chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Nausea, Oropharyngeal pain, Oxygen saturation decreased, Pharyngeal hypoaesthesia
Clinical narrative: Anaphylaxis reported to patient's primary care provider by patient From past ED visit MC 5/3- Past medical history relevant for lupus who presents to the emergency department with facial tingling. The patient states that about five days ago she started with a rash around the injection site of her second Moderna COVID-19 vaccine, and three days ago began with lip tingling which has progressively radiated up the right side of the face and a headache. The patient has no history of numbness or tingling accompanying her previous migraines and states that the rest of her family received the same vaccine without similar side effects. Her lupus has been well-managed without prednisone at home and she has outpatient follow-up with an allergist and rheumatologist through.    History is from the patient        Old records reviewed. Per review of old records the patient was evaluated in the MC ED 4/22/2021 following her second Moderna COVID-19 vaccine, ten minutes after which she started with left-sided facial tinging and throat swelling, at which time she was given IM epinephrine and PO Benadryl by EMS en route to the ED. Her mental status had deteriorated en route and she had an MRI brain which was fairly unremarkable. The patient's symptoms improved in the ED and she was felt appropriate for discharge home.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Slow response to stimuli, Somnolence, Throat tightness, Toxicologic test normal, Unresponsive to stimuli
Clinical narrative: Anaphylaxis reported to patient's primary care provider by patient From past ED visit MC 5/3- Past medical history relevant for lupus who presents to the emergency department with facial tingling. The patient states that about five days ago she started with a rash around the injection site of her second Moderna COVID-19 vaccine, and three days ago began with lip tingling which has progressively radiated up the right side of the face and a headache. The patient has no history of numbness or tingling accompanying her previous migraines and states that the rest of her family received the same vaccine without similar side effects. Her lupus has been well-managed without prednisone at home and she has outpatient follow-up with an allergist and rheumatologist through.    History is from the patient        Old records reviewed. Per review of old records the patient was evaluated in the MC ED 4/22/2021 following her second Moderna COVID-19 vaccine, ten minutes after which she started with left-sided facial tinging and throat swelling, at which time she was given IM epinephrine and PO Benadryl by EMS en route to the ED. Her mental status had deteriorated en route and she had an MRI brain which was fairly unremarkable. The patient's symptoms improved in the ED and she was felt appropriate for discharge home.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Condition aggravated, Headache, Injection site rash, Paraesthesia
Clinical narrative: Anaphylaxis reported to patient's primary care provider by patient From past ED visit MC 5/3- Past medical history relevant for lupus who presents to the emergency department with facial tingling. The patient states that about five days ago she started with a rash around the injection site of her second Moderna COVID-19 vaccine, and three days ago began with lip tingling which has progressively radiated up the right side of the face and a headache. The patient has no history of numbness or tingling accompanying her previous migraines and states that the rest of her family received the same vaccine without similar side effects. Her lupus has been well-managed without prednisone at home and she has outpatient follow-up with an allergist and rheumatologist through.    History is from the patient        Old records reviewed. Per review of old records the patient was evaluated in the MC ED 4/22/2021 following her second Moderna COVID-19 vaccine, ten minutes after which she started with left-sided facial tinging and throat swelling, at which time she was given IM epinephrine and PO Benadryl by EMS en route to the ED. Her mental status had deteriorated en route and she had an MRI brain which was fairly unremarkable. The patient's symptoms improved in the ED and she was felt appropriate for discharge home.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Anaphylaxis reported to patient's primary care provider by patient From past ED visit MC 5/3- Past medical history relevant for lupus who presents to the emergency department with facial tingling. The patient states that about five days ago she started with a rash around the injection site of her second Moderna COVID-19 vaccine, and three days ago began with lip tingling which has progressively radiated up the right side of the face and a headache. The patient has no history of numbness or tingling accompanying her previous migraines and states that the rest of her family received the same vaccine without similar side effects. Her lupus has been well-managed without prednisone at home and she has outpatient follow-up with an allergist and rheumatologist through.    History is from the patient        Old records reviewed. Per review of old records the patient was evaluated in the MC ED 4/22/2021 following her second Moderna COVID-19 vaccine, ten minutes after which she started with left-sided facial tinging and throat swelling, at which time she was given IM epinephrine and PO Benadryl by EMS en route to the ED. Her mental status had deteriorated en route and she had an MRI brain which was fairly unremarkable. The patient's symptoms improved in the ED and she was felt appropriate for discharge home.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: Patient awake day after 1st moderna vaccine with abdominal muscle spasms and they have not resolved since.  He was hospitalized and went to  ER, ER, ER, and  ER.  He has been sent to Neurology and GI Specialist with no resolution.  He had had increased memory loss, suffered a CVA, and now is having seizure disorder since this  all started and the correlation is unknown.  The only thing known is the inital symptom was the diaphragmatic spasms and this is still present.  He left my care seeking Benzodiazapines and was under  APRN for several months and then returned to my care which is why a VAERs report was not filed sooner.  I am filing now in hope I am filling now in hopes that if this is seen in other clients we can find a resolution to his diaphragmatic spasms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Cerebrovascular accident, Chest X-ray, Computerised tomogram head, Computerised tomogram thorax
Clinical narrative: Patient awake day after 1st moderna vaccine with abdominal muscle spasms and they have not resolved since.  He was hospitalized and went to  ER, ER, ER, and  ER.  He has been sent to Neurology and GI Specialist with no resolution.  He had had increased memory loss, suffered a CVA, and now is having seizure disorder since this  all started and the correlation is unknown.  The only thing known is the inital symptom was the diaphragmatic spasms and this is still present.  He left my care seeking Benzodiazapines and was under  APRN for several months and then returned to my care which is why a VAERs report was not filed sooner.  I am filing now in hope I am filling now in hopes that if this is seen in other clients we can find a resolution to his diaphragmatic spasms.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diaphragmatic spasm, Laboratory test, Magnetic resonance imaging, Muscle spasms
Clinical narrative: Patient awake day after 1st moderna vaccine with abdominal muscle spasms and they have not resolved since.  He was hospitalized and went to  ER, ER, ER, and  ER.  He has been sent to Neurology and GI Specialist with no resolution.  He had had increased memory loss, suffered a CVA, and now is having seizure disorder since this  all started and the correlation is unknown.  The only thing known is the inital symptom was the diaphragmatic spasms and this is still present.  He left my care seeking Benzodiazapines and was under  APRN for several months and then returned to my care which is why a VAERs report was not filed sooner.  I am filing now in hope I am filling now in hopes that if this is seen in other clients we can find a resolution to his diaphragmatic spasms.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Tremor
Clinical narrative: dizziness headaches high blood pressure
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Headache, Hypertension, Magnetic resonance imaging
Clinical narrative: dizziness headaches high blood pressure
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: dizziness headaches high blood pressure
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electric shock sensation, Headache, Laboratory test, Magnetic resonance imaging, Pain in extremity
Clinical narrative: Bad headache, muscle cramps, felt out of body, hand numb
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal X-ray, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head, Feeling abnormal
Clinical narrative: Bad headache, muscle cramps, felt out of body, hand numb
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Magnetic resonance imaging head, Muscle spasms, Urinary system X-ray
Clinical narrative: Bad headache, muscle cramps, felt out of body, hand numb
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hypoaesthesia, Malaise
Clinical narrative: Went to emergency room after a cascade of scary side effects.  Head felt like it was bleeding internally.  I had numbness in my hands and arms for about a month.  I had a headach for about a month.  I felt out of my body (brain fog), fatigue and a very big sense of being "unwell.:  Random shooting painsm lighning zaps in my head.  Father had same symptoms, his headache has never gone away since March.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Trigeminal neuralgia
Clinical narrative: Went to emergency room after a cascade of scary side effects.  Head felt like it was bleeding internally.  I had numbness in my hands and arms for about a month.  I had a headach for about a month.  I felt out of my body (brain fog), fatigue and a very big sense of being "unwell.:  Random shooting painsm lighning zaps in my head.  Father had same symptoms, his headache has never gone away since March.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram head, Electric shock sensation, Fatigue, Feeling abnormal
Clinical narrative: Went to emergency room after a cascade of scary side effects.  Head felt like it was bleeding internally.  I had numbness in my hands and arms for about a month.  I had a headach for about a month.  I felt out of my body (brain fog), fatigue and a very big sense of being "unwell.:  Random shooting painsm lighning zaps in my head.  Father had same symptoms, his headache has never gone away since March.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Malaise, Vaccination complication
Clinical narrative: Went to emergency room after a cascade of scary side effects.  Head felt like it was bleeding internally.  I had numbness in my hands and arms for about a month.  I had a headach for about a month.  I felt out of my body (brain fog), fatigue and a very big sense of being "unwell.:  Random shooting painsm lighning zaps in my head.  Father had same symptoms, his headache has never gone away since March.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: C-reactive protein increased, Gait disturbance, Multisystem inflammatory syndrome in children, Myalgia, Pain
Clinical narrative: Severe pains when attempting to  walk or use arms. Severe rash at injection site as well as rash under both arms and inner thighs. Fever vomiting.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pyrexia, Rash, Serum ferritin increased, Vomiting
Clinical narrative: Severe pains when attempting to  walk or use arms. Severe rash at injection site as well as rash under both arms and inner thighs. Fever vomiting.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site rash, Pain, Pyrexia, Rash, Vomiting
Clinical narrative: Severe pains when attempting to  walk or use arms. Severe rash at injection site as well as rash under both arms and inner thighs. Fever vomiting.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cardiac flutter, Eye pain, Headache, Muscular weakness
Clinical narrative: Normal arm muscle ache that went away within 3-4 days. 2. Within 12-24 hours my heart was doing some flip flopping and continues to this day. It did not do that prior to. After 3 weeks it has subsided but still does it periodically. 3. Within 24 hours a short episode of ringing in my ears was followed by a constant lighter ringing in my left side that continues to this day. 4. Within 24 hours I had tingling on the left side of my face and down my left calf. 5. About day 5 my left pinky and ring finger literally jerked upwards several times and twitching began in my left calf muscle about the same time. 6. The muscle twitching continued onto the bottom side of my left foot within hours. 7. I am more easily tired and that began within than 24  -48 hours after the shot and continues to this day. 8. On about day 6 twitching began moving to my right side between the second and third week. The twitching on the right side subsided after about week 3 after the shot.   I realize it may take time to have my body adjust to the vaccine but it is nearing week 4. The ringing continues, I am tired and periodically the muscle twitches as well as the heart flip flops are still there. Thank you.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Tinnitus
Clinical narrative: Normal arm muscle ache that went away within 3-4 days. 2. Within 12-24 hours my heart was doing some flip flopping and continues to this day. It did not do that prior to. After 3 weeks it has subsided but still does it periodically. 3. Within 24 hours a short episode of ringing in my ears was followed by a constant lighter ringing in my left side that continues to this day. 4. Within 24 hours I had tingling on the left side of my face and down my left calf. 5. About day 5 my left pinky and ring finger literally jerked upwards several times and twitching began in my left calf muscle about the same time. 6. The muscle twitching continued onto the bottom side of my left foot within hours. 7. I am more easily tired and that began within than 24  -48 hours after the shot and continues to this day. 8. On about day 6 twitching began moving to my right side between the second and third week. The twitching on the right side subsided after about week 3 after the shot.   I realize it may take time to have my body adjust to the vaccine but it is nearing week 4. The ringing continues, I am tired and periodically the muscle twitches as well as the heart flip flops are still there. Thank you.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Fatigue, Muscle twitching, Myalgia, Palpitations
Clinical narrative: Normal arm muscle ache that went away within 3-4 days. 2. Within 12-24 hours my heart was doing some flip flopping and continues to this day. It did not do that prior to. After 3 weeks it has subsided but still does it periodically. 3. Within 24 hours a short episode of ringing in my ears was followed by a constant lighter ringing in my left side that continues to this day. 4. Within 24 hours I had tingling on the left side of my face and down my left calf. 5. About day 5 my left pinky and ring finger literally jerked upwards several times and twitching began in my left calf muscle about the same time. 6. The muscle twitching continued onto the bottom side of my left foot within hours. 7. I am more easily tired and that began within than 24  -48 hours after the shot and continues to this day. 8. On about day 6 twitching began moving to my right side between the second and third week. The twitching on the right side subsided after about week 3 after the shot.   I realize it may take time to have my body adjust to the vaccine but it is nearing week 4. The ringing continues, I am tired and periodically the muscle twitches as well as the heart flip flops are still there. Thank you.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Normal arm muscle ache that went away within 3-4 days. 2. Within 12-24 hours my heart was doing some flip flopping and continues to this day. It did not do that prior to. After 3 weeks it has subsided but still does it periodically. 3. Within 24 hours a short episode of ringing in my ears was followed by a constant lighter ringing in my left side that continues to this day. 4. Within 24 hours I had tingling on the left side of my face and down my left calf. 5. About day 5 my left pinky and ring finger literally jerked upwards several times and twitching began in my left calf muscle about the same time. 6. The muscle twitching continued onto the bottom side of my left foot within hours. 7. I am more easily tired and that began within than 24  -48 hours after the shot and continues to this day. 8. On about day 6 twitching began moving to my right side between the second and third week. The twitching on the right side subsided after about week 3 after the shot.   I realize it may take time to have my body adjust to the vaccine but it is nearing week 4. The ringing continues, I am tired and periodically the muscle twitches as well as the heart flip flops are still there. Thank you.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray normal, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: ADDENDUM TO PREVIOUS SUBMISSION (VAERS #648055) Pt passed away on 10/9/2021 from complications of COVID-19 "Brief Narrative (including pertinent consultations and lab/radiology results): 74 y.o. female with a past medical history significant for Obesity, DM type II, Depression, COPD, HL, hospital stay 9/12-9/15 for covid, re-admitted 9/16 for nausea, vomiting,worsening hypoxemia. She was vaccinated in March with Pfizer. On this admission, she was on the hospitalist service from 9/16 to 9/21, when she was transferred to the ICU service for ongoing hypoxia. She was on the ICU service 9/21-9/25 and never intubated, but was on max Bipap support and iNO. She was transferred back to the hospitalist service 9/26 but remained in the ICU due to having to be on iNO. Other treatments included tociluzumab, remdesivir, and high dose steroids.     Unfortunately, despite all of these treatments, she did not improve, and in fact, worsened to the point where the next step would be intubation. Palliative care was consulted, and she said that she would not want to be on a ventilator long term. If she were intubated, she would likely never be extubated, so being intubated did not align with her wishes. She opted to be DNR/I. The iNo was weaned off, and her oxygen levels decreased despite 100% Bipap. Patient said that she wanted to be made comfortable, so comfort cares were initiated. Her friend was able to come in, and she passed away peacefully. "  Date of Death: 10/9/2021  Time of Death: 10:06 pm Autopsy Completed: No   IMMEDIATE CAUSE (Final disease or condition resulting in death) Approximate interval:  Onset to death (e.g., days, months, years) Primary: Covid 19 pneumonia  weeks Secondary: ARDS weeks Secondary: diabetes mellitus  years Secondary: N/A N/A  Above notes signed by  MD in patient's EMR
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, COVID-19, COVID-19 pneumonia, Condition aggravated, Death
Clinical narrative: ADDENDUM TO PREVIOUS SUBMISSION (VAERS #648055) Pt passed away on 10/9/2021 from complications of COVID-19 "Brief Narrative (including pertinent consultations and lab/radiology results): 74 y.o. female with a past medical history significant for Obesity, DM type II, Depression, COPD, HL, hospital stay 9/12-9/15 for covid, re-admitted 9/16 for nausea, vomiting,worsening hypoxemia. She was vaccinated in March with Pfizer. On this admission, she was on the hospitalist service from 9/16 to 9/21, when she was transferred to the ICU service for ongoing hypoxia. She was on the ICU service 9/21-9/25 and never intubated, but was on max Bipap support and iNO. She was transferred back to the hospitalist service 9/26 but remained in the ICU due to having to be on iNO. Other treatments included tociluzumab, remdesivir, and high dose steroids.     Unfortunately, despite all of these treatments, she did not improve, and in fact, worsened to the point where the next step would be intubation. Palliative care was consulted, and she said that she would not want to be on a ventilator long term. If she were intubated, she would likely never be extubated, so being intubated did not align with her wishes. She opted to be DNR/I. The iNo was weaned off, and her oxygen levels decreased despite 100% Bipap. Patient said that she wanted to be made comfortable, so comfort cares were initiated. Her friend was able to come in, and she passed away peacefully. "  Date of Death: 10/9/2021  Time of Death: 10:06 pm Autopsy Completed: No   IMMEDIATE CAUSE (Final disease or condition resulting in death) Approximate interval:  Onset to death (e.g., days, months, years) Primary: Covid 19 pneumonia  weeks Secondary: ARDS weeks Secondary: diabetes mellitus  years Secondary: N/A N/A  Above notes signed by  MD in patient's EMR
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diabetes mellitus, General physical health deterioration, Hypoxia, Intensive care, Nausea
Clinical narrative: ADDENDUM TO PREVIOUS SUBMISSION (VAERS #648055) Pt passed away on 10/9/2021 from complications of COVID-19 "Brief Narrative (including pertinent consultations and lab/radiology results): 74 y.o. female with a past medical history significant for Obesity, DM type II, Depression, COPD, HL, hospital stay 9/12-9/15 for covid, re-admitted 9/16 for nausea, vomiting,worsening hypoxemia. She was vaccinated in March with Pfizer. On this admission, she was on the hospitalist service from 9/16 to 9/21, when she was transferred to the ICU service for ongoing hypoxia. She was on the ICU service 9/21-9/25 and never intubated, but was on max Bipap support and iNO. She was transferred back to the hospitalist service 9/26 but remained in the ICU due to having to be on iNO. Other treatments included tociluzumab, remdesivir, and high dose steroids.     Unfortunately, despite all of these treatments, she did not improve, and in fact, worsened to the point where the next step would be intubation. Palliative care was consulted, and she said that she would not want to be on a ventilator long term. If she were intubated, she would likely never be extubated, so being intubated did not align with her wishes. She opted to be DNR/I. The iNo was weaned off, and her oxygen levels decreased despite 100% Bipap. Patient said that she wanted to be made comfortable, so comfort cares were initiated. Her friend was able to come in, and she passed away peacefully. "  Date of Death: 10/9/2021  Time of Death: 10:06 pm Autopsy Completed: No   IMMEDIATE CAUSE (Final disease or condition resulting in death) Approximate interval:  Onset to death (e.g., days, months, years) Primary: Covid 19 pneumonia  weeks Secondary: ARDS weeks Secondary: diabetes mellitus  years Secondary: N/A N/A  Above notes signed by  MD in patient's EMR
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oxygen saturation decreased, Positive airway pressure therapy, Vomiting
Clinical narrative: ADDENDUM TO PREVIOUS SUBMISSION (VAERS #648055) Pt passed away on 10/9/2021 from complications of COVID-19 "Brief Narrative (including pertinent consultations and lab/radiology results): 74 y.o. female with a past medical history significant for Obesity, DM type II, Depression, COPD, HL, hospital stay 9/12-9/15 for covid, re-admitted 9/16 for nausea, vomiting,worsening hypoxemia. She was vaccinated in March with Pfizer. On this admission, she was on the hospitalist service from 9/16 to 9/21, when she was transferred to the ICU service for ongoing hypoxia. She was on the ICU service 9/21-9/25 and never intubated, but was on max Bipap support and iNO. She was transferred back to the hospitalist service 9/26 but remained in the ICU due to having to be on iNO. Other treatments included tociluzumab, remdesivir, and high dose steroids.     Unfortunately, despite all of these treatments, she did not improve, and in fact, worsened to the point where the next step would be intubation. Palliative care was consulted, and she said that she would not want to be on a ventilator long term. If she were intubated, she would likely never be extubated, so being intubated did not align with her wishes. She opted to be DNR/I. The iNo was weaned off, and her oxygen levels decreased despite 100% Bipap. Patient said that she wanted to be made comfortable, so comfort cares were initiated. Her friend was able to come in, and she passed away peacefully. "  Date of Death: 10/9/2021  Time of Death: 10:06 pm Autopsy Completed: No   IMMEDIATE CAUSE (Final disease or condition resulting in death) Approximate interval:  Onset to death (e.g., days, months, years) Primary: Covid 19 pneumonia  weeks Secondary: ARDS weeks Secondary: diabetes mellitus  years Secondary: N/A N/A  Above notes signed by  MD in patient's EMR
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Urine analysis, Vaccination site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: patient is expernice pain and numbness going down from his elbow down to the top of his had after receving the first dose.  it has been going on for 6 weeks.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: patient is expernice pain and numbness going down from his elbow down to the top of his had after receving the first dose.  it has been going on for 6 weeks.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea exertional, Fatigue, Pain
Clinical narrative: hospitalization (non-ICU)
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: hospitalization (non-ICU)
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hospitalization (non-ICU)
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharospasm, Chest discomfort, Muscle tightness
Clinical narrative: patient was seen in clinic after covid vaccination pfizer, extremely anxious. she reported the following:  -left eye twitching -slight struggling with breathing -severe back pain - pleuritic chest pain despite symptomatic treatment patient remains with symtpoms and requested this provider fill out a adverse reaction form.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Back pain, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: patient was seen in clinic after covid vaccination pfizer, extremely anxious. she reported the following:  -left eye twitching -slight struggling with breathing -severe back pain - pleuritic chest pain despite symptomatic treatment patient remains with symtpoms and requested this provider fill out a adverse reaction form.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching
Clinical narrative: patient was seen in clinic after covid vaccination pfizer, extremely anxious. she reported the following:  -left eye twitching -slight struggling with breathing -severe back pain - pleuritic chest pain despite symptomatic treatment patient remains with symtpoms and requested this provider fill out a adverse reaction form.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: I contact doctor and she stated that her record is accurate. She got 2 doses of the Moderna and a Pfizer vaccine and a Moderna Booster. She said she lied to the place she got the Pfizer from and told them that she got the Pfizer vaccine because she heard that it could protect you from different strains of COVID. I informed her that is not following the manufacturers recommendations and shouldn?t of been done. She said she consulted with her husband and that is what she was going to do. She said it was not a med error on our part because she qualified for her Moderna booster. I said at this point I am going to consult you to reach out to your DR, I am not sure what kind of adverse effects one would have having 4 covid vaccines. She said ok.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: I contact doctor and she stated that her record is accurate. She got 2 doses of the Moderna and a Pfizer vaccine and a Moderna Booster. She said she lied to the place she got the Pfizer from and told them that she got the Pfizer vaccine because she heard that it could protect you from different strains of COVID. I informed her that is not following the manufacturers recommendations and shouldn?t of been done. She said she consulted with her husband and that is what she was going to do. She said it was not a med error on our part because she qualified for her Moderna booster. I said at this point I am going to consult you to reach out to your DR, I am not sure what kind of adverse effects one would have having 4 covid vaccines. She said ok.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Cold sweat, Headache
Clinical narrative: " Patient began developing elevated blood pressures on Sept 28, somewhat without  provocation known other than he had received his third dose of Pfizer COVID 19  vaccine the day prior.  Before that his pressures were doing well without meds.  They were ranging 150s over 90s and he started back on lisinopril 10mg daily. He  then had some headache and chest discomfort this past Monday so he went to the ER  at hospital where they did labs and enzymes and EKG. He did not have any ischemic  damage and was released and told to follow-up with PCP and Cardiology. PCP added additional BP med. "
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Electrocardiogram, Extra dose administered, Headache
Clinical narrative: " Patient began developing elevated blood pressures on Sept 28, somewhat without  provocation known other than he had received his third dose of Pfizer COVID 19  vaccine the day prior.  Before that his pressures were doing well without meds.  They were ranging 150s over 90s and he started back on lisinopril 10mg daily. He  then had some headache and chest discomfort this past Monday so he went to the ER  at hospital where they did labs and enzymes and EKG. He did not have any ischemic  damage and was released and told to follow-up with PCP and Cardiology. PCP added additional BP med. "
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test
Clinical narrative: " Patient began developing elevated blood pressures on Sept 28, somewhat without  provocation known other than he had received his third dose of Pfizer COVID 19  vaccine the day prior.  Before that his pressures were doing well without meds.  They were ranging 150s over 90s and he started back on lisinopril 10mg daily. He  then had some headache and chest discomfort this past Monday so he went to the ER  at hospital where they did labs and enzymes and EKG. He did not have any ischemic  damage and was released and told to follow-up with PCP and Cardiology. PCP added additional BP med. "
Age: 8.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: He received this vaccine by mistake due to pharmacy error. He is under age 12.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: He received this vaccine by mistake due to pharmacy error. He is under age 12. He was supposed to get a flu shot.   He could not bear weight on his right leg the following day. Has increased tiredness. We are waiting to see if he has any other symptoms.
Age: 10.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Product administered to patient of inappropriate age, Weight bearing difficulty, Wrong product administered
Clinical narrative: He received this vaccine by mistake due to pharmacy error. He is under age 12. He was supposed to get a flu shot.   He could not bear weight on his right leg the following day. Has increased tiredness. We are waiting to see if he has any other symptoms.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test normal, Computerised tomogram normal, Dizziness, Ear discomfort
Clinical narrative: Extremely loud ear ringing/pain/pressure;  headache and pressure; constant thirst;  nausea (nausea ended 10/09/2021);  blurry vision that shifted from eye to eye (vision issues ended 10/10/2021);  lightheadedness (this ended 10/08/2021);  fatigue;  weight loss(6 lbs. by 10/03/2021);  pain and skin irritation in injected arm that radiates down arm and into shoulder (this began 10/09/2021); Was told by a nurse to take Zyrtec-D 9/25/2021 to help with ear and head issues. Was given a shot & 6 day dose of methylPREDNISolone 9/26/2021 to fix the ear issues. These did not relieve the adverse issues. All issues that do not have an end date are still ongoing
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Head discomfort, Headache, Nausea
Clinical narrative: Extremely loud ear ringing/pain/pressure;  headache and pressure; constant thirst;  nausea (nausea ended 10/09/2021);  blurry vision that shifted from eye to eye (vision issues ended 10/10/2021);  lightheadedness (this ended 10/08/2021);  fatigue;  weight loss(6 lbs. by 10/03/2021);  pain and skin irritation in injected arm that radiates down arm and into shoulder (this began 10/09/2021); Was told by a nurse to take Zyrtec-D 9/25/2021 to help with ear and head issues. Was given a shot & 6 day dose of methylPREDNISolone 9/26/2021 to fix the ear issues. These did not relieve the adverse issues. All issues that do not have an end date are still ongoing
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin irritation, Thirst, Tinnitus, Vision blurred
Clinical narrative: Extremely loud ear ringing/pain/pressure;  headache and pressure; constant thirst;  nausea (nausea ended 10/09/2021);  blurry vision that shifted from eye to eye (vision issues ended 10/10/2021);  lightheadedness (this ended 10/08/2021);  fatigue;  weight loss(6 lbs. by 10/03/2021);  pain and skin irritation in injected arm that radiates down arm and into shoulder (this began 10/09/2021); Was told by a nurse to take Zyrtec-D 9/25/2021 to help with ear and head issues. Was given a shot & 6 day dose of methylPREDNISolone 9/26/2021 to fix the ear issues. These did not relieve the adverse issues. All issues that do not have an end date are still ongoing
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Extremely loud ear ringing/pain/pressure;  headache and pressure; constant thirst;  nausea (nausea ended 10/09/2021);  blurry vision that shifted from eye to eye (vision issues ended 10/10/2021);  lightheadedness (this ended 10/08/2021);  fatigue;  weight loss(6 lbs. by 10/03/2021);  pain and skin irritation in injected arm that radiates down arm and into shoulder (this began 10/09/2021); Was told by a nurse to take Zyrtec-D 9/25/2021 to help with ear and head issues. Was given a shot & 6 day dose of methylPREDNISolone 9/26/2021 to fix the ear issues. These did not relieve the adverse issues. All issues that do not have an end date are still ongoing
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Urticaria, Vaccine positive rechallenge
Clinical narrative: I developed hives one week after second shot. They were random in location and intermittent. They eventually stopped after approximately five months. I received my booster on Friday and was covered in hives again 24 hours later after having not had them for two months. I cannot know for sure if there is a connection between the shot and the hives but thought I should report it just in case.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Electric shock sensation, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: It started with "electrical shocks" in right side of face, occasionally. It has progressed to "shocks" non-stop in the right side of my face, skull, down both sides of neck, both ears and other various parts of body.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Myalgia, Urticaria
Clinical narrative: Welts around injection site, headache, muscle pain, stomach ache.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Pruritus, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Itchy, pink/red welts on bilateral lower extremities (below knee to ankle) that appeared approximately 24 hours after 3rd dose. Transitioned to itchy, red, macular papular rash, that has yet to resolve over one week later
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Itchy, pink/red welts on bilateral lower extremities (below knee to ankle) that appeared approximately 24 hours after 3rd dose. Transitioned to itchy, red, macular papular rash, that has yet to resolve over one week later
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Rash, Rash pruritic
Clinical narrative: Menstruation delayed two weeks after first dose.  Arm rash itchy and painful to the touch, five inches across and joint pain, headache after second vaccine dose.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein increased, Chest X-ray abnormal, Echocardiogram abnormal, Laboratory test, Pericardial drainage
Clinical narrative: Pericarditis with pleural effusion
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, Pleural effusion
Clinical narrative: Pericarditis with pleural effusion
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood magnesium, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: Rapid, irregular heart rate, diagnosed as atrial fibrillation. Unresolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Heart rate increased, Heart rate irregular, Laboratory test, Metabolic function test
Clinical narrative: Rapid, irregular heart rate, diagnosed as atrial fibrillation. Unresolved.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Rapid, irregular heart rate, diagnosed as atrial fibrillation. Unresolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Fever and chills Nausea and diarrhea
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Echocardiogram abnormal, Electrocardiogram ambulatory abnormal, Exercise tolerance decreased
Clinical narrative: Chest pain, palpitations, tachycardia extreme fatigue, exercise and heat intolerance, anxiety.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Left atrial enlargement, Palpitations, Pericardial effusion, Right atrial enlargement
Clinical narrative: Chest pain, palpitations, tachycardia extreme fatigue, exercise and heat intolerance, anxiety.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Right ventricular enlargement, Supraventricular extrasystoles, Supraventricular tachycardia, Tachycardia, Temperature intolerance
Clinical narrative: Chest pain, palpitations, tachycardia extreme fatigue, exercise and heat intolerance, anxiety.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Chest pain, palpitations, tachycardia extreme fatigue, exercise and heat intolerance, anxiety.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue, Rash, Rash macular
Clinical narrative: Widespread Rash, began on back within 60-90 min of administration. Has continued to spread and change. Does not itch very much,  started as wide finger print sized splotches on back, with tiny red dots the size of the ball on a ball point pen spread around and in between. The small head of a pen sized one's have spread to chest and arms. Again no itching really or pain. But it has been there without even fading a little bit sinceI got the vaccine. I did not go for the second or 3rd dose because of the reaction.it has been approximately 45 days since the vaccine with no signs of fading or going away.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Diarrhoea haemorrhagic, Faeces discoloured, Pain
Clinical narrative: Diarrhea progressing to Black and bloody diarrhea starting within 6h post injection and resolving 48h-72h later.   Additionally fevers, chills and body aches were present 12h post injection and lasted for ~24h duration.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Diarrhea progressing to Black and bloody diarrhea starting within 6h post injection and resolving 48h-72h later.   Additionally fevers, chills and body aches were present 12h post injection and lasted for ~24h duration.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Late menstrual cycle after 2nd dose.  Currently 7 days late. No chance of pregnancy.  No treatment. Outcome is that I?m still waiting for my cycle.  This is totally irregular.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: severe upper left abdominal pain for 2 days
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyskinesia, Musculoskeletal stiffness, Pyrexia, Skin papilloma
Clinical narrative: Stiffening of left leg within ten minutes. Fever of 103 for three days. Involuntary stretching. Reappearance of HPV wart.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Lymphadenopathy
Clinical narrative: Redness, swollen lump under skin at injection site; swollen lymph node in left armpit
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: severe upper left abdominal pain
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large red hard swollen spot at injection site. Itchy, hot to touch, painful, swollen and hard feeling
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Large red hard swollen spot at injection site. Itchy, hot to touch, painful, swollen and hard feeling
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Mouth ulceration, Oral pain
Clinical narrative: 2 Ulcers formed  in mouth, still swollen and not healed 7 days later.  Painful and swollen. No history of canker sores, cold sore, or ulcers in the mouth until after 2nd shot of the vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen(knot) , itching, injection site warm to touch
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: No additional adverse events reported.; Product confusion involving administration of VARIVAX mixed with liquid diluent of ROTARIX; Product confusion involving administration of VARIVAX mixed with liquid diluent of ROTARIX; nurse mix and administer a dose of VARlVAX with the prefilled oral applicator of liquid diluent for ROTARlX; these two products were mixed, the nurse administered the ROTATRlX diluent applicator (with VARlVAX) into a 2 month old's mouth and administered orally as directed by the ROTATRlX instructions; Inappropriate age at vaccine administration; This spontaneous report was received from a pharmacist who refers to a 9-week-old (also reported as a 2-month-old) patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and patient's pertinent medical history was not provided. On 13-SEP-2021, the nurse accidentally took virus vaccine live (oka/merck) (VARIVAX) (vial, 0.5 ml, lot # T041686, expiry date 10-DEC-2022) thinking it was the rotavirus vaccine live oral 1v (ROTARIX) and mixed it with the appropriate liquid diluent (0.1ml ) that should have been mixed with the rotavirus vaccine live oral 1v (ROTARIX). Once these two products were mixed, the nurse administered for prophylaxis the rotavirus vaccine live oral 1v (ROTARIX) diluent applicator (with virus vaccine live (oka/merck) (VARIVAX)) into patient's mouth (orally) as directed by the rotavirus vaccine live oral 1v (ROTARIX) instructions. Formulation, concentration, dose number, frequency for all suspect therapies was not provided. The lot # and expiry date for rotavirus vaccine live oral 1v (ROTARIX) and the diluent were not reported. No additional adverse event was reported. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's reported.; calling to report a temperature excursion for VARIVAX; This spontaneous report was received from a nurse referring to a 4-years-old patient of unknown gender. For all the patients, the concurrent conditions, medical history and concomitant medications were not provided.  On 15-SEP-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose (strength, dose, route, frequency, were not provided) for prophylaxis; Lot No. U015682 has been verified to be a valid lot number for [varicella virus vaccine live (Oka/Merck)], expiration date reported as 18-MAY-2023, and upon internal validation established as the same.  The nurse reported that the vaccine dose was administered on 15-SEP-2021 and there was a temperature excursion for varicella virus vaccine live (Oka/Merck) (VARIVAX). The product experienced an excursion of 4 Celsius degrees (C) from -10 C to 8 C for 20 minutes on 07-SEP-2021 during the transport; and of 4C from -10 C to 8 C for 20 minutes on 09-SEP-2021, again during transport. Previous temperature excursion included from -10°C to 8°C (4C) for 7 hours and 30 minutes. And no adverse events were reported.  This is one of 26 reports received from the same source.; Sender's Comments:  US-009507513-2109USA005628: US-009507513-2109USA005639: US-009507513-2109USA005632: US-009507513-2109USA005910: US-009507513-2109USA005891: US-009507513-2109USA005964: US-009507513-2109USA005651: US-009507513-2109USA005918: US-009507513-2109USA005744: US-009507513-2109USA005648: US-009507513-2109USA005758: US-009507513-2109USA005760: US-009507513-2109USA005705: US-009507513-2109USA005776: US-009507513-2109USA005662: US-009507513-2109USA005901: US-009507513-2109USA005752: US-009507513-2109USA005662: US-009507513-2109USA005641: US-009507513-2109USA005648: