chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: Severe nausea; vomiting bile; Sore arm (preventing sleep); Exhaustion; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 15Apr2021 at 16:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia, asthma, depression and anxiety. The patient had no known allergies to medications, food, or other products. 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. Concomitant medications included sertraline hydrochloride (ZOLOFT), buspirone hydrochloride (BUSPAR) and ethinylestradiol/norethisterone acetate (JUNEL) for an unknown indication from an unknown date and unknown if ongoing. On 15Apr2021 at 19:00, the patient experienced severe nausea (vomiting bile), sore arm (preventing sleep), exhaustion and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe nausea (vomiting bile), sore arm (preventing sleep), exhaustion and headache was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: After my second vaccine shot my period was four days late / The bleeding has now lasted 10 days; Lasted for 10 days of very heavy bleeding, and then I had medium to low amounts of bleeding for the next 30 days after that / My next cycle was 40 days long which is almost 2 weeks longer than it normally; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the arm left on 25Jan2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. 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. Concomitant medication included etonogestrel (NEXPLANON) for birth control from an unknown date and ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 04Jan2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 28Feb2021, after her second vaccine shot, the patient experienced her period was four days late. It then lasted for 10 days of very heavy bleeding, and then she had medium to low amounts of bleeding for the next 30 days after that. On an unknown date in 2021 the patient experienced her next cycle was 40 days long which was almost 2 weeks longer than it normally was. The bleeding had then lasted 10 days. The patient went and had an ultrasound done of her uterus, she was not pregnant and nor was ever pregnant. The patient did not have a miscarriage, no ovarian cyst, and no fibroids in her uterus. It was also reported that the gynaecologist cannot describe to her why her periods had changed in that way. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the events included ultrasound of uterus. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 'after my second vaccine shot my period was four days late / the bleeding has now lasted 10 days' and 'lasted for 10 days of very heavy bleeding, and then I had medium to low amounts of bleeding for the next 30 days after that / My next cycle was 40 days long which is almost 2 weeks longer than it normally' was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Muscle spasms, Myalgia
Clinical narrative: Headache; Nausea; Muscle pain; Muscle spasms; Cramps; Fever; Hot and cold chills; Shortness of breath; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. 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. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 22:00, the patient experienced headache, nausea, muscle pain, muscle spasms, cramps, fever, hot and cold chills, shortness of breath and difficulty breathing. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, muscle pain, muscle spasms, cramps, fever, hot and cold chills, shortness of breath and difficulty breathing were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache; Nausea; Muscle pain; Muscle spasms; Cramps; Fever; Hot and cold chills; Shortness of breath; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the right arm on 14Apr2021 at 10:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. 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. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 22:00, the patient experienced headache, nausea, muscle pain, muscle spasms, cramps, fever, hot and cold chills, shortness of breath and difficulty breathing. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. No therapeutic measures were taken as a result of the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea, muscle pain, muscle spasms, cramps, fever, hot and cold chills, shortness of breath and difficulty breathing were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Tinnitus
Clinical narrative: Severe Tinnitus getting louder; fluid in ears; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 02Mar2021 at 16:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) in the right arm on 26Mar2021 at 10:15 (at the age of 68-years-old) for COVID-19 immunisation. Medical history included asthma and hypertension. The patient previously took tetracycline (MANUFACTURER UNKNOWN) and duloxetine hydrochloride(CYMBALTA) on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified medication (Prescribed) within two weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the vaccination. On an unknown date in Mar2021 the patient experienced severe tinnitus getting louder and fluid in ears. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events that included referral to ENT. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe tinnitus getting louder and fluid in ears was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Urticaria
Clinical narrative: I am starting to bruise quite a bit and it seems like it is attacking weak parts of my body; hives; itch; This is a spontaneous report from a contactable consumer (patient) via  sponsored program  support. A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8734, NDC number, UPC number and expiry date: unknown), via an unspecified route of administration on 30Mar2021 (at the age of 64 years old) in right arm (shoulder) as dose 1, single for covid-19 immunisation. The medical history was not reported. Concomitant medications included blood thinners and stuff like that. Two to three days after vaccination on an unspecified date in Apr2021, the patient got hives that breakout and itched like crazy. Also, the hives would go away but it still itched, plus he had noticed he was starting to bruise quite a bit and it seemed like it was attacking weak parts of his body. He asked was that normal or was that some of the side effects that all were having. The patient had been to his family physician, and he was treated with an unspecified shot to help him, so that he doesn't breakout and itch. The patient reported that it was steroid or something, but it does not seem like it, but it helped. No unaddressed medical questions referred or forwarded to medical information. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Malaise, Muscle spasms
Clinical narrative: Violently ill 8 hrs after vaccine to 16 hrs after vaccine. Never been so sick in "my" life.; Vomiting; diarrhea; fever; chills; aches; headache; cramping; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the arm left on 15Apr2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient's medical history were reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of vaccination. On 15Apr2021 at 16:00, 8 hours after vaccine the patient experienced violently ill to 16 hours after vaccine. The patient was never been so sick in her life. The patient also experienced vomiting, diarrhea, fever, chills, aches, headache and cramping. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event violently ill was recovered on 16Apr2021, while the clinical outcome of the events vomiting, diarrhea, fever, chills, aches, headache and cramping was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Violently ill 8 hrs after vaccine to 16 hrs after vaccine. Never been so sick in "my" life.; Vomiting; diarrhea; fever; chills; aches; headache; cramping; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8735) via an unspecified route of administration in the arm left on 15Apr2021 at 08:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient's medical history were reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of vaccination. On 15Apr2021 at 16:00, 8 hours after vaccine the patient experienced violently ill to 16 hours after vaccine. The patient was never been so sick in her life. The patient also experienced vomiting, diarrhea, fever, chills, aches, headache and cramping. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event violently ill was recovered on 16Apr2021, while the clinical outcome of the events vomiting, diarrhea, fever, chills, aches, headache and cramping was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Moderate but sometimes severe joint pain in both of the knees; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6511) via an unspecified route of administration in the left arm on 05Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 01Apr2021 at 12:00, the patient experienced moderate but sometimes severe joint pain in both the knees. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event moderate but sometimes severe joint pain in both the knees was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Confusional state, Dizziness, Feeling abnormal
Clinical narrative: experienced chest pressure, palpitation & dizziness; experienced chest pressure, palpitation & dizziness; experienced chest pressure, palpitation & dizziness; chest pain; racing heart beat; confusion; brain fog/a feeling of everything being foggy around me; This is a spontaneous report from a contactable consumer or other non-health care professional reported for herself (patient). A 36-years-old non pregnant female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 10:30 (Batch/Lot Number: ER8730) (at the age of 36-years-old) as dose 1, single and dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 10:45 (Batch/Lot Number: ER8729) (at the age of 36-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergy towards penicillin, gluten, dairy, pollen, dust mites & cats from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for Covid-19 since the vaccination. On 26Mar2021 10:30, the patient experienced chest pressure, chest pain, racing heartbeat, confusion, brain fog, dizziness & a feeling of everything being foggy around her. The patient was visited for doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The patient underwent lab tests and procedures on 06Apr2021, which included Nasal swab test (sars-cov-2 test) resulted to negative. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations, SARS-CoV-2 test
Clinical narrative: experienced chest pressure, palpitation & dizziness; experienced chest pressure, palpitation & dizziness; experienced chest pressure, palpitation & dizziness; chest pain; racing heart beat; confusion; brain fog/a feeling of everything being foggy around me; This is a spontaneous report from a contactable consumer or other non-health care professional reported for herself (patient). A 36-years-old non pregnant female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 10:30 (Batch/Lot Number: ER8730) (at the age of 36-years-old) as dose 1, single and dose 2 via an unspecified route of administration, administered in arm left on 16Apr2021 10:45 (Batch/Lot Number: ER8729) (at the age of 36-years-old) as dose 2, single for covid-19 immunisation. Medical history included allergy towards penicillin, gluten, dairy, pollen, dust mites & cats from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for Covid-19 since the vaccination. On 26Mar2021 10:30, the patient experienced chest pressure, chest pain, racing heartbeat, confusion, brain fog, dizziness & a feeling of everything being foggy around her. The patient was visited for doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. The patient underwent lab tests and procedures on 06Apr2021, which included Nasal swab test (sars-cov-2 test) resulted to negative. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Confusional state, Dyspnoea, Electrocardiogram, Erythema
Clinical narrative: Pain in arm at the vaccine site; Arm was red and swollen and worsened throughout the day; Arm was red and swollen and worsened throughout the day; Extreme fatigue; Confusion; Vertigo; Shakiness; Shortness of breath; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), hydrochlorothiazide/triamterene (TRIAMTERENE/HCTZ) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 and 26Feb2021, the patient had the normal symptoms. On 01Mar2021, the patient was awakened by pain in the arm at the vaccine site. The arm was red and swollen and worsened throughout the day and also experienced symptoms of extreme fatigue, confusion, vertigo, shakiness, shortness of breath and nausea began throughout the day. The patient was trying to push through and not believe it was related to the vaccine, but after a couple days, the patient had to stop pushing. The more severe symptoms lasted two weeks and then the vertigo began to diminish. The patient was still experiencing some. The patient was giving it a month to go away. Then went to her doctor. Fatigue, shakiness and SOB were still the worst. On an unknown date, the patient underwent lab tests (unspecified) and results was normal. On an unknown date, the patient underwent electrocardiogram test (EKG) and the result was normal. On an unknown date, the patient underwent CT scan and the result was ruled out blood clots. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm at the vaccine site, arm was red and swollen, nausea, vertigo, confusion was recovered with sequelae on an unknown date in2021 and of the events extreme fatigue, shakiness and shortness of breath was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Laboratory test, Nausea, Peripheral swelling, Tremor
Clinical narrative: Pain in arm at the vaccine site; Arm was red and swollen and worsened throughout the day; Arm was red and swollen and worsened throughout the day; Extreme fatigue; Confusion; Vertigo; Shakiness; Shortness of breath; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), hydrochlorothiazide/triamterene (TRIAMTERENE/HCTZ) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 and 26Feb2021, the patient had the normal symptoms. On 01Mar2021, the patient was awakened by pain in the arm at the vaccine site. The arm was red and swollen and worsened throughout the day and also experienced symptoms of extreme fatigue, confusion, vertigo, shakiness, shortness of breath and nausea began throughout the day. The patient was trying to push through and not believe it was related to the vaccine, but after a couple days, the patient had to stop pushing. The more severe symptoms lasted two weeks and then the vertigo began to diminish. The patient was still experiencing some. The patient was giving it a month to go away. Then went to her doctor. Fatigue, shakiness and SOB were still the worst. On an unknown date, the patient underwent lab tests (unspecified) and results was normal. On an unknown date, the patient underwent electrocardiogram test (EKG) and the result was normal. On an unknown date, the patient underwent CT scan and the result was ruled out blood clots. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm at the vaccine site, arm was red and swollen, nausea, vertigo, confusion was recovered with sequelae on an unknown date in2021 and of the events extreme fatigue, shakiness and shortness of breath was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vertigo
Clinical narrative: Pain in arm at the vaccine site; Arm was red and swollen and worsened throughout the day; Arm was red and swollen and worsened throughout the day; Extreme fatigue; Confusion; Vertigo; Shakiness; Shortness of breath; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Feb2021 at 11:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, high blood pressure and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), hydrochlorothiazide/triamterene (TRIAMTERENE/HCTZ) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021 and 26Feb2021, the patient had the normal symptoms. On 01Mar2021, the patient was awakened by pain in the arm at the vaccine site. The arm was red and swollen and worsened throughout the day and also experienced symptoms of extreme fatigue, confusion, vertigo, shakiness, shortness of breath and nausea began throughout the day. The patient was trying to push through and not believe it was related to the vaccine, but after a couple days, the patient had to stop pushing. The more severe symptoms lasted two weeks and then the vertigo began to diminish. The patient was still experiencing some. The patient was giving it a month to go away. Then went to her doctor. Fatigue, shakiness and SOB were still the worst. On an unknown date, the patient underwent lab tests (unspecified) and results was normal. On an unknown date, the patient underwent electrocardiogram test (EKG) and the result was normal. On an unknown date, the patient underwent CT scan and the result was ruled out blood clots. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in arm at the vaccine site, arm was red and swollen, nausea, vertigo, confusion was recovered with sequelae on an unknown date in2021 and of the events extreme fatigue, shakiness and shortness of breath was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Lethargy, Vaccination site discomfort
Clinical narrative: Extreme lethargy; Pounding headache; Unable to use left arm (site of injection/unable to lift arm); Had to be driven home from work; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 23Mar2021 at 14:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 07:15, the patient experienced extreme lethargy, pounding headache, unable to use left arm (site of injection/unable to lift arm) and had to be driven home from work. The patient had to call off work the following day and able to return to work on day 3. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme lethargy, pounding headache, unable to use left arm (site of injection/unable to lift arm) and had to be driven home from work were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: A missed period; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. 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 05Apr2021 at 00:00, the patient experienced a missed period and reported that she was not pregnant. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event a missed period was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, Skin discolouration, X-ray
Clinical narrative: Severe pain in right hand including fingers turning white/ forearm aching tremendously/ Excruciating pain in her middle finger (right hand),severe pain with the gentlest of touch, At clinic, she indicated her pain was a 9 (out of 10); Tingling sensation; Finger tips going numb; severe pain in right hand including fingersturning white,; This is a spontaneous report from a contactable consumer. An 84-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 18:30 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa, penicillin and COVID-19 (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. Concomitant medications included levothyroxine sodium (SYNTHROID), for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. On 31Mar2021 at 19:30, the patient experienced severe pain in right hand including fingers turning white, tingling sensation and then finger tips going numb, also complained of forearm aching tremendously. On easter, 04Apr2021, had to rush mother to a medical check facility in the middle of easter dinner as she was experiencing excruciating pain in her middle finger (right hand), experienced severe pain with the gentlest of touch. At clinic, she indicated her pain was a 9 (out of 10) while discussing with the nurse practitioner. The nurse practitioner took x-rays but found no broken bones so sent her to home with a prescription of steroids and said to contact her primary care physician. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported events which included treatment with prescribed oral steroid (MANUFACTURER UNKNOWN). The clinical outcome of the event Severe pain in right hand including fingers turning white/ Forearm aching tremendously/ Excruciating pain in her middle finger (right hand), severe pain with the gentlest of touch, At clinic, she indicated her pain was a 9 (out of 10), tingling sensation and finger tips going numb was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness on my neck, on my face, on my scalp; This is a spontaneous report from a contactable Consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced itchiness and stated "I got the Pfizer vaccine, my first shot. And I just had a itchiness on my neck, on my face, on my scalp. I took an anti-histamine and it helped me out. But I was going to ask you is it safe to continue on the second vaccine if I have those types of side effects." The outcome for the events was unknown.  No follow-up attempts are possible. Lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Extreme fatigue; Temp of 101.2; Chills; Severe headache/ headache secondday after; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 14Apr2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and nature's bounty immune 24h (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 01:00, the patient experienced temperature of 101.2, chills and severe headache from "1am to 3pm" after shot, extreme fatigue and headache second day after. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 14Apr2021 patient checked her body temperature and it was 101.2 (unspecified units). Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events temperature of 101.2, chills, severe headache and extreme fatigue was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: Early periods; Late periods; Irregular cycles; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, asthma and allergy to topical drugs. The patient previously received diphenhydramine; paracetamol; phenylpropanolamine hydrochloride (BENADRYL) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the arm left on 11Feb2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation ( also reported that the patient was menstruating at time of 1st dose). The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04Mar2021, the patient experienced next menstruation was a week early, 2 hours after second dose. On an unknown date in 2021, the patient experienced the following menstrual cycle which was 4 days late, then menstruating again 15 days into her menstruation cycle. The patient had not been in any other medication, no stress, no illness, and never had irregular cycles. This was completely new since the vaccine.  The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events early periods, late periods and irregular cycles was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Chills; Headache; Fever; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 92-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 30Mar2021 at 11:30 (at the age of 92-years-old) as a single dose for COVID-19 immunisation. The medical history included A-Fib (Atrial fibrillation) and COVID-19. It was not sure whether the patient had any known allergies. 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 vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 31Mar2021, the patient experienced chills, headache, fever and extreme fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, headache, fever and extreme fatigue was recovered with sequelae on an unknown date in 2021.    No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: extreme tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8279) via an unspecified route of administration in the arm left on 12Apr2021 at 13:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic asthma, hypertension, arthritis and tinnitus. 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. Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and famotidine (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received omeprazole sodium (MANUFACTURER UNKNOWN), midazolam (MANUFACTURER UNKNOWN), ketamine (MANUFACTURER UNKNOWN) and amoxicillin/clavulanic acid (MANUFACTURER UNKNOWN) and experienced drug allergy. On 15Apr2021 at 13:15, the patient experienced extreme tinnitus since vaccination, previously patient had a history of tinnitus that had been tolerable, but after vaccination it was extreme. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. 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. Concomitant medication included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at 16:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced severe joint pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe joint pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Severe shoulder pain; Reduced mobility; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications or other products. 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 COVID-19 vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 09Apr2021, the patient experienced severe shoulder pain and reduced mobility. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shoulder pain and reduced mobility were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.