chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Severe menstrual cramps; Fever; Chills; Muscle/joint aches in legs; Muscle/joint aches in legs; Headache; Tiredness; This is a spontaneous report from a non-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: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 11:15 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included isotretinoin (MANUFACTURER UNKNOWN); on an unknown date, for unknown indication and unknown if ongoing. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 15:00 (at the age of 18-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. On 03Apr2021 at 21:30, the patient experienced severe menstrual cramps, fever, chills, muscle/joint aches in legs, headache and tiredness. Since the vaccination, on 10Apr2021, the patient underwent nasal swab SARS-CoV-2 test and the result was negative. The clinical outcome of the events severe menstrual cramps, fever, chills, muscle/joint aches in legs, muscle/joint aches in legs, muscle/joint aches in legs, headache and tiredness was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Macule, Pruritus
Clinical narrative: Deep red circle about the size of an orange appeared on arm; The area was hot to the touch; Very itchy; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 17Apr2021 at 13:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included high Blood pressure, high cholesterol and obesity. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC) and calcium/ magnesium (CALCIUM MAGNESIUM SUPPLEMENT), all taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 21Apr2021, about 4 days after the shot, the patient experienced a deep red circle about the size of an orange appeared on her arm. The area was hot to the touch and very itchy. 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. No therapeutic measures were not taken as a result of events. The clinical outcome of the events deep red circle about the size of an orange appeared on arm, the area was hot to the touch and very itchy was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch, Swollen tongue, Tongue discomfort, Tongue disorder
Clinical narrative: Tongue swelling; Tongue scratchy; Tongue burning as if ate hot soup; Tongue little bumpy; This is a spontaneous report from a contactable consumer, the patient. A 50-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 26Mar2021 at 12:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. It was unknown if the patient had 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 vaccination. Concomitant medication was not reported. On 12Apr2021, the patient experienced tongue swelling, scratchy, burning as if ate hot soup and little bumpy. It was reported that the patient did not check tongue until 15Apr2021 night and did have hot soup so didn't think much of it until she looked online because it persists. 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 event tongue swelling, scratchy, burning as if ate hot soup and little bumpy was not resolved at the time of this report. The patient had received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 16Apr2021 at 16:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Rash
Clinical narrative: Rash on the back and side of my neck; Severe chapped lips; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient 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 26Mar2021 at 10:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any 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 were not reported. On 03Apr2021, the patient experienced rash on the back and side of his neck and severe chapped lips. 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 rash on the back and side of neck and severe chapped lips was recovering at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Musculoskeletal pain, Pain
Clinical narrative: Whole left side is sore; Whole left side is sore.-  mostly sore in the arm at injection sight.; Left butt cheek felt sore like "I" received a shot there, but "I" didnt; Some joint pain in left elbow, knee and foot; Little tired; Little brain fog; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and colecalciferol (VITAMIN D3); all for unknown indication from unknown dates and unknown if ongoing. The patient received the shot in the left arm and on 21Apr2021 at 03:00 whole left side was sore. The patient was mostly sore in arm at injection site but left butt cheek felt sore, like received a shot there, but the patient had not. The patient also had some joint pain in the left elbow, knee, foot, also little tired and seen to have a little brain fog. 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 14Apr2021, the patient underwent SARS-COV2, RNA (PCR) test via nasal swab and the result was negative. The clinical outcome of the event left side sore, mostly sore in arm at injection site, left butt cheek feels sore, joint pain in left elbow, knee and foot, little tired and little brain fog was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Whole left side is sore; Whole left side is sore.-  mostly sore in the arm at injection sight.; Left butt cheek felt sore like "I" received a shot there, but "I" didnt; Some joint pain in left elbow, knee and foot; Little tired; Little brain fog; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and colecalciferol (VITAMIN D3); all for unknown indication from unknown dates and unknown if ongoing. The patient received the shot in the left arm and on 21Apr2021 at 03:00 whole left side was sore. The patient was mostly sore in arm at injection site but left butt cheek felt sore, like received a shot there, but the patient had not. The patient also had some joint pain in the left elbow, knee, foot, also little tired and seen to have a little brain fog. 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 14Apr2021, the patient underwent SARS-COV2, RNA (PCR) test via nasal swab and the result was negative. The clinical outcome of the event left side sore, mostly sore in arm at injection site, left butt cheek feels sore, joint pain in left elbow, knee and foot, little tired and little brain fog was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Heart rate abnormal
Clinical narrative: Dizzy; Extreme exhaustion; Abnormal fast heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received 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 29Mar2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 19Apr2021 at 14:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, migraine and celiac disease. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), escitalopram oxalate (LEXAPRO) and fish oil (OMEGA 3); all for an unknown indication from an unknown date  and unknown if ongoing. On an unknown date in Mar2021 (also reported at 16:30), the patient experienced dizzy, extreme exhaustion and abnormal fast heartbeat while doing simple things like walking up a flight of stairs. The patient used to work out all of the time and do CrossFit. This exhaustion, fast heartbeat and dizziness was abnormal for the patient. It started after the first dose of vaccine. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 dizzy, extreme exhaustion and abnormal fast heartbeat were not 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: Abdominal pain upper, Back pain, Burning sensation, Dyspepsia, Fatigue
Clinical narrative: Stomach cramping; Stomach and intestines burning sensation.; Stomach and intestines burning sensation.; Feet hot and burning sensation.; Feet hot and burning sensation.; Back pain; Forgetting; Headache; Extreme fatigue; Stiff joints; This is a spontaneous report from a non-contactable consumer, the patient. A 41-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 left arm on 19Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), known allergy to penicillin and carrots. 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 medication included methylphenidate (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 20Apr2021 at 06:00, the patient experienced stomach cramping, stomach and intestines burning sensation, feet hot and burning sensation, back pain, forgetting, headache, extreme fatigue and stiff joints. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramping, stomach and intestines burning sensation, feet hot and burning sensation, back pain, forgetting, headache, extreme fatigue and stiff joints was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gastrointestinal pain, Headache, Joint stiffness, Memory impairment
Clinical narrative: Stomach cramping; Stomach and intestines burning sensation.; Stomach and intestines burning sensation.; Feet hot and burning sensation.; Feet hot and burning sensation.; Back pain; Forgetting; Headache; Extreme fatigue; Stiff joints; This is a spontaneous report from a non-contactable consumer, the patient. A 41-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 left arm on 19Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), known allergy to penicillin and carrots. 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 medication included methylphenidate (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 20Apr2021 at 06:00, the patient experienced stomach cramping, stomach and intestines burning sensation, feet hot and burning sensation, back pain, forgetting, headache, extreme fatigue and stiff joints. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach cramping, stomach and intestines burning sensation, feet hot and burning sensation, back pain, forgetting, headache, extreme fatigue and stiff joints was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Severe headache bordering migraine; Severe headache bordering migraine; Muscle stiffness in neck and shoulders; Right arm injection soreness; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 27Apr2021 at 16:15 (at the age of 46-years-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 vaccination. Concomitant medications included valsartan (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC); both taken for unknown indications from an unknown date and unknown if ongoing. The patient previously took diphenhydramine hydrochloride (BENADRYL) for unknown indication and experienced drug allergy. On 27Apr2021 at 16:45, the patient experienced severe headache bordering migraine and took migraine medicine to calm pain. She had continuing dull headache, muscle stiffness in neck and shoulders, right arm injection soreness and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with unspecified migraine medication and paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache bordering migraine, muscle stiffness in neck and shoulders, right arm injection soreness and tiredness was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in lower leg both legs ankle area/Rash in back of hand/wrist area/Rash on face; This is a spontaneous report from a contactable consumer.  A 51-years-old female patient reported that she received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Arm Right on 17Apr2021 13:45 (Batch/Lot Number: EW0162) (at the age of 51-years-old ) as single dose for covid-19 immunisation.  The patient had received the first dose of bnt162b2 (Lot ER8727) on 27Mar2021 at 01:45 PM in Right arm . Medical history included High Blood Pression -taking meds, 2 pelvic surgeries, 1 hysterectomy. The patient was not pregnant. The patient had not COVID prior vaccination and did not receive other vaccine in four weeks. Concomitant medications included lisinopril 5mg for blood pressure. Past drug included Estrace vaginal hormonal cream. 5 days after vaccine on 21Apr2021, the patient experienced rash in lower leg both legs ankle area, rash in back of hand/wrist area  9-10 and rash on face after 10-11 days of second dose of vaccine. The events resulted in Doctor or other healthcare The patient was treated with Steroid Shot. The patient was not COVID tested post vaccination. The outcome was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia
Clinical narrative: Experiencing tingling across back intermittently; Exhausted; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received second dose of BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 at 13:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, hypothyroid disease, allergy to pennecillian (penicillin allergy), allergy to nickel contact, food allergy and allergy to soy. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown, whether the patient received any other vaccines within four weeks prior to the vaccination. Concomitant medications included benazepril (MANUFACTURER UNKNOWN) and thyroid (ARMOUR THYROID); both for 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: EN6204) via an unspecified route of administration in the left arm on 16Mar2021 at 09:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced tingling across back intermittently and exhausted. 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 tingling across back intermittently and exhausted was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Dysmenorrhoea, Menstruation irregular
Clinical narrative: Severe camping and bloating leading to menstruation.; Very heavy bloating; Severe camping and bloating leading to menstruation. First period since December 2019 with very heavy bloating and severe cramping.; This is a spontaneous report from a contactable consumer, the patient. A 27-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 24Apr2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, Ehlers danlos syndrome and allergy to pecans. The patient did not receive any medication within four weeks of vaccination. Concomitant medications included albuterol sulfate (MANUFACTURER UNKNOWN) from unknown date for an unknown indication and ethinylestradiol; norethisterone acetate (JUNEL) for birth control from an unknown date. 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 previously received clindamycin (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 22Mar2021 at 18:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 00:00, the patient experienced severe cramping and bloating leading to menstruation. First period since Dec2019 with very heavy bloating and severe cramping. The patient have not experienced cramping or bloating related to menstruation since 2011. Therapeutic measures were not taken as a result of the events. 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. The clinical outcome of the events severe cramping and bloating leading to menstruation was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More fatigued than usual; This is a spontaneous report from a non-contactable consumer. An adult female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Apr2021 at 09:45 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. It was unknown if the patient was pregnant at the time of this report. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced more fatigued than usual. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event more fatigued than usual was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Decreased appetite, Hypersomnia, Pyrexia, Thirst decreased
Clinical narrative: No desire to eat or drink/ No hunger/no hunger growls of stomach; No thirst; Slept most of day of vaccination and most of sat; Severe armpit pain; Running fever; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 09:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included severe bilateral leg lymphedema and morbid obesity. The patient had known allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included medroxyprogesterone acetate (PROVERA); for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 11:00, the patient had no desire to eat or drink since shot, no hunger/no hunger growls of stomach and no thirst. On 23Apr2021, the patient slept most of day of vaccination and most of 24Apr2021. On 23Apr2021 late night, the patient got severe armpit pain and started running fever. On 25Apr2021 morning, the patient realized she had not eaten nor drank anything since 23Apr2021, was not too concerned about not eating but very concerned about not feeling thirst. The patient started making it a point to eat and drank at least minimal amounts. At the time of this report, the patient's armpit pain was a lot better so was energy. On 25Apr2021 late night, the fever broke. But the patient still had absolutely no feelings of hunger or thirst. If was not mindfully making herself consume food/h20 she would not be taking in either. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever resolved on 25Apr2021, while that severe armpit pain was resolving. The clinical outcome of event of no desire to eat or drink, no hunger/no hunger growls of stomach, no thirst and slept most of day of vaccination were not resolved 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus increased; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: HFH K-9) via an unspecified route of administration in the left arm on 02Feb2021 at 09:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history reported as many overtime, "fairly good immediate health otherwise now "and known allergy to poison ivy, to insect bites which gave a fairly large result. 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 was taking unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: HFH K-9) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 17Mar2021, after second vaccination dose, the patient experienced tinnitus increased over time may be by approximately 50% to 70%. The patient was monitoring conditions that seemed to reduce problem and taking many individual actions tried to reduce tinnitus including sound input greatly reduced (example- closed captioning only on TV). The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or 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 tinnitus was recovering at the time of report.   No follow-up attempts are needed. No further information is expected
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen left lymph node in underarm/breast area.; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-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 left arm on 26Apr2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), levonorgestrel (NORTREL), minerals nos, vitamins nos (PRENATAL VITAMINS) and probiotic (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: ER8732) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 27-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. On 28Apr2021, the patient experienced swollen left lymph node in underarm/breast area. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen left lymph node in underarm/breast area was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Not an adverse reaction but did not know where else to report ''My'' signs from having COVID-19 since February 24th (shortness of breath, fog brain, chest tightness , memory recall issues) got 50% better; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 18:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypoparathyroidism, anxiety, depression, seasonal allergies, known allergies to band aid glue and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medication. On 24Apr2021 at 08:00, the patient reported that it was not an adverse reaction but did not know where else to report, her signs from COVID 19 since 24Feb (shortness of breath, fog brain, chest tightness, memory recall issues) got 50 percent better. 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 reported events. The clinical outcome of the event not an adverse reaction but did not know where else to report, signs from COVID 19 since 24Feb (shortness of breath, fog brain, chest tightness, memory recall issues) got 50% better was resolved on an unknown date in Apr2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Fever; Sore muscles and joints; Sore muscles and joints; Fatigue; Headache; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 18:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included histamine intolerance and allergy to lactose. Concomitant medications included zinc supplement (MANUFACTURER UNKNOWN) and serenoa repens (SAW PALMETTO); both medications from an unknown date and unknown if ongoing for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 01Mar2021 at 18:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, the patient had a relapse of injection side effects (fever, sore muscles and joints, fatigue, headache and upset stomach) which lasted for 24 hours which occurred one month (22Apr2021 to 23Apr2021) after the second injection. These were the exact same side effects that the patient had the day after the second injection (22Mar2021). 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 fever, sore muscles and joints, fatigue, headache and upset stomach was resolved on 23Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Sore muscles and joints; Sore muscles and joints; Fatigue; Headache; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 18:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included histamine intolerance and allergy to lactose. Concomitant medications included zinc supplement (MANUFACTURER UNKNOWN) and serenoa repens (SAW PALMETTO); both medications from an unknown date and unknown if ongoing for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 01Mar2021 at 18:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021, the patient had a relapse of injection side effects (fever, sore muscles and joints, fatigue, headache and upset stomach) which lasted for 24 hours which occurred one month (22Apr2021 to 23Apr2021) after the second injection. These were the exact same side effects that the patient had the day after the second injection (22Mar2021). 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 fever, sore muscles and joints, fatigue, headache and upset stomach was resolved on 23Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Diarrhoea, Hot flush, Pain
Clinical narrative: Very mild pain at the injection site; Tendon pain; Low grade fever; Diarrhea; Very bad body and joint aches; Very bad body and joint aches; Tendons felt inflamed; Weak tendons; Few spots of sharp pains in my upper right chest; Felt a very strong full body -hot flushing effect; Had some sharp spots in my chest; My arm start to ache; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient 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 24Apr2021 at 21:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypothyroidism, psoriasis and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), pimecrolimus (ELIDEL), minocycline hydrochloride (AMZEEQ), multivitamin (MANUFACTURER UNKNOWN) and ergocalciferol (VIT D); all medications for unknown indications from an unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN), etanercept (ENBREL), adalimumab (HUMIRA), sulfamethoxazole; trimethoprim (BACTRIM) and promethazine (PHENERGAN) and experienced drug allergy. On 24Apr2021, on the same day of vaccination, the patient experienced felt a very strong full body -hot flushing effect, had some sharp spots in chest that went away temporarily and arm start to ache (the night of the vaccine). On 25Apr2021, the patient experienced low grade fever, diarrhea, very bad body and joint aches, tendons felt inflamed and weak and few spots of sharp pains in upper right chest. On 26Apr2021, the third day after vaccination, the patient's condition was improved and she only had the arm pain, milder body/joint aches, and some tendon pain/weakness. On 27Apr2021, the fourth day after vaccination, the patient had only very mild pain at the injection site and more tendon pain/weakness. On 28Apr2021, day 5 after vaccination, she had mild tendon pain/weakness. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt a very strong full body -hot flushing effect, very mild pain at the injection site, arm start to ache, low grade fever, diarrhea, very bad body and joint aches, tendons felt inflamed, few spots of sharp pains in my upper right chest and had some sharp spots in my chest was resolved on an unspecified date in Apr2021; while that of the event mild tendon pain/weakness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash macular, Tendon disorder, Tendon pain
Clinical narrative: Very mild pain at the injection site; Tendon pain; Low grade fever; Diarrhea; Very bad body and joint aches; Very bad body and joint aches; Tendons felt inflamed; Weak tendons; Few spots of sharp pains in my upper right chest; Felt a very strong full body -hot flushing effect; Had some sharp spots in my chest; My arm start to ache; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient 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 24Apr2021 at 21:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypothyroidism, psoriasis and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), pimecrolimus (ELIDEL), minocycline hydrochloride (AMZEEQ), multivitamin (MANUFACTURER UNKNOWN) and ergocalciferol (VIT D); all medications for unknown indications from an unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN), etanercept (ENBREL), adalimumab (HUMIRA), sulfamethoxazole; trimethoprim (BACTRIM) and promethazine (PHENERGAN) and experienced drug allergy. On 24Apr2021, on the same day of vaccination, the patient experienced felt a very strong full body -hot flushing effect, had some sharp spots in chest that went away temporarily and arm start to ache (the night of the vaccine). On 25Apr2021, the patient experienced low grade fever, diarrhea, very bad body and joint aches, tendons felt inflamed and weak and few spots of sharp pains in upper right chest. On 26Apr2021, the third day after vaccination, the patient's condition was improved and she only had the arm pain, milder body/joint aches, and some tendon pain/weakness. On 27Apr2021, the fourth day after vaccination, the patient had only very mild pain at the injection site and more tendon pain/weakness. On 28Apr2021, day 5 after vaccination, she had mild tendon pain/weakness. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt a very strong full body -hot flushing effect, very mild pain at the injection site, arm start to ache, low grade fever, diarrhea, very bad body and joint aches, tendons felt inflamed, few spots of sharp pains in my upper right chest and had some sharp spots in my chest was resolved on an unspecified date in Apr2021; while that of the event mild tendon pain/weakness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tendonitis, Vaccination site pain
Clinical narrative: Very mild pain at the injection site; Tendon pain; Low grade fever; Diarrhea; Very bad body and joint aches; Very bad body and joint aches; Tendons felt inflamed; Weak tendons; Few spots of sharp pains in my upper right chest; Felt a very strong full body -hot flushing effect; Had some sharp spots in my chest; My arm start to ache; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient 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 24Apr2021 at 21:30 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, hypothyroidism, psoriasis and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), pimecrolimus (ELIDEL), minocycline hydrochloride (AMZEEQ), multivitamin (MANUFACTURER UNKNOWN) and ergocalciferol (VIT D); all medications for unknown indications from an unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN), etanercept (ENBREL), adalimumab (HUMIRA), sulfamethoxazole; trimethoprim (BACTRIM) and promethazine (PHENERGAN) and experienced drug allergy. On 24Apr2021, on the same day of vaccination, the patient experienced felt a very strong full body -hot flushing effect, had some sharp spots in chest that went away temporarily and arm start to ache (the night of the vaccine). On 25Apr2021, the patient experienced low grade fever, diarrhea, very bad body and joint aches, tendons felt inflamed and weak and few spots of sharp pains in upper right chest. On 26Apr2021, the third day after vaccination, the patient's condition was improved and she only had the arm pain, milder body/joint aches, and some tendon pain/weakness. On 27Apr2021, the fourth day after vaccination, the patient had only very mild pain at the injection site and more tendon pain/weakness. On 28Apr2021, day 5 after vaccination, she had mild tendon pain/weakness. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt a very strong full body -hot flushing effect, very mild pain at the injection site, arm start to ache, low grade fever, diarrhea, very bad body and joint aches, tendons felt inflamed, few spots of sharp pains in my upper right chest and had some sharp spots in my chest was resolved on an unspecified date in Apr2021; while that of the event mild tendon pain/weakness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.