chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Nausea, SARS-CoV-2 test positive, Vaccine breakthrough infection, Visual impairment
Clinical narrative: 11/19/21:  presented to ED three days after discharge from a 5 day stay at local Hospital for COVID PNA and acute PE.  Presented with complaints of increased SOB, productive cough with yellow sputum, weakness, and fatigue.  Lactic acid 2.5, BNP 3440, glucose 332, troponin peak 0.122, CXR bilateral pneumonia suspicious for ongoing COVID PNA and hospital acquired bacterial PNA.  Admitted for acute hypoxemic respiratory failure, bilateral HAI PNA, ongoing COVID PNA, severe sepsis, acute decompensated CHF, and hyperglycemia.  Started on IV vanco, IV cefepime, vitamin cocktail, IV decadron, baricitinib, bumex PO, and insulin SS. 11/23/21:  Discharged home with family support and new oxygen 2L NC at night and with activity.  Sat 93% on RA at rest, 86% on RA with activity.  Remained afebrile during stay. 11/24/21:  post discharge follow up patient denied any issues
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 11/19/21:  presented to ED three days after discharge from a 5 day stay at local Hospital for COVID PNA and acute PE.  Presented with complaints of increased SOB, productive cough with yellow sputum, weakness, and fatigue.  Lactic acid 2.5, BNP 3440, glucose 332, troponin peak 0.122, CXR bilateral pneumonia suspicious for ongoing COVID PNA and hospital acquired bacterial PNA.  Admitted for acute hypoxemic respiratory failure, bilateral HAI PNA, ongoing COVID PNA, severe sepsis, acute decompensated CHF, and hyperglycemia.  Started on IV vanco, IV cefepime, vitamin cocktail, IV decadron, baricitinib, bumex PO, and insulin SS. 11/23/21:  Discharged home with family support and new oxygen 2L NC at night and with activity.  Sat 93% on RA at rest, 86% on RA with activity.  Remained afebrile during stay. 11/24/21:  post discharge follow up patient denied any issues
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Asthenia, Blood glucose increased, Blood lactic acid, Brain natriuretic peptide increased
Clinical narrative: 11/19/21:  presented to ED three days after discharge from a 5 day stay at local Hospital for COVID PNA and acute PE.  Presented with complaints of increased SOB, productive cough with yellow sputum, weakness, and fatigue.  Lactic acid 2.5, BNP 3440, glucose 332, troponin peak 0.122, CXR bilateral pneumonia suspicious for ongoing COVID PNA and hospital acquired bacterial PNA.  Admitted for acute hypoxemic respiratory failure, bilateral HAI PNA, ongoing COVID PNA, severe sepsis, acute decompensated CHF, and hyperglycemia.  Started on IV vanco, IV cefepime, vitamin cocktail, IV decadron, baricitinib, bumex PO, and insulin SS. 11/23/21:  Discharged home with family support and new oxygen 2L NC at night and with activity.  Sat 93% on RA at rest, 86% on RA with activity.  Remained afebrile during stay. 11/24/21:  post discharge follow up patient denied any issues
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, Cardiac failure congestive, Chest X-ray abnormal, Dyspnoea, Fatigue
Clinical narrative: 11/19/21:  presented to ED three days after discharge from a 5 day stay at local Hospital for COVID PNA and acute PE.  Presented with complaints of increased SOB, productive cough with yellow sputum, weakness, and fatigue.  Lactic acid 2.5, BNP 3440, glucose 332, troponin peak 0.122, CXR bilateral pneumonia suspicious for ongoing COVID PNA and hospital acquired bacterial PNA.  Admitted for acute hypoxemic respiratory failure, bilateral HAI PNA, ongoing COVID PNA, severe sepsis, acute decompensated CHF, and hyperglycemia.  Started on IV vanco, IV cefepime, vitamin cocktail, IV decadron, baricitinib, bumex PO, and insulin SS. 11/23/21:  Discharged home with family support and new oxygen 2L NC at night and with activity.  Sat 93% on RA at rest, 86% on RA with activity.  Remained afebrile during stay. 11/24/21:  post discharge follow up patient denied any issues
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperglycaemia, Pneumonia, Pneumonia bacterial, Productive cough, Pulmonary embolism
Clinical narrative: 11/19/21:  presented to ED three days after discharge from a 5 day stay at local Hospital for COVID PNA and acute PE.  Presented with complaints of increased SOB, productive cough with yellow sputum, weakness, and fatigue.  Lactic acid 2.5, BNP 3440, glucose 332, troponin peak 0.122, CXR bilateral pneumonia suspicious for ongoing COVID PNA and hospital acquired bacterial PNA.  Admitted for acute hypoxemic respiratory failure, bilateral HAI PNA, ongoing COVID PNA, severe sepsis, acute decompensated CHF, and hyperglycemia.  Started on IV vanco, IV cefepime, vitamin cocktail, IV decadron, baricitinib, bumex PO, and insulin SS. 11/23/21:  Discharged home with family support and new oxygen 2L NC at night and with activity.  Sat 93% on RA at rest, 86% on RA with activity.  Remained afebrile during stay. 11/24/21:  post discharge follow up patient denied any issues
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sepsis, Sputum discoloured, Troponin
Clinical narrative: 11/19/21:  presented to ED three days after discharge from a 5 day stay at local Hospital for COVID PNA and acute PE.  Presented with complaints of increased SOB, productive cough with yellow sputum, weakness, and fatigue.  Lactic acid 2.5, BNP 3440, glucose 332, troponin peak 0.122, CXR bilateral pneumonia suspicious for ongoing COVID PNA and hospital acquired bacterial PNA.  Admitted for acute hypoxemic respiratory failure, bilateral HAI PNA, ongoing COVID PNA, severe sepsis, acute decompensated CHF, and hyperglycemia.  Started on IV vanco, IV cefepime, vitamin cocktail, IV decadron, baricitinib, bumex PO, and insulin SS. 11/23/21:  Discharged home with family support and new oxygen 2L NC at night and with activity.  Sat 93% on RA at rest, 86% on RA with activity.  Remained afebrile during stay. 11/24/21:  post discharge follow up patient denied any issues
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infection, Neck pain
Clinical narrative: Severe pain/pressure developed along my left sternocleidomastoid within 2 hours of getting vaccine, followed by severe cluster headaches that were intermittent in nature for the following days. 3 days after, along with continued previous symptoms, I developed numbness and tingling across my face and some blurred vision.  This resolved by day 5 post vaccine but on day 7, I had sudden lower leg weakness (along with continued headaches, pain and stiffness/swelling to left shoulder/ collarbone, neck region. I went to a Urgent Care 11/10/2021 and was referred to a Emergency Room. I went to a ER the following evening and was told my blood work was normal and was ?outside the window? for a serious event from the vaccine but had notable swelling on left side and was recommended ?massage? and rest.   Swelling / pain and headaches continued along with lessening mobility to left arm due to pain. I called a teledoc 11/16/2021 to ask for steroids to help with swelling while I reached out to my doctor. Two days later, I started with a petechial rash on my abdomen and sporadic bruising throughout my legs. One week later- 11/19/2021, I returned to the ER due to worsening headaches, pain and difficulty swallowing. CT was negative, WBC was elevated and was told I had a soft tissue infection from the vaccine. I was started on Bactrim and continue Prednisone, along with RX Norco for pain and to follow up with my PCP. I saw my PCP 11/24/2021 and dx with toxic reaction from the vaccine, with continued antibiotics/ steroids and pain management and follow up labs in two weeks. Labs were done last week, results reported today 12/15/2021 and appear benign. However, being off antibiotics and steroids for almost a week- the severe pain has returned to my neck along with cluster headaches. I am awaiting my doctor to return my call for further orders. I have not been able to work for this period.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Cluster headache, Contusion, Dysphagia, Hypoaesthesia
Clinical narrative: Severe pain/pressure developed along my left sternocleidomastoid within 2 hours of getting vaccine, followed by severe cluster headaches that were intermittent in nature for the following days. 3 days after, along with continued previous symptoms, I developed numbness and tingling across my face and some blurred vision.  This resolved by day 5 post vaccine but on day 7, I had sudden lower leg weakness (along with continued headaches, pain and stiffness/swelling to left shoulder/ collarbone, neck region. I went to a Urgent Care 11/10/2021 and was referred to a Emergency Room. I went to a ER the following evening and was told my blood work was normal and was ?outside the window? for a serious event from the vaccine but had notable swelling on left side and was recommended ?massage? and rest.   Swelling / pain and headaches continued along with lessening mobility to left arm due to pain. I called a teledoc 11/16/2021 to ask for steroids to help with swelling while I reached out to my doctor. Two days later, I started with a petechial rash on my abdomen and sporadic bruising throughout my legs. One week later- 11/19/2021, I returned to the ER due to worsening headaches, pain and difficulty swallowing. CT was negative, WBC was elevated and was told I had a soft tissue infection from the vaccine. I was started on Bactrim and continue Prednisone, along with RX Norco for pain and to follow up with my PCP. I saw my PCP 11/24/2021 and dx with toxic reaction from the vaccine, with continued antibiotics/ steroids and pain management and follow up labs in two weeks. Labs were done last week, results reported today 12/15/2021 and appear benign. However, being off antibiotics and steroids for almost a week- the severe pain has returned to my neck along with cluster headaches. I am awaiting my doctor to return my call for further orders. I have not been able to work for this period.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Muscular weakness, Musculoskeletal stiffness, Paraesthesia, Petechiae
Clinical narrative: Severe pain/pressure developed along my left sternocleidomastoid within 2 hours of getting vaccine, followed by severe cluster headaches that were intermittent in nature for the following days. 3 days after, along with continued previous symptoms, I developed numbness and tingling across my face and some blurred vision.  This resolved by day 5 post vaccine but on day 7, I had sudden lower leg weakness (along with continued headaches, pain and stiffness/swelling to left shoulder/ collarbone, neck region. I went to a Urgent Care 11/10/2021 and was referred to a Emergency Room. I went to a ER the following evening and was told my blood work was normal and was ?outside the window? for a serious event from the vaccine but had notable swelling on left side and was recommended ?massage? and rest.   Swelling / pain and headaches continued along with lessening mobility to left arm due to pain. I called a teledoc 11/16/2021 to ask for steroids to help with swelling while I reached out to my doctor. Two days later, I started with a petechial rash on my abdomen and sporadic bruising throughout my legs. One week later- 11/19/2021, I returned to the ER due to worsening headaches, pain and difficulty swallowing. CT was negative, WBC was elevated and was told I had a soft tissue infection from the vaccine. I was started on Bactrim and continue Prednisone, along with RX Norco for pain and to follow up with my PCP. I saw my PCP 11/24/2021 and dx with toxic reaction from the vaccine, with continued antibiotics/ steroids and pain management and follow up labs in two weeks. Labs were done last week, results reported today 12/15/2021 and appear benign. However, being off antibiotics and steroids for almost a week- the severe pain has returned to my neck along with cluster headaches. I am awaiting my doctor to return my call for further orders. I have not been able to work for this period.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, Vision blurred, White blood cell count increased
Clinical narrative: Severe pain/pressure developed along my left sternocleidomastoid within 2 hours of getting vaccine, followed by severe cluster headaches that were intermittent in nature for the following days. 3 days after, along with continued previous symptoms, I developed numbness and tingling across my face and some blurred vision.  This resolved by day 5 post vaccine but on day 7, I had sudden lower leg weakness (along with continued headaches, pain and stiffness/swelling to left shoulder/ collarbone, neck region. I went to a Urgent Care 11/10/2021 and was referred to a Emergency Room. I went to a ER the following evening and was told my blood work was normal and was ?outside the window? for a serious event from the vaccine but had notable swelling on left side and was recommended ?massage? and rest.   Swelling / pain and headaches continued along with lessening mobility to left arm due to pain. I called a teledoc 11/16/2021 to ask for steroids to help with swelling while I reached out to my doctor. Two days later, I started with a petechial rash on my abdomen and sporadic bruising throughout my legs. One week later- 11/19/2021, I returned to the ER due to worsening headaches, pain and difficulty swallowing. CT was negative, WBC was elevated and was told I had a soft tissue infection from the vaccine. I was started on Bactrim and continue Prednisone, along with RX Norco for pain and to follow up with my PCP. I saw my PCP 11/24/2021 and dx with toxic reaction from the vaccine, with continued antibiotics/ steroids and pain management and follow up labs in two weeks. Labs were done last week, results reported today 12/15/2021 and appear benign. However, being off antibiotics and steroids for almost a week- the severe pain has returned to my neck along with cluster headaches. I am awaiting my doctor to return my call for further orders. I have not been able to work for this period.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Anal incontinence, Condition aggravated, Dehydration, Diarrhoea
Clinical narrative: dose received: 3; Fainting (3 times in 10 minutes); collapse; bowel incontinence; low blood pressure (105/63); short-term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Oct2021 10:00 (Lot number: FG3527) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; CARVEDILOL; AFLURIA QUADRIVALENT, administration date 05Oct2021. Also reported received "Atorv". Vaccination history included: Bnt162b2 (brand=Pfizer, lot number: EW0176, administration date: 29Apr2021, dose number: 2, Vaccine location: Right arm), administration date: 29Apr2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (brand=Pfizer, lot number: ER8734, administration date: 01Apr2021, dose number: 1, Vaccine location: Right arm), administration date: 01Apr2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose received: 3"; SYNCOPE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "Fainting (3 times in 10 minutes)"; CIRCULATORY COLLAPSE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "collapse"; ANAL INCONTINENCE (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "bowel incontinence"; HYPOTENSION (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "low blood pressure (105/63)"; AMNESIA (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "short-term memory loss". The events "fainting (3 times in 10 minutes)", "collapse", "bowel incontinence", "low blood pressure (105/63)" and "short-term memory loss" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; chest x-ray: (2021) unknown results; computerised tomogram: (2021) unknown results; electrocardiogram: (2021) unknown results; hypotension: (31Oct2021) low; (31Oct2021) 105/63. Therapeutic measures were taken as a result of syncope, circulatory collapse, anal incontinence, hypotension, amnesia.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Fear, Injection site pain, Muscular weakness, Speech disorder
Clinical narrative: dose received: 3; Fainting (3 times in 10 minutes); collapse; bowel incontinence; low blood pressure (105/63); short-term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Oct2021 10:00 (Lot number: FG3527) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; CARVEDILOL; AFLURIA QUADRIVALENT, administration date 05Oct2021. Also reported received "Atorv". Vaccination history included: Bnt162b2 (brand=Pfizer, lot number: EW0176, administration date: 29Apr2021, dose number: 2, Vaccine location: Right arm), administration date: 29Apr2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (brand=Pfizer, lot number: ER8734, administration date: 01Apr2021, dose number: 1, Vaccine location: Right arm), administration date: 01Apr2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose received: 3"; SYNCOPE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "Fainting (3 times in 10 minutes)"; CIRCULATORY COLLAPSE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "collapse"; ANAL INCONTINENCE (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "bowel incontinence"; HYPOTENSION (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "low blood pressure (105/63)"; AMNESIA (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "short-term memory loss". The events "fainting (3 times in 10 minutes)", "collapse", "bowel incontinence", "low blood pressure (105/63)" and "short-term memory loss" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; chest x-ray: (2021) unknown results; computerised tomogram: (2021) unknown results; electrocardiogram: (2021) unknown results; hypotension: (31Oct2021) low; (31Oct2021) 105/63. Therapeutic measures were taken as a result of syncope, circulatory collapse, anal incontinence, hypotension, amnesia.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: dose received: 3; Fainting (3 times in 10 minutes); collapse; bowel incontinence; low blood pressure (105/63); short-term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Oct2021 10:00 (Lot number: FG3527) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; CARVEDILOL; AFLURIA QUADRIVALENT, administration date 05Oct2021. Also reported received "Atorv". Vaccination history included: Bnt162b2 (brand=Pfizer, lot number: EW0176, administration date: 29Apr2021, dose number: 2, Vaccine location: Right arm), administration date: 29Apr2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (brand=Pfizer, lot number: ER8734, administration date: 01Apr2021, dose number: 1, Vaccine location: Right arm), administration date: 01Apr2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose received: 3"; SYNCOPE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "Fainting (3 times in 10 minutes)"; CIRCULATORY COLLAPSE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "collapse"; ANAL INCONTINENCE (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "bowel incontinence"; HYPOTENSION (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "low blood pressure (105/63)"; AMNESIA (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "short-term memory loss". The events "fainting (3 times in 10 minutes)", "collapse", "bowel incontinence", "low blood pressure (105/63)" and "short-term memory loss" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; chest x-ray: (2021) unknown results; computerised tomogram: (2021) unknown results; electrocardiogram: (2021) unknown results; hypotension: (31Oct2021) low; (31Oct2021) 105/63. Therapeutic measures were taken as a result of syncope, circulatory collapse, anal incontinence, hypotension, amnesia.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Anal incontinence, Blood test, Chest X-ray, Circulatory collapse
Clinical narrative: dose received: 3; Fainting (3 times in 10 minutes); collapse; bowel incontinence; low blood pressure (105/63); short-term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Oct2021 10:00 (Lot number: FG3527) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; CARVEDILOL; AFLURIA QUADRIVALENT, administration date 05Oct2021. Also reported received "Atorv". Vaccination history included: Bnt162b2 (brand=Pfizer, lot number: EW0176, administration date: 29Apr2021, dose number: 2, Vaccine location: Right arm), administration date: 29Apr2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (brand=Pfizer, lot number: ER8734, administration date: 01Apr2021, dose number: 1, Vaccine location: Right arm), administration date: 01Apr2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose received: 3"; SYNCOPE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "Fainting (3 times in 10 minutes)"; CIRCULATORY COLLAPSE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "collapse"; ANAL INCONTINENCE (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "bowel incontinence"; HYPOTENSION (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "low blood pressure (105/63)"; AMNESIA (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "short-term memory loss". The events "fainting (3 times in 10 minutes)", "collapse", "bowel incontinence", "low blood pressure (105/63)" and "short-term memory loss" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; chest x-ray: (2021) unknown results; computerised tomogram: (2021) unknown results; electrocardiogram: (2021) unknown results; hypotension: (31Oct2021) low; (31Oct2021) 105/63. Therapeutic measures were taken as a result of syncope, circulatory collapse, anal incontinence, hypotension, amnesia.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Hypotension, Immunisation, Syncope
Clinical narrative: dose received: 3; Fainting (3 times in 10 minutes); collapse; bowel incontinence; low blood pressure (105/63); short-term memory loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Oct2021 10:00 (Lot number: FG3527) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing), notes: Other medical history: obesity; "hypertension" (unspecified if ongoing), notes: Other medical history: hypertension. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Concomitant medication(s) included: LISINOPRIL; HYDROCHLOROTHIAZIDE; CARVEDILOL; AFLURIA QUADRIVALENT, administration date 05Oct2021. Also reported received "Atorv". Vaccination history included: Bnt162b2 (brand=Pfizer, lot number: EW0176, administration date: 29Apr2021, dose number: 2, Vaccine location: Right arm), administration date: 29Apr2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (brand=Pfizer, lot number: ER8734, administration date: 01Apr2021, dose number: 1, Vaccine location: Right arm), administration date: 01Apr2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "dose received: 3"; SYNCOPE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "Fainting (3 times in 10 minutes)"; CIRCULATORY COLLAPSE (medically significant) with onset 31Oct2021 20:00, outcome "recovered", described as "collapse"; ANAL INCONTINENCE (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "bowel incontinence"; HYPOTENSION (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "low blood pressure (105/63)"; AMNESIA (non-serious) with onset 31Oct2021 20:00, outcome "recovered", described as "short-term memory loss". The events "fainting (3 times in 10 minutes)", "collapse", "bowel incontinence", "low blood pressure (105/63)" and "short-term memory loss" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown results; chest x-ray: (2021) unknown results; computerised tomogram: (2021) unknown results; electrocardiogram: (2021) unknown results; hypotension: (31Oct2021) low; (31Oct2021) 105/63. Therapeutic measures were taken as a result of syncope, circulatory collapse, anal incontinence, hypotension, amnesia.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, Chest pain, Echocardiogram normal, Electrocardiogram normal, Troponin increased
Clinical narrative: Chest pain started on the evening of December 5. 6PM after eating.,  substernal Chest Pain, worse with inspiration - started as 4/10 and worsened to 7/10. Did not take medication.  Did go to sleep that night but woke up early morning by the pain and went to the Emergency Room at Hospital in the early morning on December 6.  He was admitted becaue lab tests ( troponin and BNP were elevated  and stayed for one night and discharged Dec 7 feeling better.and with improving labs.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, C-reactive protein normal, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Chest pain started on the evening of December 5. 6PM after eating.,  substernal Chest Pain, worse with inspiration - started as 4/10 and worsened to 7/10. Did not take medication.  Did go to sleep that night but woke up early morning by the pain and went to the Emergency Room at Hospital in the early morning on December 6.  He was admitted becaue lab tests ( troponin and BNP were elevated  and stayed for one night and discharged Dec 7 feeling better.and with improving labs.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Painful respiration, Troponin increased
Clinical narrative: Chest pain started on the evening of December 5. 6PM after eating.,  substernal Chest Pain, worse with inspiration - started as 4/10 and worsened to 7/10. Did not take medication.  Did go to sleep that night but woke up early morning by the pain and went to the Emergency Room at Hospital in the early morning on December 6.  He was admitted becaue lab tests ( troponin and BNP were elevated  and stayed for one night and discharged Dec 7 feeling better.and with improving labs.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: The child was receiving her second dose of the 5-11 year old Pfizer covid-19 vaccine. Child pulled away from the nurse administering and was not given full dose of 0.2 ml. Nurse attempted to administer remainder of vaccine, but  it was noted that vaccine was on child's arm. Nurse reported unknown amount administered and mother reported child received about 1/2 of the recommended dose. Per CDC guidance, the child came back into the Health Department on 12/13/2021 and received a repeated 0.2 ml dose of vaccine.
Age: 5.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Incorrect dose administered
Clinical narrative: The child was receiving her second dose of the 5-11 year old Pfizer covid-19 vaccine. Child pulled away from the nurse administering and was not given full dose of 0.2 ml. Nurse attempted to administer remainder of vaccine, but  it was noted that vaccine was on child's arm. Nurse reported unknown amount administered and mother reported child received about 1/2 of the recommended dose. Per CDC guidance, the child came back into the Health Department on 12/13/2021 and received a repeated 0.2 ml dose of vaccine.
Age: 34.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC4
Symptoms: Injection site bruising, Injection site pain, Injection site pruritus
Clinical narrative: PATIENT REPORTED INTENSE ITCHING AT THE INJECTION SITE
Age: 34.0
Sex: F
Vaccine: COVID19, FLUC4, COVID19, FLUC4
Symptoms: Injection site pruritus
Clinical narrative: PATIENT REPORTED INTENSE ITCHING AT THE INJECTION SITE
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Patient reported on 12/12/2021 to a review on Google that she experienced SIRVA from the vaccine given by us on 11/20/2021 "limited range of motion and pain of shoulder" "inhibited to use in activities"
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Shoulder injury related to vaccine administration
Clinical narrative: Patient reported on 12/12/2021 to a review on Google that she experienced SIRVA from the vaccine given by us on 11/20/2021 "limited range of motion and pain of shoulder" "inhibited to use in activities"
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Local reaction
Clinical narrative: Moderna Booster on 11/4             - immediate redness and swelling             - now pruritic            - did have small blisters form             - has tried benadryl cream and gold bold healing lotion             - denies fevers, chills.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Immediate post-injection reaction, Pruritus, Swelling
Clinical narrative: Moderna Booster on 11/4             - immediate redness and swelling             - now pruritic            - did have small blisters form             - has tried benadryl cream and gold bold healing lotion             - denies fevers, chills.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: racing heart from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (racing heart from first dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B1A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced PALPITATIONS (racing heart from first dose). On 12-Apr-2021, PALPITATIONS (racing heart from first dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications also included asthma inhaler for Asthma.  No Treatment mediations were reported.; Sender's Comments: This is a spontaneous case concerning a 35-year-old female  patient with concomitant medication of asthma inhaler who experienced unexpected event of palpitations. The event occurred the same day after the first dose of mRNA-1273 vaccine. The event resolved the same day. Asthma inhaler remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My grandson who is only 16 was given the moderns COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My grandson who is only 16 was given the moderns COVID 19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My grandson who is only 16 was given the moderns COVID 19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My grandson who is only 16 was given the moderns COVID 19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was administered expired PROQUAD; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported.  On 18-NOV-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD), lot # T016990, expiration date: 11-NOV-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). It was confirmed that no temperature excursion was reported for the suspect vaccine. There was no additional adverse event (AE) and no product qualitycomplain (PQC).
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's; vaccine that underwent a temperature excursion was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 27-OCT-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe injection, lot # T026324, expiration date 22-FEB-2023, (exact dose, injection site and route of administration were not reported) to prevent human papilloma virus infection, that underwent temperature excursion.  No additional adverse events were reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported.; a patient received her first dose of GARDASIL 9 in 2013 at age 13 years old and her second dose in 2019 at age 17 years old; This spontaneous report was received from a physician and refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On an unknown date in 2013 (at age 13 years old), the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (injection site, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2019 (at age 17 years old), the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (injection site, route of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration).  The reported did not want to provide any patient information. No additional adverse events (AE) were reported.
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 52-year-old male patient. The patient's historical drugs, medical history and concurrent conditions were not reported. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT) 0.5 ml, one time, lot# U001953, expiration date 18-JAN-2023. On 30-NOV-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml one time, lot# N017698, expiration date 09-JUN-2019, for prophylaxis (strength, route and frequency were not reported) (expired product administered). There was no temperature excursion. No other adverse event reported.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: The patient fainted; vomited after receiving 4 vaccines in one day; she had a low grade fever; This spontaneous report was received from a medical assistant via company representative and refers to a 13 years old female patient. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, anatomical location, route of administration, lot# and expiration date were not reported). Concomitant therapies received on the same day included unknown influenza vaccine, unknown tetanus vaccine and unknown meningitis vaccine (exact dose, anatomical location, route of administration, lot# and expiration date were not reported for all vaccines). On the same day, while she was still in the clinic, she fainted and vomited. The outcome of the event was unknown. The causality assessment between the events and the suspect therapy was not provided.  Upon internal review, the event of "fainted" was determined to be medically significant.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No additional AE reported; first dose in September 2021, second dose in November 2021, and third dose today; This spontaneous report was received from a physician referring to a 39-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On an unspecified date in September 2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).   On an unspecified date in November 2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).   On an unspecified date in December 2021, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 mL for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported). No additional adverse event (AE) was reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: inadvertent administration of Gardasil 9 to a pregnant patient instead of TDap vaccine; no additional adverse events reported; inadvertent administration of Gardasil 9 to a pregnant patient instead of TDap vaccine; This spontaneous prospective pregnancy report was received from a physician via a company representative referring to a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2021, the patient became pregnant. The last menstrual period (LMP) was on an unknown date in 2021; the estimated delivery date (EDD) was not known. The pregnancy outcome was pending.  On 09-DEC-2021, the patient was inadvertent vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, location, lot# and expiration date were not reported) for prophylaxis instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid(TDAP). No additional adverse event details were reported. No product quality complaint was involved.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Pyrexia
Clinical narrative: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) both have the same ingredient of "varicella virus vaccine live", were administered on the same day; Fever of 103F; This spontaneous report was received from a medical assistant referring to currently 12-months-old female patient.  The patient's current condition, medical history, drug reactions, allergies and concomitant therapies were not provided.    On 07-DEC-2021 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 1 dosage form (lot # T032144 and expiration date provided as 20-MAR-2022) and varicella virus vaccine live (oka/merck)(VARIVAX), 1 dosage form (lot # U015689 and expiration date provided as 18-MAY-2023) for prophylaxis on same day (Overdose). On same day HAVRIX and PREVNAR 13 were administered.  On 10-DEC-2021, the patient experienced a fever of 103F.   The outcome and causality assessment of pyrexia was not provided.
Age: 0.75
Sex: F
Vaccine: FLUN4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A spontaneous report has been received from a health professional. The report concerns a female patient of Native American ethnic origin (age 8 months). No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown No concomitant products were reported. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number NH2013) (expiration date DEC-2021) once/single administration, via nasal route, on 10-NOV-2021. No malfunction has been reported for FLUMIST QUADRIVALENT. The report described a medication error for Flumist Quadrivalent. The reported term was medicated was given to patient under the age of 2 (Preferred term: Product administered to patient of inappropriate age). The outcome of the event was unknown. The event was considered non-serious. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): medicated was given to patient under the age of 2. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): medicated was given to patient under the age of 2. Device Information:  Combination Product Report: Yes Product As Reported: FLUMIST QUADRIVALENT Common Device Name: Nasal Spray Procode: CCQ  Product Role: Suspect.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via(Facebook)interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. The reporter considered the injection site pain to be related to Shingles vaccine. Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient mentioned that, shingles vaccine hurts. The follow up would not possible as no contact information was available. For tolerance of second dose refer linked case US2021AMR251010, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR251010:same patient/ different dose.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Malaise, Pain, Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: put me flat on my back/not feeling well; chills; pins and needle in face; still ache; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine (received on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced malaise, chills, pins and needles and pain. The patient was treated with ibuprofen (Advil) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the malaise, chills and pins and needles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the malaise, chills, pins and needles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced such bad reaction worse than the COVID vaccine, put him/her flat on his/her back, chills, pins and needles in his/her face and still ache but not feeling well. The patient stated that Benadryl and Advil took care of that. The patient got tested twice to make sure it was not COVID negative both times. The patient asked did anyone else had a reation to a Shingles vaccine. The patient scared to get it. Still have to get his/her booster dose but there was so much different information on how long to wait after COVID. No further information reported.