chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia oral, Nausea, Swelling face
Clinical narrative: Had an anaphylactic reaction; SOB; lips and tongue numb; lips and tongue numb; swollen face and eyes; swollen face and eyes; throat tightening; nausea; weakness; elevated heartrate; diaphoretic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration into left arm on 10Mar2021 12:15 at single dose for COVID-19 immunisation in doctor's office/urgent care. Medical history included Asthma well controlled, fibromyalgia. Allergies to sulfa meds and cilantro. Patient was not pregnant. Concomitant medication included cyclobenzaprine, sertraline, gabapentin and levothyroxine. No other vaccine in four weeks. Patient previously had Paroxetine and mRNA vaccine and had allergies. Patient had an anaphylactic reaction. SOB, lips and tongue numb, swollen face and eyes, throat tightening, nausea, weakness elevated heartrate, diaphoretic on 10Mar2021 12:15 PM. events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No covid prior vaccination, No covid tested post vaccination. Treatment included Epinephrine, iv diphenhydramine, prednisone 50 mg. patient was recovering from the events.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded  based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Had an anaphylactic reaction; SOB; lips and tongue numb; lips and tongue numb; swollen face and eyes; swollen face and eyes; throat tightening; nausea; weakness; elevated heartrate; diaphoretic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration into left arm on 10Mar2021 12:15 at single dose for COVID-19 immunisation in doctor's office/urgent care. Medical history included Asthma well controlled, fibromyalgia. Allergies to sulfa meds and cilantro. Patient was not pregnant. Concomitant medication included cyclobenzaprine, sertraline, gabapentin and levothyroxine. No other vaccine in four weeks. Patient previously had Paroxetine and mRNA vaccine and had allergies. Patient had an anaphylactic reaction. SOB, lips and tongue numb, swollen face and eyes, throat tightening, nausea, weakness elevated heartrate, diaphoretic on 10Mar2021 12:15 PM. events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). No covid prior vaccination, No covid tested post vaccination. Treatment included Epinephrine, iv diphenhydramine, prednisone 50 mg. patient was recovering from the events.; Sender's Comments: A causal relationship between BNT162B2 and the reported events cannot be excluded  based on temporal association. 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 RAs, Ethics Committees, and Investigators, as appropriate .
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Muscle tightness
Clinical narrative: faint; headache; neck tightened; shaky; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9265) via an unspecified route of administration on the left arm on 03Feb2021 at a single dose for COVID-19 immunisation. Medical history included Allergies: Penicillin, sulfa drugs. The patient's concomitant medications were not reported. On 03Feb2021 09:30 AM, 10 min after shot the patient felt faint, neck tightened, shaky. Have had a headache ever since. Almost 4 weeks. The events resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported syncope cannot be excluded based on temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle tightness, Syncope, Tremor
Clinical narrative: faint; headache; neck tightened; shaky; This is a spontaneous report from a contactable other healthcare professional (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9265) via an unspecified route of administration on the left arm on 03Feb2021 at a single dose for COVID-19 immunisation. Medical history included Allergies: Penicillin, sulfa drugs. The patient's concomitant medications were not reported. On 03Feb2021 09:30 AM, 10 min after shot the patient felt faint, neck tightened, shaky. Have had a headache ever since. Almost 4 weeks. The events resulted to a doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported syncope cannot be excluded based on temporal association.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood albumin decreased, C-reactive protein increased, Haemoglobin decreased, Liver function test abnormal
Clinical narrative: Extreme pain all over specially above knees, below knees, arms, wrist; Heavy sweats; heart rate high to 145; low blood pressure (80/40); oxygen low saturation 95; no appetite; insomnia; sugar level 340 and above; pain in right arm; high fever; headaches; pain in the knees/Extreme pain all over specially above knees, below knees, arms, wrist; not feeling well overall; This is a spontaneous report from a contactable consumer (parent). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in arm right on 18Feb2021 12:45 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included diabetes, allergy to barley from an unknown date. No allergies to medication. Concomitant medication(s) in two weeks included atenolol; atorvastatin; glipizide; metformin; tamsulosin, all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The same day two hours after having the shot pain in right arm, started with fever at night, headaches, pain in the knees and not feeling well overall. Next day -Feb 21st same symptoms, managed per primary Dr. with Tylenol and Ibuprofen. On Feb 22-24 symptoms worsen, went to Dr's office she gave him an steroids shot and one shot for pain killer. Feb 25th feeling better. 26Feb admitted to emergency room, many exams, only given Tylenol and Ibuprofen. Feb 27th and 28th stayed home and got worst. Mar 1st- Admitted back to hospital and remains in hospital. Every day since then blood test are done. Symptoms - High Fever, Extreme pain all over specially above knees, below knees, arms, wrist, headaches. Heavy sweats, heart rate high to 145, low blood pressure (80/40), oxygen low saturation 95, no appetite, insomnia, sugar level 340 and above. Adverse event start date was from 18Feb2021 02:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalization was 11. No covid prior vaccination. No covid tested post vaccination.Covid test post vaccination included covid test type post vaccination=Nasal Swab, covid test date=26Feb2021, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Nasal Swab, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Blood test, covid test result=Negative; covid test date=03Mar2021, covid test type post vaccination=Blood test, covid test result=Negative. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Platelet count increased, Pyrexia, Red blood cell sedimentation rate increased, Serum ferritin increased
Clinical narrative: Extreme pain all over specially above knees, below knees, arms, wrist; Heavy sweats; heart rate high to 145; low blood pressure (80/40); oxygen low saturation 95; no appetite; insomnia; sugar level 340 and above; pain in right arm; high fever; headaches; pain in the knees/Extreme pain all over specially above knees, below knees, arms, wrist; not feeling well overall; This is a spontaneous report from a contactable consumer (parent). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in arm right on 18Feb2021 12:45 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included diabetes, allergy to barley from an unknown date. No allergies to medication. Concomitant medication(s) in two weeks included atenolol; atorvastatin; glipizide; metformin; tamsulosin, all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The same day two hours after having the shot pain in right arm, started with fever at night, headaches, pain in the knees and not feeling well overall. Next day -Feb 21st same symptoms, managed per primary Dr. with Tylenol and Ibuprofen. On Feb 22-24 symptoms worsen, went to Dr's office she gave him an steroids shot and one shot for pain killer. Feb 25th feeling better. 26Feb admitted to emergency room, many exams, only given Tylenol and Ibuprofen. Feb 27th and 28th stayed home and got worst. Mar 1st- Admitted back to hospital and remains in hospital. Every day since then blood test are done. Symptoms - High Fever, Extreme pain all over specially above knees, below knees, arms, wrist, headaches. Heavy sweats, heart rate high to 145, low blood pressure (80/40), oxygen low saturation 95, no appetite, insomnia, sugar level 340 and above. Adverse event start date was from 18Feb2021 02:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalization was 11. No covid prior vaccination. No covid tested post vaccination.Covid test post vaccination included covid test type post vaccination=Nasal Swab, covid test date=26Feb2021, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Nasal Swab, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Blood test, covid test result=Negative; covid test date=03Mar2021, covid test type post vaccination=Blood test, covid test result=Negative. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Still's disease, White blood cell count increased
Clinical narrative: Extreme pain all over specially above knees, below knees, arms, wrist; Heavy sweats; heart rate high to 145; low blood pressure (80/40); oxygen low saturation 95; no appetite; insomnia; sugar level 340 and above; pain in right arm; high fever; headaches; pain in the knees/Extreme pain all over specially above knees, below knees, arms, wrist; not feeling well overall; This is a spontaneous report from a contactable consumer (parent). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in arm right on 18Feb2021 12:45 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included diabetes, allergy to barley from an unknown date. No allergies to medication. Concomitant medication(s) in two weeks included atenolol; atorvastatin; glipizide; metformin; tamsulosin, all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The same day two hours after having the shot pain in right arm, started with fever at night, headaches, pain in the knees and not feeling well overall. Next day -Feb 21st same symptoms, managed per primary Dr. with Tylenol and Ibuprofen. On Feb 22-24 symptoms worsen, went to Dr's office she gave him an steroids shot and one shot for pain killer. Feb 25th feeling better. 26Feb admitted to emergency room, many exams, only given Tylenol and Ibuprofen. Feb 27th and 28th stayed home and got worst. Mar 1st- Admitted back to hospital and remains in hospital. Every day since then blood test are done. Symptoms - High Fever, Extreme pain all over specially above knees, below knees, arms, wrist, headaches. Heavy sweats, heart rate high to 145, low blood pressure (80/40), oxygen low saturation 95, no appetite, insomnia, sugar level 340 and above. Adverse event start date was from 18Feb2021 02:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalization was 11. No covid prior vaccination. No covid tested post vaccination.Covid test post vaccination included covid test type post vaccination=Nasal Swab, covid test date=26Feb2021, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Nasal Swab, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Blood test, covid test result=Negative; covid test date=03Mar2021, covid test type post vaccination=Blood test, covid test result=Negative. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood glucose increased, Blood pressure measurement, Blood test, Decreased appetite
Clinical narrative: Extreme pain all over specially above knees, below knees, arms, wrist; Heavy sweats; heart rate high to 145; low blood pressure (80/40); oxygen low saturation 95; no appetite; insomnia; sugar level 340 and above; pain in right arm; high fever; headaches; pain in the knees/Extreme pain all over specially above knees, below knees, arms, wrist; not feeling well overall; This is a spontaneous report from a contactable consumer (parent). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in arm right on 18Feb2021 12:45 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included diabetes, allergy to barley from an unknown date. No allergies to medication. Concomitant medication(s) in two weeks included atenolol; atorvastatin; glipizide; metformin; tamsulosin, all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The same day two hours after having the shot pain in right arm, started with fever at night, headaches, pain in the knees and not feeling well overall. Next day -Feb 21st same symptoms, managed per primary Dr. with Tylenol and Ibuprofen. On Feb 22-24 symptoms worsen, went to Dr's office she gave him an steroids shot and one shot for pain killer. Feb 25th feeling better. 26Feb admitted to emergency room, many exams, only given Tylenol and Ibuprofen. Feb 27th and 28th stayed home and got worst. Mar 1st- Admitted back to hospital and remains in hospital. Every day since then blood test are done. Symptoms - High Fever, Extreme pain all over specially above knees, below knees, arms, wrist, headaches. Heavy sweats, heart rate high to 145, low blood pressure (80/40), oxygen low saturation 95, no appetite, insomnia, sugar level 340 and above. Adverse event start date was from 18Feb2021 02:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalization was 11. No covid prior vaccination. No covid tested post vaccination.Covid test post vaccination included covid test type post vaccination=Nasal Swab, covid test date=26Feb2021, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Nasal Swab, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Blood test, covid test result=Negative; covid test date=03Mar2021, covid test type post vaccination=Blood test, covid test result=Negative. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hyperhidrosis, Hypotension
Clinical narrative: Extreme pain all over specially above knees, below knees, arms, wrist; Heavy sweats; heart rate high to 145; low blood pressure (80/40); oxygen low saturation 95; no appetite; insomnia; sugar level 340 and above; pain in right arm; high fever; headaches; pain in the knees/Extreme pain all over specially above knees, below knees, arms, wrist; not feeling well overall; This is a spontaneous report from a contactable consumer (parent). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in arm right on 18Feb2021 12:45 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included diabetes, allergy to barley from an unknown date. No allergies to medication. Concomitant medication(s) in two weeks included atenolol; atorvastatin; glipizide; metformin; tamsulosin, all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The same day two hours after having the shot pain in right arm, started with fever at night, headaches, pain in the knees and not feeling well overall. Next day -Feb 21st same symptoms, managed per primary Dr. with Tylenol and Ibuprofen. On Feb 22-24 symptoms worsen, went to Dr's office she gave him an steroids shot and one shot for pain killer. Feb 25th feeling better. 26Feb admitted to emergency room, many exams, only given Tylenol and Ibuprofen. Feb 27th and 28th stayed home and got worst. Mar 1st- Admitted back to hospital and remains in hospital. Every day since then blood test are done. Symptoms - High Fever, Extreme pain all over specially above knees, below knees, arms, wrist, headaches. Heavy sweats, heart rate high to 145, low blood pressure (80/40), oxygen low saturation 95, no appetite, insomnia, sugar level 340 and above. Adverse event start date was from 18Feb2021 02:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalization was 11. No covid prior vaccination. No covid tested post vaccination.Covid test post vaccination included covid test type post vaccination=Nasal Swab, covid test date=26Feb2021, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Nasal Swab, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Blood test, covid test result=Negative; covid test date=03Mar2021, covid test type post vaccination=Blood test, covid test result=Negative. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Investigation, Malaise, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: Extreme pain all over specially above knees, below knees, arms, wrist; Heavy sweats; heart rate high to 145; low blood pressure (80/40); oxygen low saturation 95; no appetite; insomnia; sugar level 340 and above; pain in right arm; high fever; headaches; pain in the knees/Extreme pain all over specially above knees, below knees, arms, wrist; not feeling well overall; This is a spontaneous report from a contactable consumer (parent). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in arm right on 18Feb2021 12:45 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included diabetes, allergy to barley from an unknown date. No allergies to medication. Concomitant medication(s) in two weeks included atenolol; atorvastatin; glipizide; metformin; tamsulosin, all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The same day two hours after having the shot pain in right arm, started with fever at night, headaches, pain in the knees and not feeling well overall. Next day -Feb 21st same symptoms, managed per primary Dr. with Tylenol and Ibuprofen. On Feb 22-24 symptoms worsen, went to Dr's office she gave him an steroids shot and one shot for pain killer. Feb 25th feeling better. 26Feb admitted to emergency room, many exams, only given Tylenol and Ibuprofen. Feb 27th and 28th stayed home and got worst. Mar 1st- Admitted back to hospital and remains in hospital. Every day since then blood test are done. Symptoms - High Fever, Extreme pain all over specially above knees, below knees, arms, wrist, headaches. Heavy sweats, heart rate high to 145, low blood pressure (80/40), oxygen low saturation 95, no appetite, insomnia, sugar level 340 and above. Adverse event start date was from 18Feb2021 02:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalization was 11. No covid prior vaccination. No covid tested post vaccination.Covid test post vaccination included covid test type post vaccination=Nasal Swab, covid test date=26Feb2021, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Nasal Swab, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Blood test, covid test result=Negative; covid test date=03Mar2021, covid test type post vaccination=Blood test, covid test result=Negative. The outcome of the events was not recovered.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Extreme pain all over specially above knees, below knees, arms, wrist; Heavy sweats; heart rate high to 145; low blood pressure (80/40); oxygen low saturation 95; no appetite; insomnia; sugar level 340 and above; pain in right arm; high fever; headaches; pain in the knees/Extreme pain all over specially above knees, below knees, arms, wrist; not feeling well overall; This is a spontaneous report from a contactable consumer (parent). A 65-years-old male patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in arm right on 18Feb2021 12:45 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included diabetes, allergy to barley from an unknown date. No allergies to medication. Concomitant medication(s) in two weeks included atenolol; atorvastatin; glipizide; metformin; tamsulosin, all taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The same day two hours after having the shot pain in right arm, started with fever at night, headaches, pain in the knees and not feeling well overall. Next day -Feb 21st same symptoms, managed per primary Dr. with Tylenol and Ibuprofen. On Feb 22-24 symptoms worsen, went to Dr's office she gave him an steroids shot and one shot for pain killer. Feb 25th feeling better. 26Feb admitted to emergency room, many exams, only given Tylenol and Ibuprofen. Feb 27th and 28th stayed home and got worst. Mar 1st- Admitted back to hospital and remains in hospital. Every day since then blood test are done. Symptoms - High Fever, Extreme pain all over specially above knees, below knees, arms, wrist, headaches. Heavy sweats, heart rate high to 145, low blood pressure (80/40), oxygen low saturation 95, no appetite, insomnia, sugar level 340 and above. Adverse event start date was from 18Feb2021 02:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Days hospitalization was 11. No covid prior vaccination. No covid tested post vaccination.Covid test post vaccination included covid test type post vaccination=Nasal Swab, covid test date=26Feb2021, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Nasal Swab, covid test result=Negative; covid test date=01Mar2021, covid test type post vaccination=Blood test, covid test result=Negative; covid test date=03Mar2021, covid test type post vaccination=Blood test, covid test result=Negative. The outcome of the events was not recovered.
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Cellulitis, Lethargy, Malaise, Oropharyngeal pain
Clinical narrative: developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; This spontaneous report was received from a female patient of unknown age reporting on herself via other company Pfizer (manufacturer control # 2021277435). The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-OCT-1998, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot #, expiration date, anatomical location and route of administration were not reported) for prophylaxis.   On an unknown date, the patient experienced an allergy to the vaccine, she developed cellulitis and her arm blew up to twice the size that it normally was, fever, malaise and knee pain. She said that it was a pretty bad allergy. It was reported that he symptoms lasted 3 weeks, however, the outcome was not provided. The patient was advised to never get the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again. The reporter also stated that "pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) has bacterial sugars from 23 pneumococcal viruses and has a preservative called phenol".  The casual relationship between the events of cellulitis, malaise, arthralgia and pyrexia was not provided.  Upon internal review, the event of cellulitis was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; This spontaneous report was received from a female patient of unknown age reporting on herself via other company Pfizer (manufacturer control # 2021277435). The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-OCT-1998, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot #, expiration date, anatomical location and route of administration were not reported) for prophylaxis.   On an unknown date, the patient experienced an allergy to the vaccine, she developed cellulitis and her arm blew up to twice the size that it normally was, fever, malaise and knee pain. She said that it was a pretty bad allergy. It was reported that he symptoms lasted 3 weeks, however, the outcome was not provided. The patient was advised to never get the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again. The reporter also stated that "pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) has bacterial sugars from 23 pneumococcal viruses and has a preservative called phenol".  The casual relationship between the events of cellulitis, malaise, arthralgia and pyrexia was not provided.  Upon internal review, the event of cellulitis was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Cellulitis, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; developed a allergy to it: cellulitis and her arm blew up to twice the size that it normally is, fever, malaise , and knee pain; This spontaneous report was received from a female patient of unknown age reporting on herself via other company Pfizer (manufacturer control # 2021277435). The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 28-OCT-1998, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot #, expiration date, anatomical location and route of administration were not reported) for prophylaxis.   On an unknown date, the patient experienced an allergy to the vaccine, she developed cellulitis and her arm blew up to twice the size that it normally was, fever, malaise and knee pain. She said that it was a pretty bad allergy. It was reported that he symptoms lasted 3 weeks, however, the outcome was not provided. The patient was advised to never get the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) again. The reporter also stated that "pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) has bacterial sugars from 23 pneumococcal viruses and has a preservative called phenol".  The casual relationship between the events of cellulitis, malaise, arthralgia and pyrexia was not provided.  Upon internal review, the event of cellulitis was determined to be medically significant.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: was in so much pain / pain was horrific; arm was / painful; arm was stiff; shaking; could not sleep; she could not dress / shower, wash her hair / do daily activities; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2021 16:00, the patient received Shingrix (intramuscular). On 18th February 2021, 3 hrs after receiving Shingrix, the patient experienced pain, pain in arm, stiffness, tremor, insomnia and activities of daily living impaired. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the pain in arm, stiffness, tremor, insomnia and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain, pain in arm, stiffness, tremor, insomnia and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had second dose around 4 pm and by 7 pm, her arm was stiff and painful. She was in so much pain she was shaking and could not sleep for days. She could not dress herself, shower, wash her hair or do daily activities. The patient told that pain was horrific and the physician suggested medicines ibuprofen 800 mg just to sleep. The patient would like to know how long this was going to last. The patient was provided with medical disclaimer, referred to health care professional, offered and emailed package instructions. The patient did not consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain in extremity, Tremor
Clinical narrative: was in so much pain / pain was horrific; arm was / painful; arm was stiff; shaking; could not sleep; she could not dress / shower, wash her hair / do daily activities; This case was reported by a consumer via call center representative and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th February 2021 16:00, the patient received Shingrix (intramuscular). On 18th February 2021, 3 hrs after receiving Shingrix, the patient experienced pain, pain in arm, stiffness, tremor, insomnia and activities of daily living impaired. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the pain in arm, stiffness, tremor, insomnia and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain, pain in arm, stiffness, tremor, insomnia and activities of daily living impaired to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had second dose around 4 pm and by 7 pm, her arm was stiff and painful. She was in so much pain she was shaking and could not sleep for days. She could not dress herself, shower, wash her hair or do daily activities. The patient told that pain was horrific and the physician suggested medicines ibuprofen 800 mg just to sleep. The patient would like to know how long this was going to last. The patient was provided with medical disclaimer, referred to health care professional, offered and emailed package instructions. The patient did not consented to follow up.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood iron, Blood thyroid stimulating hormone, Chest pain, Diarrhoea, Dizziness
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Fatigue, Full blood count, Headache
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipids, Nausea, Pain in extremity, Palpitations, Reticulocyte count
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Serum ferritin, Sluggishness, Syncope, Thyroxine
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitamin B12
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Diarrhoea, Dizziness
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Headache, Hyperhidrosis, Pain, SARS-CoV-2 test negative
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Throat irritation
Clinical narrative: 2/13/21 - patient woke up with severe headache and body aches - dizziness with moving around.  Body aches went away after a week, but headaches continue - headache daily and dizziness has also continued daily - some days worse than others -dizziness happens when standing from sitting position. On 2/24/21 - patient woke with dripping sweat - tightness in chest, diarrhea, throat burning and syncopal. Patient saw health care provider 2/25/21 - blood work was done (not sure specifics). Patient reports blood work normal. BP checked laying, sitting and standing - no significant changes noted in BP with change in position per patient. Cardiac testing scheduled. Covid test on 3/7/21 - negative - stress test and ultra sound on 3/12/21 - these tests were normal per patient. Patient continues to have headache and dizziness. Patient is continuing to work at this time with MD note.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Amphetamines positive, Arteriosclerosis, Autopsy, Cardiac disorder
Clinical narrative: Sudden cardiac arrest resulting in death while watching movie with patient's family.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Drug screen positive, Vaccination complication
Clinical narrative: Sudden cardiac arrest resulting in death while watching movie with patient's family.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Death
Clinical narrative: Sudden cardiac arrest resulting in death while watching movie with patient's family.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Blood thyroid stimulating hormone increased, Echocardiogram, Electrocardiogram abnormal, Fibrin D dimer increased
Clinical narrative: Immediate (2 min after injection) increase in rest pulse to 150 bpm accompanied by hot flushes through the body. Three spikes within 2 hours, then diminishing and dissapeering completely in the evening. Next day (03/09/2021) - sudden dizinnes and a short lost of concious, following by pulse spike to 150 bpm, pounding heartbit, difficulty to breeze, shaking. Called 911 and was transported by paramedics to hospital. Blood work, echo, CT scan, EKG, and echo were normal.  Monitored overnight, relesed the next day without a diagnosis/prescription.  Continue on page 3
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Flushing, Palpitations, Sinus tachycardia, Thyroxine normal, Troponin normal
Clinical narrative: Immediate (2 min after injection) increase in rest pulse to 150 bpm accompanied by hot flushes through the body. Three spikes within 2 hours, then diminishing and dissapeering completely in the evening. Next day (03/09/2021) - sudden dizinnes and a short lost of concious, following by pulse spike to 150 bpm, pounding heartbit, difficulty to breeze, shaking. Called 911 and was transported by paramedics to hospital. Blood work, echo, CT scan, EKG, and echo were normal.  Monitored overnight, relesed the next day without a diagnosis/prescription.  Continue on page 3
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Dyspnoea, Echocardiogram normal
Clinical narrative: Immediate (2 min after injection) increase in rest pulse to 150 bpm accompanied by hot flushes through the body. Three spikes within 2 hours, then diminishing and dissapeering completely in the evening. Next day (03/09/2021) - sudden dizinnes and a short lost of concious, following by pulse spike to 150 bpm, pounding heartbit, difficulty to breeze, shaking. Called 911 and was transported by paramedics to hospital. Blood work, echo, CT scan, EKG, and echo were normal.  Monitored overnight, relesed the next day without a diagnosis/prescription.  Continue on page 3
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Flushing, Heart rate increased, Loss of consciousness, Palpitations
Clinical narrative: Immediate (2 min after injection) increase in rest pulse to 150 bpm accompanied by hot flushes through the body. Three spikes within 2 hours, then diminishing and dissapeering completely in the evening. Next day (03/09/2021) - sudden dizinnes and a short lost of concious, following by pulse spike to 150 bpm, pounding heartbit, difficulty to breeze, shaking. Called 911 and was transported by paramedics to hospital. Blood work, echo, CT scan, EKG, and echo were normal.  Monitored overnight, relesed the next day without a diagnosis/prescription.  Continue on page 3