chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: It felt the flu x2; After my first dose about 3 to Four hours after I got a severe migraine; diarrhea; fever; body ache; body was just craving anykind of juice I got very thirsty; This is a spontaneous report from a contactable consumer, the patient. A 61-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 09Apr2021 at 13:45(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included meningioma, stent in head, hypertension, rheumatoid, osteoporosis and disc degradation. The patient had unspecified allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. 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 09Apr2021 at 16:45 the patient experienced, after three to four hours of first dose, severe migraine, diarrhea, fever, body aches and could not got out of bed. It felt the flu x2 and the body was just craving any kind of juice as felt very thirsty. Had seen some of these side effects on the website but did not see some of the ones that what the patient had experienced. And it was known that quite a few people that have had the same. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event severe migraine, diarrhea, fever, body aches, felt flu, could not get out of bed and thirsty were recovering at the time of this report.  No follow up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nasal congestion
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 07Apr2021 at 15:45 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. Concomitant medications included vitamins (LOVEWELLNESS), from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 07Apr2021 at 17:45, the patient experienced pain at injection site after 2 hours of vaccine. On 08Apr2021 at 07:45, after 16 hours of vaccine, the patient experienced aches in joints, felt tired and run down, nasal congestion, headache and chills. The adverse events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events pain at injection site, aches in joints, felt tired and run down, nasal congestion, headache and chills were resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533), via an unspecified route of administration in the left arm on 07Apr2021 at 15:45 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. Concomitant medications included vitamins (LOVEWELLNESS), from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 16Mar2021 at 15:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 07Apr2021 at 17:45, the patient experienced pain at injection site after 2 hours of vaccine. On 08Apr2021 at 07:45, after 16 hours of vaccine, the patient experienced aches in joints, felt tired and run down, nasal congestion, headache and chills. The adverse events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events pain at injection site, aches in joints, felt tired and run down, nasal congestion, headache and chills were resolved on an unspecified date in Apr2021. No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Rash, Rash morbilliform
Clinical narrative: Morbilliform rash appeared on legs; "rash had spread to trunk and arms"; "Temperature 97.7 F"; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153) via an unspecified route of administration in the right arm on 06Apr2021 at 13:15 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension controlled with medications. The patient had no known allergies. Concomitant medications were reported as "yes prescribed medications". The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 15Mar2021 at 13:45 (at the age of 74-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 08Apr2021 at 06:30, approximately 30 hours after second dose of vaccine, the patient experienced morbilliform rash appeared on legs approximately. On 08Apr2021 at 06:30, the patient had the "rash had spread to trunk and arms" and "temperature 97.7 F", no itching or discomfort. As of 10Apr2021 at 07:30, rash persists and temperature remains normal (97.7 F) and there was no itching or discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events morbilliform rash appeared on legs, "rash had spread to trunk and arms" and the event "temperature 97.7 F" were not recovered 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: Aphthous ulcer, Burning sensation, Fatigue, Formication, Heavy menstrual bleeding
Clinical narrative: Burning sensation within 10 minutes of taking shot.; Muscle soreness within 10 minutes of taking shot; Prolonged and extended extreme tiredness; Tingling; Crawling sensation in skin that is ongoing since shot.; Menstrual cycle although completedweeks prior restarted within a day ofshot and continued for 2 weeks withheavy bleeding; Developed canker sore in mouth; Developed fever blister; Pain tingling in hands and feet; 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: EN6207) via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 14:15, the patient experienced burning sensation and muscle soreness within 10 minutes of taking shot, prolonged and extended extreme tiredness, tingling and crawling sensation in skin that was ongoing since shot, menstrual cycle although completed weeks prior restarted within a day of shot and continued for 2 weeks with heavy bleeding. Developed canker sore in mouth, developed fever blister, pain tingling in hands and feet. 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, emergency room/department or urgent care. The clinical outcomes of the events burning sensation and muscle soreness within 10 minutes of taking shot, prolonged and extended extreme tiredness, tingling and crawling sensation in skin, menstrual cycle although completed weeks prior restarted within a day of shot and continued for 2 weeks with heavy bleeding, developed canker sore in mouth, developed fever blister, pain tingling in hands and feet was recovering 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: Myalgia, Oral herpes, Pain, Paraesthesia
Clinical narrative: Burning sensation within 10 minutes of taking shot.; Muscle soreness within 10 minutes of taking shot; Prolonged and extended extreme tiredness; Tingling; Crawling sensation in skin that is ongoing since shot.; Menstrual cycle although completedweeks prior restarted within a day ofshot and continued for 2 weeks withheavy bleeding; Developed canker sore in mouth; Developed fever blister; Pain tingling in hands and feet; 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: EN6207) via an unspecified route of administration in the left arm on 25Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 14:15, the patient experienced burning sensation and muscle soreness within 10 minutes of taking shot, prolonged and extended extreme tiredness, tingling and crawling sensation in skin that was ongoing since shot, menstrual cycle although completed weeks prior restarted within a day of shot and continued for 2 weeks with heavy bleeding. Developed canker sore in mouth, developed fever blister, pain tingling in hands and feet. 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, emergency room/department or urgent care. The clinical outcomes of the events burning sensation and muscle soreness within 10 minutes of taking shot, prolonged and extended extreme tiredness, tingling and crawling sensation in skin, menstrual cycle although completed weeks prior restarted within a day of shot and continued for 2 weeks with heavy bleeding, developed canker sore in mouth, developed fever blister, pain tingling in hands and feet was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Scrotal swelling, Testicular pain
Clinical narrative: Testicle soreness; Scrotum swelling; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 21Mar2021 at 00:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and supraventricular arrhythmia. The patient did not take any concomitant medication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 12:00, the patient experienced testicle soreness and scrotum swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events testicle soreness and scrotum swelling was recovered on an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Pregnancy test
Clinical narrative: "Delayed menstruation. I have a prettyregular cycle, and I am now 6 dayslate on my period"; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 29Mar2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Concomitant medications included loratadine (CLARITIN) and ibuprofen (ADVIL), Prenatal vitamins ; all from unknown dates for unspecified indication. The patient previously took Fluconazole and experienced drug allergy. 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 05Apr2021, the patient experienced delayed menstruation. She had a pretty regular cycle, and she was six days late on her period. She had taken two negative pregnancy tests. The patient was planning to try to get pregnant later this spring, but now  she was very concerned the shot will negatively impact her fertility and menstruation cycle. 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. The clinical outcome of the event delayed menstruation was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling face
Clinical narrative: Tingly face with some puffiness; Tingly face with some puffiness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm right on 09Apr2021 at 10:45(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included high BP, high cholesterol and hypothyroidism. Concomitant medications included olmesartan medoxomil (BENICAR), levothyroxine sodium (SYNTHYROID) and rosuvastatin calcium (CRESTOR) for unknown indication and from an unknown date. The patient had no known 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 09Apr2021 at 11:00, the patient experienced tingly face with some puffiness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event tingly face with some puffiness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Headache; "Day 1-6 was mildly tired"/ "I was hit with extreme exhaustion"; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the leg left on 30Mar2021 at 08:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant past medical history. The patient had no known allergies to food, medications or other products. Concomitant medications included escitalopram oxalate (LEXAPRO), pyridoxine hydrochloride, tocopherol, folic acid, thiamine, nicotinic acid, riboflavin, calcium, selenium, cimicifuga racemose extract, magnolia officinalis, vitamin b12 nos, boron, glycine max extract (ESTROVEN) and linoleic acid (CLA); all from unknown dates for unknown indications. 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 31Mar2021, "day 1-6, the patient was mildly tired". She was hit with extreme exhaustion and headache started 7 days to day 17 post injection (as reported). She missed work and could not function for half the day. It was an exhaustion she had never experienced before and could not "push" through and overcome. 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. On 08Apr2021, the patient underwent lab tests and procedures which included nasal swab test and the result was negative. The clinical outcome of the event "Day 1-6 was mildly tired"/ "I was hit with extreme exhaustion and headache was resolving 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
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Fever - 102.4 F; Moderate fatigue; Severe headache; Moderate chills; Moderate muscle pain; Moderate joint pain; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ8729), via an unspecified route of administration in the left arm on 09Apr2021 at 09:15 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Mar2021 at 10:15 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 09Apr2021 at 21:00, the patient experienced fever - 102.4 degrees Fahrenheit(F), moderate fatigue, severe headache, moderate chills, moderate muscle pain and moderate joint pain. The patient underwent lab test and procedures which included body temperature test on 09Apr2021 and the result was 102.4 F. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever - 102.4 F, moderate fatigue, severe headache, moderate chills, moderate muscle pain and moderate joint pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever - 102.4 F; Moderate fatigue; Severe headache; Moderate chills; Moderate muscle pain; Moderate joint pain; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ8729), via an unspecified route of administration in the left arm on 09Apr2021 at 09:15 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have a history of allergies to any food or medications or other products. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration in the left arm on 12Mar2021 at 10:15 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 09Apr2021 at 21:00, the patient experienced fever - 102.4 degrees Fahrenheit(F), moderate fatigue, severe headache, moderate chills, moderate muscle pain and moderate joint pain. The patient underwent lab test and procedures which included body temperature test on 09Apr2021 and the result was 102.4 F. No therapeutic measures were taken for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever - 102.4 F, moderate fatigue, severe headache, moderate chills, moderate muscle pain and moderate joint pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Nasal congestion
Clinical narrative: Nasal congestion; Dizziness; Heart palpitations; Nausea; Joint pain; Headache; Tiredness; Pain and swelling at injection site; Pain and swelling at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second 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 15:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food, or other products. Concomitant medications included vitamin d nos (VITAMIN D) and multivitamins from an unknown date for an unknown indication. 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 left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine 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 09Apr2021 at 10:00, the patient experienced dizziness, nausea, joint pain, headache, heart palpitations, tiredness, pain and swelling at injection site, nasal congestion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with unspecified emergency medical treatment (EMT). The clinical outcomes of dizziness, nausea, joint pain, headache, heart palpitations, tiredness, pain and swelling at injection site, nasal congestion were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Vaccination site pain, Vaccination site swelling
Clinical narrative: Nasal congestion; Dizziness; Heart palpitations; Nausea; Joint pain; Headache; Tiredness; Pain and swelling at injection site; Pain and swelling at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second 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 15:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food, or other products. Concomitant medications included vitamin d nos (VITAMIN D) and multivitamins from an unknown date for an unknown indication. 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 left arm on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine 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 09Apr2021 at 10:00, the patient experienced dizziness, nausea, joint pain, headache, heart palpitations, tiredness, pain and swelling at injection site, nasal congestion. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with unspecified emergency medical treatment (EMT). The clinical outcomes of dizziness, nausea, joint pain, headache, heart palpitations, tiredness, pain and swelling at injection site, nasal congestion were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Severe Vertigo; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 21Mar2021 at 18:00 (at the age of 47-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. 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 08Apr2021 at 07:00, the patient experienced severe vertigo when woke up from the bed in the morning and had to hold himself, otherwise he could have fallen. No therapeutic measures were taken for the events. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event vertigo was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Cyst, Erythema, Feeling hot, Osteoarthritis
Clinical narrative: World's largest mosquito bite, welt 4" dia; hot to touch; painful; extreme itching; red; swollen/hard in thecenter; sleepiness; osteoarthritis; flair-up of mucous cysts on my fingers; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (High BP), hereditary hemochromatosis, osteoarthritis, mitral valve prolapse (MVP), rheumatic fever (2 times), diverticulitis, acid reflux (oesophageal), irritable bowel syndrome (IBS) and osteopenia. Patient did not report any known allergies to food, medications or other products. Concomitant medications included dexlansoprazole (DEXILANT), metoprolol (MANUFACTURER UNKNOWN), solifenacin succinate (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN); all for unknown indication and from an unknown start date. 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 left arm on 17Mar2021 at 15:30 (at the age of 64-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 08Apr2021 at 13:00, the patient experienced world's largest mosquito bite, welt 4 dia, hot to touch, painful, extreme itching, red, swollen, hard in the center, sleepiness, osteoarthritis and flair-up of mucous cysts on fingers. 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, emergency room/department or urgent care. The clinical outcomes of the event world's largest mosquito bite, welt 4 dia, hot to touch, painful, extreme itching, red, swollen, hard in the center, sleepiness, osteoarthritis and flair-up of mucous cysts on fingers were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Somnolence, Swelling
Clinical narrative: World's largest mosquito bite, welt 4" dia; hot to touch; painful; extreme itching; red; swollen/hard in thecenter; sleepiness; osteoarthritis; flair-up of mucous cysts on my fingers; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 15:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high (High BP), hereditary hemochromatosis, osteoarthritis, mitral valve prolapse (MVP), rheumatic fever (2 times), diverticulitis, acid reflux (oesophageal), irritable bowel syndrome (IBS) and osteopenia. Patient did not report any known allergies to food, medications or other products. Concomitant medications included dexlansoprazole (DEXILANT), metoprolol (MANUFACTURER UNKNOWN), solifenacin succinate (MANUFACTURER UNKNOWN) and diclofenac (MANUFACTURER UNKNOWN); all for unknown indication and from an unknown start date. 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 left arm on 17Mar2021 at 15:30 (at the age of 64-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 08Apr2021 at 13:00, the patient experienced world's largest mosquito bite, welt 4 dia, hot to touch, painful, extreme itching, red, swollen, hard in the center, sleepiness, osteoarthritis and flair-up of mucous cysts on fingers. 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, emergency room/department or urgent care. The clinical outcomes of the event world's largest mosquito bite, welt 4 dia, hot to touch, painful, extreme itching, red, swollen, hard in the center, sleepiness, osteoarthritis and flair-up of mucous cysts on fingers were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: awoke with Vertigo ...not just dizziness with the room spinning; Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 17:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included high (LDL) and allergy to pork and adhesive. The patient did not take any concomitant medication. 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 29Mar2021 the patient awoke with Vertigo ...not just dizziness with the room spinning. Patient had to lay back down 2 times before episode past and in the evening it happened again. Since this time, she had issues with Vertigo, Dizziness and nausea and seen ENT doctor and doctor gave her exercises to help with the dizziness and Vertigo. she still felt like she was always on the edge of having an episode of Vertigo. She had never had Vertigo before and on 29Mar2021, patient had not connected that it could be a side effect of the Pfizer vaccine. Patient friend said that they had heard of this potential side effect. So, patient did an internet search and found several people commenting about having Vertigo and dizziness several days after their first dose of Pfizer versus an immediate reaction and that it had been ongoing. Patient were concerned if they should have second dose due to this continuous side effect. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included exercises to try and correct. The clinical outcome of the events vertigo, dizziness and nausea were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Arm pain that kept me awake at night; Body aches; massive exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hemochromatosis, rhinitis and migraine. The patient did not have any allergies to medications, food, or other products. Concomitant medications included paracetamol (manufacturer-TYLENOL), ibuprofen (MANUFACTURER UNKNOWN), ondansetron (manufacturer-ZOFRAN), cyclobenzaprine hydrochloride (manufacturer-FLEXERIL), vitamin D nos (MANUFACTURER UNKNOWN) and cod-liver oil(manufacturer-FISH OIL) all started from an unknown date for unknown indication. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 18:00, the patient experienced arm pain that kept the patient awake at night, body aches and massive exhaustion but no fever for 2 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events arm pain that kept the patient awake at night, body aches and massive exhaustion were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: "My left arm has been weak since 2nd shot"; body aches; "It's like a dead arm from someone punching it"; This is a spontaneous report from a contactable consumer, the patient. A 38-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 arm left on 23Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN). 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 03Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient experienced his left arm had been weak since 2nd shot. It was like a dead arm from someone punching it. Felt the weakness every time he lifted the objects or himself. The patient also experienced body aches that lasted one day after shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event "My left arm has been weak since 2nd shot", "It's like a dead arm from someone punching it" was not resolved. The clinical outcome of the event body aches was resolved on 24Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: An hour later, I developed a rash on the front of my neck.; itching in my toes/ My entire body felt itchy; deep redness in my finger and hands; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 09Apr2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included photorefractive keratectomy performed two months prior, COVID-19. The patient had no known allergies. Concomitant medications included fluorometholone (EFFLUMIDEX) eye drops, lisdexamfetamine mesilate (VYVANSE) 30 mg, and acetylsalicylic acid (ASPIRIN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the arm right on 19Mar2021 at 16:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 15:20 the patient experienced deep redness in finger and hands, also developed itching in toes. On the same day at 16:00, the patient experienced a rash on the front of neck. On the same day at 15:30, experienced entire body felt itchy, especially fingers and toes. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events deep redness in finger and hands, also developed itching in toes. rash on the front of neck. entire body felt itchy, especially fingers and toes recovered on 09Apr2021 at 18:00.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: Spots or pimples appeared on stomach and face; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, hay fever and grass allergy. Concomitant medications included vitamins nos and minerals nos (CENTRUM), lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPRIN) low dose used for unknown indication from 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 09Apr2021 at 08:00, 19 hours after receiving second shot, the patient experienced spots or pimples appeared on stomach and face. 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. The clinical outcome of the event spots or pimples appeared on stomach and face was not recovered 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: Diarrhoea, Headache, Nausea, Taste disorder
Clinical narrative: All of my food tastes like plastic now; Also I have a headache; diahhrea; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 18-years-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 07Apr2021 at 15:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included mental health issues and chronic urinary reflux. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and ethinylestradiol and norethisterone acetate (JUNEL) both for an unknown indication from an unknown date. The patient took BACTRIM on an unspecified date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 08Apr2021, the patient experienced all of her food tasted like plastic and also had headache, diarrhea and nausea. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events food tasted like plastic, headache, diarrhea and nausea were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Vaccination site pain
Clinical narrative: headache; injection site pain; fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food or other products. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) and amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for unknown indications from unknown dates. 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 09Apr2021 at 00:45, the patient experienced brain fog, headache, fatigue and injection site pain. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events brain fog, headache, fatigue and injection site pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body hives; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 07:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and sulfa allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and dulaglutide (TRULICITY), both taken from unknown dates. 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 25Mar2021 at 09:00 (at the age of 63-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 09Apr2021 at 07:00, 24 hours after the vaccination, the patient experienced full body hives. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with antihistamine. The clinical outcome of the event full body hives was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.