chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Cardiac failure, Cardiomegaly, Cardiomyopathy
Clinical narrative: Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Constipation, Cytomegalovirus test, Cytomegalovirus test negative
Clinical narrative: Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram abnormal, Ejection fraction decreased, Epstein-Barr virus antibody negative
Clinical narrative: Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatitis viral test negative, Hilar lymphadenopathy, Hypertension, Left ventricular dysfunction, Lymphadenopathy mediastinal
Clinical narrative: Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Myocarditis, Obesity, Pain in extremity, Pericardial effusion
Clinical narrative: Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, Pulmonary oedema, Respiratory viral panel, Right ventricular ejection fraction decreased, SARS-CoV-2 antibody test negative
Clinical narrative: Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Sleep apnoea syndrome, Ventricular hypokinesia
Clinical narrative: Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site joint movement impairment, Injection site pain, Injection site pruritus, Lymph node pain
Clinical narrative: headache, nausea, dry heaves. swollen lymph node under arm, pain and itching at injection site.   lymph node under arm was painful and swollen for 1 week.  Out of work on 1/12 due to inability to lift arm and use as node was very painful.   fully resolved as on 1/15/21
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Retching
Clinical narrative: headache, nausea, dry heaves. swollen lymph node under arm, pain and itching at injection site.   lymph node under arm was painful and swollen for 1 week.  Out of work on 1/12 due to inability to lift arm and use as node was very painful.   fully resolved as on 1/15/21
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: NONE
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pruritus, Tenderness, Vaccination site reaction
Clinical narrative: 15 minutes after vaccine- itchy all over-  took benedryl severe fatigue starting the next day vaccine  and lasting for 7 days Arm tender for first 48 hours 9 days AFTER vaccine- area where vaccine given very red, swollen , hot to touch and itchy
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: 15 minutes after vaccine- itchy all over-  took benedryl severe fatigue starting the next day vaccine  and lasting for 7 days Arm tender for first 48 hours 9 days AFTER vaccine- area where vaccine given very red, swollen , hot to touch and itchy
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: A week after my vaccine woke up my arm was swollen, red, hot to touch, sore, and very itchy.  The swelling has decreased but is still there. The swelling has moved around. Redness has spread to other area's of my arm. Still very itchy, but is no longer hot to touch. Arm is only sore when its touched.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Rash
Clinical narrative: 12 hours after receiving the second vaccine I developed a temp of 103 that lasted approximately 36 hours. I also developed a rash on my forearms 24 hours after the vaccine which lasted approximately 24 hours
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure decreased, Diarrhoea, Dysstasia, Feeling hot
Clinical narrative: 20 minutes after vax, started having a headache, feeling hot, BP was 51/37, nausea, severe pain in lower back, felt paralyzed, couldn't stand up, diarrhea, collapsed on bathroom floor. Took Zofran for nausea.  went to lie down in bed and after a while, BP went back to normal.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: 20 minutes after vax, started having a headache, feeling hot, BP was 51/37, nausea, severe pain in lower back, felt paralyzed, couldn't stand up, diarrhea, collapsed on bathroom floor. Took Zofran for nausea.  went to lie down in bed and after a while, BP went back to normal.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Horrible headache for 30 hours       Bad body aches
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Blood albumin decreased, Blood chloride normal, Blood creatinine increased, Blood potassium increased
Clinical narrative: Tremors, elevated BUP and Heart Rate, Elevated temperature of 100.6 that continued to rise to 101.6 despite tylenol being administered. Altered Level of consciousness.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium decreased, Blood urea increased, Body temperature increased, Glomerular filtration rate increased, Haematocrit decreased
Clinical narrative: Tremors, elevated BUP and Heart Rate, Elevated temperature of 100.6 that continued to rise to 101.6 despite tylenol being administered. Altered Level of consciousness.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Heart rate increased, Lymphocyte count decreased, Mean cell volume increased, Protein total decreased
Clinical narrative: Tremors, elevated BUP and Heart Rate, Elevated temperature of 100.6 that continued to rise to 101.6 despite tylenol being administered. Altered Level of consciousness.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count decreased, Red cell distribution width increased, Tremor, White blood cell count normal
Clinical narrative: Tremors, elevated BUP and Heart Rate, Elevated temperature of 100.6 that continued to rise to 101.6 despite tylenol being administered. Altered Level of consciousness.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: the patient has not complained of any adverse reactions; a dose of MMRII or VARIVAX mixed with a non Merck diluent; This spontaneous report as received from a registered nurse refers to a 35-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 16-DEC-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml or varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml (lot #, expiration date and route of administration were not reported for both) for prophylaxis that was reconstituted with an improper diluent. The diluent used was for zoster rgE vaccine (mammalian) (SHINGRIX) (reported as SHINGREX) and read "Asolb mono phospholipid lipid a qs-21 natural compound extracted from the soap bark tree, combined in liposomal formulation". The patient had not complained of any adverse reactions.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA001793:
Sex: U
Vaccine: VARZOS
Symptoms: Nervous system disorder, Neuralgia, Visual impairment
Clinical narrative: Postherpetic neuralgia, vision problems and neurological issues; Postherpetic neuralgia, vision problems and neurological issues; Postherpetic neuralgia, vision problems and neurological issues; Information has been received from a lawyer regarding a case in litigation, referring to a currently 65 year old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 07-DEC-2015, the patient was vaccinated at a clinic with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, lot # and expiration date were not provided),for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the patient was treated by a provided for the following injuries: post herpetic neuralgia, vision problems (visual impairment) and neurological issues (nervous system disorder). The patient claimed damages as result of injuries to themselves and economic losses. At the time of the report, the outcome of post herpetic neuralgia, nervous system disorder and visual impairment was unknown. The lawyer considered post herpetic neuralgia, nervous system disorder and visual impairment to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Epiglottitis, Oropharyngeal pain, Salivary hypersecretion
Clinical narrative: Sore throat with excessive saliva / diagnosed with Epiglottitis; excessive saliva; Tuesday had a sore throat / received IM anti-biotic / Thursday still had a very bad sore throat; This case was reported by a nurse via sales rep and described the occurrence of epiglottitis in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In May 2019, the patient received the 1st dose of Shingrix .5 ml. In May 2019, 1 day after receiving Shingrix, the patient experienced sore throat. On an unknown date, the patient experienced epiglottitis (serious criteria hospitalization and GSK medically significant) and saliva secretion excessive. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the epiglottitis, sore throat and saliva secretion excessive were recovered/resolved.   It was unknown if the reporter considered the epiglottitis, sore throat and saliva secretion excessive to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  The patient received Shingrix .5ml dose on a Monday around May 2019. The next day on Tuesday, this patient had a sore throat, on Wednesday he received an IM anti-biotic, on Thursday still had a very bad sore throat with excessive saliva so went to hospital and diagnosed with Epiglottitis. This patient's condition eventually resolved with no further issues. The patient never received a second Shingrix immunization. Supposedly this patient did experience a case of Shingles the year before he received the Shingrix vaccine.  This nurse wanted to know if the patient could receive a COVID vaccine. The reporter did not know if there was any causal relationship with the vaccine so she never reported.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unknown number of patients patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter had a few patients that reported a severe reaction following Shingrix, flu like symptoms that lasted several days. The reporter consented to follow up. No additional details available. The case has been linked with the case US2020244472 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244472:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Sensory disturbance
Clinical narrative: generalized burning sensation; paresthesia / abnormal skin sensation; This case was reported by a nurse via call center representative and described the occurrence of burning sensation in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced burning sensation and paresthesia. On an unknown date, the outcome of the burning sensation and paresthesia were unknown.   It was unknown if the reporter considered the burning sensation and paresthesia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that couple of patients experienced generalized ,burning sensation, paresthesia, abnormal skin sensation following Shingrix administration. The reporter consented to follow up. No additional details available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020244470:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Injection site pain
Clinical narrative: diagnosed with breast cancer / right breast / 2 cm. in size; received the injection / hurt / as being bit by a Jersey mosquito; This case was reported by a consumer via call center representative and described the occurrence of breast cancer in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant) and injection site pain. On an unknown date, the outcome of the breast cancer and injection site pain were unknown.   It was unknown if the reporter considered the breast cancer and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she received her first dose of Shingrix and she was diagnosed with breast cancer around the same time. The patient could not recall the exact date of her diagnosis and she couldn't confirm if the diagnosis occurred before or after the vaccination.  The patient claimed that the breast cancer was in her right breast and was 2 cm. in size.   The patient planned to undergo chemotherapy. She also reported that when she received the injection, it hurt which she described as being bit by a mosquito. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Choking, Confusional state, Dizziness
Clinical narrative: Body aches; Fever 99.8F; Chills; Entire left arm muscle is in pain on movement; Choking in the throat; Facial Flush; Blurred vision; Dizziness; Confusion; I had no emotions; A spontaneous report was received from a pharmacist concerning a 48-years old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced choking, flushing, vision blurred, dizziness, confusional state, emotional disorder, body aches, pyrexia, chills and limb discomfort.  The patient's medical history included migraines and a hysterectomy. Products known to have been used by the patient, within two weeks prior to the event, included sumatriptan, naratriptan hydrochloride, and galconezumab.  On 02 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist called stating she received the Moderna COVID-19 vaccine on 02 Jan 2021 at 9:45am in her left deltoid. Immediately after receiving the vaccine, she had facial flushing, blurred vision, dizziness, confusion and choking in the throat that lasted 20 minutes. After a few hours, she stated confusion would come and go, and she had no emotions. The next morning, the confusion was gone. On 03 Jan 2021, she reported having body aches and a fever of 99.8 degrees Fahrenheit. She reported chills, body aches, and a lot of pain in the left arm. If she tried to move her left arm, the entire muscle in the left arm hurt.  Treatment for the events included acetaminophen and an antihistamine.    Action taken with mRNA-1273 in response to the events was withdrawn.   The events, choking, flushing, vision blurred, were considered resolved on 02 Jan 2021. The events, confusional state, emotional disorder, and dizziness, were considered resolved on 03 Jan 2021. The events, body aches, pyrexia, chills, and limb discomfort, were not considered resolved.; Reporter's Comments: This case concerns a 48 year old female patient with medical history of migraines, who experienced a serious unexpected event of Choking, non-serious unexpected events of Flushing, Vision blurred, Dizziness, Confusional state, Emotional disorder, Pain, and Limb discomfort, and non-serious expected events of Pyrexia and Chills. The events of Choking, Flushing, Vision blurred, Dizziness, and Confusional state occurred immediately after administration of their first of two planned doses of mRNA-1273 (Lot number: 025L20A). The event of Emotional disorder occurred on the same day when the patient received mRNA-1273. The events of Pain, Pyrexia, Chills, and Limb discomfort occurred on the next day of mRNA-1273 administration. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Flushing, Limb discomfort, Pain, Pain in extremity
Clinical narrative: Body aches; Fever 99.8F; Chills; Entire left arm muscle is in pain on movement; Choking in the throat; Facial Flush; Blurred vision; Dizziness; Confusion; I had no emotions; A spontaneous report was received from a pharmacist concerning a 48-years old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced choking, flushing, vision blurred, dizziness, confusional state, emotional disorder, body aches, pyrexia, chills and limb discomfort.  The patient's medical history included migraines and a hysterectomy. Products known to have been used by the patient, within two weeks prior to the event, included sumatriptan, naratriptan hydrochloride, and galconezumab.  On 02 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist called stating she received the Moderna COVID-19 vaccine on 02 Jan 2021 at 9:45am in her left deltoid. Immediately after receiving the vaccine, she had facial flushing, blurred vision, dizziness, confusion and choking in the throat that lasted 20 minutes. After a few hours, she stated confusion would come and go, and she had no emotions. The next morning, the confusion was gone. On 03 Jan 2021, she reported having body aches and a fever of 99.8 degrees Fahrenheit. She reported chills, body aches, and a lot of pain in the left arm. If she tried to move her left arm, the entire muscle in the left arm hurt.  Treatment for the events included acetaminophen and an antihistamine.    Action taken with mRNA-1273 in response to the events was withdrawn.   The events, choking, flushing, vision blurred, were considered resolved on 02 Jan 2021. The events, confusional state, emotional disorder, and dizziness, were considered resolved on 03 Jan 2021. The events, body aches, pyrexia, chills, and limb discomfort, were not considered resolved.; Reporter's Comments: This case concerns a 48 year old female patient with medical history of migraines, who experienced a serious unexpected event of Choking, non-serious unexpected events of Flushing, Vision blurred, Dizziness, Confusional state, Emotional disorder, Pain, and Limb discomfort, and non-serious expected events of Pyrexia and Chills. The events of Choking, Flushing, Vision blurred, Dizziness, and Confusional state occurred immediately after administration of their first of two planned doses of mRNA-1273 (Lot number: 025L20A). The event of Emotional disorder occurred on the same day when the patient received mRNA-1273. The events of Pain, Pyrexia, Chills, and Limb discomfort occurred on the next day of mRNA-1273 administration. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred, Vital signs measurement
Clinical narrative: Body aches; Fever 99.8F; Chills; Entire left arm muscle is in pain on movement; Choking in the throat; Facial Flush; Blurred vision; Dizziness; Confusion; I had no emotions; A spontaneous report was received from a pharmacist concerning a 48-years old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced choking, flushing, vision blurred, dizziness, confusional state, emotional disorder, body aches, pyrexia, chills and limb discomfort.  The patient's medical history included migraines and a hysterectomy. Products known to have been used by the patient, within two weeks prior to the event, included sumatriptan, naratriptan hydrochloride, and galconezumab.  On 02 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) in the left deltoid intramuscularly for prophylaxis of COVID-19 infection.   A pharmacist called stating she received the Moderna COVID-19 vaccine on 02 Jan 2021 at 9:45am in her left deltoid. Immediately after receiving the vaccine, she had facial flushing, blurred vision, dizziness, confusion and choking in the throat that lasted 20 minutes. After a few hours, she stated confusion would come and go, and she had no emotions. The next morning, the confusion was gone. On 03 Jan 2021, she reported having body aches and a fever of 99.8 degrees Fahrenheit. She reported chills, body aches, and a lot of pain in the left arm. If she tried to move her left arm, the entire muscle in the left arm hurt.  Treatment for the events included acetaminophen and an antihistamine.    Action taken with mRNA-1273 in response to the events was withdrawn.   The events, choking, flushing, vision blurred, were considered resolved on 02 Jan 2021. The events, confusional state, emotional disorder, and dizziness, were considered resolved on 03 Jan 2021. The events, body aches, pyrexia, chills, and limb discomfort, were not considered resolved.; Reporter's Comments: This case concerns a 48 year old female patient with medical history of migraines, who experienced a serious unexpected event of Choking, non-serious unexpected events of Flushing, Vision blurred, Dizziness, Confusional state, Emotional disorder, Pain, and Limb discomfort, and non-serious expected events of Pyrexia and Chills. The events of Choking, Flushing, Vision blurred, Dizziness, and Confusional state occurred immediately after administration of their first of two planned doses of mRNA-1273 (Lot number: 025L20A). The event of Emotional disorder occurred on the same day when the patient received mRNA-1273. The events of Pain, Pyrexia, Chills, and Limb discomfort occurred on the next day of mRNA-1273 administration. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: FLUC3
Symptoms: Mouth swelling, Oral discomfort, Tongue discomfort
Clinical narrative: Swelling; Scratcky tongue; Scratchy mouth; This spontaneous case was received on 21-Dec-2020 from nurse via Agency (reference number: SEQW20-05868) and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.   On an unspecified date in 2019, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent, dose, route of administration and anatomical location: not reported) for flu prevention. The batch number was not reported.   On an unspecified date in 2019, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed scratchy tongue, swelling and scratchy mouth.   The outcome of the events was not reported.  The reporter did not provide a causality assessment.  This case as assessed as non-serious.  Company comment: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed scratchy tongue, swelling and scratchy mouth. Causal role of the suspect vaccine is unassessable, due to lack of information regarding temporal relationship, diagnostic findings and corrective treatment.; Sender's Comments: A patient of an unreported age was vaccinated with Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed scratchy tongue, swelling and scratchy mouth. Causal role of the suspect vaccine is unassessable, due to lack of information regarding temporal relationship, diagnostic findings and corrective treatment.
Sex: M
Vaccine: FLUA3
Symptoms: Adverse reaction, Vascular dementia
Clinical narrative: Vascular dementia; Had a reaction; This spontaneous case was received on 06-Jan-2021 from a pharmacist via Health Authority (reference number: SEQW21-00057) with additional information received on the same date (reference number: SEQW21-00058) (being processed together) and concerned an elderly, male patient. At the time of this report, the patient was an 84-year-old.    The patient's medical history and concomitant medications were not reported.    On an unknown date in 2018, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration and anatomical location: not reported) for flu prophylaxis. The batch number was not reported.    On an unspecified date in 2018, unknown amount of time after receiving Fluad (TIV), the patient had a reaction at that point, but the reporter did not know what kind of reaction.   On an unknown date, the patient was diagnosed with vascular dementia that got worse and was now in a nursing home.    The reporter did not provide causality assessment. The reporter stated patient was diagnosed with vascular dementia, but they were not sure if this was related to the vaccine.   At the time of initial reporting on 06-Jan-2021, the patient had not recovered from the event of vascular dementia.   The outcome of event 'adverse reaction' was not reported.   The event of vascular dementia was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 84-year-old male patient experienced adverse reaction unknown amount of time after administration of Fluad (TIV). Vascular dementia was diagnosed on an unknown date. The patient's medical history and concomitant medications were not reported. Causality is unassessable for both events due to low narrative data.; Reporter's Comments: The reporter stated patient was diagnosed with dementia, but they were not sure if this was related to the vaccine.; Sender's Comments: A 84-year-old male patient experienced adverse reaction unknown amount of time after administration of Fluad (TIV). Vascular dementia was diagnosed on an unknown date. The patient's medical history and concomitant medications were not reported. Causality is unassessable for both events due to low narrative data.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing
Clinical narrative: Became flushed from head to toe, rapidly, and became "very hot."
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Lymphadenitis
Clinical narrative: 7 DAYS OF SINSTOMES,PAIN ON IJECTION SITE,SWELLING ON INJECTION SITE PAIN AND SWELLING ON RIGHT ARM PIT (GANGLIOS INFAMATION )
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: Right arm  numbness/tingling. Decreased to  2 fingers after  30 minutes of monitoring.  01/14/2021 starting having sporadic HA until today 01/18/2021.
Age: 45.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Excruciating pain (9 on scale of 0-10; unable to move arm), chills, low fever (94 degrees F). Pain started a few hours after injection and continued for approximately 24 hours unabated, after which pain subsided somewhat. For the next 24 hours pain was still extreme (8 on scale of 0-10) though the range of motion in my arm increase a bit. After approximately 48 hours pain was dramatically reduced, and by day 3 I was near 100%. The magnitude of pain (9 out of 10) is why I thought it would be useful to report the event. The pharmacist said I should expect a lot of pain, but a complete in ability to move my arm due to searing pain seemed exceptional. The pain was so intense it caused dizziness and nausea as well.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hemianopia, Impaired work ability, Ophthalmological examination, Vision blurred
Clinical narrative: Pt. C/O blurred vision peripherally in both eyes. She denied Hx of migraines, did not have any headache. No other symptoms
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Erythema, Fatigue
Clinical narrative: 1/8/21 DURING DAY: FATIGUE AND HEADACHE STARTED; DURING EVENINGS: CHILLS, BODYACHES, JOINT PAIN, SORE THROAT, AND FEVER (100.9 WHILE ON EXTRA STRENGTH TYLENOL). SATURDAY MORNING: RED, HOT, WELT (ITCHY AT TIMES) AND STOMACH ISSUES. TOOK ADVIL AND EXTRA STRENGTH TYLENOL.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia, Urticaria
Clinical narrative: 1/8/21 DURING DAY: FATIGUE AND HEADACHE STARTED; DURING EVENINGS: CHILLS, BODYACHES, JOINT PAIN, SORE THROAT, AND FEVER (100.9 WHILE ON EXTRA STRENGTH TYLENOL). SATURDAY MORNING: RED, HOT, WELT (ITCHY AT TIMES) AND STOMACH ISSUES. TOOK ADVIL AND EXTRA STRENGTH TYLENOL.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. states she has had swelling, itching  and redness around injection site.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Dizziness, Dysgeusia
Clinical narrative: Within minutes of receiving the injection, I developed a metallic taste in my mouth. I also felt a bit light-headed and woozy. I informed the staff at the site that I felt this way and they asked me to remain for additional monitoring. Over the next 15 minutes, my tongue began to swell. 15 minutes later my jaw began to stiffen and I had difficulty swallowing. After another 15 minutes the staff asked the EMS personnel to screen me and check my vitals. All were normal. After another 30 minutes of monitoring by EMS the symptoms began to subside and I went home.   At home, I began to feel weak and went to bed. My body began to ache and I took ibuprofen to ease the pain. Within 15 hours of receiving the dose, I had a 100.9-degree fever and chills. The fever lasted the next day. I could not get out of bed for the next day. When I tried to sit up and watch TV I had back pain so severe it left me in tears.  I went back to bed and stayed there until the following morning. All told, I could not get out of bed for 36 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Joint stiffness, Mobility decreased, Pain, Pyrexia
Clinical narrative: Within minutes of receiving the injection, I developed a metallic taste in my mouth. I also felt a bit light-headed and woozy. I informed the staff at the site that I felt this way and they asked me to remain for additional monitoring. Over the next 15 minutes, my tongue began to swell. 15 minutes later my jaw began to stiffen and I had difficulty swallowing. After another 15 minutes the staff asked the EMS personnel to screen me and check my vitals. All were normal. After another 30 minutes of monitoring by EMS the symptoms began to subside and I went home.   At home, I began to feel weak and went to bed. My body began to ache and I took ibuprofen to ease the pain. Within 15 hours of receiving the dose, I had a 100.9-degree fever and chills. The fever lasted the next day. I could not get out of bed for the next day. When I tried to sit up and watch TV I had back pain so severe it left me in tears.  I went back to bed and stayed there until the following morning. All told, I could not get out of bed for 36 hours.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Within minutes of receiving the injection, I developed a metallic taste in my mouth. I also felt a bit light-headed and woozy. I informed the staff at the site that I felt this way and they asked me to remain for additional monitoring. Over the next 15 minutes, my tongue began to swell. 15 minutes later my jaw began to stiffen and I had difficulty swallowing. After another 15 minutes the staff asked the EMS personnel to screen me and check my vitals. All were normal. After another 30 minutes of monitoring by EMS the symptoms began to subside and I went home.   At home, I began to feel weak and went to bed. My body began to ache and I took ibuprofen to ease the pain. Within 15 hours of receiving the dose, I had a 100.9-degree fever and chills. The fever lasted the next day. I could not get out of bed for the next day. When I tried to sit up and watch TV I had back pain so severe it left me in tears.  I went back to bed and stayed there until the following morning. All told, I could not get out of bed for 36 hours.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red Bull?s eye erythemic area ~ 8cm x 4cm; initial warmth & swelling, noted on day 9.  Erythema & warmth continues with mild itching.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Left armpit lymph node pain and swelling
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Developed Covid on 12/24.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Moderna