chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, X-ray
Clinical narrative: Severe chest pain; extremely breathing difficulty; Patient's parent suspected that the chest pain was casued by surrounding muscle aches, which caused breathing difficulties and lack of oxygen; This is a spontaneous report from a contactable consumer or other non hcp (reported for herself). A 17-years-old non-regnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in Arm Left ((at the age of 17 years) on 07May2021 15:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for Covid-19 Immunisation. The patient medical history and concomitant medications were none. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route of administration on 16Apr2021 at 10.30 AM, dose 1 single administered in Left arm for Covid-19 Immunisation. Patient did not have Covid prior to vaccination. Patient did not test for Covid-post vaccination. Patient had severe chest pain and extremely breathing difficulty 36 hours after 2nd dose on 09May2021 8:00 AM. Blood oxygen level in 70-80% range. Checked into ER at 1pm. Blood tests, urine tests, and x-ray all were normal. Finally, a simple Tylenol (650 mg) took care of the chest pain. Patient's parent suspected that the chest pain was caused by surrounding muscle aches, which caused breathing difficulties and lack of oxygen. The outcome of events was recovered on an unknown date in May2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Skin rash covering entire body; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER0158) via an unspecified route of administration in the left arm on 22Apr2021 at 13:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included desvenlafaxine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN) all for unspecified 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: ER8732) via an unspecified route of administration in the right arm on 24Mar2021 at 14:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 the patient experienced hives and skin rash covering entire body within 24 hours of receiving the second COVID-19 vaccine. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hives and skin rash covering entire body were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: High Fever; Chills; Vomiting; Facial numbness on one side; Body aches; Exhaustion; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 11:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included von willebrand's disease. 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 escitalopram oxalate (LEXAPRO) 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: EL0266) via an unspecified route of administration in the left arm on 16Feb2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient previously took tranexamic acid (MANUFACTURER UNKNOWN) and experienced drug allergy. On 09Mar2021 at 18:00, the patient experienced high fever, chills, vomiting, facial numbness on one side, body aches, exhaustion and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events high fever, chills, vomiting, facial numbness on one side, body aches, exhaustion and pain at injection site was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: High Fever; Chills; Vomiting; Facial numbness on one side; Body aches; Exhaustion; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 11:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included von willebrand's disease. 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 escitalopram oxalate (LEXAPRO) 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: EL0266) via an unspecified route of administration in the left arm on 16Feb2021 at 12:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient previously took tranexamic acid (MANUFACTURER UNKNOWN) and experienced drug allergy. On 09Mar2021 at 18:00, the patient experienced high fever, chills, vomiting, facial numbness on one side, body aches, exhaustion and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events high fever, chills, vomiting, facial numbness on one side, body aches, exhaustion and pain at injection site was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Genital ulceration, SARS-CoV-2 test
Clinical narrative: Developed Lipshtz ulcers and they increased in pain, swelling, and severity; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 01May2021 at 11:30 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, cleft soft palate repair, club foot repaired, syndactyly repaired and hearing loss right ear. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and gliclazide (CLARITIN) both for unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 10Apr2021 at 11:15 (at the age of 14-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 22:00 the patient developed Lipshtz ulcers beginning hours after 2nd vaccine dose and they increased in pain, swelling, and severity. The event resulted in emergency room/department or urgent care on 04May2021, doctor or other healthcare professional office/clinic visit on 06May2021and pediatric gynecology visit on 07May2021. Therapeutic measures were taken as a result of the event and included treatment with steroid cream (MANUFACTURER UNKNOWN), lidocaine (MANUFACTURER UNKNOWN) and macrogol (MIROLAX). On 07May2021, the patient underwent unknown test (nasal swab) and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event developed  Lipshtz ulcers beginning hours after 2nd vaccine dose and they increased in pain, swelling, and severity was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus began within a couples of days; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 03Feb2021 at 13:30 (at the age of 59-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 24Feb2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any 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 COVID-19 vaccine. Concomitant medications of the patient were not reported. On 06Feb2021 at 23:00, the patient experienced "tinnitus began within a couples of days, continued to this day". Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 24Feb2021, the patient underwent vault (SARS-COV-2) test and the result was negative. The clinical outcome of the event "tinnitus began within a couples of days, continued to this day" was not recovered at the time of this report.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: experiencing joint/muscle pain throughout my body; experiencing joint/muscle pain throughout my body; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 10:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, acid reflux (esophageal), sleep apnea, blood pressure high and sulfonamide allergy (sulfa products). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included montelukast (MANUFACTURER UNKNOWN), Medoxomill (MANUFACTURER UNKNOWN) and olmesartan (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 10:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, beginning one week after second vaccine, he began experiencing joint/muscle pain throughout his body when he exerted a regular amount of usage with arms or legs. It had been ongoing (when reported). He just had a tele visit with his doctor to alert him of his symptoms. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if therapeutic measures were taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain and muscle pain were not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: Loss off smell and taste; Loss off smell and taste; Stuffy nose; Sinus pressure; Headache; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any 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 COVID vaccine. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and multi vitamins (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. On 08May2021 at 01:00, the patient experienced headache and sore throat. It was reported that on the second day also the patient experienced headache and sore throat. On 10May2021, 3rd and 4th day, the patient experienced loss of smell and taste, stuffy nose and sinus pressure. 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 been tested for COVID-19. On 10May2021, the patient underwent SARS-CoV-2 test and the result was pending. The clinical outcome of the events headache, sore throat, loss of smell and taste, stuffy nose and sinus pressure were not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: Loss off smell and taste; Loss off smell and taste; Stuffy nose; Sinus pressure; Headache; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old patient of unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 14:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any 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 COVID vaccine. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and multi vitamins (MANUFACTURER UNKNOWN); both from unknown dates for unspecified indications. On 08May2021 at 01:00, the patient experienced headache and sore throat. It was reported that on the second day also the patient experienced headache and sore throat. On 10May2021, 3rd and 4th day, the patient experienced loss of smell and taste, stuffy nose and sinus pressure. 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 been tested for COVID-19. On 10May2021, the patient underwent SARS-CoV-2 test and the result was pending. The clinical outcome of the events headache, sore throat, loss of smell and taste, stuffy nose and sinus pressure were not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Lip swelling, Malaise, Urticaria
Clinical narrative: Hives everywhere; eyes swollen; malaise; fatigue; Lips swollen; This is a spontaneous report from a contactable consumer, the patient. A 37-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 right arm on 09May2021 at 11:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known drug allergies.  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 and did not receive any medication within two weeks of vaccination. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) in the left arm on unknown date as a single dose for COVID-19 immunisation.  On 10May2021 at 09:00 the patient experienced hives everywhere, lips and eyes swollen, malaise and fatigue. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event hives everywhere, lips and eyes swollen, malaise and fatigue were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Dizziness, Fatigue, Headache, Hyperhidrosis
Clinical narrative: brusing; hot sweats; dizziness; eye sight weak; muscles hurt; nausea; headache; fatigue; vomiting; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8733) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 vaccine. Concomitant medications included paracetamol (TYLENOL), mefenamic acid (ADVIL) and ibuprofen sodium (MANUFACTURER UNKNOWN); all for unknown indication taken on unknown date and unknown if still ongoing. The patient did not have allergies to medications, food, or other products. On 10Apr2021 at 12:00, the patient experienced sore arm, brusing, vomiting, hot sweats, nausea, dizziness, headache, fatigue, muscles hurt and eye sight weak. 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 sore arm, bruising, vomiting, hot sweats, nausea, dizziness, headache, fatigue, muscles hurt and eye sight weak was resolved on an unknown date in May2021. Later patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0172) via an unspecified route of administration in the left arm on 05May2021 at 21:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Visual impairment, Vomiting
Clinical narrative: brusing; hot sweats; dizziness; eye sight weak; muscles hurt; nausea; headache; fatigue; vomiting; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8733) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. 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 vaccine. Concomitant medications included paracetamol (TYLENOL), mefenamic acid (ADVIL) and ibuprofen sodium (MANUFACTURER UNKNOWN); all for unknown indication taken on unknown date and unknown if still ongoing. The patient did not have allergies to medications, food, or other products. On 10Apr2021 at 12:00, the patient experienced sore arm, brusing, vomiting, hot sweats, nausea, dizziness, headache, fatigue, muscles hurt and eye sight weak. 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 sore arm, bruising, vomiting, hot sweats, nausea, dizziness, headache, fatigue, muscles hurt and eye sight weak was resolved on an unknown date in May2021. Later patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0172) via an unspecified route of administration in the left arm on 05May2021 at 21:00 (at the age of 26-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 27Apr2021 at 13:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 vaccine. Concomitant medications included unspecified prescribed medicines. The patient had no known allergies to medications, food or other products. On 11May2021 at 00:00, the patient experienced insomnia. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were 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 insomnia was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Terrible body pain; Unable to do daily activity; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 22-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 right arm on 10May2021 at 13:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol; levonorgestrel (VIENVA) for oral contraception from an unknown date and allergy pill (MANUFACTURER UNKNOWN) for an 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: UNKNOWN) via an unspecified route of administration in the right arm on 19Apr2021 at 13:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. On 11May2021 at 06:30, the patient experienced terrible body pain, fever, chills, headache and unable to do daily activity. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events terrible body pain, fever, chills, headache and unable to do daily activity 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Tinnitus
Clinical narrative: Ringing in ears; Started to feel achy and tired; Started to feel achy and tired; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW015B) via an unspecified route of administration in the left arm on 28Apr2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 in Nov2020 and high cholesterol. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ethinylestradiol, levonorgestrel (CAMRESE), gliclazide (CLARITIN), atorvastatin (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she received second shot at 16:15, went home and fell asleep then on 28Apr2021 at 20:00, the patient started to feel achy and tired and on 28Apr2021 at 21:00, the patient woke up with incredibly ringing in ears. It's been two weeks and it has not stopped since. The patient had no pre-existing conditions and felt fine otherwise and had not contacted the doctor as the patient felt there was nothing the doctor would be able to do anyways. 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 started to feel achy and tired and ringing in ears was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Skin warm
Clinical narrative: Left shoulder bruised; Left shoulder bruised and very warm; 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 08May2021 at 12:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient had no relevant medical history. It was unknown whether the patient have any allergies. 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 vaccine. 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 left arm on 17Apr2021 at 09:00 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. On 10May2021 at 17:00, 3 days after the second shot, the patient experienced left shoulder bruised and very warm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left shoulder bruised and very warm were not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymph node pain, Lymphadenopathy, Migraine
Clinical narrative: 36 hours after vaccine swollen lymph nodes on neck, over left clavicle front of should to left arm pit- lasted about 14 days; Migraine within 12 hours, brain fog and migraine lasted about 10days,; Brain fog; Lymph nodes still sore; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 12Apr2021 at 12:30 (at the age of 17-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm left on 03May2021 at 12:30 (at the age of 17-year-old); as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 13Apr2021 at 00:30, within 12 hours the patient experienced migraine, brain fog and migraine lasted about 10days, didn't response to meds. On14Apr2021 at 00:30, 36 hours after vaccine the patient had swollen lymph nodes on neck, over left clavicle front of should to left arm pit- lasted about 14 days. Lymph nodes still sore but not enlarged, did second round and within hours all symptoms returned. Lymph nodes still enlarged 8 days after. The events resulted in doctor or other healthcare professional office/clinic visit. 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 migraine, brain fog and migraine lasted about 10days, didn't response to meds, swollen lymph nodes on neck, over left clavicle front of should to left arm pit- lasted about 14 days, lymph nodes still sore but not enlarged was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Neck pain, Pain in extremity
Clinical narrative: Sore arm; Sore neck; Sore shoulder; Headaches; Dizziness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 60-year-old) and 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 an unknown date in 2021 (at the age of 60-year-old) as a single dose for COVID-19 immunization. Medical history included inflammatory bowel disease (IBD) and penicillin allergy. 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 estrogens conjugated (PREMARIN), cetrizine hydrochloride (ZYRTEC) and paracetamol (TYLENOL), all for unknown indications on unknown dates and unknown if ongoing. The patient was allergic to dairy products and wheat. On 22Apr2021 at 08:00, the patient experienced sore arm, sore neck, sore shoulder, headaches and  dizziness. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm, sore neck, sore shoulder, headaches and  dizziness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Lip dry, Pain, Palpitations, Thirst
Clinical narrative: Heart palpatations; dry mouth; dry lips; very thirsty; body aches; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07May2021 at 11:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism. The patient had allergy to penicillin. 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 levothyroxine sodium (SYNTHROID) for unknown indication from an unknown date and unknown if ongoing. The patient previously took vancomycin (MANUFACTURER UNKNOWN) and experienced drug allergy.  On 08May2021, the patient experienced heart palpitations, dry mouth, dry lips, very thirsty and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event heart palpitations, dry mouth, dry lips, very thirsty and body aches 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Random pain in left arm at the injection site. Deep pain like it was in the bone at the site.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 11Mar2021 at 09:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs (sulfonamide allergy). 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 buspirone (MANUFACTURER UNKNOWN) and atorvastatin calcium (LIPITOR) for unknown indication on unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264) via an unspecified route of administration in the left arm on 18Feb2021 at 10:30 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 11Mar2021 at 10:00 the patient experienced random pain in left arm at the injection site, deep pain like it was in the bone at the site. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event random pain in left arm at the injection site was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: Red rash; Hives; Itching; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EW0158) via an unspecified route of administration in the left arm on 22Apr2021 at 21:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, arthritis and obesity. 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 received unspecified concomitant medications. The patient previously received tetracycline (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), and cholesterol medicines (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:15, the patient experienced red rash, hives and itching. The events did not result in doctor or other healthcare professional office/clinic visit, 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 the reported events which included treatment with diphenhydramine hydrochloride (BENADRYL) 50 mg orally. The clinical outcome of the events red rash, hives and itching were recovered on an unspecified date in 2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Visual impairment
Clinical narrative: Visual disturbances.; Perceived left arm not to be his own; Tingling in hands, arms and feet; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On 03May2021 at 09:00 (also reported as 96 hours after the second shot), the patient experienced visual disturbances and perceived left arm not to be his own. The patient began to feel tingling in hands, arms and feet which increased in intensity and persisted for several days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events.  The clinical outcome of the events visual disturbances, perceived left arm not to be his own and tingling in hands, arms and feet were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Little rash on arm left arm that itch; Welts (like insect bites) on both of arms and hands that itches like crazy; Rash on my arm my left arm that itch/ both of arms and hands that itches like crazy; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the right arm on 30Apr2021 at 08:00 (at the age of 50-year-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknow if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730) via an unspecified route of administration in the left arm on 09Apr2021 at 08:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. On 04May2021 at 10:00, the patient started to experience a little rash on arm (left arm) that itch, to welts (like insect bites) on both of her arms and hands that itches like crazy. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure was taken as a result of the events which included treatment methyl predisolone on an unspecified date. The clinical outcome of the events little rash on arm (left arm) that itch, welts (like insect bites) on both arms and hands that itches like crazy were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: Confusion with time of day by about 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO182) via an unspecified route of administration in the left arm on 05May2021 at 08:15 as a single dose for COVID-19 immunisation. Medical history included blood pressure. The patient had unspecified allergies. Concomitant medications included Blood Pressure (BP) medications (MANUFACTURER UNKNOWN) and herbal teas (MANUFACTURER UNKNOWN), both taken from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021 at 09:45, the patient experienced confusion with time of day by about 24 hours. The event 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 event. The clinical outcome of the event confusion was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms, legs, back, stomach, ears, and neck.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0165) via an unspecified route of administration in the right arm on 06May2021 at 15:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and its derivatives. 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 concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 15Apr2021 at 15:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. On 09May2021 the patient experienced hives on arms, legs, back, stomach, ears, and neck. The event did not result in doctor or other healthcare professional office/clinic visit, 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 the events included treatment with diphenhydramine (BENADRYL) tablets. The clinical outcome of the event hives on arms, legs, back, stomach, ears, and neck was resolved on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash erythematous, Rash pruritic
Clinical narrative: Itchy, red rash on neck and chest; Itchy, red rash on neck and chest; swollen lymph node on left side near ear; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8753) via an unspecified route of administration in the left arm on 28Apr2021 at 15:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hyperlipemia, hypertension and COVID-19. The patient previously had strawberries and experienced fruit allergy; she also had peanut butter and experienced food allergy. Concomitant medications taken within two weeks of vaccination included metformin 1000 milligram (MANUFACTURER UNKNOWN), hydrochlorothiazide 12.5 milligram (MANUFACTURER UNKNOWN) and dapagliflozin propanediol monohydrate (FARXIGA); all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 07:00, the patient experienced itchy, red rash on neck and chest, swollen lymph node on left side near ear. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itchy, red rash on neck and chest, swollen lymph node on left side near ear was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.