chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder dilatation, Blood alkaline phosphatase increased, Blood glucose normal, Blood magnesium normal, Blood phosphorus normal
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Blood sodium decreased, Bordetella test negative, COVID-19, Cerebral atrophy, Chest X-ray abnormal
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chlamydia test negative, Clostridium difficile infection, Colectomy, Computerised tomogram abdomen, Computerised tomogram head abnormal
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test negative, Cough, Diarrhoea, Electrocardiogram normal, Enterovirus test negative
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured, Fall, Feeding disorder, Full blood count normal, Human metapneumovirus test
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Human rhinovirus test, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Intestinal anastomosis
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Metabolic function test, Mycoplasma test negative, Nausea, Nephrolithiasis
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Osteoma, Pneumobilia, Respiratory syncytial virus test negative, Retching, SARS-CoV-2 test positive
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Scan with contrast, Spinal compression fracture, Urine analysis normal, Vomiting
Clinical narrative: Patient is a 80 y.o. male with past medical history significant for type 1 diabetes mellitus, with insulin pump, dumping syndrome, prior TIA, history of ampullary cancer, who presents to the emergency department today for evaluation of generalized weakness, multiple falls at home, and intractable nausea, vomiting.  He was recently admitted to the emergency department observation unit for similar symptoms, was found to have C difficile, and has since completed 10 days of oral vancomycin.   Since completing antibiotics, he reports significant improvement in diarrhea, but still having some. He reports dark brown bowel movements, denies tarry black stools or hematochezia.  He reports severe nausea and vomiting to the point of dry heaving.  Has not been able to eat any food over the past 24 hours secondary to this.  He does normally receive biweekly IV fluid infusions, but has required many increased infusions recently due to GI losses.   His nausea and vomiting is worse with palpation of the abdomen and with position changes. He is tender with palpation of his abdomen.  Denies fevers, chills.  He does report slight cough, but no significant dyspnea.  No chest pain. No urinary symptoms.    The patient arrived in the emergency department hemodynamically stable, afebrile and non-hypoxic on room air. CBC was unremarkable. CMP was remarkable for Na 133, glucose 119, alk phos 153. Mag and phos were normal. hstnt baseline 16, hstnt 2hr 15 (delta - 1).  The patient denies chest pain.  UA was unremarkable.  EKG was obtained and independently reviewed, with normal sinus rhythm, rate 83, QTC 415, no ischemic changes.  Chest x-ray was independently reviewed, with persistent right upper lobe opacity, similar apical scarring to past CXRs. CT head was independently reviewed, with mild intracranial volume loss and chronic small-vessel changes.  The patient was given 1 L normal saline, 4 mg IV Zofran.  The patient was admitted to the hospitalist service for further workup and management.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myocarditis
Clinical narrative: headache myocarditis
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Chest pain, Cough, Diarrhoea
Clinical narrative: History and physical obtained using telehealth technology with the assistance of the bedside nurse.   a 72 y.o. male  who presents to hospital. The patient states that he developed shortness of breath, coughing and fevers. The symptoms started about 10 days ago. It all started with sore throat and then symptoms progressively worsened with nasal discharge and burning feeling in his lungs. + slight fever in the first 4 days which progressively worsened. Highest was 103.7. No vomiting. + nausea but only with severe coughing spells. + diarrhea x 2 days. No black or bloody stools that he knows of recently. However, about 3 weeks ago he had some blood stools but does have hemorrhoids.    He came in today because the triage nurse convinced him to come in when he was scheduling his wife for COVID testing. His SOB was not severe, he was able to walk out to the mailbox.    He was vaccinated back in febrauary/march x 2 vaccinations.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haematochezia, Haemorrhoids, Lung consolidation, Lung infiltration
Clinical narrative: History and physical obtained using telehealth technology with the assistance of the bedside nurse.   a 72 y.o. male  who presents to hospital. The patient states that he developed shortness of breath, coughing and fevers. The symptoms started about 10 days ago. It all started with sore throat and then symptoms progressively worsened with nasal discharge and burning feeling in his lungs. + slight fever in the first 4 days which progressively worsened. Highest was 103.7. No vomiting. + nausea but only with severe coughing spells. + diarrhea x 2 days. No black or bloody stools that he knows of recently. However, about 3 weeks ago he had some blood stools but does have hemorrhoids.    He came in today because the triage nurse convinced him to come in when he was scheduling his wife for COVID testing. His SOB was not severe, he was able to walk out to the mailbox.    He was vaccinated back in febrauary/march x 2 vaccinations.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pneumonia, Pyrexia, Rhinorrhoea
Clinical narrative: History and physical obtained using telehealth technology with the assistance of the bedside nurse.   a 72 y.o. male  who presents to hospital. The patient states that he developed shortness of breath, coughing and fevers. The symptoms started about 10 days ago. It all started with sore throat and then symptoms progressively worsened with nasal discharge and burning feeling in his lungs. + slight fever in the first 4 days which progressively worsened. Highest was 103.7. No vomiting. + nausea but only with severe coughing spells. + diarrhea x 2 days. No black or bloody stools that he knows of recently. However, about 3 weeks ago he had some blood stools but does have hemorrhoids.    He came in today because the triage nurse convinced him to come in when he was scheduling his wife for COVID testing. His SOB was not severe, he was able to walk out to the mailbox.    He was vaccinated back in febrauary/march x 2 vaccinations.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: History and physical obtained using telehealth technology with the assistance of the bedside nurse.   a 72 y.o. male  who presents to hospital. The patient states that he developed shortness of breath, coughing and fevers. The symptoms started about 10 days ago. It all started with sore throat and then symptoms progressively worsened with nasal discharge and burning feeling in his lungs. + slight fever in the first 4 days which progressively worsened. Highest was 103.7. No vomiting. + nausea but only with severe coughing spells. + diarrhea x 2 days. No black or bloody stools that he knows of recently. However, about 3 weeks ago he had some blood stools but does have hemorrhoids.    He came in today because the triage nurse convinced him to come in when he was scheduling his wife for COVID testing. His SOB was not severe, he was able to walk out to the mailbox.    He was vaccinated back in febrauary/march x 2 vaccinations.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea, Fibrin D dimer increased, Full blood count, Hypoaesthesia
Clinical narrative: SOB, bilateral hands and feet numbness.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, N-terminal prohormone brain natriuretic peptide, Troponin
Clinical narrative: SOB, bilateral hands and feet numbness.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Caller reports vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  On 01-OCT-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (0.5 mL, lot # U015689 has been verified to be a valid lot number, expiration date was reported as 13-MAY-2023, but upon internal validation it was established as 18-MAY-2023; strength not reported), administered subcutaneously for prophylaxis. It was reported that the vaccine had a temperature excursion and was exposed to 25.9 Fahrenheit for 1 hour and 30 minutes (product storage error), but there was no pervious temperature excursion. No other adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late second dose/ second dose not administered at time of call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 19th September 2019 with batch number 9AB33).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix. In January 2020, the reporter called the patient back to administer the second dose, but she refused to get 2nd dose of Shingrix. The patient never went back to receive the second dose, which led to incomplete course of vaccination. No further details about adverse events were reported at the time of reporting.  The reporter consented to follow up by phone. The VAERS details reported for 1st dose of Shingrix.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an adult female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date in SEP-2021, the patient tested positive for Covid (suspected covid-19 infection), though had vaccinated 3-4 months ago (suspected clinical vaccination failure). Patient had completed a week and a half period of isolation on 03-OCT-2021. The patient stated feeling like hit by a truck after being asked for symptoms and mentioned no hospitalization. The patient was a teacher and likely picked it up at school. The action taken with covid-19 vaccine was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000195910.; Sender's Comments: V0: 20211006359-COVID-19 VACCINE -suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOTS; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. No concomitant medications were reported.  On an unspecified date, it was reported that the reporter's uncle had clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211009238.; Sender's Comments: V0: 20211009150-Covid-19 vaccine ad26.cov2.s -Clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: SWELLING IN ARM; STABBING PAIN IN THE ARM SLIGHTLY LOWER THAN THE INJECTION SITE (MILD IN NATURE); STRESS HEADACHE AT THE TEMPLES; This spontaneous report received from a patient concerned a 22 year old male. The patient's weight was 135 pounds, and height was 72 inches. The patient's concurrent conditions included: non-alcoholic, and non-smoker, and other pre-existing medical conditions included: Patient had no pre existing medical condition and no usage of any medications. No known allergies. No illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, and batch number: 212A21A expiry: UNKNOWN) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced swelling in arm. On 04-OCT-2021, the patient experienced stabbing pain in the arm slightly lower than the injection site (mild in nature). On 04-OCT-2021, the patient experienced stress headache at the temples. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in arm, stabbing pain in the arm slightly lower than the injection site (mild in nature), and stress headache at the temples. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: having strong menstruations lately; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (having strong menstruations lately) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (having strong menstruations lately). At the time of the report, HEAVY MENSTRUAL BLEEDING (having strong menstruations lately) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.   The treatment history was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Non significant follow up received on 27-SEP-2021 and does not contain any new information
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest X-ray, Chest discomfort, Chronic obstructive pulmonary disease, Cough
Clinical narrative: SNEEZING; Chest tightness; COUGH; RUNNY NOSE; PAIN IN THE ARM; COPD; Asthma; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic pain and Non-smoker.    On 27-Jan-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 29-Jul-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ASTHMA (Asthma). On an unknown date, the patient experienced COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH) and PAIN IN EXTREMITY (PAIN IN THE ARM) outcome was unknown and RHINORRHOEA (RUNNY NOSE) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Chest X-ray: asthma and copd (abnormal) she had Asthma and COPD.         Relevant concomitant medications were not reported.   This case was linked to MOD-2021-278377 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received include ethnicity, medical history, treatment medication and newevents added.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: SNEEZING; Chest tightness; COUGH; RUNNY NOSE; PAIN IN THE ARM; COPD; Asthma; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic pain and Non-smoker.    On 27-Jan-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 29-Jul-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and ASTHMA (Asthma). On an unknown date, the patient experienced COUGH (COUGH), RHINORRHOEA (RUNNY NOSE) and PAIN IN EXTREMITY (PAIN IN THE ARM). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ASTHMA (Asthma), COUGH (COUGH) and PAIN IN EXTREMITY (PAIN IN THE ARM) outcome was unknown and RHINORRHOEA (RUNNY NOSE) and HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2021, Chest X-ray: asthma and copd (abnormal) she had Asthma and COPD.         Relevant concomitant medications were not reported.   This case was linked to MOD-2021-278377 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow-up received include ethnicity, medical history, treatment medication and newevents added.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chromaturia, Dyspnoea, Headache, Loss of personal independence in daily activities
Clinical narrative: Could barely talk; husband had to take her to the bathroom; Trouble breathing; Pressure in the chest/Pressure on chest comes and goes; Brown Urine; Could barely move; Itchy Bumps on both legs; Tiny Bumps on both legs; Rash on both legs; Fever 103 F; Vomiting; Severe Nausea; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move) and PRURITUS (Itchy Bumps on both legs) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2021.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache). On 22-Jul-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes). On 17-Sep-2021, the patient experienced SPEECH DISORDER (Could barely talk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SPEECH DISORDER (Could barely talk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Body temperature: 103 (High) High. On 22-Jul-2021, Echocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data included ECG, cardiac test, cardiac enzymes. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-Sep-21: DOB added and age updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: Could barely talk; husband had to take her to the bathroom; Trouble breathing; Pressure in the chest/Pressure on chest comes and goes; Brown Urine; Could barely move; Itchy Bumps on both legs; Tiny Bumps on both legs; Rash on both legs; Fever 103 F; Vomiting; Severe Nausea; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move) and PRURITUS (Itchy Bumps on both legs) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2021.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache). On 22-Jul-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes). On 17-Sep-2021, the patient experienced SPEECH DISORDER (Could barely talk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SPEECH DISORDER (Could barely talk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Body temperature: 103 (High) High. On 22-Jul-2021, Echocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data included ECG, cardiac test, cardiac enzymes. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-Sep-21: DOB added and age updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Speech disorder, Vomiting
Clinical narrative: Could barely talk; husband had to take her to the bathroom; Trouble breathing; Pressure in the chest/Pressure on chest comes and goes; Brown Urine; Could barely move; Itchy Bumps on both legs; Tiny Bumps on both legs; Rash on both legs; Fever 103 F; Vomiting; Severe Nausea; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move) and PRURITUS (Itchy Bumps on both legs) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2021.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache). On 22-Jul-2021, the patient experienced DYSPNOEA (Trouble breathing) and CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes). On 17-Sep-2021, the patient experienced SPEECH DISORDER (Could barely talk) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Trouble breathing), CHEST DISCOMFORT (Pressure in the chest/Pressure on chest comes and goes), CHROMATURIA (Brown Urine), MOBILITY DECREASED (Could barely move), PRURITUS (Itchy Bumps on both legs), SPEECH DISORDER (Could barely talk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (husband had to take her to the bathroom), SKIN MASS (Tiny Bumps on both legs), RASH (Rash on both legs), PYREXIA (Fever 103 F), VOMITING (Vomiting), NAUSEA (Severe Nausea) and HEADACHE (Severe Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, Body temperature: 103 (High) High. On 22-Jul-2021, Echocardiogram: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lab data included ECG, cardiac test, cardiac enzymes. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-Sep-21: DOB added and age updated.
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 29 SEP 2021: contains No New Information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact