chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax normal, Dyspnoea, Dyspnoea exertional, Echocardiogram normal
Clinical narrative: Sent to ER, Dx migraine; arthritis; dyspnea; Headache; This is a spontaneous report from a contactable healthcare professional. A 67-year-old male patient received the first dose of BNT162B2 at 67-year-old, intramuscularly in arm left on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunisation. Medical history included COVID-19, ongoing coronary artery disease (CAD) from Sep2020, ongoing hypogonadism from 15May2021, ongoing anxiety, ongoing depression, ongoing osteopenia, ongoing osteoarthritis, ongoing obstructive sleep apnoea syndrome (OSA), and coronary artery bypass (CABG) from Sep2020. Concomitant medications included alendronate sodium (ALENDRONATE), atorvastatin, acetylsalicylic acid/ascorbic acid (ASPIRIN), buspirone, isosorbide dinitrate (ISOSORBIDE), metoprolol, omeprazole, potassium chloride, prasugrel, vitamin d3, and fluoxetine. Patient experienced headache on 29Apr2021, had a MRI, MRA, saw cardiology and optimists SED rate negative, MRA. Developmental hypoplasia vs chronic conclusion. MRI, WNL sent to ER, Dx migraine not improved. Had cardiac Cath on 14May2021 to PCL not improved sent to neurology. Artery bx negative but exam c/w GCA a temoral arthritis. Had on high dose prednisolone with some relief. Continued to have increased dyspnea. Palm said covid longer to chronic steroid use. Back in hospital in Oct2021 for Dyspnea near (Withheld), cardiac clearance, rheumatological work up pending. Relevant tests in May2021: MRI brain (magnetic resonance imaging head): Negative; MRA brain: Negative; Temporary artery: Negative; SED rate: Negative. Outcome of event migraine was not resolved, and of other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Migraine and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Giant cell arteritis, Headache, Magnetic resonance imaging head normal, Presyncope
Clinical narrative: Sent to ER, Dx migraine; arthritis; dyspnea; Headache; This is a spontaneous report from a contactable healthcare professional. A 67-year-old male patient received the first dose of BNT162B2 at 67-year-old, intramuscularly in arm left on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunisation. Medical history included COVID-19, ongoing coronary artery disease (CAD) from Sep2020, ongoing hypogonadism from 15May2021, ongoing anxiety, ongoing depression, ongoing osteopenia, ongoing osteoarthritis, ongoing obstructive sleep apnoea syndrome (OSA), and coronary artery bypass (CABG) from Sep2020. Concomitant medications included alendronate sodium (ALENDRONATE), atorvastatin, acetylsalicylic acid/ascorbic acid (ASPIRIN), buspirone, isosorbide dinitrate (ISOSORBIDE), metoprolol, omeprazole, potassium chloride, prasugrel, vitamin d3, and fluoxetine. Patient experienced headache on 29Apr2021, had a MRI, MRA, saw cardiology and optimists SED rate negative, MRA. Developmental hypoplasia vs chronic conclusion. MRI, WNL sent to ER, Dx migraine not improved. Had cardiac Cath on 14May2021 to PCL not improved sent to neurology. Artery bx negative but exam c/w GCA a temoral arthritis. Had on high dose prednisolone with some relief. Continued to have increased dyspnea. Palm said covid longer to chronic steroid use. Back in hospital in Oct2021 for Dyspnea near (Withheld), cardiac clearance, rheumatological work up pending. Relevant tests in May2021: MRI brain (magnetic resonance imaging head): Negative; MRA brain: Negative; Temporary artery: Negative; SED rate: Negative. Outcome of event migraine was not resolved, and of other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Migraine and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Sent to ER, Dx migraine; arthritis; dyspnea; Headache; This is a spontaneous report from a contactable healthcare professional. A 67-year-old male patient received the first dose of BNT162B2 at 67-year-old, intramuscularly in arm left on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunisation. Medical history included COVID-19, ongoing coronary artery disease (CAD) from Sep2020, ongoing hypogonadism from 15May2021, ongoing anxiety, ongoing depression, ongoing osteopenia, ongoing osteoarthritis, ongoing obstructive sleep apnoea syndrome (OSA), and coronary artery bypass (CABG) from Sep2020. Concomitant medications included alendronate sodium (ALENDRONATE), atorvastatin, acetylsalicylic acid/ascorbic acid (ASPIRIN), buspirone, isosorbide dinitrate (ISOSORBIDE), metoprolol, omeprazole, potassium chloride, prasugrel, vitamin d3, and fluoxetine. Patient experienced headache on 29Apr2021, had a MRI, MRA, saw cardiology and optimists SED rate negative, MRA. Developmental hypoplasia vs chronic conclusion. MRI, WNL sent to ER, Dx migraine not improved. Had cardiac Cath on 14May2021 to PCL not improved sent to neurology. Artery bx negative but exam c/w GCA a temoral arthritis. Had on high dose prednisolone with some relief. Continued to have increased dyspnea. Palm said covid longer to chronic steroid use. Back in hospital in Oct2021 for Dyspnea near (Withheld), cardiac clearance, rheumatological work up pending. Relevant tests in May2021: MRI brain (magnetic resonance imaging head): Negative; MRA brain: Negative; Temporary artery: Negative; SED rate: Negative. Outcome of event migraine was not resolved, and of other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Migraine and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthritis, Dyspnoea, Giant cell arteritis, Headache, Magnetic resonance imaging head
Clinical narrative: Sent to ER, Dx migraine; arthritis; dyspnea; Headache; This is a spontaneous report from a contactable healthcare professional. A 67-year-old male patient received the first dose of BNT162B2 at 67-year-old, intramuscularly in arm left on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunisation. Medical history included COVID-19, ongoing coronary artery disease (CAD) from Sep2020, ongoing hypogonadism from 15May2021, ongoing anxiety, ongoing depression, ongoing osteopenia, ongoing osteoarthritis, ongoing obstructive sleep apnoea syndrome (OSA), and coronary artery bypass (CABG) from Sep2020. Concomitant medications included alendronate sodium (ALENDRONATE), atorvastatin, acetylsalicylic acid/ascorbic acid (ASPIRIN), buspirone, isosorbide dinitrate (ISOSORBIDE), metoprolol, omeprazole, potassium chloride, prasugrel, vitamin d3, and fluoxetine. Patient experienced headache on 29Apr2021, had a MRI, MRA, saw cardiology and optimists SED rate negative, MRA. Developmental hypoplasia vs chronic conclusion. MRI, WNL sent to ER, Dx migraine not improved. Had cardiac Cath on 14May2021 to PCL not improved sent to neurology. Artery bx negative but exam c/w GCA a temoral arthritis. Had on high dose prednisolone with some relief. Continued to have increased dyspnea. Palm said covid longer to chronic steroid use. Back in hospital in Oct2021 for Dyspnea near (Withheld), cardiac clearance, rheumatological work up pending. Relevant tests in May2021: MRI brain (magnetic resonance imaging head): Negative; MRA brain: Negative; Temporary artery: Negative; SED rate: Negative. Outcome of event migraine was not resolved, and of other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Migraine and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Red blood cell sedimentation rate
Clinical narrative: Sent to ER, Dx migraine; arthritis; dyspnea; Headache; This is a spontaneous report from a contactable healthcare professional. A 67-year-old male patient received the first dose of BNT162B2 at 67-year-old, intramuscularly in arm left on 15Apr2021 (Batch/Lot Number: EW0162) at single dose for COVID-19 immunisation. Medical history included COVID-19, ongoing coronary artery disease (CAD) from Sep2020, ongoing hypogonadism from 15May2021, ongoing anxiety, ongoing depression, ongoing osteopenia, ongoing osteoarthritis, ongoing obstructive sleep apnoea syndrome (OSA), and coronary artery bypass (CABG) from Sep2020. Concomitant medications included alendronate sodium (ALENDRONATE), atorvastatin, acetylsalicylic acid/ascorbic acid (ASPIRIN), buspirone, isosorbide dinitrate (ISOSORBIDE), metoprolol, omeprazole, potassium chloride, prasugrel, vitamin d3, and fluoxetine. Patient experienced headache on 29Apr2021, had a MRI, MRA, saw cardiology and optimists SED rate negative, MRA. Developmental hypoplasia vs chronic conclusion. MRI, WNL sent to ER, Dx migraine not improved. Had cardiac Cath on 14May2021 to PCL not improved sent to neurology. Artery bx negative but exam c/w GCA a temoral arthritis. Had on high dose prednisolone with some relief. Continued to have increased dyspnea. Palm said covid longer to chronic steroid use. Back in hospital in Oct2021 for Dyspnea near (Withheld), cardiac clearance, rheumatological work up pending. Relevant tests in May2021: MRI brain (magnetic resonance imaging head): Negative; MRA brain: Negative; Temporary artery: Negative; SED rate: Negative. Outcome of event migraine was not resolved, and of other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the event Migraine and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Fever; rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks; itching; light sensitivity at area of rash; fatigue; diarrhea; nausea; headache; chills; sore ankles; weight loss; the onset of a drunk; Sneezing; booster 3rd dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), dose 3 via intramuscular route of administration, administered in Arm Left on 18Oct2021 14:00 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included osteoporosis, complex regional pain syndrome, fibromyalgia. The allergies was reported with Codeine (hives), Amoxicillin, Doxycycline, Cefdinir, doxycycline, gluten bigotry. Concomitant medication(s) Other medications included in two weeks involved vitamin c [ascorbic acid], vitamin d, calcium, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and influenza vaccine taken for an unspecified indication on 23Sep2021 at left arm taken in 4 weeks. the patient taking any medications prior to the event being reported included Vitamin C, Vitamin E, melatonin, probiotics. Patient was not covid prior vaccination and had not tested covid post vaccination. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 28Feb2021 12:00 as DOSE 1, SINGLE for covid-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 21Mar2021 12:00 as DOSE 2, SINGLE for covid-19 immunization. On 19Oct2021 10:00 the patient experienced fever, rash on neck within 24 hours/rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks, itching, light sensitivity at area of rash, fatigue, diarrhoea, nausea, headache, chills, sore ankles, weight loss. Adverse events leaded to Physician Office Visit. The patient was not admitted to an Emergency Department or Intensive Care Unit. The treatment for adverse event involved Steroid cream, Rx antihistamine. The outcome of the event rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks was recovered on unspecified date of 2021. While rest of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pruritus, Pyrexia, Rash, Skin sensitisation
Clinical narrative: Fever; rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks; itching; light sensitivity at area of rash; fatigue; diarrhea; nausea; headache; chills; sore ankles; weight loss; the onset of a drunk; Sneezing; booster 3rd dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), dose 3 via intramuscular route of administration, administered in Arm Left on 18Oct2021 14:00 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included osteoporosis, complex regional pain syndrome, fibromyalgia. The allergies was reported with Codeine (hives), Amoxicillin, Doxycycline, Cefdinir, doxycycline, gluten bigotry. Concomitant medication(s) Other medications included in two weeks involved vitamin c [ascorbic acid], vitamin d, calcium, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and influenza vaccine taken for an unspecified indication on 23Sep2021 at left arm taken in 4 weeks. the patient taking any medications prior to the event being reported included Vitamin C, Vitamin E, melatonin, probiotics. Patient was not covid prior vaccination and had not tested covid post vaccination. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 28Feb2021 12:00 as DOSE 1, SINGLE for covid-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 21Mar2021 12:00 as DOSE 2, SINGLE for covid-19 immunization. On 19Oct2021 10:00 the patient experienced fever, rash on neck within 24 hours/rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks, itching, light sensitivity at area of rash, fatigue, diarrhoea, nausea, headache, chills, sore ankles, weight loss. Adverse events leaded to Physician Office Visit. The patient was not admitted to an Emergency Department or Intensive Care Unit. The treatment for adverse event involved Steroid cream, Rx antihistamine. The outcome of the event rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks was recovered on unspecified date of 2021. While rest of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Fever; rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks; itching; light sensitivity at area of rash; fatigue; diarrhea; nausea; headache; chills; sore ankles; weight loss; the onset of a drunk; Sneezing; booster 3rd dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), dose 3 via intramuscular route of administration, administered in Arm Left on 18Oct2021 14:00 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included osteoporosis, complex regional pain syndrome, fibromyalgia. The allergies was reported with Codeine (hives), Amoxicillin, Doxycycline, Cefdinir, doxycycline, gluten bigotry. Concomitant medication(s) Other medications included in two weeks involved vitamin c [ascorbic acid], vitamin d, calcium, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and influenza vaccine taken for an unspecified indication on 23Sep2021 at left arm taken in 4 weeks. the patient taking any medications prior to the event being reported included Vitamin C, Vitamin E, melatonin, probiotics. Patient was not covid prior vaccination and had not tested covid post vaccination. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 28Feb2021 12:00 as DOSE 1, SINGLE for covid-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 21Mar2021 12:00 as DOSE 2, SINGLE for covid-19 immunization. On 19Oct2021 10:00 the patient experienced fever, rash on neck within 24 hours/rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks, itching, light sensitivity at area of rash, fatigue, diarrhoea, nausea, headache, chills, sore ankles, weight loss. Adverse events leaded to Physician Office Visit. The patient was not admitted to an Emergency Department or Intensive Care Unit. The treatment for adverse event involved Steroid cream, Rx antihistamine. The outcome of the event rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks was recovered on unspecified date of 2021. While rest of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Fever; rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks; itching; light sensitivity at area of rash; fatigue; diarrhea; nausea; headache; chills; sore ankles; weight loss; the onset of a drunk; Sneezing; booster 3rd dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), dose 3 via intramuscular route of administration, administered in Arm Left on 18Oct2021 14:00 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included osteoporosis, complex regional pain syndrome, fibromyalgia. The allergies was reported with Codeine (hives), Amoxicillin, Doxycycline, Cefdinir, doxycycline, gluten bigotry. Concomitant medication(s) Other medications included in two weeks involved vitamin c [ascorbic acid], vitamin d, calcium, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and influenza vaccine taken for an unspecified indication on 23Sep2021 at left arm taken in 4 weeks. the patient taking any medications prior to the event being reported included Vitamin C, Vitamin E, melatonin, probiotics. Patient was not covid prior vaccination and had not tested covid post vaccination. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 28Feb2021 12:00 as DOSE 1, SINGLE for covid-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 21Mar2021 12:00 as DOSE 2, SINGLE for covid-19 immunization. On 19Oct2021 10:00 the patient experienced fever, rash on neck within 24 hours/rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks, itching, light sensitivity at area of rash, fatigue, diarrhoea, nausea, headache, chills, sore ankles, weight loss. Adverse events leaded to Physician Office Visit. The patient was not admitted to an Emergency Department or Intensive Care Unit. The treatment for adverse event involved Steroid cream, Rx antihistamine. The outcome of the event rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks was recovered on unspecified date of 2021. While rest of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunisation, Nausea, Photosensitivity reaction, Pruritus
Clinical narrative: Fever; rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks; itching; light sensitivity at area of rash; fatigue; diarrhea; nausea; headache; chills; sore ankles; weight loss; the onset of a drunk; Sneezing; booster 3rd dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), dose 3 via intramuscular route of administration, administered in Arm Left on 18Oct2021 14:00 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included osteoporosis, complex regional pain syndrome, fibromyalgia. The allergies was reported with Codeine (hives), Amoxicillin, Doxycycline, Cefdinir, doxycycline, gluten bigotry. Concomitant medication(s) Other medications included in two weeks involved vitamin c [ascorbic acid], vitamin d, calcium, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and influenza vaccine taken for an unspecified indication on 23Sep2021 at left arm taken in 4 weeks. the patient taking any medications prior to the event being reported included Vitamin C, Vitamin E, melatonin, probiotics. Patient was not covid prior vaccination and had not tested covid post vaccination. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 28Feb2021 12:00 as DOSE 1, SINGLE for covid-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 21Mar2021 12:00 as DOSE 2, SINGLE for covid-19 immunization. On 19Oct2021 10:00 the patient experienced fever, rash on neck within 24 hours/rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks, itching, light sensitivity at area of rash, fatigue, diarrhoea, nausea, headache, chills, sore ankles, weight loss. Adverse events leaded to Physician Office Visit. The patient was not admitted to an Emergency Department or Intensive Care Unit. The treatment for adverse event involved Steroid cream, Rx antihistamine. The outcome of the event rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks was recovered on unspecified date of 2021. While rest of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Sneezing, Weight decreased
Clinical narrative: Fever; rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks; itching; light sensitivity at area of rash; fatigue; diarrhea; nausea; headache; chills; sore ankles; weight loss; the onset of a drunk; Sneezing; booster 3rd dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2589), dose 3 via intramuscular route of administration, administered in Arm Left on 18Oct2021 14:00 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included osteoporosis, complex regional pain syndrome, fibromyalgia. The allergies was reported with Codeine (hives), Amoxicillin, Doxycycline, Cefdinir, doxycycline, gluten bigotry. Concomitant medication(s) Other medications included in two weeks involved vitamin c [ascorbic acid], vitamin d, calcium, cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported and influenza vaccine taken for an unspecified indication on 23Sep2021 at left arm taken in 4 weeks. the patient taking any medications prior to the event being reported included Vitamin C, Vitamin E, melatonin, probiotics. Patient was not covid prior vaccination and had not tested covid post vaccination. Patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6200 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 28Feb2021 12:00 as DOSE 1, SINGLE for covid-19 immunization and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208 dose 1 via intramuscular route of administration, administered in Arm Left (LD) on 21Mar2021 12:00 as DOSE 2, SINGLE for covid-19 immunization. On 19Oct2021 10:00 the patient experienced fever, rash on neck within 24 hours/rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks, itching, light sensitivity at area of rash, fatigue, diarrhoea, nausea, headache, chills, sore ankles, weight loss. Adverse events leaded to Physician Office Visit. The patient was not admitted to an Emergency Department or Intensive Care Unit. The treatment for adverse event involved Steroid cream, Rx antihistamine. The outcome of the event rash on neck within 24 hours/Rash spreading within 48 hours to breasts, arms, wrist, leg, and buttocks was recovered on unspecified date of 2021. While rest of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Dermatitis, Pruritus, Rash, Rash pruritic
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Patient had full torso rash, resolved after about 30 days, scars remain, was treated for upper respiratory issues but being treated by cardiologist now instead. Patient also taking Plaquenil, Alfulsozin, and Cymbalta prior to immunization administation.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash pustular, Scar, Skin warm
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Patient had full torso rash, resolved after about 30 days, scars remain, was treated for upper respiratory issues but being treated by cardiologist now instead. Patient also taking Plaquenil, Alfulsozin, and Cymbalta prior to immunization administation.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Patient had full torso rash, resolved after about 30 days, scars remain, was treated for upper respiratory issues but being treated by cardiologist now instead. Patient also taking Plaquenil, Alfulsozin, and Cymbalta prior to immunization administation.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Rash, Respiratory disorder, Scar
Clinical narrative: Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Additional Details: Patient had full torso rash, resolved after about 30 days, scars remain, was treated for upper respiratory issues but being treated by cardiologist now instead. Patient also taking Plaquenil, Alfulsozin, and Cymbalta prior to immunization administation.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Condition aggravated, Dizziness, Tremor
Clinical narrative: FINAL IMPRESSION 1. Adverse reaction to COVID-19 vaccine      PLAN Discharge Medication List as of 11/4/2021  9:33 PM       PATIENT INSTRUCTIONS Discharge Instructions    At this time, no sign of a serious heart or lung problem. May continue tylenol 650-1000 mg up to four times daily. May rarely use naproxen/Aleve 250-500 mg.  Push fluids to stay hydrated.    "   FOLLOW-UP:   COURSE & MEDICAL DECISION MAKING Patient was triaged to ED and evaluated by me. Given her concerns, cardiac panel ordered. She was given Naproxen here with relief.  Labs were reassuring including undetectable troponin I. COVID negative. CXR clear. She feels reassured.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Blood test normal, Chest X-ray normal, SARS-CoV-2 test negative, Troponin I normal
Clinical narrative: FINAL IMPRESSION 1. Adverse reaction to COVID-19 vaccine      PLAN Discharge Medication List as of 11/4/2021  9:33 PM       PATIENT INSTRUCTIONS Discharge Instructions    At this time, no sign of a serious heart or lung problem. May continue tylenol 650-1000 mg up to four times daily. May rarely use naproxen/Aleve 250-500 mg.  Push fluids to stay hydrated.    "   FOLLOW-UP:   COURSE & MEDICAL DECISION MAKING Patient was triaged to ED and evaluated by me. Given her concerns, cardiac panel ordered. She was given Naproxen here with relief.  Labs were reassuring including undetectable troponin I. COVID negative. CXR clear. She feels reassured.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, COVID-19, Cardiac failure congestive, Chest X-ray abnormal, Condition aggravated
Clinical narrative: The client was diagnosed with COVID-19 on October 26, 2021.  She was fully-vaccinated at the time.  Other health conditions (subacute NSTEMI) prompted her to seek emergent care. The client was hospitalized locally then transferred to Hospital. Once stable, she returned to the local hospital and was subsequently discharged to a skilled nursing facility (on or around November 14, 2021).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: The client was diagnosed with COVID-19 on October 26, 2021.  She was fully-vaccinated at the time.  Other health conditions (subacute NSTEMI) prompted her to seek emergent care. The client was hospitalized locally then transferred to Hospital. Once stable, she returned to the local hospital and was subsequently discharged to a skilled nursing facility (on or around November 14, 2021).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, COVID-19
Clinical narrative: The client was diagnosed with COVID-19 on October 26, 2021.  She was fully-vaccinated at the time.  Other health conditions (subacute NSTEMI) prompted her to seek emergent care. The client was hospitalized locally then transferred to Hospital. Once stable, she returned to the local hospital and was subsequently discharged to a skilled nursing facility (on or around November 14, 2021).
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Dysstasia, Fatigue, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: 3203080), via an unspecified route of administration, administered in Arm Left on 04Nov2021 16:30 (at the age of 40 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included asthma, depression, new thyroid issue from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B 12) taken for an unspecified indication, start and stop date were not reported; vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) in left arm on 18Feb2021 at 12:00 PM  (at the age of 40 years old) as single dose and first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) in left arm on 28Jan2021 at 12:00 PM (at the age of 40 years old) for COVID-19 immunisation. The patient experienced extreme exhaustion, dizzy - can't stand up, nausea, continued vomiting on 05Nov2021 17:00. The patient did not receive any treatment. Facility type vaccine was Pharmacy or Drug Store. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: 3203080), via an unspecified route of administration, administered in Arm Left on 04Nov2021 16:30 (at the age of 40 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included asthma, depression, new thyroid issue from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B 12) taken for an unspecified indication, start and stop date were not reported; vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) in left arm on 18Feb2021 at 12:00 PM  (at the age of 40 years old) as single dose and first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) in left arm on 28Jan2021 at 12:00 PM (at the age of 40 years old) for COVID-19 immunisation. The patient experienced extreme exhaustion, dizzy - can't stand up, nausea, continued vomiting on 05Nov2021 17:00. The patient did not receive any treatment. Facility type vaccine was Pharmacy or Drug Store. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Fatigue, Nausea, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot Number: 3203080), via an unspecified route of administration, administered in Arm Left on 04Nov2021 16:30 (at the age of 40 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included asthma, depression, new thyroid issue from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for an unspecified indication, start and stop date were not reported; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B 12) taken for an unspecified indication, start and stop date were not reported; vit d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received second dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) in left arm on 18Feb2021 at 12:00 PM  (at the age of 40 years old) as single dose and first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) in left arm on 28Jan2021 at 12:00 PM (at the age of 40 years old) for COVID-19 immunisation. The patient experienced extreme exhaustion, dizzy - can't stand up, nausea, continued vomiting on 05Nov2021 17:00. The patient did not receive any treatment. Facility type vaccine was Pharmacy or Drug Store. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Gait inability, Limb discomfort, Musculoskeletal stiffness, Pain
Clinical narrative: Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Muscles hurt like the flu after second dose.; Muscles hurt like the flu after second dose.; Sore arm, after  first and second dose; Tired after first and second doses; This is a spontaneous report from a contactable consumer(patient). A 64-year-old female patient received bnt162b2 (Pfizer BioNTech Covid 19 Vaccine), dose 2 via an unspecified route of administration on 07Oct2021 10:00 (Lot Number: FF2590) at the age of 64-year-old, as single dose at left arm for covid-19 immunisation. Medical history included knee replacement of her left knee back in May2021. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2(Lot Number: FC3183) on 16Sep2021 2PM at the age of 64-year-old at left arm for covid-19 immunisation and experienced sore arm and fatigue. No additional vaccines administered on same date of the Pfizer Suspect. The patient had no prior vaccinations (within 4 weeks). The patient experienced sore arm, after first and second dose on 07Oct2021 13:00 with outcome of recovered, tired after first and second doses on 07Oct2021 13:00 with outcome of recovered, muscles hurt like the flu after second dose on 08Oct2021 in the morning with outcome of recovered on 09Oct2021, pain in knee, down leg, couldn't walk, right leg, after second dose on 13Oct2021 in the morning with outcome of not recovered(she can't walk even now with a walker). Events resulted in emergency room and physician office visit on 05Nov2021. The patient underwent lab tests and procedures which included ultrasound right leg on 17Oct2021 and 03Nov2021: normal; CT Scan right leg on 03Nov2021: normal; X-ray of right leg on 03Nov2021 and 05Nov2021: normal. The clinical course was reported as follows: The patient was  having an adverse reaction to the vaccine. She had a sore arm, was tired, and muscles hurt like the flu after the second vaccine. She had a knee replacement of her left knee back in May2021. On 17Oct2021 she went to the emergency room, she couldn't walk and they did an ultrasound of her leg and it was normal. She was taken to the hospital by ambulance after that because she couldn't walk and had a CT can, Ultrasound, and X-ray which were all normal. The patient was going for an MRI on 09Nov2021. The patient couldn't walk, and it started with pain in her knee and down her leg. Patient thought this was a reaction from the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound Doppler normal, Ultrasound scan normal, Walking aid user
Clinical narrative: Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Muscles hurt like the flu after second dose.; Muscles hurt like the flu after second dose.; Sore arm, after  first and second dose; Tired after first and second doses; This is a spontaneous report from a contactable consumer(patient). A 64-year-old female patient received bnt162b2 (Pfizer BioNTech Covid 19 Vaccine), dose 2 via an unspecified route of administration on 07Oct2021 10:00 (Lot Number: FF2590) at the age of 64-year-old, as single dose at left arm for covid-19 immunisation. Medical history included knee replacement of her left knee back in May2021. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2(Lot Number: FC3183) on 16Sep2021 2PM at the age of 64-year-old at left arm for covid-19 immunisation and experienced sore arm and fatigue. No additional vaccines administered on same date of the Pfizer Suspect. The patient had no prior vaccinations (within 4 weeks). The patient experienced sore arm, after first and second dose on 07Oct2021 13:00 with outcome of recovered, tired after first and second doses on 07Oct2021 13:00 with outcome of recovered, muscles hurt like the flu after second dose on 08Oct2021 in the morning with outcome of recovered on 09Oct2021, pain in knee, down leg, couldn't walk, right leg, after second dose on 13Oct2021 in the morning with outcome of not recovered(she can't walk even now with a walker). Events resulted in emergency room and physician office visit on 05Nov2021. The patient underwent lab tests and procedures which included ultrasound right leg on 17Oct2021 and 03Nov2021: normal; CT Scan right leg on 03Nov2021: normal; X-ray of right leg on 03Nov2021 and 05Nov2021: normal. The clinical course was reported as follows: The patient was  having an adverse reaction to the vaccine. She had a sore arm, was tired, and muscles hurt like the flu after the second vaccine. She had a knee replacement of her left knee back in May2021. On 17Oct2021 she went to the emergency room, she couldn't walk and they did an ultrasound of her leg and it was normal. She was taken to the hospital by ambulance after that because she couldn't walk and had a CT can, Ultrasound, and X-ray which were all normal. The patient was going for an MRI on 09Nov2021. The patient couldn't walk, and it started with pain in her knee and down her leg. Patient thought this was a reaction from the vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight bearing difficulty, X-ray limb
Clinical narrative: Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Pain in knee, down leg, couldn''t walk, right leg, after second dose.; Muscles hurt like the flu after second dose.; Muscles hurt like the flu after second dose.; Sore arm, after  first and second dose; Tired after first and second doses; This is a spontaneous report from a contactable consumer(patient). A 64-year-old female patient received bnt162b2 (Pfizer BioNTech Covid 19 Vaccine), dose 2 via an unspecified route of administration on 07Oct2021 10:00 (Lot Number: FF2590) at the age of 64-year-old, as single dose at left arm for covid-19 immunisation. Medical history included knee replacement of her left knee back in May2021. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2(Lot Number: FC3183) on 16Sep2021 2PM at the age of 64-year-old at left arm for covid-19 immunisation and experienced sore arm and fatigue. No additional vaccines administered on same date of the Pfizer Suspect. The patient had no prior vaccinations (within 4 weeks). The patient experienced sore arm, after first and second dose on 07Oct2021 13:00 with outcome of recovered, tired after first and second doses on 07Oct2021 13:00 with outcome of recovered, muscles hurt like the flu after second dose on 08Oct2021 in the morning with outcome of recovered on 09Oct2021, pain in knee, down leg, couldn't walk, right leg, after second dose on 13Oct2021 in the morning with outcome of not recovered(she can't walk even now with a walker). Events resulted in emergency room and physician office visit on 05Nov2021. The patient underwent lab tests and procedures which included ultrasound right leg on 17Oct2021 and 03Nov2021: normal; CT Scan right leg on 03Nov2021: normal; X-ray of right leg on 03Nov2021 and 05Nov2021: normal. The clinical course was reported as follows: The patient was  having an adverse reaction to the vaccine. She had a sore arm, was tired, and muscles hurt like the flu after the second vaccine. She had a knee replacement of her left knee back in May2021. On 17Oct2021 she went to the emergency room, she couldn't walk and they did an ultrasound of her leg and it was normal. She was taken to the hospital by ambulance after that because she couldn't walk and had a CT can, Ultrasound, and X-ray which were all normal. The patient was going for an MRI on 09Nov2021. The patient couldn't walk, and it started with pain in her knee and down her leg. Patient thought this was a reaction from the vaccine.