chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Dizziness postural, Dyspnoea
Clinical narrative: Narrative:  Admission: 9/23/2021 Discharge 10/11/2021 DISCHARGE DIAGNOSIS: COVID, Atrial Fibrillation 86 yo M with past medical history of essential tremor, restless legs syndrome, CAD, Atrial fibrillation (on apixaban), COPD, HLD, HTN, and Type 2 Diabetes who presented to the Emergency Department for diarrhea, poor po intake, cough, increased SOB, and generalized weakness for the previous 5-7 days and was found to be COVID positive (despite being fully vaccinated with the Pfizer vaccine (April and May) and in Afib with a rapid ventricular rate (RVR). Over the previous few days to a week he was feeling fatigued and dizzy, especially when standing. He felt too weak to walk. He also endorses a productive cough with clear sputum, increased SOB/DOE, decreased appetite, and intermittent diarrhea. He had been experiencing intermittent R sided chest pressure and palpitations as well. He had been around his son who tested positive for COVID one week ago. Patient initially had to be admitted to the ICU for Afib with RVR in the setting of a COVID infection. CXR without signs of active COVID Pneumonia. Initially satting well on room air, though placed on 2L NC intermittently. He was eventually discharged in stable condition. Symptoms:  & HOSPITALIZATION FOR COVID DESPITE FULL VACCINATON X 2 Treatment:  CASIRIVIMAB/IMDEVIMAB (EUA) 1200 MG ONCE
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Exposure to SARS-CoV-2, Fatigue, Gait disturbance, Hypophagia
Clinical narrative: Narrative:  Admission: 9/23/2021 Discharge 10/11/2021 DISCHARGE DIAGNOSIS: COVID, Atrial Fibrillation 86 yo M with past medical history of essential tremor, restless legs syndrome, CAD, Atrial fibrillation (on apixaban), COPD, HLD, HTN, and Type 2 Diabetes who presented to the Emergency Department for diarrhea, poor po intake, cough, increased SOB, and generalized weakness for the previous 5-7 days and was found to be COVID positive (despite being fully vaccinated with the Pfizer vaccine (April and May) and in Afib with a rapid ventricular rate (RVR). Over the previous few days to a week he was feeling fatigued and dizzy, especially when standing. He felt too weak to walk. He also endorses a productive cough with clear sputum, increased SOB/DOE, decreased appetite, and intermittent diarrhea. He had been experiencing intermittent R sided chest pressure and palpitations as well. He had been around his son who tested positive for COVID one week ago. Patient initially had to be admitted to the ICU for Afib with RVR in the setting of a COVID infection. CXR without signs of active COVID Pneumonia. Initially satting well on room air, though placed on 2L NC intermittently. He was eventually discharged in stable condition. Symptoms:  & HOSPITALIZATION FOR COVID DESPITE FULL VACCINATON X 2 Treatment:  CASIRIVIMAB/IMDEVIMAB (EUA) 1200 MG ONCE
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Palpitations, Productive cough, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Admission: 9/23/2021 Discharge 10/11/2021 DISCHARGE DIAGNOSIS: COVID, Atrial Fibrillation 86 yo M with past medical history of essential tremor, restless legs syndrome, CAD, Atrial fibrillation (on apixaban), COPD, HLD, HTN, and Type 2 Diabetes who presented to the Emergency Department for diarrhea, poor po intake, cough, increased SOB, and generalized weakness for the previous 5-7 days and was found to be COVID positive (despite being fully vaccinated with the Pfizer vaccine (April and May) and in Afib with a rapid ventricular rate (RVR). Over the previous few days to a week he was feeling fatigued and dizzy, especially when standing. He felt too weak to walk. He also endorses a productive cough with clear sputum, increased SOB/DOE, decreased appetite, and intermittent diarrhea. He had been experiencing intermittent R sided chest pressure and palpitations as well. He had been around his son who tested positive for COVID one week ago. Patient initially had to be admitted to the ICU for Afib with RVR in the setting of a COVID infection. CXR without signs of active COVID Pneumonia. Initially satting well on room air, though placed on 2L NC intermittently. He was eventually discharged in stable condition. Symptoms:  & HOSPITALIZATION FOR COVID DESPITE FULL VACCINATON X 2 Treatment:  CASIRIVIMAB/IMDEVIMAB (EUA) 1200 MG ONCE
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Pt received two doses of pfizer/biontec vaccination in Jan/Feb2021, contracted COVID-19 on 10/12/2021. LAB RESULTS: Date Test Name Result 10/12/2021@02:15 COVID-19 PCR DETECTED 09/28/2021@14:35 COVID-19 PCR NotDetected 09/25/2021@01:59 COVID-19 PCR NotDetected 09/22/2021@11:35:05 COVID-19 PCR NotDetected The patient has early acute COVID-19 infection without overt symptoms and meets the criteria for monoclonal antibody infusion (bamlanivimab/etesevimab) therapy to prevent further decompensation of COVID-19 infection, if the patient is able to provide informed consent. Risk factors: - Hypertension - Prior CVA - Hyperlipidemia Symptoms: & COVID-19 infection Treatment: BAMLANIVIMAB (EUA) , BAMLANIVIMAB/ETESEVIMAB (EUA) etesevimab
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Aspiration, COVID-19, COVID-19 pneumonia
Clinical narrative: Narrative:  72yr direct admit from hospital to agency hospital with COVID-19 found to be in acute respiratory failure, superimposed COVID PNA, on arrival HR was 178 and there was concern for possible SVT - he was loaded with lovenox 1mg/kg, ketamine and propofol and underwent synchronized cardioversion. Also found to have Troponin Elevation c/f type II NSTEMI vs type1 on admission. Tested positive for COVID 9.13; hospitalized at hospital 9.25 transferred to agency hospital on 9.27. He was intubated (9.27 x 2 days) for worsening hypercarbic respiratory failure and increased work of breathing after failure of BiPAP. It is unclear exactly what triggered his COPD exacerbation though aspiration vs bacterial pneumonia vs COVID-19 infection. Hospitalization Couse: 8 days COVID Therapeutics: Dexamethasone 6mg, transitioned methylprednislone IV, then prednisone 40mg IV PMH: CAD, HTN, Dyslipidemia, COPD, on 2 to 4 L oxygen at baseline, Asthma, Osteoporosis, Anxiety, Parkinsonism, Tricuspid regurgitation, GERD, BPH Pertinent information: COVID Vaccine: Moderna x 2 (Feb and March 2021) Symptoms:  RespDepression, CoughWheeze, Diarrhea & Tachycardia Treatment:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Diarrhoea
Clinical narrative: Narrative:  72yr direct admit from hospital to agency hospital with COVID-19 found to be in acute respiratory failure, superimposed COVID PNA, on arrival HR was 178 and there was concern for possible SVT - he was loaded with lovenox 1mg/kg, ketamine and propofol and underwent synchronized cardioversion. Also found to have Troponin Elevation c/f type II NSTEMI vs type1 on admission. Tested positive for COVID 9.13; hospitalized at hospital 9.25 transferred to agency hospital on 9.27. He was intubated (9.27 x 2 days) for worsening hypercarbic respiratory failure and increased work of breathing after failure of BiPAP. It is unclear exactly what triggered his COPD exacerbation though aspiration vs bacterial pneumonia vs COVID-19 infection. Hospitalization Couse: 8 days COVID Therapeutics: Dexamethasone 6mg, transitioned methylprednislone IV, then prednisone 40mg IV PMH: CAD, HTN, Dyslipidemia, COPD, on 2 to 4 L oxygen at baseline, Asthma, Osteoporosis, Anxiety, Parkinsonism, Tricuspid regurgitation, GERD, BPH Pertinent information: COVID Vaccine: Moderna x 2 (Feb and March 2021) Symptoms:  RespDepression, CoughWheeze, Diarrhea & Tachycardia Treatment:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, Pneumonia bacterial, Positive airway pressure therapy, Respiratory depression
Clinical narrative: Narrative:  72yr direct admit from hospital to agency hospital with COVID-19 found to be in acute respiratory failure, superimposed COVID PNA, on arrival HR was 178 and there was concern for possible SVT - he was loaded with lovenox 1mg/kg, ketamine and propofol and underwent synchronized cardioversion. Also found to have Troponin Elevation c/f type II NSTEMI vs type1 on admission. Tested positive for COVID 9.13; hospitalized at hospital 9.25 transferred to agency hospital on 9.27. He was intubated (9.27 x 2 days) for worsening hypercarbic respiratory failure and increased work of breathing after failure of BiPAP. It is unclear exactly what triggered his COPD exacerbation though aspiration vs bacterial pneumonia vs COVID-19 infection. Hospitalization Couse: 8 days COVID Therapeutics: Dexamethasone 6mg, transitioned methylprednislone IV, then prednisone 40mg IV PMH: CAD, HTN, Dyslipidemia, COPD, on 2 to 4 L oxygen at baseline, Asthma, Osteoporosis, Anxiety, Parkinsonism, Tricuspid regurgitation, GERD, BPH Pertinent information: COVID Vaccine: Moderna x 2 (Feb and March 2021) Symptoms:  RespDepression, CoughWheeze, Diarrhea & Tachycardia Treatment:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Superinfection, Tachycardia, Troponin increased
Clinical narrative: Narrative:  72yr direct admit from hospital to agency hospital with COVID-19 found to be in acute respiratory failure, superimposed COVID PNA, on arrival HR was 178 and there was concern for possible SVT - he was loaded with lovenox 1mg/kg, ketamine and propofol and underwent synchronized cardioversion. Also found to have Troponin Elevation c/f type II NSTEMI vs type1 on admission. Tested positive for COVID 9.13; hospitalized at hospital 9.25 transferred to agency hospital on 9.27. He was intubated (9.27 x 2 days) for worsening hypercarbic respiratory failure and increased work of breathing after failure of BiPAP. It is unclear exactly what triggered his COPD exacerbation though aspiration vs bacterial pneumonia vs COVID-19 infection. Hospitalization Couse: 8 days COVID Therapeutics: Dexamethasone 6mg, transitioned methylprednislone IV, then prednisone 40mg IV PMH: CAD, HTN, Dyslipidemia, COPD, on 2 to 4 L oxygen at baseline, Asthma, Osteoporosis, Anxiety, Parkinsonism, Tricuspid regurgitation, GERD, BPH Pertinent information: COVID Vaccine: Moderna x 2 (Feb and March 2021) Symptoms:  RespDepression, CoughWheeze, Diarrhea & Tachycardia Treatment:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Narrative:  72yr direct admit from hospital to agency hospital with COVID-19 found to be in acute respiratory failure, superimposed COVID PNA, on arrival HR was 178 and there was concern for possible SVT - he was loaded with lovenox 1mg/kg, ketamine and propofol and underwent synchronized cardioversion. Also found to have Troponin Elevation c/f type II NSTEMI vs type1 on admission. Tested positive for COVID 9.13; hospitalized at hospital 9.25 transferred to agency hospital on 9.27. He was intubated (9.27 x 2 days) for worsening hypercarbic respiratory failure and increased work of breathing after failure of BiPAP. It is unclear exactly what triggered his COPD exacerbation though aspiration vs bacterial pneumonia vs COVID-19 infection. Hospitalization Couse: 8 days COVID Therapeutics: Dexamethasone 6mg, transitioned methylprednislone IV, then prednisone 40mg IV PMH: CAD, HTN, Dyslipidemia, COPD, on 2 to 4 L oxygen at baseline, Asthma, Osteoporosis, Anxiety, Parkinsonism, Tricuspid regurgitation, GERD, BPH Pertinent information: COVID Vaccine: Moderna x 2 (Feb and March 2021) Symptoms:  RespDepression, CoughWheeze, Diarrhea & Tachycardia Treatment:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Mass, Peripheral swelling, Pruritus, Rash
Clinical narrative: Narrative: No reaction reported after 1st Pfizer COVID-19 vaccine dose. Received 2nd dose on 3/23/21, about 10 hours following second Pfizer COVID-19 dose patient facial swelling around his lower jaw area and right hand. Patient reported to the ED the following morning on 3/24/21 and states he has developed lumps over his bilateral hands, back of his head, and buttock. No urticaria, wheezing, or edema of the tongue or OP. Treated with IV Benadryl, steroids, and pepcid with improvement of his symptoms. He was observed for 4 hours in the ED without progression of allergic reaction. Returned to ED 4 days later on 3/28/21 complaining of pruritic rash on scalp and back of neck.  Symptoms: Angioedema, Rash & UrticariaPruritus Treatment: DIPHENHYDRAMINE, FAMOTIDINE, METHYLPREDNISOLONE
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling face, Urticaria
Clinical narrative: Narrative: No reaction reported after 1st Pfizer COVID-19 vaccine dose. Received 2nd dose on 3/23/21, about 10 hours following second Pfizer COVID-19 dose patient facial swelling around his lower jaw area and right hand. Patient reported to the ED the following morning on 3/24/21 and states he has developed lumps over his bilateral hands, back of his head, and buttock. No urticaria, wheezing, or edema of the tongue or OP. Treated with IV Benadryl, steroids, and pepcid with improvement of his symptoms. He was observed for 4 hours in the ED without progression of allergic reaction. Returned to ED 4 days later on 3/28/21 complaining of pruritic rash on scalp and back of neck.  Symptoms: Angioedema, Rash & UrticariaPruritus Treatment: DIPHENHYDRAMINE, FAMOTIDINE, METHYLPREDNISOLONE
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Blood gases abnormal, Blood pH normal, COVID-19, Chest X-ray abnormal
Clinical narrative: Narrative:  Patient received the Pfizer vaccine dose #1 on 1/21/2021 and dose #2 on 2/15/2021. He tested positive for COVID-19 on 10/11/2021. He reported that symptoms began ~9/27/2021. ABG revealed hypoxic respiratory failure (pH 7.41, pCO2 35, pO2 60). CXR revealed reticular opacities in mid-lungs and LLL. CTA was negative for PE but did reveal multifocal bilateral PNA. Patient was deemed to not a be a candidate for casirivimab/imdevimab due to duration of symptoms (~2 weeks) and SpO2 trending to low 90s on room air. Oxygen was placed at 1LPM via nasal cannula. Patient was not given any medications in the ED. He was admitted to ICU as Medical Stepdown status for further care. He received remdesivir and dexamethasone. He was transferred to the Medical COVID Unit on 10/12/2021 and discharged home on 10/13/2021.  Symptoms:  & Hospitalization
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Lung opacity, Malaise, PCO2 normal, PO2 decreased
Clinical narrative: Narrative:  Patient received the Pfizer vaccine dose #1 on 1/21/2021 and dose #2 on 2/15/2021. He tested positive for COVID-19 on 10/11/2021. He reported that symptoms began ~9/27/2021. ABG revealed hypoxic respiratory failure (pH 7.41, pCO2 35, pO2 60). CXR revealed reticular opacities in mid-lungs and LLL. CTA was negative for PE but did reveal multifocal bilateral PNA. Patient was deemed to not a be a candidate for casirivimab/imdevimab due to duration of symptoms (~2 weeks) and SpO2 trending to low 90s on room air. Oxygen was placed at 1LPM via nasal cannula. Patient was not given any medications in the ED. He was admitted to ICU as Medical Stepdown status for further care. He received remdesivir and dexamethasone. He was transferred to the Medical COVID Unit on 10/12/2021 and discharged home on 10/13/2021.  Symptoms:  & Hospitalization
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient received the Pfizer vaccine dose #1 on 1/21/2021 and dose #2 on 2/15/2021. He tested positive for COVID-19 on 10/11/2021. He reported that symptoms began ~9/27/2021. ABG revealed hypoxic respiratory failure (pH 7.41, pCO2 35, pO2 60). CXR revealed reticular opacities in mid-lungs and LLL. CTA was negative for PE but did reveal multifocal bilateral PNA. Patient was deemed to not a be a candidate for casirivimab/imdevimab due to duration of symptoms (~2 weeks) and SpO2 trending to low 90s on room air. Oxygen was placed at 1LPM via nasal cannula. Patient was not given any medications in the ED. He was admitted to ICU as Medical Stepdown status for further care. He received remdesivir and dexamethasone. He was transferred to the Medical COVID Unit on 10/12/2021 and discharged home on 10/13/2021.  Symptoms:  & Hospitalization
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient was given covid vaccine dose 1 and 2 at outside facility. She received dose 1 on 1/12/21 Moderna vaccine Lot #025J20A. When she went back to the same facility on 2/9/21 for her 2nd dose she was given Pfizer vaccine Lot #EL1283. She came to the Facility for a booster dose and was given 3rd dose on 10/9/21 Pfizer vaccine Lot #ER8735. The patient did not have an adverse reaction to any of the 3 doses and has not tested positive for COVID that we are aware of. Relevant medical history: Lung adenocarcinoma T1aN0M0-stage IA s/p segmentectomy 9/2017 & completed vaccine series with different manufacturer
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated
Clinical narrative: PATIENT REPORTED HE WAS HOSPITALIZED FOR SECOND DOSE OF COVID SHOT & WAS ADVISED IT WAS BECAUSE OF ASTHMA.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pruritus, Rash
Clinical narrative: After taking my 2nd dosage of Shingrix on 10/12/2021, my skin became itchy. On Sunday 10/17/2021, I noticed that I had a rash covering my stomach. Today, it is even more visible on my breasts. I have been taking Benadryl and applying Triamcinolone Acetonide cream 0.1 % to no avail. I am miserable.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Impaired healing, Injection site pain, Injection site reaction
Clinical narrative: Second dose of the MODERNA Covid-19 vaccine given to me on September 9, 2021. Subsequent prolonged and serious dizziness and ear ringing. Site of injection will not heal. Continued shot site scabbed and painful.
Sex: F
Vaccine: COVID19
Symptoms: Injection site scab, Tinnitus
Clinical narrative: Second dose of the MODERNA Covid-19 vaccine given to me on September 9, 2021. Subsequent prolonged and serious dizziness and ear ringing. Site of injection will not heal. Continued shot site scabbed and painful.
Sex: F
Vaccine: FLUX
Symptoms: Wrong product administered
Clinical narrative: Per hospital event report "Patient was given Flu vaccine instead of a tdap. The mistake was made when I sat box of tdap vaccines down in fridge beside flu." Patient returned on 10/5/21 to receive TDAP
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Herpes zoster, Hypertension
Clinical narrative: shingles on the right upper side of my torso (front and back); This is a spontaneous report from a contactable consumer (patient). An 80-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration administered in right arm on 05Feb2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunization at public health clinic/veterans administration facility. The patient medical history was not reported. Concomitant medication included levothyroxine taken for an unspecified indication from an unknown date. List of any other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient previously took polyethylene glycol compound and experienced allergies: poly-ethylene glycol. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that 2 weeks after the first vaccine on Feb2021 she came down with shingles on the right upper side of her torso (front and back). Was treated by a physician for symptoms. Therapeutic measures were taken as a result of shingles on the right upper side of my torso (front and back). The reporter assessed the seriousness as non-serious. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Rash
Clinical narrative: shingles on the right upper side of my torso (front and back); This is a spontaneous report from a contactable consumer (patient). An 80-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration administered in right arm on 05Feb2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunization at public health clinic/veterans administration facility. The patient medical history was not reported. Concomitant medication included levothyroxine taken for an unspecified indication from an unknown date. List of any other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient previously took polyethylene glycol compound and experienced allergies: poly-ethylene glycol. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that 2 weeks after the first vaccine on Feb2021 she came down with shingles on the right upper side of her torso (front and back). Was treated by a physician for symptoms. Therapeutic measures were taken as a result of shingles on the right upper side of my torso (front and back). The reporter assessed the seriousness as non-serious. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles on the right upper side of my torso (front and back); This is a spontaneous report from a contactable consumer (patient). An 80-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL3247, expiration date was not reported), via an unspecified route of administration administered in right arm on 05Feb2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunization at public health clinic/veterans administration facility. The patient medical history was not reported. Concomitant medication included levothyroxine taken for an unspecified indication from an unknown date. List of any other medications the patient received within 2 weeks of vaccination included levothyroxine. The patient previously took polyethylene glycol compound and experienced allergies: poly-ethylene glycol. Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that 2 weeks after the first vaccine on Feb2021 she came down with shingles on the right upper side of her torso (front and back). Was treated by a physician for symptoms. Therapeutic measures were taken as a result of shingles on the right upper side of my torso (front and back). The reporter assessed the seriousness as non-serious. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Pain in extremity, Ultrasound abdomen, X-ray
Clinical narrative: NEUROPATHY IN FEET; IMPAIRED QUALITY OF LIFE; ISSUES THINKING/ GO BLANK ON THOUGHTS WHILE HAVING A CONVERSATION; This spontaneous report received from a patient concerned a male of unspecified age, 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 08-JUN-2021) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, soon after the vaccination he was diagnosed with neuropathy in his feet and also had issues thinking and would get blank on his thoughts while a conversation with his staff. The patient visited to his primary care physician (PCP) and Orthopedic. Then he scheduled to see a neurologist. He was in constant pain and his feet both hurted 24/7. His pain level went from a 4-5, and at night to 6-7. He rubbed his feet several times a day with recommended creamer just to get a little relief. He also stated that he need assistance, this was affecting his work and mobility and quality of life. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy in feet, and impaired quality of life, and the outcome of issues thinking/ go blank on thoughts while having a conversation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211028677-Covid-19 vaccine ad26.cov2.s -Neuropathy in feet. 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).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired quality of life, Neuropathy peripheral, Pain assessment, Thinking abnormal
Clinical narrative: NEUROPATHY IN FEET; IMPAIRED QUALITY OF LIFE; ISSUES THINKING/ GO BLANK ON THOUGHTS WHILE HAVING A CONVERSATION; This spontaneous report received from a patient concerned a male of unspecified age, 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 08-JUN-2021) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, soon after the vaccination he was diagnosed with neuropathy in his feet and also had issues thinking and would get blank on his thoughts while a conversation with his staff. The patient visited to his primary care physician (PCP) and Orthopedic. Then he scheduled to see a neurologist. He was in constant pain and his feet both hurted 24/7. His pain level went from a 4-5, and at night to 6-7. He rubbed his feet several times a day with recommended creamer just to get a little relief. He also stated that he need assistance, this was affecting his work and mobility and quality of life. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy in feet, and impaired quality of life, and the outcome of issues thinking/ go blank on thoughts while having a conversation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211028677-Covid-19 vaccine ad26.cov2.s -Neuropathy in feet. 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: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Imaging procedure abnormal, Vascular imaging, Venous stenosis
Clinical narrative: Initially diagnosed with subclavian venous stenosis and thoracic outlet syndrome on the right (non-vaccinated) side. Then began having intermittent shoulder pain on this side which progressed to intermittent bilateral upper extremity pain and neuropathy as well as intermittent bilateral knee pain. Was diagnosed with inflammatory arthritis. Taking glucorticoids with temporary relief and plan to initiate DMARD if remission does not occur.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Headache, SARS-CoV-2 test, Thoracic outlet syndrome, Vasodilatation
Clinical narrative: Initially diagnosed with subclavian venous stenosis and thoracic outlet syndrome on the right (non-vaccinated) side. Then began having intermittent shoulder pain on this side which progressed to intermittent bilateral upper extremity pain and neuropathy as well as intermittent bilateral knee pain. Was diagnosed with inflammatory arthritis. Taking glucorticoids with temporary relief and plan to initiate DMARD if remission does not occur.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vein disorder
Clinical narrative: Initially diagnosed with subclavian venous stenosis and thoracic outlet syndrome on the right (non-vaccinated) side. Then began having intermittent shoulder pain on this side which progressed to intermittent bilateral upper extremity pain and neuropathy as well as intermittent bilateral knee pain. Was diagnosed with inflammatory arthritis. Taking glucorticoids with temporary relief and plan to initiate DMARD if remission does not occur.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Arthritis, Neuropathy peripheral, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: Initially diagnosed with subclavian venous stenosis and thoracic outlet syndrome on the right (non-vaccinated) side. Then began having intermittent shoulder pain on this side which progressed to intermittent bilateral upper extremity pain and neuropathy as well as intermittent bilateral knee pain. Was diagnosed with inflammatory arthritis. Taking glucorticoids with temporary relief and plan to initiate DMARD if remission does not occur.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rheumatoid factor increased, Subclavian vein stenosis, Thoracic outlet syndrome
Clinical narrative: Initially diagnosed with subclavian venous stenosis and thoracic outlet syndrome on the right (non-vaccinated) side. Then began having intermittent shoulder pain on this side which progressed to intermittent bilateral upper extremity pain and neuropathy as well as intermittent bilateral knee pain. Was diagnosed with inflammatory arthritis. Taking glucorticoids with temporary relief and plan to initiate DMARD if remission does not occur.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Headache, Musculoskeletal disorder, Speech disorder
Clinical narrative: had a stroke; confused; trouble hearing information; writing the wrong thing down; This is a spontaneous report from a contactable consumer (patient). A 68 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 67 years old on 04Feb2021 (Lot Number: EL9269) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 67 years old on 14Jan2021 (lot number: EL3249) for Covid-19 immunization and experienced horrible itching.  The patient stated that after having her covid vaccination she had a stroke and had been out of work and in a nursing home. She reported that she still got caught up on little words and got confused and had trouble hearing information and writing the wrong thing down. Outcome of events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke; confused; trouble hearing information; writing the wrong thing down; This is a spontaneous report from a contactable consumer (patient). A 68 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 67 years old on 04Feb2021 (Lot Number: EL9269) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 67 years old on 14Jan2021 (lot number: EL3249) for Covid-19 immunization and experienced horrible itching.  The patient stated that after having her covid vaccination she had a stroke and had been out of work and in a nursing home. She reported that she still got caught up on little words and got confused and had trouble hearing information and writing the wrong thing down. Outcome of events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Confusional state, Dysgraphia, Hypoacusis
Clinical narrative: had a stroke; confused; trouble hearing information; writing the wrong thing down; This is a spontaneous report from a contactable consumer (patient). A 68 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 67 years old on 04Feb2021 (Lot Number: EL9269) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 67 years old on 14Jan2021 (lot number: EL3249) for Covid-19 immunization and experienced horrible itching.  The patient stated that after having her covid vaccination she had a stroke and had been out of work and in a nursing home. She reported that she still got caught up on little words and got confused and had trouble hearing information and writing the wrong thing down. Outcome of events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident
Clinical narrative: had a stroke; confused; trouble hearing information; writing the wrong thing down; This is a spontaneous report from a contactable consumer (patient). A 68 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 67 years old on 04Feb2021 (Lot Number: EL9269) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at age of 67 years old on 14Jan2021 (lot number: EL3249) for Covid-19 immunization and experienced horrible itching.  The patient stated that after having her covid vaccination she had a stroke and had been out of work and in a nursing home. She reported that she still got caught up on little words and got confused and had trouble hearing information and writing the wrong thing down. Outcome of events was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: horrible itching; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 67-years-old on 14Jan2021 (Lot Number: EL3249) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced horrible itching after the first dose on an unspecified date. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: horrible itching; This is a spontaneous report from a contactable consumer. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration at age of 67-years-old on 14Jan2021 (Lot Number: EL3249) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced horrible itching after the first dose on an unspecified date. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glossodynia, Mononucleosis heterophile test negative, Pharyngeal swelling, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Tongue and throat swelling; Tongue and throat swelling; Inflammation in ears and lymph nodes; Inflammation in ears and lymph nodes; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Pains down neck and jaw; Pains down neck and jaw; Weight loss; anxiety; Metallic taste and mouth; ears ringing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0191 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 hours, as dose 2, single (at the age of 29-years-old) for COVID-19 immunization. Medical history included known allergies to penicillin, sulfa and COVID-19 (prior to vaccination) (all from unknown date to unknown if ongoing). The patient concomitant medications/other medications in two weeks included birth control. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0168 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 09May2021 at 12:00 hours, as dose 1, single (at the age of 29-years-old) for COVID-19 immunization. Patient previously had no health issues or on any medication. Patient had no other vaccine in four weeks. On an unspecified date of 2021, patient had been tested for Covid-19, post vaccination via nasal swab, result was negative. On 01Jun2021, patient experienced tongue and throat swelling (going on for 9 weeks now), inflammation in ears and lymph nodes. Patient was diagnosed with geographic tongue, tongue gets inflamed after eating and burns. Patient had pains down neck and jaw, had weight loss, anxiety, metallic taste and mouth and ears ringing. Patient had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of all the events and treatment included prednisone and Benadryl which did not help. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Thyroid function test normal, Tongue geographic, Ultrasound scan normal
Clinical narrative: Tongue and throat swelling; Tongue and throat swelling; Inflammation in ears and lymph nodes; Inflammation in ears and lymph nodes; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Pains down neck and jaw; Pains down neck and jaw; Weight loss; anxiety; Metallic taste and mouth; ears ringing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0191 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 hours, as dose 2, single (at the age of 29-years-old) for COVID-19 immunization. Medical history included known allergies to penicillin, sulfa and COVID-19 (prior to vaccination) (all from unknown date to unknown if ongoing). The patient concomitant medications/other medications in two weeks included birth control. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0168 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 09May2021 at 12:00 hours, as dose 1, single (at the age of 29-years-old) for COVID-19 immunization. Patient previously had no health issues or on any medication. Patient had no other vaccine in four weeks. On an unspecified date of 2021, patient had been tested for Covid-19, post vaccination via nasal swab, result was negative. On 01Jun2021, patient experienced tongue and throat swelling (going on for 9 weeks now), inflammation in ears and lymph nodes. Patient was diagnosed with geographic tongue, tongue gets inflamed after eating and burns. Patient had pains down neck and jaw, had weight loss, anxiety, metallic taste and mouth and ears ringing. Patient had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of all the events and treatment included prednisone and Benadryl which did not help. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dysgeusia, Glossitis, Inflammation, Lymphadenopathy
Clinical narrative: Tongue and throat swelling; Tongue and throat swelling; Inflammation in ears and lymph nodes; Inflammation in ears and lymph nodes; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Pains down neck and jaw; Pains down neck and jaw; Weight loss; anxiety; Metallic taste and mouth; ears ringing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0191 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 hours, as dose 2, single (at the age of 29-years-old) for COVID-19 immunization. Medical history included known allergies to penicillin, sulfa and COVID-19 (prior to vaccination) (all from unknown date to unknown if ongoing). The patient concomitant medications/other medications in two weeks included birth control. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0168 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 09May2021 at 12:00 hours, as dose 1, single (at the age of 29-years-old) for COVID-19 immunization. Patient previously had no health issues or on any medication. Patient had no other vaccine in four weeks. On an unspecified date of 2021, patient had been tested for Covid-19, post vaccination via nasal swab, result was negative. On 01Jun2021, patient experienced tongue and throat swelling (going on for 9 weeks now), inflammation in ears and lymph nodes. Patient was diagnosed with geographic tongue, tongue gets inflamed after eating and burns. Patient had pains down neck and jaw, had weight loss, anxiety, metallic taste and mouth and ears ringing. Patient had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of all the events and treatment included prednisone and Benadryl which did not help. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in jaw, Pharyngeal swelling, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Tongue and throat swelling; Tongue and throat swelling; Inflammation in ears and lymph nodes; Inflammation in ears and lymph nodes; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Diagnosed with geographic tongue, tongue gets inflamed after eating and burns; Pains down neck and jaw; Pains down neck and jaw; Weight loss; anxiety; Metallic taste and mouth; ears ringing; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non-pregnant female patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0191 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 hours, as dose 2, single (at the age of 29-years-old) for COVID-19 immunization. Medical history included known allergies to penicillin, sulfa and COVID-19 (prior to vaccination) (all from unknown date to unknown if ongoing). The patient concomitant medications/other medications in two weeks included birth control. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ZW0168 and Expiration date was not reported) via an unspecified route of administration, administered in left arm on 09May2021 at 12:00 hours, as dose 1, single (at the age of 29-years-old) for COVID-19 immunization. Patient previously had no health issues or on any medication. Patient had no other vaccine in four weeks. On an unspecified date of 2021, patient had been tested for Covid-19, post vaccination via nasal swab, result was negative. On 01Jun2021, patient experienced tongue and throat swelling (going on for 9 weeks now), inflammation in ears and lymph nodes. Patient was diagnosed with geographic tongue, tongue gets inflamed after eating and burns. Patient had pains down neck and jaw, had weight loss, anxiety, metallic taste and mouth and ears ringing. Patient had doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit for the events. Therapeutic measures were taken as a result of all the events and treatment included prednisone and Benadryl which did not help. The outcome of all the events was not recovered.   Follow-up attempts are completed. No further information is expected.