pfizer dose #2) on 4/13/2021. It was injected too high. The injection was given on the left bursae according to the patient's daughter who filed the complaint and is a nurse who also administers vaccines. He is complaining of neck pain. It could be a side effect or as a result of the poor IM injection placement (SIRVA).
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cerebrovascular accident, Mobility decreased, Nausea, Pain
Clinical narrative: Patient had vaccine administered at her home 3/9/21. Daughter called facility on 3/17/21 stating patient may have had a stroke, unable to move Rt side and not able to speak. Regained speech & movement. Placed into Hospice care on 3/18/21, and passed away 3/22/21.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Patient had vaccine administered at her home 3/9/21. Daughter called facility on 3/17/21 stating patient may have had a stroke, unable to move Rt side and not able to speak. Regained speech & movement. Placed into Hospice care on 3/18/21, and passed away 3/22/21.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Death, Hemiparesis
Clinical narrative: Patient had vaccine administered at her home 3/9/21. Daughter called facility on 3/17/21 stating patient may have had a stroke, unable to move Rt side and not able to speak. Regained speech & movement. Placed into Hospice care on 3/18/21, and passed away 3/22/21.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash vesicular
Clinical narrative: Vaccine given on 4/8/21   rash appeared on 4/9/21     Called the doctor and Claritin was ordered.10 mg given. 4/10/21 red rash continued all over the body and blisters and hives and discoloration  of skin  all over the body . Scratched the blisters and bleeding occurred at that site. No fever.  4/16/21  brought to ER via ambulance  to Hospital transferred to another location  referred to dermatologist on 4/16/21.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Haemorrhage, Rash, Rash erythematous, Scratch
Clinical narrative: Vaccine given on 4/8/21   rash appeared on 4/9/21     Called the doctor and Claritin was ordered.10 mg given. 4/10/21 red rash continued all over the body and blisters and hives and discoloration  of skin  all over the body . Scratched the blisters and bleeding occurred at that site. No fever.  4/16/21  brought to ER via ambulance  to Hospital transferred to another location  referred to dermatologist on 4/16/21.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Urticaria
Clinical narrative: Vaccine given on 4/8/21   rash appeared on 4/9/21     Called the doctor and Claritin was ordered.10 mg given. 4/10/21 red rash continued all over the body and blisters and hives and discoloration  of skin  all over the body . Scratched the blisters and bleeding occurred at that site. No fever.  4/16/21  brought to ER via ambulance  to Hospital transferred to another location  referred to dermatologist on 4/16/21.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram head, Gait disturbance, Hypoaesthesia, Lumbar puncture
Clinical narrative: Pt presented w/progressive sensory disturbance and gait ataxia. Had struggled w/discomfort of sinuses for several weeks, but with treatment had resolved shortly before presenting with sensory disturbances. After receiving first Moderna vaccination dose on 3/23/21, developed area of induration, pruritis and mild erythema at injection site which lasted 2 days only. After 1 week of immunization, developed tingling in fingers which have progressively worsened ascending to calves and forearms and eventually affecting her mobility.  Pt's clinical history, areflexia, and abnormal CSF consistent w/diagnosis of AIDP/Guillain-Barre syndrome. Received 5 days of IVIG and PT/OT. No personal family hx of autoimmune disorders.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Paraesthesia, Sensory disturbance
Clinical narrative: Pt presented w/progressive sensory disturbance and gait ataxia. Had struggled w/discomfort of sinuses for several weeks, but with treatment had resolved shortly before presenting with sensory disturbances. After receiving first Moderna vaccination dose on 3/23/21, developed area of induration, pruritis and mild erythema at injection site which lasted 2 days only. After 1 week of immunization, developed tingling in fingers which have progressively worsened ascending to calves and forearms and eventually affecting her mobility.  Pt's clinical history, areflexia, and abnormal CSF consistent w/diagnosis of AIDP/Guillain-Barre syndrome. Received 5 days of IVIG and PT/OT. No personal family hx of autoimmune disorders.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Areflexia, Ataxia, CSF protein increased, Computerised tomogram head, Guillain-Barre syndrome
Clinical narrative: Pt presented w/progressive sensory disturbance and gait ataxia. Had struggled w/discomfort of sinuses for several weeks, but with treatment had resolved shortly before presenting with sensory disturbances. After receiving first Moderna vaccination dose on 3/23/21, developed area of induration, pruritis and mild erythema at injection site which lasted 2 days only. After 1 week of immunization, developed tingling in fingers which have progressively worsened ascending to calves and forearms and eventually affecting her mobility.  Pt's clinical history, areflexia, and abnormal CSF consistent w/diagnosis of AIDP/Guillain-Barre syndrome. Received 5 days of IVIG and PT/OT. No personal family hx of autoimmune disorders.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Injection site erythema, Injection site induration, Injection site pruritus, Magnetic resonance imaging head normal
Clinical narrative: Pt presented w/progressive sensory disturbance and gait ataxia. Had struggled w/discomfort of sinuses for several weeks, but with treatment had resolved shortly before presenting with sensory disturbances. After receiving first Moderna vaccination dose on 3/23/21, developed area of induration, pruritis and mild erythema at injection site which lasted 2 days only. After 1 week of immunization, developed tingling in fingers which have progressively worsened ascending to calves and forearms and eventually affecting her mobility.  Pt's clinical history, areflexia, and abnormal CSF consistent w/diagnosis of AIDP/Guillain-Barre syndrome. Received 5 days of IVIG and PT/OT. No personal family hx of autoimmune disorders.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Mobility decreased, Paraesthesia, Sensory disturbance
Clinical narrative: Pt presented w/progressive sensory disturbance and gait ataxia. Had struggled w/discomfort of sinuses for several weeks, but with treatment had resolved shortly before presenting with sensory disturbances. After receiving first Moderna vaccination dose on 3/23/21, developed area of induration, pruritis and mild erythema at injection site which lasted 2 days only. After 1 week of immunization, developed tingling in fingers which have progressively worsened ascending to calves and forearms and eventually affecting her mobility.  Pt's clinical history, areflexia, and abnormal CSF consistent w/diagnosis of AIDP/Guillain-Barre syndrome. Received 5 days of IVIG and PT/OT. No personal family hx of autoimmune disorders.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient falsified DOB when registering for vaccination. Guardian did not consent to the vaccination. Department of Health verified with statistical records the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient falsified DOB when registering for vaccination. Guardian did not consent to the vaccination. Department of Health verified with statistical records the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Within about 2 hours, I felt really tired. A couple hours later I got body aches and tingling sensation on the left leg.  That night it got worse, hurt and some numbness. The following day I had abdominal pain and still had leg symptoms. On Saturday I needed up going to Urgent Care .  They did a Urine test, that was negative, but did see traces of blood but she wasn't concerned and did I send it our for a culture test. She sis an exam and a little concern because she wasn't aware of the side effects and ordered an ultra sound. She told me to take Tylenol and sent me home. I was still experiencing all everything the next day and developed a headache. The Urgent care Dr had called me the next day asked me to go in and get the Ultra sound.  They didn't find anything. I did have another ultra sound scheduled and had it done, I got the results and it was fine. She thinks the vaccine effected my nerves.  I also seen my Primary Physician because I had a fever as well, she did an exam and ordered Blood work and CT scan (abdomen). Everything came back normal.  My OCO believes it's my nerves as well. I believe it effected my mensural   cycle as well because it's earlier and heavier.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Fatigue, Headache
Clinical narrative: Within about 2 hours, I felt really tired. A couple hours later I got body aches and tingling sensation on the left leg.  That night it got worse, hurt and some numbness. The following day I had abdominal pain and still had leg symptoms. On Saturday I needed up going to Urgent Care .  They did a Urine test, that was negative, but did see traces of blood but she wasn't concerned and did I send it our for a culture test. She sis an exam and a little concern because she wasn't aware of the side effects and ordered an ultra sound. She told me to take Tylenol and sent me home. I was still experiencing all everything the next day and developed a headache. The Urgent care Dr had called me the next day asked me to go in and get the Ultra sound.  They didn't find anything. I did have another ultra sound scheduled and had it done, I got the results and it was fine. She thinks the vaccine effected my nerves.  I also seen my Primary Physician because I had a fever as well, she did an exam and ordered Blood work and CT scan (abdomen). Everything came back normal.  My OCO believes it's my nerves as well. I believe it effected my mensural   cycle as well because it's earlier and heavier.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Neuralgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Within about 2 hours, I felt really tired. A couple hours later I got body aches and tingling sensation on the left leg.  That night it got worse, hurt and some numbness. The following day I had abdominal pain and still had leg symptoms. On Saturday I needed up going to Urgent Care .  They did a Urine test, that was negative, but did see traces of blood but she wasn't concerned and did I send it our for a culture test. She sis an exam and a little concern because she wasn't aware of the side effects and ordered an ultra sound. She told me to take Tylenol and sent me home. I was still experiencing all everything the next day and developed a headache. The Urgent care Dr had called me the next day asked me to go in and get the Ultra sound.  They didn't find anything. I did have another ultra sound scheduled and had it done, I got the results and it was fine. She thinks the vaccine effected my nerves.  I also seen my Primary Physician because I had a fever as well, she did an exam and ordered Blood work and CT scan (abdomen). Everything came back normal.  My OCO believes it's my nerves as well. I believe it effected my mensural   cycle as well because it's earlier and heavier.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: Within about 2 hours, I felt really tired. A couple hours later I got body aches and tingling sensation on the left leg.  That night it got worse, hurt and some numbness. The following day I had abdominal pain and still had leg symptoms. On Saturday I needed up going to Urgent Care .  They did a Urine test, that was negative, but did see traces of blood but she wasn't concerned and did I send it our for a culture test. She sis an exam and a little concern because she wasn't aware of the side effects and ordered an ultra sound. She told me to take Tylenol and sent me home. I was still experiencing all everything the next day and developed a headache. The Urgent care Dr had called me the next day asked me to go in and get the Ultra sound.  They didn't find anything. I did have another ultra sound scheduled and had it done, I got the results and it was fine. She thinks the vaccine effected my nerves.  I also seen my Primary Physician because I had a fever as well, she did an exam and ordered Blood work and CT scan (abdomen). Everything came back normal.  My OCO believes it's my nerves as well. I believe it effected my mensural   cycle as well because it's earlier and heavier.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Abdominal tenderness, Diarrhoea, Headache
Clinical narrative: DIARRHEA; HEADACHE; NAUSEA; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 200 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced abdominal pain. On an unspecified date, the subject experienced diarrhea, headache, and nausea. Treatment medications (dates unspecified) included: ibuprofen, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea, and had not recovered from diarrhea, and abdominal pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Nausea, Rectal haemorrhage
Clinical narrative: DIARRHEA; HEADACHE; NAUSEA; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 200 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced abdominal pain. On an unspecified date, the subject experienced diarrhea, headache, and nausea. Treatment medications (dates unspecified) included: ibuprofen, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea, and had not recovered from diarrhea, and abdominal pain. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Headache, Nausea
Clinical narrative: DIARRHEA; HEADACHE; NAUSEA; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 200 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and  expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced abdominal pain. On an unspecified date, the subject experienced diarrhea, headache, and nausea. Treatment medications (dates unspecified) included: ibuprofen, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea, and had not recovered from diarrhea, and abdominal pain. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Hypoaesthesia, Lacunar stroke, Magnetic resonance imaging head abnormal
Clinical narrative: 5 days after vaccine administration patient developed sudden onset of R facial and R hand numbness. No other neurologic deficits. MRI evaluation in ER revealed ischemic CVA.  He was d/c on DAPT (ASA and Plavix) and appropriate therapy for close follow up.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antiplatelet therapy, Cerebrovascular accident, Hypoaesthesia, Magnetic resonance imaging head abnormal
Clinical narrative: 5 days after vaccine administration patient developed sudden onset of R facial and R hand numbness. No other neurologic deficits. MRI evaluation in ER revealed ischemic CVA.  He was d/c on DAPT (ASA and Plavix) and appropriate therapy for close follow up.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Headache, Nausea, Pyrexia
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cavernous sinus thrombosis, Computerised tomogram head abnormal, Fibrin D dimer increased, Full blood count, Magnetic resonance imaging head abnormal
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Thrombocytopenia, Venogram abnormal
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Chills, Computerised tomogram head abnormal, Full blood count, Headache
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Intensive care, Magnetic resonance imaging head abnormal, Nausea, Pain
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Pyrexia, Scan with contrast abnormal, Thrombosis
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blood count abnormal, Body temperature, Cavernous sinus thrombosis, Chills
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram head abnormal, Fibrin D dimer increased, Full blood count, Headache
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging head abnormal, Nausea, Pain, Platelet count
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Pyrexia, Thrombocytopenia, Venogram, Venogram abnormal
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Anticoagulant therapy, Cerebral thrombosis, Chills, Computerised tomogram head abnormal
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count abnormal, Headache, Intensive care, Magnetic resonance imaging head abnormal, Nausea
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Platelet count decreased, Pyrexia, Scan with contrast abnormal, Thrombosis with thrombocytopenia syndrome
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood count abnormal, Cavernous sinus thrombosis, Computerised tomogram, Computerised tomogram head abnormal, Fibrin D dimer
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Full blood count, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Platelet count
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Thrombocytopenia, Venogram, Venogram abnormal
Clinical narrative: venous thrombotic  cavern sinus and thrombocytopenia 25,000
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Computerised tomogram thorax, Disease risk factor, Dyspnoea exertional, Fibrin D dimer increased
Clinical narrative: patient came in for routine physical exam on 4/12. had gotten J/J vaccine on 3/17. husband reported onset of dyspnea a few weeks prior, eg starting some time after her vaccine. worsened significantly 2-3 days prior to her physical, but she refused to go to hospital. was found to be hypoxic at her routine physical and sent by ambulance to ED, had large saddle PE requiring thrombolysis, left leg DVT. was in ICU. now home off oxygen on anticoagulation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial strain, Oxygen saturation decreased, Pulmonary embolism
Clinical narrative: patient came in for routine physical exam on 4/12. had gotten J/J vaccine on 3/17. husband reported onset of dyspnea a few weeks prior, eg starting some time after her vaccine. worsened significantly 2-3 days prior to her physical, but she refused to go to hospital. was found to be hypoxic at her routine physical and sent by ambulance to ED, had large saddle PE requiring thrombolysis, left leg DVT. was in ICU. now home off oxygen on anticoagulation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Dyspnoea, Hypoxia, Intensive care
Clinical narrative: patient came in for routine physical exam on 4/12. had gotten J/J vaccine on 3/17. husband reported onset of dyspnea a few weeks prior, eg starting some time after her vaccine. worsened significantly 2-3 days prior to her physical, but she refused to go to hospital. was found to be hypoxic at her routine physical and sent by ambulance to ED, had large saddle PE requiring thrombolysis, left leg DVT. was in ICU. now home off oxygen on anticoagulation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Thrombolysis
Clinical narrative: patient came in for routine physical exam on 4/12. had gotten J/J vaccine on 3/17. husband reported onset of dyspnea a few weeks prior, eg starting some time after her vaccine. worsened significantly 2-3 days prior to her physical, but she refused to go to hospital. was found to be hypoxic at her routine physical and sent by ambulance to ED, had large saddle PE requiring thrombolysis, left leg DVT. was in ICU. now home off oxygen on anticoagulation.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Blood potassium increased, Blood urea increased, Condition aggravated, Dyspnoea
Clinical narrative: wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis; shortness of breath; increased confusion; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the female patient who we sent out with shortness of breath and increased confusion, she wound up in the ER (emergency room) with hypoxia and sepsis and she passed away. The events were serious as hospitalization and death. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on the limited available information, the Company considered there was not a reasonable possibility that the reported events were related to the suspect product  BNT162B2 (COMIRNATY). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: increased confusion; shortness of breath; wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, General physical health deterioration, Hypotension, International normalised ratio increased, Laboratory test abnormal
Clinical narrative: wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis; shortness of breath; increased confusion; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the female patient who we sent out with shortness of breath and increased confusion, she wound up in the ER (emergency room) with hypoxia and sepsis and she passed away. The events were serious as hospitalization and death. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on the limited available information, the Company considered there was not a reasonable possibility that the reported events were related to the suspect product  BNT162B2 (COMIRNATY). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: increased confusion; shortness of breath; wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Unresponsive to stimuli, White blood cell count increased
Clinical narrative: wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis; shortness of breath; increased confusion; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the female patient who we sent out with shortness of breath and increased confusion, she wound up in the ER (emergency room) with hypoxia and sepsis and she passed away. The events were serious as hospitalization and death. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on the limited available information, the Company considered there was not a reasonable possibility that the reported events were related to the suspect product  BNT162B2 (COMIRNATY). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: increased confusion; shortness of breath; wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dyspnoea, Hypoxia, Sepsis
Clinical narrative: wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis; shortness of breath; increased confusion; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the female patient who we sent out with shortness of breath and increased confusion, she wound up in the ER (emergency room) with hypoxia and sepsis and she passed away. The events were serious as hospitalization and death. The patient died on an unspecified date.  It was not reported if an autopsy was performed.; Sender's Comments: Based on the limited available information, the Company considered there was not a reasonable possibility that the reported events were related to the suspect product  BNT162B2 (COMIRNATY). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: increased confusion; shortness of breath; wound up in the ER with hypoxia and sepsis; wound up in the ER with hypoxia and sepsis
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Syncope
Clinical narrative: Fainted within 5 minutes of receiving vaccine.  Taken by ambulance to hospital.  Have been sick with chills, severe shaking, panic attacks, sweating, since then (almost 3 weeks).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Chills, Hyperhidrosis, Laboratory test, Panic attack
Clinical narrative: Fainted within 5 minutes of receiving vaccine.  Taken by ambulance to hospital.  Have been sick with chills, severe shaking, panic attacks, sweating, since then (almost 3 weeks).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Tremor
Clinical narrative: Fainted within 5 minutes of receiving vaccine.  Taken by ambulance to hospital.  Have been sick with chills, severe shaking, panic attacks, sweating, since then (almost 3 weeks).
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Muscle tightness, Paraesthesia, Throat tightness
Clinical narrative: After around 8 min after shot, started to get severe tingling and tightness in left side of jaw, then tightness in whole jaw, then throat felt like it was swelling, then had minor difficulty breathing and chest got very tight. Then got lightheaded/dizzy after walking to report symptoms to nurse. Was given 50 mg liquid benadryl and two epi pens after breathing continued to become more difficult and chest was very tight/cramping. EMTs took me to ER by ambulance, was monitored for about 4 hours and released. Continued having very tight/painful chest and swollen throat each time benadryl wore off and had to go back to ER following day. All tests were clear and was released. Severe allergic reaction but not anaphylaxis.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Hypersensitivity, Muscle tightness
Clinical narrative: After around 8 min after shot, started to get severe tingling and tightness in left side of jaw, then tightness in whole jaw, then throat felt like it was swelling, then had minor difficulty breathing and chest got very tight. Then got lightheaded/dizzy after walking to report symptoms to nurse. Was given 50 mg liquid benadryl and two epi pens after breathing continued to become more difficult and chest was very tight/cramping. EMTs took me to ER by ambulance, was monitored for about 4 hours and released. Continued having very tight/painful chest and swollen throat each time benadryl wore off and had to go back to ER following day. All tests were clear and was released. Severe allergic reaction but not anaphylaxis.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Pharyngeal swelling
Clinical narrative: After around 8 min after shot, started to get severe tingling and tightness in left side of jaw, then tightness in whole jaw, then throat felt like it was swelling, then had minor difficulty breathing and chest got very tight. Then got lightheaded/dizzy after walking to report symptoms to nurse. Was given 50 mg liquid benadryl and two epi pens after breathing continued to become more difficult and chest was very tight/cramping. EMTs took me to ER by ambulance, was monitored for about 4 hours and released. Continued having very tight/painful chest and swollen throat each time benadryl wore off and had to go back to ER following day. All tests were clear and was released. Severe allergic reaction but not anaphylaxis.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Chest pain, Computerised tomogram, Dyspnoea, Pleuritic pain
Clinical narrative: I received the vaccine on the 7th and in the night a migraine started along with fever on and off and on the 16th I went to the Emergency room with a migraine and chest pains and after running some tests I have pulmonary embolisms
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram head, Computerised tomogram thorax, Migraine, On and off phenomenon
Clinical narrative: I received the vaccine on the 7th and in the night a migraine started along with fever on and off and on the 16th I went to the Emergency room with a migraine and chest pains and after running some tests I have pulmonary embolisms
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Pyrexia
Clinical narrative: I received the vaccine on the 7th and in the night a migraine started along with fever on and off and on the 16th I went to the Emergency room with a migraine and chest pains and after running some tests I have pulmonary embolisms
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein normal, Cellulitis, Computerised tomogram normal, Full blood count normal, Pain
Clinical narrative: Patient had first dose of moderna covid vaccine on April 9th. On 9th and 10th patient had runny nose. Has allergies so patient attributed it to that. 10th evening patient noted nodule on side of nose by inner eye and then began spreading. On 12th, more swollen and painful so patient presented to immediate care visit with swollen area on left nose/cheek-diagnosed as facial cellulitis and started on oral antibiotics clindamycin and augmentin. On 13th, more pain hot - was advised to go to ED but did not wait to be seen. On 14th returned to ED - antibiotics changed to doxycycline and augumentin continued.  Patient woke up with eye swollen shut per md notes. By 4/16 some improvement in swelling noted.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital swelling, Red blood cell count normal, Skin mass
Clinical narrative: Patient had first dose of moderna covid vaccine on April 9th. On 9th and 10th patient had runny nose. Has allergies so patient attributed it to that. 10th evening patient noted nodule on side of nose by inner eye and then began spreading. On 12th, more swollen and painful so patient presented to immediate care visit with swollen area on left nose/cheek-diagnosed as facial cellulitis and started on oral antibiotics clindamycin and augmentin. On 13th, more pain hot - was advised to go to ED but did not wait to be seen. On 14th returned to ED - antibiotics changed to doxycycline and augumentin continued.  Patient woke up with eye swollen shut per md notes. By 4/16 some improvement in swelling noted.