chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Rash morbilliform
Clinical narrative: upper body measles-type rash (stomach, chest, back); facial flush; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself.  A 66-year-old (non-pregnant) female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), via intramuscular route of administration, administered in the Left arm on 23Feb2021 at 14.00 as dose 1, single for COVID-19 immunisation. The patient's medical history includes known allergies to Benadryl, codeine, gadolinium contrast medium, PCN, Tramadol, Zyrtec, mushrooms. Other medical History includes, esophageal spasms, inverse psoriasis, tachycardia, IBS, Vitamin B & D deficiency. The patient's concomitant medications/List of other medications the patient received within 2 weeks of vaccination includes: Famotidine; Metoprolol; Trazodone; fexofenadine hydrochloride (ALLEGRA); colecalciferol (D3); cyanocobalamin (B12) all taken for unspecified indication and unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The adverse events (AE) start time was reported as 14:15, on 23Feb2021 the patient experienced upper body measles-type rash (stomach, chest, back); facial flush Symptoms began 12 minutes after medication dispensed IM Symptoms began dissipating 90 minutes after onset, completely cleared at 3 hours post injection. Seen at site by paramedics, suggested Benadryl, refused due to allergy; remained at site for 90 minutes, then sent home. Reaction reported to primary care physician 24Feb2021. No treatment received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The adverse events were reported as non-serious. The outcome of the adverse events was reported as recovered on 23Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Painful respiration, Sleep disorder, Swelling
Clinical narrative: headache; difficulty breathing/This morning I was out of breath from doing almost nothing; couldn't lay flat, had to sit up; neck swelling; Maternal Exposure During Pregnancy, third trimester; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother(herself) and foetus/baby. This is a maternal report. A 37-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20May2021 11:15 (at the age of 37 years), as dose 2, single for Covid-19 immunisation. The patient was pregnant at the time of vaccination. Medical history included pregnancy from an unknown date and unknown if ongoing. Concomitant medications included piroxicam (ROGAM) taken for an unspecified indication from 05Apr2021 to 05Apr2021; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication from 05Apr2021 to 05Apr2021; sertraline hydrochloride (ZOLOF) and acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for Covid-19. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 29Apr2021 at 11:15AM as dose 1, single for Covid-19 immunisation. The patient stated that after 2nd dose shot at 11:15am, she took Tylenol at 9pm because she had a headache and that was what was recommended and a prenatal vitamin. At 9:30 difficulty breathing, could only take small, short breathes, could not lay flat, had to sit up, neck swelling, had to remove her necklaces, finally lessened around 5am when she was able to go back to sleep. This morning (20May2021) she was out of breath from doing almost nothing". The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 39 Weeks pregnant at the onset of the event. The mother was due to deliver on 10Jun2021. The mother delivered the pregnancy on 10Jun2021. Events assessed as non-serious. Therapeutic measures were taken as a result of headache and unknown for other events. The clinical outcome of the event Maternal Exposure During Pregnancy, third trimester was unknown, remaining all other events was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Loss of personal independence in daily activities, Maternal exposure during pregnancy, Swelling
Clinical narrative: headache; difficulty breathing/This morning I was out of breath from doing almost nothing; couldn't lay flat, had to sit up; neck swelling; Maternal Exposure During Pregnancy, third trimester; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother(herself) and foetus/baby. This is a maternal report. A 37-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 20May2021 11:15 (at the age of 37 years), as dose 2, single for Covid-19 immunisation. The patient was pregnant at the time of vaccination. Medical history included pregnancy from an unknown date and unknown if ongoing. Concomitant medications included piroxicam (ROGAM) taken for an unspecified indication from 05Apr2021 to 05Apr2021; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication from 05Apr2021 to 05Apr2021; sertraline hydrochloride (ZOLOF) and acetylsalicylic acid (ASPRIN) taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for Covid-19. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 29Apr2021 at 11:15AM as dose 1, single for Covid-19 immunisation. The patient stated that after 2nd dose shot at 11:15am, she took Tylenol at 9pm because she had a headache and that was what was recommended and a prenatal vitamin. At 9:30 difficulty breathing, could only take small, short breathes, could not lay flat, had to sit up, neck swelling, had to remove her necklaces, finally lessened around 5am when she was able to go back to sleep. This morning (20May2021) she was out of breath from doing almost nothing". The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. The mother reported she became pregnant while taking bnt162b2. The mother was 39 Weeks pregnant at the onset of the event. The mother was due to deliver on 10Jun2021. The mother delivered the pregnancy on 10Jun2021. Events assessed as non-serious. Therapeutic measures were taken as a result of headache and unknown for other events. The clinical outcome of the event Maternal Exposure During Pregnancy, third trimester was unknown, remaining all other events was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Asthenia, Back pain, Biopsy endometrium, Blood test
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Endocrine test, Fatigue
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Glucose urine present, Haematuria, Menstrual disorder, Muscle spasms
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Pelvic pain, Thirst, Ultrasound scan
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary tract infection, Vaginal haemorrhage
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glucose urine present, Haematuria, Headache, Muscle spasms, Pain in extremity
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pelvic pain, Urinary tract infection, Uterine haemorrhage, Vaginal haemorrhage
Clinical narrative: chills; uterine/vaginal bleeding-profuse/severe/abnormal; uterine/vaginal bleeding-profuse/severe/abnormal; sudden onset UTI; hematuria; sugar in urine; leg pain; leg pain/cramping; heart palpitations; headache; light headed/ light flow dizziness; Difficulty breathing; Severe pelvic cramping/ severe pelvic pain; lower back pain; fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0172, first dose) solution for injection intramuscular in the right arm on 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included IBS (irritable bowel syndrome) for 20 years, uterine fibroids (bulk symptoms/ no bleeding), Barrett's esophagus, and no menstruation or spotting from Mar2021. Last menstrual cycle was in Feb2021. Concomitant medications included atenolol and daily supplements. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 01May2021, the patient experienced leg pain/cramping, heart palpitations, headache, lightheaded, difficulty breathing, severe pelvic cramping, lower back pain, fatigue. On 07May2021, the patient had sudden onset UTI (urinary tract infection), hematuria unspecified/sugar in urine. On 14May2021 at 15:00, the patient had sudden onset uterine/vaginal bleeding- profuse/severe/abnormal duration 14May2021- 17May2021- profuse. On 18May2021 - 22May2021 (currently) the patient had light  flow dizziness, chills, leg cramp/pain, fatigue, severe pelvic pain, difficulty breathing. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included iron supplements. The outcome of the events uterine/vaginal bleeding was recovered on 17May2021. The outcome of the events leg pain/cramping, lightheaded, difficulty breathing, pelvic pain, fatigue, chills was not recovered. The outcome of the other events was unknown. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed. No further information expected.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Other than a temporal association and based on the available information there is no evidence or argument to suggest a causal relationship between the reported events and BNT162B2 administration.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle spasms, Muscle tightness, Musculoskeletal discomfort, Palpitations
Clinical narrative: Heart palpitations; Muscle spams; Ringing in ears; Headache; Tingling in hands, feet, and legs; This is a spontaneous report from a contactable consumer (patient).  A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 at 13:30 as 2nd dose, single for COVID-19 immunization (at the age of 36-years). The patient medical history, family history and concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP6955; expiration date: unknown, NDC Number: unknown) via an unspecified route in Left arm on 16Mar2021 for covid-19 immunization. Patient did not receive any additional vaccines administered on same date of the Pfizer suspect. Also, she did not receive any prior vaccinations (within 4 weeks). On an unspecified date, the patient experienced about 2 weeks after the second dose of the Covid Vaccine she began experiencing ringing in her ears and this was continued. Reporter stated that she had other symptoms as well. She had tingling in her hands, feet, and legs that is continuing. She had muscle spasms that was continuing. She had heart palpitations; states they continue as she had some today. States that she had headaches. The patient has been to a couple of ear, nose and throat doctors, the emergency room, her primary care doctor, and the urgent care. The outcome of headache was recovered on an unspecified date in 2021, while outcome of other events was not recovered.   Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.  Follow up attempts are needed; Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Syncope, Tinnitus
Clinical narrative: Heart palpitations; Muscle spams; Ringing in ears; Headache; Tingling in hands, feet, and legs; This is a spontaneous report from a contactable consumer (patient).  A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 at 13:30 as 2nd dose, single for COVID-19 immunization (at the age of 36-years). The patient medical history, family history and concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP6955; expiration date: unknown, NDC Number: unknown) via an unspecified route in Left arm on 16Mar2021 for covid-19 immunization. Patient did not receive any additional vaccines administered on same date of the Pfizer suspect. Also, she did not receive any prior vaccinations (within 4 weeks). On an unspecified date, the patient experienced about 2 weeks after the second dose of the Covid Vaccine she began experiencing ringing in her ears and this was continued. Reporter stated that she had other symptoms as well. She had tingling in her hands, feet, and legs that is continuing. She had muscle spasms that was continuing. She had heart palpitations; states they continue as she had some today. States that she had headaches. The patient has been to a couple of ear, nose and throat doctors, the emergency room, her primary care doctor, and the urgent care. The outcome of headache was recovered on an unspecified date in 2021, while outcome of other events was not recovered.   Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.  Follow up attempts are needed; Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscle spasms, Palpitations, Paraesthesia, Tinnitus
Clinical narrative: Heart palpitations; Muscle spams; Ringing in ears; Headache; Tingling in hands, feet, and legs; This is a spontaneous report from a contactable consumer (patient).  A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 at 13:30 as 2nd dose, single for COVID-19 immunization (at the age of 36-years). The patient medical history, family history and concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: EP6955; expiration date: unknown, NDC Number: unknown) via an unspecified route in Left arm on 16Mar2021 for covid-19 immunization. Patient did not receive any additional vaccines administered on same date of the Pfizer suspect. Also, she did not receive any prior vaccinations (within 4 weeks). On an unspecified date, the patient experienced about 2 weeks after the second dose of the Covid Vaccine she began experiencing ringing in her ears and this was continued. Reporter stated that she had other symptoms as well. She had tingling in her hands, feet, and legs that is continuing. She had muscle spasms that was continuing. She had heart palpitations; states they continue as she had some today. States that she had headaches. The patient has been to a couple of ear, nose and throat doctors, the emergency room, her primary care doctor, and the urgent care. The outcome of headache was recovered on an unspecified date in 2021, while outcome of other events was not recovered.   Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.  Follow up attempts are needed; Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left leg on an unspecified date in 2021 as dose number unknown, single for covid-19 immunisation at workplace clinic. The patient did not have any known allergies and other medical history was reported as none. List of any other medications the patient received within 2 weeks of vaccination included birth control allergy medicine. On an unspecified date in 2021, the patient experienced vaginal bleeding. Reportedly, vaginal bleeding has not stopped. It was reported that the Obgyn has to put her on progesterone to stop the bleeding. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left leg on an unspecified date in 2021 as dose number unknown, single for covid-19 immunisation at workplace clinic. The patient did not have any known allergies and other medical history was reported as none. List of any other medications the patient received within 2 weeks of vaccination included birth control allergy medicine. On an unspecified date in 2021, the patient experienced vaginal bleeding. Reportedly, vaginal bleeding has not stopped. It was reported that the Obgyn has to put her on progesterone to stop the bleeding. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The case was reported as non-serious with no seriousness criteria (Results in death/ Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/ Congenital anomaly/birth defect). The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Neuralgia, Plantar fasciitis
Clinical narrative: I had plantar fasciitis that was almost healed and the morning after dose 2(which was Apr 22 around 3 pm), my plantar felt like it was tearing open; Plantar fasciitis; tingling foot; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 22Apr2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and plantar fasciitis. The patient previously took Tegretol and Dilantin and experienced allergy to the medications. The patient received medications within two weeks of vaccination, but the medications were unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ex8732) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 04:00, the patient reported that plantar felt like it was tearing open and had tingling in foot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events plantar fasciitis and tingling in foot which included treatment with acupuncture, non-steroidal anti-inflammatory drugs (NSAIDs), shiatsu massage and physical therapy (PT). Since the vaccination, the patient had not been tested for COVID-19 The clinical outcome of the event plantar felt like it was tearing open and had tingling in foot was not recovered at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Paraesthesia, Plantar fasciitis
Clinical narrative: I had plantar fasciitis that was almost healed and the morning after dose 2(which was Apr 22 around 3 pm), my plantar felt like it was tearing open; Plantar fasciitis; tingling foot; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 22Apr2021 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and plantar fasciitis. The patient previously took Tegretol and Dilantin and experienced allergy to the medications. The patient received medications within two weeks of vaccination, but the medications were unspecified. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ex8732) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 04:00, the patient reported that plantar felt like it was tearing open and had tingling in foot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events plantar fasciitis and tingling in foot which included treatment with acupuncture, non-steroidal anti-inflammatory drugs (NSAIDs), shiatsu massage and physical therapy (PT). Since the vaccination, the patient had not been tested for COVID-19 The clinical outcome of the event plantar felt like it was tearing open and had tingling in foot was not recovered at the time of this report.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Injection site pain,; Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 20May2021 at 12:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertensive, hypercholesterolemia, sleep apnea, cervical pap smear abnormal, allergy to pineapple and COVID-19. Patient received unspecified other medications within two weeks of vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN), unysen and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, arm pain were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Injection site pain,; Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 20May2021 at 12:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertensive, hypercholesterolemia, sleep apnea, cervical pap smear abnormal, allergy to pineapple and COVID-19. Patient received unspecified other medications within two weeks of vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN), unysen and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, arm pain were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Injection site pain,; Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 20May2021 at 12:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertensive, hypercholesterolemia, sleep apnea, cervical pap smear abnormal, allergy to pineapple and COVID-19. Patient received unspecified other medications within two weeks of vaccination. The patient previously took morphine (MANUFACTURER UNKNOWN), unysen and experienced drug allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20May2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, arm pain were resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.