chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anisomastia, Blood parathyroid hormone increased, Blood test, Body temperature increased, Breast cyst
Clinical narrative: The morning after the vax, it felt like I had COVID all over again. It was accompanied by a migraine that lasted 23 days and neck stiffness for 5 days. I cancelled my 2nd dose and went to my Dr. I haven't had a regular period since the vaccine.  It started as heavy bleeding and haven't had period since 1/1/22. In late Oct I developed a cyst in my right breast to the point that it caused my breast to shift. I went to the ER for that on 11/25 where they did an ultrasound and a week later I went to have a mammogram where they drained the cyst. As far as the neck pain, they tested me for an auto-immune and referred me to a rheumatologists who told me a para-thyroid levels were high. They took a ultrasound of my neck and discovered a tumor in the left side of my neck. I'm also experiencing extremely high internal temperature.  I am seeing a neck surgeon soon.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast cyst drainage, Computerised tomogram, Heavy menstrual bleeding, Mammogram, Menstruation delayed
Clinical narrative: The morning after the vax, it felt like I had COVID all over again. It was accompanied by a migraine that lasted 23 days and neck stiffness for 5 days. I cancelled my 2nd dose and went to my Dr. I haven't had a regular period since the vaccine.  It started as heavy bleeding and haven't had period since 1/1/22. In late Oct I developed a cyst in my right breast to the point that it caused my breast to shift. I went to the ER for that on 11/25 where they did an ultrasound and a week later I went to have a mammogram where they drained the cyst. As far as the neck pain, they tested me for an auto-immune and referred me to a rheumatologists who told me a para-thyroid levels were high. They took a ultrasound of my neck and discovered a tumor in the left side of my neck. I'm also experiencing extremely high internal temperature.  I am seeing a neck surgeon soon.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Migraine, Musculoskeletal stiffness, Neck pain, Neoplasm
Clinical narrative: The morning after the vax, it felt like I had COVID all over again. It was accompanied by a migraine that lasted 23 days and neck stiffness for 5 days. I cancelled my 2nd dose and went to my Dr. I haven't had a regular period since the vaccine.  It started as heavy bleeding and haven't had period since 1/1/22. In late Oct I developed a cyst in my right breast to the point that it caused my breast to shift. I went to the ER for that on 11/25 where they did an ultrasound and a week later I went to have a mammogram where they drained the cyst. As far as the neck pain, they tested me for an auto-immune and referred me to a rheumatologists who told me a para-thyroid levels were high. They took a ultrasound of my neck and discovered a tumor in the left side of my neck. I'm also experiencing extremely high internal temperature.  I am seeing a neck surgeon soon.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan, X-ray
Clinical narrative: The morning after the vax, it felt like I had COVID all over again. It was accompanied by a migraine that lasted 23 days and neck stiffness for 5 days. I cancelled my 2nd dose and went to my Dr. I haven't had a regular period since the vaccine.  It started as heavy bleeding and haven't had period since 1/1/22. In late Oct I developed a cyst in my right breast to the point that it caused my breast to shift. I went to the ER for that on 11/25 where they did an ultrasound and a week later I went to have a mammogram where they drained the cyst. As far as the neck pain, they tested me for an auto-immune and referred me to a rheumatologists who told me a para-thyroid levels were high. They took a ultrasound of my neck and discovered a tumor in the left side of my neck. I'm also experiencing extremely high internal temperature.  I am seeing a neck surgeon soon.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Pulmonary thrombosis
Clinical narrative: four blood clots in lungs; could not breathe, trouble breathing; in severe pain; told them she probably had Af-ib; quality of life has been destroyed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: ER8734) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6207), administration date: 10Mar2021, when the patient was 79 years old, for Covid-19 Immunization. The reporter stated they were told by their doctor that they had to get the vaccine, stated that she demanded it because of their age. Since they have gotten the vaccine they have been progressively getting worse. On 15Oct2021, the patient had four blood clots in her lungs and they were diagnosed on 15Oct2021 in the emergency room. It was horrible experience for the patient because she could not breathe/ trouble breathing, in severe pain and they were told that she probably had Af-ib and probably had blood clots. The patient was sent to the emergency room, was hospitalized for three days (as reported). Cardiology put the patient on apixaban (ELIQUIS) but then they put her on metoprolol and rivaroxaban (XARELTO) which was a little better financially. The reporter also stated their quality of life has been destroyed, on an unspecified date. The patient was hospitalized for pulmonary thrombosis, dyspnoea, pain, atrial fibrillation (start date: 15Oct2021, discharge date: 17Oct2021, hospitalization duration: 2 day(s)). The events "four blood clots in lungs", "could not breathe, trouble breathing", "in severe pain", "told them she probably had af-ib" and "quality of life has been destroyed" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pulmonary thrombosis, dyspnoea, pain, atrial fibrillation. The reporter stated that patient have improved and they were continuing monitoring the clots for now. Doctors said it could take up to 6 months for them to dissolve. The reporter stated that  they couldn't believe the patient was alive when she got to the emergency room. It was further reported that the patient never had any issues with any medical issues prior to the injections. Doctor stated she had one of the strongest hearts of a 79 year old that he had seen prior to all of this.  The outcome of all events was recovering.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Dyspnoea, Impaired quality of life, Pain, Pulmonary thrombosis
Clinical narrative: four blood clots in lungs; could not breathe, trouble breathing; in severe pain; told them she probably had Af-ib; quality of life has been destroyed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Lot number: ER8734) at the age of 79 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6207), administration date: 10Mar2021, when the patient was 79 years old, for Covid-19 Immunization. The reporter stated they were told by their doctor that they had to get the vaccine, stated that she demanded it because of their age. Since they have gotten the vaccine they have been progressively getting worse. On 15Oct2021, the patient had four blood clots in her lungs and they were diagnosed on 15Oct2021 in the emergency room. It was horrible experience for the patient because she could not breathe/ trouble breathing, in severe pain and they were told that she probably had Af-ib and probably had blood clots. The patient was sent to the emergency room, was hospitalized for three days (as reported). Cardiology put the patient on apixaban (ELIQUIS) but then they put her on metoprolol and rivaroxaban (XARELTO) which was a little better financially. The reporter also stated their quality of life has been destroyed, on an unspecified date. The patient was hospitalized for pulmonary thrombosis, dyspnoea, pain, atrial fibrillation (start date: 15Oct2021, discharge date: 17Oct2021, hospitalization duration: 2 day(s)). The events "four blood clots in lungs", "could not breathe, trouble breathing", "in severe pain", "told them she probably had af-ib" and "quality of life has been destroyed" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pulmonary thrombosis, dyspnoea, pain, atrial fibrillation. The reporter stated that patient have improved and they were continuing monitoring the clots for now. Doctors said it could take up to 6 months for them to dissolve. The reporter stated that  they couldn't believe the patient was alive when she got to the emergency room. It was further reported that the patient never had any issues with any medical issues prior to the injections. Doctor stated she had one of the strongest hearts of a 79 year old that he had seen prior to all of this.  The outcome of all events was recovering.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid vaccine monitoring documentation. PT admission 1/21/22 ? 1/31/22. COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 03/17/2021 lot 006B21A. COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 04/14/2021 lot 036B21A.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid vaccine monitoring documentation. PT admission 1/21/22 ? 1/31/22. COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 03/17/2021 lot 006B21A. COVID-19, mRNA, LNP-S, PF, 100 mcg/ 0.5 mL dose (MODERNA) 04/14/2021 lot 036B21A.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood magnesium, Computerised tomogram head, Hypoaesthesia, Metabolic function test, Muscle twitching
Clinical narrative: Systemic reaction to booster/ having reactions to your product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: UNEVALUABLE EVENT (non-serious), outcome "unknown", described as "Systemic reaction to booster/ having reactions to your product".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Skin burning sensation, Thyroid function test normal, Vitamin B12 normal
Clinical narrative: Systemic reaction to booster/ having reactions to your product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: UNEVALUABLE EVENT (non-serious), outcome "unknown", described as "Systemic reaction to booster/ having reactions to your product".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Systemic reaction to booster/ having reactions to your product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Regulatory Authority. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: UNEVALUABLE EVENT (non-serious), outcome "unknown", described as "Systemic reaction to booster/ having reactions to your product".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Intensive care, SARS-CoV-2 test positive
Clinical narrative: Patient passed away from COVID
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Death
Clinical narrative: Patient passed away from COVID
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute sinusitis, Autopsy, Blood urine present, Cardiac arrest, Chest X-ray normal
Clinical narrative: Death
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Death, Eye pain, Grip strength decreased, Haemoptysis
Clinical narrative: Death
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Myocarditis, Neck mass, Oropharyngeal pain, Pain in extremity
Clinical narrative: Death
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Paranasal sinus discomfort, Photophobia, Sinus congestion, Sinus operation
Clinical narrative: Death
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Spermatozoa abnormal, Toxicologic test, Unresponsive to stimuli, Vaccination complication, Vomiting
Clinical narrative: Death
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Death
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Blood pressure abnormal, Deep vein thrombosis, Dyspnoea, Endotracheal intubation
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; This spontaneous report received from a health care professional concerned a 68 year old male. The patient's height, and weight were not reported. The patient was using a wheelchair due to mobility and pain issues. The patient's concurrent conditions included: chronic pain, and mobility issue. The patient had no known allergies to medications, food, or other products. Patient had no other illnesses at the time of vaccination and up to one month prior. The patient had no adverse event following any previous vaccine. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 10-JUL-2021 for prophylactic vaccination. No adverse events reported post primary vaccination (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s vaccine (Dose number in series 2) (suspension for injection, intramuscular, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 19-NOV-2021 at 12:00 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication.  On 09-FEB-2022 at 17:00, after 2.5 months after booster dose, patient had been dyspneic for 36 hours. First responder noted oxygen saturation of 78 percent. Patient was transferred to the outside hospital emergency room for further treatment and care. Patient ended up being intubated, admitted to the ICU (Intensive Care Unit) and was diagnosed with pulmonary embolism and deep vein thrombosis. Patient had acute respiratory distress syndrome and was needing mechanical ventilation still for almost 3.5 weeks at the time of reporting, blood pressure support and tracheostomy (Dose number in series 2). On an unspecified date, the patient was hospitalized. Number of days of hospitalization was 24. No medical tests and laboratory results related to the adverse event(s) were performed before complaining of dyspnea (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, deep vein thrombosis and acute respiratory distress syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20220316804-Covid-19 vaccine ad26.cov2.s- Acute respiratory distress syndrome, Pulmonary embolism, Deep vein thrombosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Mechanical ventilation, Pulmonary embolism, Tracheostomy
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; This spontaneous report received from a health care professional concerned a 68 year old male. The patient's height, and weight were not reported. The patient was using a wheelchair due to mobility and pain issues. The patient's concurrent conditions included: chronic pain, and mobility issue. The patient had no known allergies to medications, food, or other products. Patient had no other illnesses at the time of vaccination and up to one month prior. The patient had no adverse event following any previous vaccine. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 10-JUL-2021 for prophylactic vaccination. No adverse events reported post primary vaccination (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s vaccine (Dose number in series 2) (suspension for injection, intramuscular, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 19-NOV-2021 at 12:00 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication.  On 09-FEB-2022 at 17:00, after 2.5 months after booster dose, patient had been dyspneic for 36 hours. First responder noted oxygen saturation of 78 percent. Patient was transferred to the outside hospital emergency room for further treatment and care. Patient ended up being intubated, admitted to the ICU (Intensive Care Unit) and was diagnosed with pulmonary embolism and deep vein thrombosis. Patient had acute respiratory distress syndrome and was needing mechanical ventilation still for almost 3.5 weeks at the time of reporting, blood pressure support and tracheostomy (Dose number in series 2). On an unspecified date, the patient was hospitalized. Number of days of hospitalization was 24. No medical tests and laboratory results related to the adverse event(s) were performed before complaining of dyspnea (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, deep vein thrombosis and acute respiratory distress syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20220316804-Covid-19 vaccine ad26.cov2.s- Acute respiratory distress syndrome, Pulmonary embolism, Deep vein thrombosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory distress syndrome, Deep vein thrombosis, Oxygen saturation, Pulmonary embolism
Clinical narrative: ACUTE RESPIRATORY DISTRESS SYNDROME; PULMONARY EMBOLISM; DEEP VEIN THROMBOSIS; This spontaneous report received from a health care professional concerned a 68 year old male. The patient's height, and weight were not reported. The patient was using a wheelchair due to mobility and pain issues. The patient's concurrent conditions included: chronic pain, and mobility issue. The patient had no known allergies to medications, food, or other products. Patient had no other illnesses at the time of vaccination and up to one month prior. The patient had no adverse event following any previous vaccine. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 10-JUL-2021 for prophylactic vaccination. No adverse events reported post primary vaccination (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s vaccine (Dose number in series 2) (suspension for injection, intramuscular, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 19-NOV-2021 at 12:00 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication.  On 09-FEB-2022 at 17:00, after 2.5 months after booster dose, patient had been dyspneic for 36 hours. First responder noted oxygen saturation of 78 percent. Patient was transferred to the outside hospital emergency room for further treatment and care. Patient ended up being intubated, admitted to the ICU (Intensive Care Unit) and was diagnosed with pulmonary embolism and deep vein thrombosis. Patient had acute respiratory distress syndrome and was needing mechanical ventilation still for almost 3.5 weeks at the time of reporting, blood pressure support and tracheostomy (Dose number in series 2). On an unspecified date, the patient was hospitalized. Number of days of hospitalization was 24. No medical tests and laboratory results related to the adverse event(s) were performed before complaining of dyspnea (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism, deep vein thrombosis and acute respiratory distress syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20220316804-Covid-19 vaccine ad26.cov2.s- Acute respiratory distress syndrome, Pulmonary embolism, Deep vein thrombosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, COVID-19, Death, Dyspnoea, Fibrosis
Clinical narrative: Pt presented to hospital via EMS with sob and dyspnea on exertion; pmh of renal and pancreas transplant on immunosuppression, dm, htn, hld, gerd; pt visited urgent care for diarrhea and muscle aches and found to be COVID positive on 10/15 and told to isolate; sob got progressively worse which brought her to the hospital; initial O2 sat was in 50s; pt was febrile at 39.1 C, bp 128/74, hr 117, rr 28 and satting low 90s hfnc 40 L at 100% FiO2. Dx?d with pneumonia due to COVID-19; former smoker; allergies: flagyl; treatments dexamethasone, baricitnib, guifenesin codeine cough syrup; pancreas began to fail; pt started on insulin; pt was sent to icu, proned; required bipap and vaptherm and put on anticoagulation; pt continued to decline and CXR worsened; bipap removed 11/09 after discussion with family and pt became asystole shortly after; pt passed away the afternoon of 11/09/21
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: General physical health deterioration, Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: Pt presented to hospital via EMS with sob and dyspnea on exertion; pmh of renal and pancreas transplant on immunosuppression, dm, htn, hld, gerd; pt visited urgent care for diarrhea and muscle aches and found to be COVID positive on 10/15 and told to isolate; sob got progressively worse which brought her to the hospital; initial O2 sat was in 50s; pt was febrile at 39.1 C, bp 128/74, hr 117, rr 28 and satting low 90s hfnc 40 L at 100% FiO2. Dx?d with pneumonia due to COVID-19; former smoker; allergies: flagyl; treatments dexamethasone, baricitnib, guifenesin codeine cough syrup; pancreas began to fail; pt started on insulin; pt was sent to icu, proned; required bipap and vaptherm and put on anticoagulation; pt continued to decline and CXR worsened; bipap removed 11/09 after discussion with family and pt became asystole shortly after; pt passed away the afternoon of 11/09/21
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Cardiac arrest, Chest X-ray abnormal
Clinical narrative: Pt presented to hospital via EMS with sob and dyspnea on exertion; pmh of renal and pancreas transplant on immunosuppression, dm, htn, hld, gerd; pt visited urgent care for diarrhea and muscle aches and found to be COVID positive on 10/15 and told to isolate; sob got progressively worse which brought her to the hospital; initial O2 sat was in 50s; pt was febrile at 39.1 C, bp 128/74, hr 117, rr 28 and satting low 90s hfnc 40 L at 100% FiO2. Dx?d with pneumonia due to COVID-19; former smoker; allergies: flagyl; treatments dexamethasone, baricitnib, guifenesin codeine cough syrup; pancreas began to fail; pt started on insulin; pt was sent to icu, proned; required bipap and vaptherm and put on anticoagulation; pt continued to decline and CXR worsened; bipap removed 11/09 after discussion with family and pt became asystole shortly after; pt passed away the afternoon of 11/09/21
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Diarrhoea, Dyspnoea, Dyspnoea exertional, General physical health deterioration
Clinical narrative: Pt presented to hospital via EMS with sob and dyspnea on exertion; pmh of renal and pancreas transplant on immunosuppression, dm, htn, hld, gerd; pt visited urgent care for diarrhea and muscle aches and found to be COVID positive on 10/15 and told to isolate; sob got progressively worse which brought her to the hospital; initial O2 sat was in 50s; pt was febrile at 39.1 C, bp 128/74, hr 117, rr 28 and satting low 90s hfnc 40 L at 100% FiO2. Dx?d with pneumonia due to COVID-19; former smoker; allergies: flagyl; treatments dexamethasone, baricitnib, guifenesin codeine cough syrup; pancreas began to fail; pt started on insulin; pt was sent to icu, proned; required bipap and vaptherm and put on anticoagulation; pt continued to decline and CXR worsened; bipap removed 11/09 after discussion with family and pt became asystole shortly after; pt passed away the afternoon of 11/09/21
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insulin therapy, Intensive care, Myalgia, Pancreatic failure, Positive airway pressure therapy
Clinical narrative: Pt presented to hospital via EMS with sob and dyspnea on exertion; pmh of renal and pancreas transplant on immunosuppression, dm, htn, hld, gerd; pt visited urgent care for diarrhea and muscle aches and found to be COVID positive on 10/15 and told to isolate; sob got progressively worse which brought her to the hospital; initial O2 sat was in 50s; pt was febrile at 39.1 C, bp 128/74, hr 117, rr 28 and satting low 90s hfnc 40 L at 100% FiO2. Dx?d with pneumonia due to COVID-19; former smoker; allergies: flagyl; treatments dexamethasone, baricitnib, guifenesin codeine cough syrup; pancreas began to fail; pt started on insulin; pt was sent to icu, proned; required bipap and vaptherm and put on anticoagulation; pt continued to decline and CXR worsened; bipap removed 11/09 after discussion with family and pt became asystole shortly after; pt passed away the afternoon of 11/09/21
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Pt presented to hospital via EMS with sob and dyspnea on exertion; pmh of renal and pancreas transplant on immunosuppression, dm, htn, hld, gerd; pt visited urgent care for diarrhea and muscle aches and found to be COVID positive on 10/15 and told to isolate; sob got progressively worse which brought her to the hospital; initial O2 sat was in 50s; pt was febrile at 39.1 C, bp 128/74, hr 117, rr 28 and satting low 90s hfnc 40 L at 100% FiO2. Dx?d with pneumonia due to COVID-19; former smoker; allergies: flagyl; treatments dexamethasone, baricitnib, guifenesin codeine cough syrup; pancreas began to fail; pt started on insulin; pt was sent to icu, proned; required bipap and vaptherm and put on anticoagulation; pt continued to decline and CXR worsened; bipap removed 11/09 after discussion with family and pt became asystole shortly after; pt passed away the afternoon of 11/09/21
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Asthenia, Taste disorder
Clinical narrative: no energy/weakness; she has not been feeling well for about  2-3 weeks; food tasting like perfume today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Apr2021 (Lot number: ER8727) at the age of 74 years as dose 2, single and administration date 08Apr2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "no energy/weakness "; MALAISE (non-serious), outcome "unknown", described as "she has not been feeling well for about 2-3 weeks"; TASTE DISORDER (non-serious) with onset 09Nov2021, outcome "unknown", described as "food tasting like perfume today".  Additional information: Caller reports receiving first and second dose of Pfizer covid vaccine 08Apr2021, 28Apr2021, and was scheduled to receive the booster dose today but canceled due to experiencing for the past three weeks no energy, weakness and food tasting like perfume today. Caller stated she was concerned and asked if she should get the booster dose. Caller states that she has no energy and she has not been feeling well for about 2-3 weeks. Caller states somedays she can get up but she was still weak. Caller states her biggest thing was weakness. Caller states she also has no energy. Caller states she fixed a sandwich today and the first bite of food she took, the food taste like perfume. Caller states she was going to take the booster today, but she wanted to call first and she was going to check with her doctor next.   Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Malaise, Taste disorder
Clinical narrative: no energy/weakness; she has not been feeling well for about  2-3 weeks; food tasting like perfume today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Apr2021 (Lot number: ER8727) at the age of 74 years as dose 2, single and administration date 08Apr2021 (Lot number: EN6207) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "no energy/weakness "; MALAISE (non-serious), outcome "unknown", described as "she has not been feeling well for about 2-3 weeks"; TASTE DISORDER (non-serious) with onset 09Nov2021, outcome "unknown", described as "food tasting like perfume today".  Additional information: Caller reports receiving first and second dose of Pfizer covid vaccine 08Apr2021, 28Apr2021, and was scheduled to receive the booster dose today but canceled due to experiencing for the past three weeks no energy, weakness and food tasting like perfume today. Caller stated she was concerned and asked if she should get the booster dose. Caller states that she has no energy and she has not been feeling well for about 2-3 weeks. Caller states somedays she can get up but she was still weak. Caller states her biggest thing was weakness. Caller states she also has no energy. Caller states she fixed a sandwich today and the first bite of food she took, the food taste like perfume. Caller states she was going to take the booster today, but she wanted to call first and she was going to check with her doctor next.   Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Peroneal nerve palsy
Clinical narrative: per patient . , experienced pain  and inflammation in the legs and muscle weakness , patient reported o the ER , hospitalized for 1 day  ,did spinal tap , and the conclusion per medical team  was Guillain-Barre syndrome.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Inflammation, Lumbar puncture, Muscular weakness, Pain in extremity
Clinical narrative: per patient . , experienced pain  and inflammation in the legs and muscle weakness , patient reported o the ER , hospitalized for 1 day  ,did spinal tap , and the conclusion per medical team  was Guillain-Barre syndrome.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was vaccinated with the Janssen COVID-19 vaccine.  He was not eligible to receive it as he is minor. Patient did not report having an adverse reaction.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction. Just want to report that a 16 year old received a Moderna Booster. So far not adverse reaction. She should have gotten the Pfizer booster instead.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Musculoskeletal chest pain, Pain, Rash
Clinical narrative: Shingles: started as pain around lower back, started radiating around my ribs the next day and developed into a rash just under my sternum after 3 days
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram head abnormal, Headache
Clinical narrative: On May 31,2021 I began to suffer with headache by June2,2021 at 1 in the morning I couldnt take it anymore and had sept most of the 3 days...then I began to have neck stiffness to the point I could not move...My son called 911 they took me to the hospital where they did ct scan and found i was bleeding by my brain, then I was life flighted to another hospital and addmitted to neurological icu unit and told i suffered subarachnoid hemorrhage and a stroke...I was discharged on June 8,2021
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Intensive care, Movement disorder, Musculoskeletal stiffness, Subarachnoid haemorrhage
Clinical narrative: On May 31,2021 I began to suffer with headache by June2,2021 at 1 in the morning I couldnt take it anymore and had sept most of the 3 days...then I began to have neck stiffness to the point I could not move...My son called 911 they took me to the hospital where they did ct scan and found i was bleeding by my brain, then I was life flighted to another hospital and addmitted to neurological icu unit and told i suffered subarachnoid hemorrhage and a stroke...I was discharged on June 8,2021
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Biopsy skin abnormal, C-reactive protein increased, Joint swelling, Liver function test normal
Clinical narrative: Developed biopsy-proven urticaria, facial swelling and joint swelling approx 10 days after 3rd injection which occurred 3 weeks after lab-confirmed Covid-19 infection. 3 weeks after start of reaction, has nearly reesolved.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Developed biopsy-proven urticaria, facial swelling and joint swelling approx 10 days after 3rd injection which occurred 3 weeks after lab-confirmed Covid-19 infection. 3 weeks after start of reaction, has nearly reesolved.
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Biopsy lymph gland abnormal, Blood alkaline phosphatase increased, Chest X-ray abnormal, Eosinophil count increased, Full blood count abnormal
Clinical narrative: Mother of pt noted small rash about 2 weeks before first Covid-19 injection (about 1 week after Influenza vaccine). Similar rash with severe flare on day of the first Pfizer Covid-19 vaccine. Worsening of same rash right after second Pfizer vaccine. Rash resolved with oral steroids. Approx 1 month after rash began, patient was admitted for facial swelling and neck venous distention. CXR showed thymic mass. Biopsy proven Hodgkin Lymphoma stage IV
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Hodgkin's disease, Monocyte count increased, Neoplasm of thymus, Neutrophil count increased, Rash
Clinical narrative: Mother of pt noted small rash about 2 weeks before first Covid-19 injection (about 1 week after Influenza vaccine). Similar rash with severe flare on day of the first Pfizer Covid-19 vaccine. Worsening of same rash right after second Pfizer vaccine. Rash resolved with oral steroids. Approx 1 month after rash began, patient was admitted for facial swelling and neck venous distention. CXR showed thymic mass. Biopsy proven Hodgkin Lymphoma stage IV
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Swelling, Swelling face, Urine analysis abnormal, Urine leukocyte esterase positive, Vasodilatation
Clinical narrative: Mother of pt noted small rash about 2 weeks before first Covid-19 injection (about 1 week after Influenza vaccine). Similar rash with severe flare on day of the first Pfizer Covid-19 vaccine. Worsening of same rash right after second Pfizer vaccine. Rash resolved with oral steroids. Approx 1 month after rash began, patient was admitted for facial swelling and neck venous distention. CXR showed thymic mass. Biopsy proven Hodgkin Lymphoma stage IV
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: White blood cell count increased
Clinical narrative: Mother of pt noted small rash about 2 weeks before first Covid-19 injection (about 1 week after Influenza vaccine). Similar rash with severe flare on day of the first Pfizer Covid-19 vaccine. Worsening of same rash right after second Pfizer vaccine. Rash resolved with oral steroids. Approx 1 month after rash began, patient was admitted for facial swelling and neck venous distention. CXR showed thymic mass. Biopsy proven Hodgkin Lymphoma stage IV
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccine positive rechallenge
Clinical narrative: Itchy skin since the first vaccine, worse after the second one and got almost out of control after booster shot.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Polyarthritis, Rheumatic fever, Rheumatic heart disease
Clinical narrative: Rheumatic fever; Migratory arthritis; Rheumatic heart disease; This is a spontaneous report received from contactable reporter (consumer). The reporter is the parent.  A 14-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 08Oct2021 16:30 (lot number: 30155BA) at the age of 14-years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162B2 (batch/lot number: 30130BA, administered in left arm at 14:30 as dose 1, single), administration date: 17Sep2021, when the patient was 14-years-old, for COVID-19 immunisation. The following information was reported: RHEUMATIC FEVER (medically significant) with onset 23Nov2021 06:00, outcome "recovering", described as "Rheumatic fever"; POLYARTHRITIS (medically significant) with onset 23Nov2021 06:00, outcome "recovering", described as "Migratory arthritis"; and RHEUMATIC HEART DISEASE (medically significant) with onset 23Nov2021 06:00, outcome "recovering", described as "Rheumatic heart disease." The events "rheumatic fever", "migratory arthritis" and "rheumatic heart disease" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of rheumatic fever, polyarthritis, and rheumatic heart disease and included treatment with monthly penicillin shots and 400 mg ibuprofen. Clinical course: The patient has no known allergies. Prior to vaccination, she was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as other. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19.
Age: 1.17
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: Testing The form
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Decreased appetite, Fatigue
Clinical narrative: Body pain; pain in the left armpit glands; pain and swelling of the right armpit glands; body joint pain; Fever; Chills; Tiredness; loss of appetite; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jan2022 13:30 (Lot number: 30025BD) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, lot number: EW0187, Location: right arm), administration date: 07Jun2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, lot number: EW0175, location: right arm), administration date: 17May2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Body pain"; AXILLARY PAIN (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "pain in the left armpit glands"; LYMPHADENOPATHY (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "pain and swelling of the right armpit glands"; ARTHRALGIA (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "body joint pain"; PYREXIA (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Tiredness"; DECREASED APPETITE (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "loss of appetite"; MYALGIA (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "muscle pain". Therapeutic measures were not taken as a result of pain, axillary pain, lymphadenopathy, arthralgia, pyrexia, chills, fatigue, decreased appetite, myalgia.  Additional information: The did not receive any other vaccine in four weeks and also not received other medications in two weeks. The patient did not have covid prior to the vaccination and had not been tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain, Pyrexia
Clinical narrative: Body pain; pain in the left armpit glands; pain and swelling of the right armpit glands; body joint pain; Fever; Chills; Tiredness; loss of appetite; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Jan2022 13:30 (Lot number: 30025BD) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, lot number: EW0187, Location: right arm), administration date: 07Jun2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, lot number: EW0175, location: right arm), administration date: 17May2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Body pain"; AXILLARY PAIN (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "pain in the left armpit glands"; LYMPHADENOPATHY (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "pain and swelling of the right armpit glands"; ARTHRALGIA (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "body joint pain"; PYREXIA (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "Tiredness"; DECREASED APPETITE (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "loss of appetite"; MYALGIA (non-serious) with onset 05Jan2022 16:30, outcome "recovering", described as "muscle pain". Therapeutic measures were not taken as a result of pain, axillary pain, lymphadenopathy, arthralgia, pyrexia, chills, fatigue, decreased appetite, myalgia.  Additional information: The did not receive any other vaccine in four weeks and also not received other medications in two weeks. The patient did not have covid prior to the vaccination and had not been tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: 1st dose - Sore Arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 16:30 (Lot number: ER8727) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: Hashimoto; "depression" (unspecified if ongoing), notes: depression; "anxiety" (unspecified if ongoing), notes: anxiety; "Known allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penicillin. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "1st dose - Sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.