chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 41-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 28Apr2021 at 16:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included uterine fibroids. Concomitant medications included vitamin B complex (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN) and D (unspecified), all taken from unknown dates for unspecified indications. The patient previously took 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 08Apr2021 at 16:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 06:00, the patient experienced shortness of breath and chest tightness. The clinical outcome of the events shortness of breath and chest tightness were resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Feverish; Pain in injection side after one day of vaccine; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8737) via an unspecified route of administration in the arm left on 07Apr2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and cholesterol high. Concomitant medications included metformin hydrochloride 1000 (METFORMIN), atorvastatin 40 (MANUFACTURER UNKNOWN), acetylsalicylic acid 81 (ASPRIN) and glimepiride 4 (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 08:00, the patient experienced headache, feverish, pain in injection side after one day of vaccine. The clinical outcome of the event headache, feverish, vaccination site pain was not resolved 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: Body temperature, Myalgia, Pyrexia
Clinical narrative: Fever; Muscle ache (shoulder, back, butt, legs); This is a spontaneous report from a contactable consumer. A 42-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 28Apr2021(at the age of 42-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient past drug was reported as apple. 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 right arm on 07Apr2021 at 14:45 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 11:00, the patient experienced fever and muscle ache (shoulder, back, butt, legs). The patient underwent lab tests and procedures which included body temperature on 29Apr2021 and the result was 100.0-100.5 (unit not specified). The clinical outcome of the events fever and muscle ache was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, SARS-CoV-2 antibody test, Tremor
Clinical narrative: Shaking and numbness in my legs for more than six days; Shaking and numbness in my legs for more than six days; A paralytic feel; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on 15Apr2021 15:00 (Batch/Lot number, Expiry date was not reported and Age at the vaccination: 40-years-old) as single for covid-19 immunization. The patient's medical history and past drugs reported as no. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19 was mentioned as no whereas since the vaccination, the patient had been tested for COVID-19 was mentioned as yes. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications the patient received within 2 weeks of vaccination was reported as No. On 16Apr2021 12:00 AM, the patient experienced major shakes throughout the body within 24 hours of the first dose. The shakes went away but had persistent numbness and shaking in the lower extremity of both her legs. A paralytic feel. After taking antihistamines, the side effects got better but still to this day had not gone away when going down a flight of stairs. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test (Nasal Swab) was negative on 26Jun2021. The outcome of events was not recovered.   Information about lot/batch number was requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia, Vaccination site warmth
Clinical narrative: Arm was very hot to the touch at the injection site; Sporadic low grade fever; No energy.; This is a spontaneous report from a contactable consumer, the patient. A 40-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 25Apr2021 at 13:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 30Mar2021(at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021 at 13:00, the patient reported that her arm was very hot to touch at the injection site (vaccination site warmth) for more than four days at the time of reporting. On 26Apr2021 at 13:00, the patient also experienced sporadic low-grade fever and she reported that she had no energy. The clinical outcome of all the events arm was very hot to touch at the injection site (vaccination site warmth), sporadic low-grade fever and no energy were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: 1 inch of skin around the injection site was mildly warm to touch; 1 inch of skin around the injection site is red; 1 inch of skin around the injection site is painful; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 27Apr2021 at 13:15 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included general anxiety disorder. Concomitant medications included cetirizine (MANUFACTURER UNKNOWN) and prenatal vitamins. 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 left arm on 06Apr2021 at 13:15 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 12:00, the patient experienced 1 inch of skin around the injection site was red, painful and warm to touch. The clinical outcome of the events 1 inch of skin around the injection site was red, painful and warm to touch was not resolved 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: Abdominal pain upper, Dyspepsia, Headache, Myalgia
Clinical narrative: Heartburn - lasting all day; stomach cramps; muscle aches; headache; 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: EW0170) via an unspecified route of administration in the left arm on 28Apr2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease, hypothyroidism and bariatric surgery. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took Tapazole for unknown indication on unknown date. 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. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 at 08:15 the patient experienced heartburn - lasting all day, stomach cramps, muscle aches and headache. The clinical outcome of the events heartburn - lasting all day, stomach cramps, muscle aches and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Spots and rash developed on torso, hands, arms and legs.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731) via an unspecified route of administration in the left arm on 06Apr2021 at 12:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously did not receive any past drug medications. The patient did not receive any concomitant medication within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 the patient experienced spots and rash developed on torso, hands, arms and legs. The clinical outcome of the event spots and rash developed on torso, hands, arms and legs was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: aches for 24 hours; Chills; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 32-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 left arm on 27Apr2021 at 12:00 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient previously did not receive any medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 03:00 the patient experienced Chills, fever, aches for 24 hours. The clinical outcome of the event Chills, fever, aches for 24 hours was recovered on 29Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fluid retention, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: Retaining water; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; Legs are swollen, feel heavy, ache.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 26Apr2021 at 12:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. It was unknown whether the patient had any known allergies. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), glucosamine (MANUFACTURER UNKNOWN) and testosterone supplement (MANUFACTURER UNKNOWN), all were taken for unknown indication on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 00:00, the patient experienced retaining water, legs swollen, feel heavy and ache. It was unknown whether the adverse event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient had received any treatment for the reported events. The clinical outcome of the events retaining water, legs swollen, feel heavy and ache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Heart rate, Heart rate increased
Clinical narrative: rapid heart rate ranging between 100-130; extreme fatigue; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A  48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 11Mar2021 at 11:15  (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included electrocauterization and heart disorder; the patient reported that she had an electrocauterization in 1990 for a heart defect. She last saw a cardiologist in Jan2020 and all was good with her heart. But with this history, She was very concerned with her high heart rate. Concomitant medications included magnesium (MANUFACTURER UNKNOWN) from unknown date for unknown indication and multivitamins from unknown date for unknown indication. The patient did not have a history of allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 10:00, the patient experienced rapid heart rate ranging between 100-130, extreme fatigue and joint pain. On an unknown date, the patient underwent heart rate test and the result was heart rate ranging between 100-130. The patient reported that she experienced rapid heart rate ranging between 100-130. This lasted for four hours. For two weeks, she experienced extreme fatigue and joint pain. she emailed her doctor to see if she should get her second dose, and doctor did not respond. She opted not to get her second dose and now she was wondering what her options are. therapeutic measures taken were unknown. The clinical outcome of the event rapid heart rate ranging between 100-130 resolved on 12Mar2021 and that of extreme fatigue and joint pain was resolved on 26Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstrual disorder
Clinical narrative: vaccine affected menstrual cycle by 5 days; spotting prior to menstruating; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. The patient did not receive any other concomitant medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021, the patient experienced affected menstrual cycle by 5 days and had spotting prior to menstruating which was very out of the ordinary for her. The clinical outcome of the events of menstrual disorder and spotting menstrual was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer
Clinical narrative: Day 7-8 canker sores on my tongue; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included ascorbic acid (VITAMIN C), magnesium (MANUFACTURER UNKNOWN) and ubidecarenone (COQ10); all from unknown date for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021, on day 7-8, the patient experienced canker sores on tongue. The clinical outcome of the event canker sores on tongue was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Loss of bladder sensation
Clinical narrative: Lymph node pain; Loss of bladder control; Neckache; Fever; Chills; Headache; Lymph node swelling; Body aches; Shortness of breath on exertion; Extreme fatigue- slept 35hrs; 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: ER8735) via an unspecified route of administration in the arm left on 24Apr2021 at 15:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism and Meniere's disease. Concomitant medications include DEVA multivitamin and mineral supplements. Past drug history includes codeine. The patient previously 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 03Apr2021 at 10:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 22:30 the patient experienced fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue(slept 35 hrs). The clinical outcome of the event fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue were resolved with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain, Pain, Pyrexia
Clinical narrative: Lymph node pain; Loss of bladder control; Neckache; Fever; Chills; Headache; Lymph node swelling; Body aches; Shortness of breath on exertion; Extreme fatigue- slept 35hrs; 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: ER8735) via an unspecified route of administration in the arm left on 24Apr2021 at 15:15 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included hyperthyroidism and Meniere's disease. Concomitant medications include DEVA multivitamin and mineral supplements. Past drug history includes codeine. The patient previously 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 03Apr2021 at 10:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 22:30 the patient experienced fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue(slept 35 hrs). The clinical outcome of the event fever for 24 hours, chills, headache; neckache, lymph nodes swelling/pain, body aches, loss of bladder control, shortness of breath on exertion and extreme fatigue were resolved with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Headache, SARS-CoV-2 test
Clinical narrative: Terrible headache; Severe bone pain; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the arm left on 02Apr2021 at 14:00(at the age of 41-year-old), as a single dose for COVID-19 immunisation. Concomitant medications included levothyroxine (L-THYROXINE) started on an unknown date for an unknown indication. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced terrible headache, severe bone pain. The bone pain went away the second day; however, still have headaches. The headache was not severe, but had it constantly. On 26Apr2021, lab test included salvia test and the result was negative. The clinical outcome of the event severe bone pain was recovered on 03Apr2021; and that of the event terrible headache was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Loss of personal independence in daily activities, Nausea
Clinical narrative: Severe full body muscle aches resulting in loss of work; severe full body muscle aches resulting in loss of work and difficulty getting out of bed; Continued period, and approximately 1 week after the shot; Heavy bleeding; Very heavy bleeding and severe cramps; Nausea; Fatigue; Severe arm soreness at shot location; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in right arm on 20Apr2021 at 15:15 hours (at the age of 22-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included blood clots (continued use of blood thinners), depression and a birth control user at the time of this report. The patient received rivaroxaban (XARELTO) 10 mg, norethisterone (NORETHINDRONE), citalopram (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in left arm on 30Mar2021 at 15:15 hours as single dose for COVID immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 21Apr2021, on the day following the vaccine shot, the patient experienced severe arm soreness at shot location, nausea, fatigue, and severe full body muscle aches resulting in loss of work and difficulty getting out of bed. Pain was still serious after taking acetaminophen but was eased after taking Percocet. The patient was on period at the time of the COVID vaccine and it should have ended a few days after receiving it. However, it continued for approximately one week after the shot, it intensified to several days of very heavy bleeding and severe cramps. For comparison, she did not have cramps that bad since beginning birth control three years ago, and the cramps usually never last longer than 24 hours. The flow was also greatly increased, around twice as heavy as her usual heavy days. These increased cramps and bleeding lasted around four days. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen and Percocet. The clinical outcome for the events severe arm soreness at shot location, nausea, fatigue, severe full body muscle aches resulting in loss of work and difficulty getting out of bed was recovering and for the events of continued period, for approximately one week after the shot, heavy bleeding and severe cramps was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Severe full body muscle aches resulting in loss of work; severe full body muscle aches resulting in loss of work and difficulty getting out of bed; Continued period, and approximately 1 week after the shot; Heavy bleeding; Very heavy bleeding and severe cramps; Nausea; Fatigue; Severe arm soreness at shot location; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in right arm on 20Apr2021 at 15:15 hours (at the age of 22-year-old) as single dose for COVID-19 immunisation. The medical history of the patient included blood clots (continued use of blood thinners), depression and a birth control user at the time of this report. The patient received rivaroxaban (XARELTO) 10 mg, norethisterone (NORETHINDRONE), citalopram (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN) on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in left arm on 30Mar2021 at 15:15 hours as single dose for COVID immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 21Apr2021, on the day following the vaccine shot, the patient experienced severe arm soreness at shot location, nausea, fatigue, and severe full body muscle aches resulting in loss of work and difficulty getting out of bed. Pain was still serious after taking acetaminophen but was eased after taking Percocet. The patient was on period at the time of the COVID vaccine and it should have ended a few days after receiving it. However, it continued for approximately one week after the shot, it intensified to several days of very heavy bleeding and severe cramps. For comparison, she did not have cramps that bad since beginning birth control three years ago, and the cramps usually never last longer than 24 hours. The flow was also greatly increased, around twice as heavy as her usual heavy days. These increased cramps and bleeding lasted around four days. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen and Percocet. The clinical outcome for the events severe arm soreness at shot location, nausea, fatigue, severe full body muscle aches resulting in loss of work and difficulty getting out of bed was recovering and for the events of continued period, for approximately one week after the shot, heavy bleeding and severe cramps was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph node in left armpit; Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on 28Apr2021 at 08:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW011A) via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 16:30 the patient experienced swollen lymph node in the left armpit and soreness in the left arm. There was no information regarding the events whether resulted in doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The clinical outcome of the events swollen lymph node in left armpit and soreness in left arm were not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Red rash on the abdomen, spread to the back, arms, and legs.; The spots are red and slightly raised.; 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: EWO153) via an unspecified route of administration on 09Apr2021 at 15:00 (at the age of 40-years-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, seven days after receiving the first dose, the patient experienced a red rash on the abdomen. It gradually spread to her back, arms, and legs over the course of the next two weeks. The rash was not itchy, but the spots were red and slightly raised (no blisters). The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of red and slightly raised rash and included treatment with steroid cream. The clinical outcome of the events red and slightly raised rash on the abdomen, back, arms, and legs was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: the red spot has grown; injection site swelling; injection site redness; injection site itching; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 29Apr2021 at 12:45 (at the age of 34-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on unknown dates. Concomitant medications included esomeprazole magnesium (NEXIUM), omeprazole (PRILOSEC) and loratadine (CLARITIN); all taken for unspecified indications from unknown dates. The patient previously took codeine and other pain medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on 08Apr2021 (at the age of 34-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 COVID vaccine. On 29Apr2021 at 17:30, the patient experienced pain in the left arm at the injection site . On 30Apr2021 at 11:45, the patient noticed some swelling, redness as well as itching. Patient had been icing it. On 30Apr2021 at 15:00 patient took a picture to send to someone and on 01May2021 at 19:00, patient took another picture to compare and noticed that red spot had grown. At 20:00 and 23:00, patient took benadryl to see if it helps and at 23:00, patient took another picture to see if the benadryl was helping and patient was not sure it was. The clinical outcome of the events pain in the left arm at the injection site, swelling, redness as well as itching and red spot had grown was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737) via an unspecified route of administration on 30Apr2021 at 15:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications were not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 07:00, the patient experienced headache, backache, chest pain (sharp pain in chest), and difficulty breathing deeply. The clinical outcome of the events headache, backache, chest pain (sharp pain in chest), and difficulty breathing deeply were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Nausea
Clinical narrative: Nausea; Abdominal pain; Very weak; This is a spontaneous report from a contactable consumer, the patient. An 18-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 29Apr2021 at 13:00 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from unknown date. 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 unknown date (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 16:00, the patient experienced nausea paired with abdominal pain that will not let the patient sleep, body is very weak. The patient had eaten nothing out of the ordinary but on her period. The clinical outcome of the events nausea paired with abdominal pain and very weak were not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Running nose past one day; This is a spontaneous report from a contactable consumer, the patient. A 32-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 27Apr2021 at 08:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included hemorrhoids. Concomitant medication included conception vitamins (MANUFACTURER UNKNOWN) for male taken 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: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01May2021 at 04:00, the patient experienced running nose in the past one day. The clinical outcome of the event running nose past one day was not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Mild fever (101); Chills; This is a spontaneous report from a contactable consumer. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration on 01May2021 at 13:30 hours (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications included dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL): both from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 02:00 hours, the patient experienced mild fever (101) and chills. The patient underwent lab test and procedures, which included Body temperature and the result was 101 unit unspecified. Therapeutic measures were taken as a result of mild fever (101) and chills and included treatment with Tylenol. The clinical outcomes of the mild fever (101) and chills was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: feeling of burning and needles (not numbness) poking me throughout body; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EWO158) via an unspecified route of administration in the right arm on 10Apr2021 at 14:00 as a single dose for COVID-19 immunisation.  The patient did not have any relevant medical history. The patient had no known allergies. Concomitant medications included TRI-LO-MARZIA  and nature made multi vitamin gummies (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 06:00, the patient experienced feeling of burning and needles (not numbness) poking  throughout her body. The patient reported that the feeling of wearing clothing hurted her. The clinical outcome of the event feeling of burning and needles (not numbness) poking throughout her body was recovered 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: Constipation, Flatulence, Tinnitus
Clinical narrative: Tinnitus- ringing in left hear; Gas pains; Slight constipation; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EW0151), via an unspecified route of administration in the right arm on 10Apr2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN). The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number:  EP7534), via an unspecified route of administration in the left arm on 18Mar2021 at 12:30 (at the age of 41-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 12:00, the patient experienced tinnitus- ringing in left hear, gas pains and slight constipation. The patient did not receive any treatment for the events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tinnitus- ringing in left hear, gas pains and slight constipation was resolving.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19, symptomatic; This is a spontaneous report from a 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 right arm on 04Apr2021 at 08:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 09Apr2021 at 08:00, the patient was tested positive for symptomatic, COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tested positive for symptomatic, COVID-19 and included treatment with over-the-counter cold medicines and isolation from unknown date to unknown date. On 13Apr2021, the patient underwent nasal swab test and the result was positive. The clinical outcome of the event tested positive for symptomatic, COVID-19 was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Nausea, Pain, Restlessness
Clinical narrative: Chills; Nausea; Vomiting; Heavy chest; Restlessness; Ache; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 01May2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (polycystic ovarian syndrome), vulvodynia and COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (MOTRIN), loratadine (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL); for unknown indications and from an unknown date. Past drug history included any protein pump inhibitor, latex, cinnamon, coconut and berberine (MANUFACTURER UNKNOWN). Prior to 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 COVID-19 vaccine. On 01May2021, the patient experienced chills, nausea, vomiting, heavy chest, restlessness and ache. The clinical outcomes of the events chills, nausea, vomiting, heavy chest, restlessness and ache were not recovered at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.