chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Body is really itchy; Certain parts of body have turned red; This is a spontaneous report from a contactable consumer, the patient. A 23-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 21Apr2021 at 09:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety and leukopenia from an unknown date and unknown if ongoing. The patient had no known allergies to medications, food or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (MANUFACTURER UNKNOWN) and unspecified birth control (MANUFACTURE UNKNOWN) taken for unspecified indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021 at 13:00, the patient experienced body was really itchy and certain parts of her body had turned to red. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events body was really itchy and certain parts of body had turned to red was not recovered at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: waking up next morning with headache; fever; chills; body aches; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a 45-year-old female patient that.  A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 16:00 as (At the age of 45-years-old) dose 2, single for covid-19 immunisation. Medical history included Ibuprofen allergy. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No covid prior vaccination. No covid tested post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 04:00 PM as dose 1, single for covid-19 immunisation. It was unknown Facility where the most recent COVID-19 vaccine was administered. The patient experienced waking up next morning with headache, fever, chills, body aches, and fatigue on 22Apr2021. It was reported patient reported waking up next morning with headache. By that afternoon crawled into bed with fever, chills and body aches. Also reports fatigue. Patient did not receive any treatment for events. The outcome of events was unknown at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Fatigue, Headache, Nausea
Clinical narrative: Fever 101; Body aches; Severe headache; Stomach ache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 21Apr2021 at 07:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 30Mar2021 at 15:15 (at the age of 59-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 22Apr2021 at 23:00, the patient experienced fever 101, body aches, severe headache, stomach ache, nausea and fatigue for more than 48 hours. 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. On 22Apr2021, the patient underwent lab test which included body temperature test and the result was found to be 101 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101, body aches, severe headache, stomachache, nausea and fatigue were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever 101; Body aches; Severe headache; Stomach ache; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 21Apr2021 at 07:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 30Mar2021 at 15:15 (at the age of 59-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 22Apr2021 at 23:00, the patient experienced fever 101, body aches, severe headache, stomach ache, nausea and fatigue for more than 48 hours. 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. On 22Apr2021, the patient underwent lab test which included body temperature test and the result was found to be 101 (units unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101, body aches, severe headache, stomachache, nausea and fatigue were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Glossodynia, Oral pain
Clinical narrative: Extremely sore mouth; sore tongue; dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 13Apr2021(at the age of 40-year-old), as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). 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. The patient did not receive any medication within two weeks of vaccination. The patient previously took doxycycline (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. On 14Apr2021, the patient experienced extremely sore mouth and tongue and dry mouth. 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 extremely sore mouth and tongue, dry mouth was 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear disorder, Myalgia, Pyrexia
Clinical narrative: Left ear feels like there is water in it; Slight fever; Chills; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed on an unknown date prior to the vaccination. 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 allium sativum (GARLIC SUPPLEMENTS), hydrastis canadensis (GOLDENSEAL TINCTU) and AF compound (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration on 01Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient felt like there was water in her left ear. The patient had a slight fever, chills and muscle aches. 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 left ear feels like there is water in it, slight fever, chills and muscle aches was not recovered 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: Dysacusis, Ear discomfort, Tinnitus
Clinical narrative: Severe ringing in the ears and echoing; Left ear felt clogged; Left ear felt popping; left ear felt clogged and echoing; 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: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 16:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes. Prior to vaccination, the patient was not diagnosed with COVID-19... The patient took unspecified concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 16:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. On 23Apr2021 at 16:00, the patient experienced severe ringing in the ears and left ear felt clogged and echoing and popping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events  severe ringing in the ears, left ear  felt clogged and  echoing and popping   were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: Fever at 38 centigrade; Swollen lymph node in neck; Continuous moderate headache; Strong pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 35-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 right arm on 22Apr2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (poultry). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks, prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 22:00, 8 hours after the vaccination, the patient experienced fever at 38 centigrade, swollen lymph nodes in neck, continuous moderate headache and strong pain in arm. On the same day the patient underwent body temperature test and the result was found to be 38 centigrade. The events had not resulted in doctor/other health care 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 fever at 38 centigrade, swollen lymph nodes in neck, continuous moderate headache and strong pain in arm 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: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Tinnitus; Ear fullness in left ear; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 14:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date, prior to the vaccination. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 16:15, 1.5 hours after injection into left arm, the patient experienced tinnitus and ear fullness in left ear that started, and still persisted two weeks later. The events resulted 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 events. The clinical outcome of the events tinnitus and ear fullness in left ear was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Pain in extremity
Clinical narrative: Sore arm; increased breakthrough bleeding; Heavier and bright red (fast flowing) than otherbreak through bleeding; Mild cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 03Apr2021 at 15:00 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history included panic disorder, anxiety, severe polycystic ovarian syndrome (PCOS), lactose intolerant and allergy to molds (outdoor tree mold allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for an unknown indication from an unknown date and unknown if ongoing; ethinylestradiol/ ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) taken for birth control from an unknown date and was ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:00, the patient experienced a sore arm. On the same day, the patient had breakthrough bleeding which started unexpectedly less than 24 hours after the vaccine even after being on birth control (LoLoestrin FE a low dose oral contraceptive). The breakthrough bleeding was not that severe and the patient had used only 1 pad per day. On 04Apr2021, the patient had mild cramping and noted that her breakthrough bleeding was heavier and bright red (fast-flowing) than any other breakthrough bleeding which the patient had experienced and had always been very minimal and dark brown. It was reported that breakthrough bleeding lasted for about 7 days (until 10Apr2021) with no other side effects. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and mild cramping were recovered on an unknown date in Apr2021, while that of the event increased breakthrough bleeding and heavier and bright red (fast-flowing) were recovered on 10Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: Severe vertigo which caused vomiting; Severe vertigo which caused vomiting; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 28Mar2021 at 13:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, obese (obesity) and high BP (blood pressure high). The patient had allergy to some unspecified antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation and experienced no side effects. On an unknown date in Mar2021 (reported as 04Apr2021), the patient experienced nausea. It was reported that day 1 was fine. On 29Mar2021 (reported as 04Apr2021), day 2 after the vaccine the patient experienced severe vertigo which caused vomiting. On 01Apr2021, day 5, the symptoms are diminishing but still present. 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 nausea was recovered on an unknown date in Mar2021 (reported as after day 2, the patient did not have nausea). The clinical outcomes of the events severe vertigo which caused vomiting were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Skin discolouration, Swelling
Clinical narrative: Finger on left hand was dark(nearly black) on the inside on the palm.; Slightly swollen/ little swollen; Slight pain to touch; First dose on 06Apr2021 and second dose on 20Apr2021; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, pre diabetic, herpes and known allergies to pollen and etc regular allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), aciclovir (ACYCLOVIR), acetylsalicylic acid (ASPRIN), metformin (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN), all for an 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. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 06:00, the patient experienced finger on left hand was dark (nearly black) on the inside on the palm. No noticeable pain and appeared slightly swollen. Currently it was PM the finger had somewhat cleared of the darkness except on the inside of the finger still a little swollen and slight pain to touch. 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 taken as a result of the reported events. The clinical outcome of the events finger on left hand was dark (nearly black) on the inside on the palm. No noticeable pain and appeared slightly swollen, currently it was PM the finger had somewhat cleared of the darkness except on the inside of the finger still a little swollen and slight pain to touch was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: Swollen eye area around filler; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 31Mar2021 at 15:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 23:00, the patient experienced swollen eye area around filler. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of reported event which included treatment with diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event swollen eye area around filler was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Injection site is red, painful, itching and a large lump; Injection site is red, painful, itching and a large lump; Injection site is red, painful, itching and a large lump; Injection site is red, painful, itching and a large lump; 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: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 00:15 (at the age of 38-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. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, 4 days later the vaccination, the patient's injection site was red, painful, itching and a large lump. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site was red, injection site painful, injection site itching and injection site large lump was 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea exertional, Fatigue, Myalgia
Clinical narrative: Difficulty breathing at some times, mostly while exercising; Muscle and joint pain; Muscle and joint pain, joint pain in her fingers and toes; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified medication for an unknown indication from an unknown date and unknown if ongoing. On 19Apr2021, the patient experienced difficulty breathing at some times, mostly while exercising, muscle and joint pain. joint pain in her fingers and toes and tiredness. 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. The clinical outcome of the events difficulty breathing at some times, mostly while exercising, muscle and joint pain, joint pain in her fingers and toes and tiredness was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Nausea
Clinical narrative: Body aches; Nausea; Nausea followed by vomiting.; Then extreme chills, headache and fever of 102.7; Then extreme chills, headache and fever of 102.7; Then extreme chills, headache and fever of 102.7; Currently still have fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient 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 21Apr2021 at 15:45 (at the age of 49-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. Concomitant medications included paracetamol (TYLENOL), rosuvastatin (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and tamsulosin (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: EW0161) via an unspecified route of administration in the right arm on 30Mar2021 at 15:45 (at the age of 49-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 22Apr2021 at 14:45, approximately 24 hours after second dose, the patient experienced body aches, nausea followed by vomiting, then extreme chills, headache, fatigue and fever of 102.7, which lasted for approximately 11 hours. On 22Apr2021, the patient underwent lab test which included body temperature test and the result was found to be 102.7 (units unspecified). 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 body aches, nausea followed by vomiting, then extreme chills, headache and fever of 102.7 were resolved on an unknown date in Apr2021; while that of the event fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Body aches; Nausea; Nausea followed by vomiting.; Then extreme chills, headache and fever of 102.7; Then extreme chills, headache and fever of 102.7; Then extreme chills, headache and fever of 102.7; Currently still have fatigue.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient 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 21Apr2021 at 15:45 (at the age of 49-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. Concomitant medications included paracetamol (TYLENOL), rosuvastatin (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) and tamsulosin (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: EW0161) via an unspecified route of administration in the right arm on 30Mar2021 at 15:45 (at the age of 49-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 22Apr2021 at 14:45, approximately 24 hours after second dose, the patient experienced body aches, nausea followed by vomiting, then extreme chills, headache, fatigue and fever of 102.7, which lasted for approximately 11 hours. On 22Apr2021, the patient underwent lab test which included body temperature test and the result was found to be 102.7 (units unspecified). 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 body aches, nausea followed by vomiting, then extreme chills, headache and fever of 102.7 were resolved on an unknown date in Apr2021; while that of the event fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives over face, neck, scalp, ears (whole head); Rash over face, neck, scalp, ears (whole head); This is a spontaneous report from a contactable consumer, the patient. A 47-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 21Apr2021 at 10:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy, migraine and allergic to penicillin (PCN), sulfa and nuts. 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 lamotrigine (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC), oxcarbazepine (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); all taken for an unknown indication from an unknown date and unknown if ongoing. On 21Apr2021 at 14:00, the patient experienced hives and rash over face, neck, scalp, ears (whole head). 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 hives and rash over face, neck, scalp, ears (whole head) was resolving 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Balance disorder, Chest pain, Dizziness postural, Fatigue
Clinical narrative: Pain in right side of chest; Dizziness when standing; Soreness/ sharp pains in right armpit; Severe fatigue; Feels like balance is off; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the right arm on 22Apr2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included IBS-C (constipation predominant irritable bowel syndrome). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naloxone hydrochloride/ buprenorphine hydrochloride (SUBOXONE); for an 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6128) via an unspecified route of administration in the right arm on 31Mar2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient also previously received clarithromycin (BIAXIN) antibiotic for unknown indication from an unknown date and experienced drug allergy. On 23Apr2021 at 06:15, the patient experienced pain in right side of chest, dizziness when standing, soreness/ sharp pains in right armpit, severe fatigue and feels like balance is off. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events pain in right side of chest, dizziness when standing, soreness/ sharp pains in right armpit, severe fatigue and feels like balance is off was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Neck pain, Pyrexia
Clinical narrative: Increased heart rate (120 bpm resting); Severe neck pain on same side ofinjection site; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 22Apr2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS) and latex allergy. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d (VITAMIN D) and levonorgestrel (KYLEENA) intrauterine device (IUD), all started on 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: ER8733) via an unspecified route of administration in the right arm on 24Mar2021 at 17:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, the patient experienced increased heart rate (120 bpm resting), severe neck pain on same side of injection site and fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 23Apr2021, the patient underwent a heart rate check and the result of the resting heart rate was 120 beats per minute. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events increased heart rate (120 bpm resting), severe neck pain on same side of injection site and fever was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: I stopped the pills on morning Saturday 17Apr2021 and had a full (shorter than usual, but normal heavy flow x 2 days and then tapering off over next 3 days) period; Despite being on birth control and not missing any doses ''I'' got ''my'' period again on 14Apr2021.; After spotting for 3 days, ''I'' stopped the pills on morning; This is a spontaneous report from a contactable pharmacist, the patient. A 42-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 09Apr2021 at 13:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid, obese. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing and birth control (MANUFACTURER UNKNOWN) was ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; EN6208) via an unspecified route of administration in the left arm on 18Mar 2021 at 12:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient previously also received amoxicillin (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. The previous period of patient finished on 06Apr2021 and she only stopped active birth control and got her period once a quarter; despite being on birth control and not missing any doses she got her period again on 14Apr2021. After spotting for 3 days, the patient stopped the pills on morning Saturday on 17Apr2021 and had a full (shorter than usual, but normal heavy flow x 2 days and then tapering off over next 3 days) period, and restarted birth control on Mon 19Apr2021. 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 reported events. The clinical outcome of the events despite being on birth control and not missing any doses she got her period again on an unknown date in Apr2021 and stopped the pills on morning Saturday 17Apr2021, spotting for 3 days was recovered on 17Apr2021 and had a full (shorter than usual, but normal heavy flow x 2 days and then tapering off over next 3 days) period was recovered on 19Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Tremor
Clinical narrative: 104.1f fever; Violent shaking; Terrible stabbing headache over eyes; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE0153) via an unspecified route of administration in the left arm on 22Apr2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to 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 did not receive any concomitant medications. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 02Apr2021 at 07:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 05:00, the patient experienced 104.1f fever, violent shaking and terrible stabbing headache over eyes. On 23Apr2021, the patient underwent body temperature test and the result was 104.1 fahrenheit. 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 104.1f fever, violent shaking and terrible stabbing headache over eyes were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Lymphadenopathy, Nerve compression
Clinical narrative: 100.3 degree fever; Severe headache; Diarrhea; Soreness near teeth; Pain at injection site; Swollen lymph nodes in neck and armpit aggravated; Swollen lymph nodes in neck and armpit aggravated a pinched nerve in ''my'' shoulder on the same side; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included elongated bone at base of neck that often results in pinched nerves. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for birth control. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 01Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced 100.3 degree fever, severe headache, diarrhea, soreness near teeth, pain at injection site and swollen lymph nodes in neck and armpit aggravated a pinched nerve in my shoulder on the same side that she received the shot. 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. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events 100.3 degree fever, severe headache, diarrhea, soreness near teeth, pain at injection site and swollen lymph nodes in neck and armpit aggravated a pinched nerve in my shoulder was recovering 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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Toothache, Vaccination site pain
Clinical narrative: 100.3 degree fever; Severe headache; Diarrhea; Soreness near teeth; Pain at injection site; Swollen lymph nodes in neck and armpit aggravated; Swollen lymph nodes in neck and armpit aggravated a pinched nerve in ''my'' shoulder on the same side; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included elongated bone at base of neck that often results in pinched nerves. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified birth control pills (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing for birth control. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. 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 01Apr2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced 100.3 degree fever, severe headache, diarrhea, soreness near teeth, pain at injection site and swollen lymph nodes in neck and armpit aggravated a pinched nerve in my shoulder on the same side that she received the shot. 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. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events 100.3 degree fever, severe headache, diarrhea, soreness near teeth, pain at injection site and swollen lymph nodes in neck and armpit aggravated a pinched nerve in my shoulder was recovering 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.