chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: felt very weak and tired; felt very weak and tired; body aches; Nausea; Chills; headache; swollen lymphnode under clavicle; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: BW0170) via an unspecified route of administration in the left arm on 23Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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: ER8734) via an unspecified route of administration in the left arm on 01Apr2021 at 18:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Apr2021, the next day of the second shot, the patient felt very weak, tired, had body aches, nausea and chills. The next couple of days, the patient had a headache and also seemed to have a swollen lymph node under her clavicle. 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 felt very weak and tired, body aches, nausea, chills , headache and swollen lymph node under clavicle were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Arm pain; Arm pain that radiates to shoulder and upper left back around scapula (left).; Pain wraps around side rib cage to under breast (left); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in left arm on 04Apr2021 at 13:45 (at the age of 53-years old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Apr2021, the patient experienced arm pain that radiated to shoulder and upper left back around scapula (left) and wrapped around side rib cage to under breast (left). The pain had continued for one week with no ease and nothing eased the pain. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events, arm pain that radiated to shoulder and upper left back around scapula (left) and wrapped around side rib cage to under breast (left) was not recovered 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: Body temperature, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: Fever 101 degrees the day after vaccination; Chills; Body aches; Dizziness; This is a spontaneous report from a non-contactable physician, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via intramuscular route of administration in the left arm on 26Apr2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously took aspirin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 the patient experienced fever 101 degrees (Unspecified units) the day after vaccination, chills, body aches and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with acetaminophen (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101 degrees (Unspecified units) the day after vaccination, chills, body aches and dizziness were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Increase occurrence of cold sores on lips; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. On 07Apr2021 at 00:00, the patient experienced increased occurrence of cold sores on lips. The event did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event increased occurrence of cold sores on lips was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives on back of left arm.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 13:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The medical history included anemia and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. On 18Apr2021 at 19:00, the patient developed hives on back of left arm. The patient did not receive any treatment for the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient not been tested for COVID-19. The clinical outcome of the event hives on back of left arm was recovered on an unknown date in Apr2021.    No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Genital herpes, Herpes simplex, Herpes zoster, Hyperaesthesia
Clinical narrative: Sore on the same hand on the middle finger; Nerve tingling in back of legs; Genital herpes outbreak; Mild shingles; Herpes 2; Mild shingles case in addition to the herpes 2; Left pointer finger started to become sensitive to touch, like a bruise would be; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included varicella as child, HSV-2 (herpes simplex type 2) and AFIB (atrial fibrillation) periodically. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 20Apr2021, about 11 days after the first dose, the patient reported that the left pointer finger started to become sensitive to touch, like a bruise would be. On 26Apr2021, 6 days later she noticed a sore on the same hand on the middle finger. She also had nerve tingling on back of legs and developed a genital herpes outbreak at the same time. Her doctor believed that the patient had a mild shingles case in addition to the herpes 2. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with valacyclovir (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left pointer finger started to become sensitive to touch like a bruise, sore on the same hand on the middle finger, nerve tingling on back of legs, genital herpes outbreak, mild shingles case in addition to the herpes 2 were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin lesion
Clinical narrative: Sore on the same hand on the middle finger; Nerve tingling in back of legs; Genital herpes outbreak; Mild shingles; Herpes 2; Mild shingles case in addition to the herpes 2; Left pointer finger started to become sensitive to touch, like a bruise would be; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included varicella as child, HSV-2 (herpes simplex type 2) and AFIB (atrial fibrillation) periodically. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 20Apr2021, about 11 days after the first dose, the patient reported that the left pointer finger started to become sensitive to touch, like a bruise would be. On 26Apr2021, 6 days later she noticed a sore on the same hand on the middle finger. She also had nerve tingling on back of legs and developed a genital herpes outbreak at the same time. Her doctor believed that the patient had a mild shingles case in addition to the herpes 2. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with valacyclovir (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left pointer finger started to become sensitive to touch like a bruise, sore on the same hand on the middle finger, nerve tingling on back of legs, genital herpes outbreak, mild shingles case in addition to the herpes 2 were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache; body ache; chills; fever; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 28Apr2021 at 08:45 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. 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 loratadine (CLARITIN), montelukast (MANUFACTURER UNKNOWN), fluticasone propionate (XHANCE) and unspecified birth control pills; all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 16:45, the patient experienced headache, body ache, chills, fever and fatigue. 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 headache, body ache, chills, fever and fatigue was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Lymphadenopathy, Pain
Clinical narrative: Aches; Chills; Discomfort; L lymph node swelling under arm and L side of neck; This is a spontaneous report from a contactable pharmacist, the patient. A 50-year-old, female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route in the left arm on 21Apr2021 (at an age of 50-year-old) as single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received oral contraceptives (OC) (MANUFACTURER UNKNOWN), calcium sodium lactate, calcium phosphate and ergocalciferol (CALCIUM WITH VITAMIN D) and AREDS with 2 weeks of COVID-19 vaccination for unknown indications. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route in the left arm on 31Mar2021 as single dose for COVID-19 immunisation. On 23Apr2021, after 8 hours of vaccination, post the second dose, the patient developed chills and aches, resolving in 24 hours. Following, she developed L lymph node swelling under arm and L side of neck, resulting in discomfort on an unknown date in Apr2021. The patient was able to do most activities except normal exercise. These resolved with any interventions after 5 days. Since the vaccination, the patient had not been tested for COVID-19. 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 events of aches, discomfort, L lymph node swelling under arm and L side of neck and chills 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: Conjunctivitis, Erythema
Clinical narrative: Pink eye; Red face; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 26Apr2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included diabetes, non-alcoholic steatohepatitis (NASH) cirrhosis and a known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN), famotidine (PEPCID), atorvastatin (MANUFACTURER UNKNOWN) and empagliflozin (JARDY); all for unspecified indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 28Apr2021 at 01:00 the patient experienced pink eye and red face. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with eye drops and diphenhydramine (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pink eye and red face 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Chills within 12 hours of second dose; Body aches within 12 hours of second dose; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 27Apr2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (BLISOVI 24 FE) and fluticasone propionate (MANUFACTURER UNKNOWN) and lorraine (MANUFACTURER UNKNOWN) ;all for unknown indications on unknown date and unknown if still ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 06Apr2021 at 01:00 as a single dose for COVID-19 immunisation. On 28Apr2021 at 01:00 the patient experienced chills and body aches within 12 hours of second dose. 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 taken as a result of the events. The clinical outcome of the events chills and body aches within 12 hours of second dose was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Swollen lymph node under left arm pit; Aches; 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: EW0172) via an unspecified route of administration in the left arm on 27Apr2021 at 17:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included rosuvastatin (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 06Apr2021 at 17:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. On 28Apr2021 at 06:00, the patient experienced swollen lymph node under left arm pit and 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 swollen lymph node under left arm pit and aches were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain at injection site that returned a week after the 1st dose.; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 21Apr2021 at 11:30(at the age of 54-year-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient's history of known allergies was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 28Apr2021 at 12:00, the patient experienced arm pain at injection site that returned a week after the first dose. Therapeutic measures were not taken as a result of the adverse event. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of arm pain at injection site was unknown 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Vaccination site erythema
Clinical narrative: Raise hump at injection which was hot to touch and red; Raise hump at injection which was hot to touch and red; Aches; Raise hump at injection which was hot to touch and red; Fatigue; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 27Apr2021 at 10:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 12:00, the patient experienced fatigue, fever, chills, aches, and raised hump at injection which was hot to touch and red. 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 fatigue, fever, chills, aches and raise hump at injection which was hot to touch and red was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: Raise hump at injection which was hot to touch and red; Raise hump at injection which was hot to touch and red; Aches; Raise hump at injection which was hot to touch and red; Fatigue; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 27Apr2021 at 10:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cashews. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 11:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 12:00, the patient experienced fatigue, fever, chills, aches, and raised hump at injection which was hot to touch and red. 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 fatigue, fever, chills, aches and raise hump at injection which was hot to touch and red was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: The pain came back to the right of the vaccination site and has remained for a week and remained at the same level of intensity.; My arm hurt for a week afterwards then stopped.; This is a spontaneous report from a contactable consumer, the patient. A 22-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 arm left on 09Apr2021 at 09:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The medical history included generalized anxiety disorder (GAD), chillblains, raynauds and possible citrus allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included trazodone hydrochloride (TRAZADONE), sertraline hydrochloride (ZOLOFT), valeriana officinalis (VALERIAN), calcium (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C), all from unknown dates and for unknown indications. On 09Apr2021, the patient underwent SARS-CoV-2 (nasal swab) test and the result was negative. On an unknown date in Apr2021, the patient experienced arm hurt for a week afterwards, then stopped. On 22Apr2021, the patient's pain came back to the right of the vaccination site and has remained for a week and remained at the same level of intensity. Therapeutic measures were not taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event arm hurt was recovered on an unknown date in Apr2021, while that of the pain came back to the right of the vaccination site was not resolved at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Inflammation, Nausea
Clinical narrative: Intense chills; Fever; Skin hypersensitivity; Intense inflammation; Nausea; Loss of appetite; Intense fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient had no allergies to food, medication or other products. On 25Apr2021 at 19:00, the patient experienced intense chills, fever, skin hypersensitivity lasting 8 hours, along with intense inflammation lasting 14-18 hours, 4 hours of nausea, 48-hour loss of appetite and 3-4 days intense fatigue. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea was resolved on 25Apr2021 at 23:00 and the events chills, pyrexia and skin hypersensitivity were resolved on 26Apr2021 at 03:00. The outcome of the event intense inflammation was recovered on 26Apr2021 and loss of appetite was recovered on 27Apr2021 at 19:00 and for event intense fatigue 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin
Clinical narrative: Intense chills; Fever; Skin hypersensitivity; Intense inflammation; Nausea; Loss of appetite; Intense fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 11:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient had no allergies to food, medication or other products. On 25Apr2021 at 19:00, the patient experienced intense chills, fever, skin hypersensitivity lasting 8 hours, along with intense inflammation lasting 14-18 hours, 4 hours of nausea, 48-hour loss of appetite and 3-4 days intense fatigue. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event nausea was resolved on 25Apr2021 at 23:00 and the events chills, pyrexia and skin hypersensitivity were resolved on 26Apr2021 at 03:00. The outcome of the event intense inflammation was recovered on 26Apr2021 and loss of appetite was recovered on 27Apr2021 at 19:00 and for event intense fatigue 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Oral mucosal eruption, Pain
Clinical narrative: Rash on stomach/e rash on face, got worse, moved down chest and neck; Chills; Aches; Headache/ had a severe headachewhenever laying down.; Fatigue; Felt like rash was in mouth, gums; Throat felt tingly.; gums and throat felt tingly; 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: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rash on face (Face rash whenever get sick) and seizure (Controlled seizure disorder). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included phenytoin (DILANTIN) and tiagabine hydrochloride (GABITRIL) 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: 7534) via an unspecified route of administration in the left arm on 05Mar2021 at 10:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. 06Apr2021 at 22:45, the patient experienced chills, aches, headache, fatigue lasting 7 days, but improved a bit each day. Also had rash on stomach 12 hours after vaccine lasting one day. On 08Apr2021 the patient experienced, day 3 after 2nd vaccine had a severe rash on face, got worse, moved down chest and neck day 4. On an unknown date in Apr2021, the patient experienced felt like rash was in mouth, gums and throat felt tingly, took Benadryl and went away around day 6. On 13Apr2021, the patient experienced 8 days following 2nd vaccine had a severe headache whenever laying down lasting entire night, but always went away 25 minutes after being up and about. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events felt like rash was in mouth, gums and throat felt tingly and included treatment with BENADRYL. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021, the patient underwent Saliva (SARS-COV-2 test) and the result was Negative. The clinical outcome of the events chills, aches, headache, fatigue, had a severe rash on face, got worse, moved down chest and neck, had a severe headache whenever laying down (lasting entire night) but always went away 25 minutes after being up and about recovered on an unknown date in Apr2021. The clinical outcome of the event felt like rash was in mouth, gums and throat felt tingly recovered on 11Apr2021.While the clinical outcome of the event had rash on stomach recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Rash, SARS-CoV-2 test
Clinical narrative: Rash on stomach/e rash on face, got worse, moved down chest and neck; Chills; Aches; Headache/ had a severe headachewhenever laying down.; Fatigue; Felt like rash was in mouth, gums; Throat felt tingly.; gums and throat felt tingly; 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: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included rash on face (Face rash whenever get sick) and seizure (Controlled seizure disorder). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included phenytoin (DILANTIN) and tiagabine hydrochloride (GABITRIL) 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: 7534) via an unspecified route of administration in the left arm on 05Mar2021 at 10:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. 06Apr2021 at 22:45, the patient experienced chills, aches, headache, fatigue lasting 7 days, but improved a bit each day. Also had rash on stomach 12 hours after vaccine lasting one day. On 08Apr2021 the patient experienced, day 3 after 2nd vaccine had a severe rash on face, got worse, moved down chest and neck day 4. On an unknown date in Apr2021, the patient experienced felt like rash was in mouth, gums and throat felt tingly, took Benadryl and went away around day 6. On 13Apr2021, the patient experienced 8 days following 2nd vaccine had a severe headache whenever laying down lasting entire night, but always went away 25 minutes after being up and about. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events felt like rash was in mouth, gums and throat felt tingly and included treatment with BENADRYL. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021, the patient underwent Saliva (SARS-COV-2 test) and the result was Negative. The clinical outcome of the events chills, aches, headache, fatigue, had a severe rash on face, got worse, moved down chest and neck, had a severe headache whenever laying down (lasting entire night) but always went away 25 minutes after being up and about recovered on an unknown date in Apr2021. The clinical outcome of the event felt like rash was in mouth, gums and throat felt tingly recovered on 11Apr2021.While the clinical outcome of the event had rash on stomach recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus, Vertigo
Clinical narrative: Vertigo; Tinnitus; Face tingling; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 09Apr2021 at 11:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 07:00, the patient experienced vertigo, face tingling and tinnitus which was constant and has lasted 16 days now. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events which included treatment with unspecified anti-anxiety medications. The clinical outcome of the events vertigo, face tingling and tinnitus were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: General aches and pain; Fatigue; This is a spontaneous report from a contactable consumer. An unspecified aged adult male 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 28Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced fatigue and general aches and pain. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcomes of events fatigue and general aches and pain were recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Derealisation, Disturbance in attention, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Feelings of dizziness; sore arm; sense of derealization; hard to focus and concentrate; floating outside of my body; going to faint; heavy fatigue; sweaty palms & feet; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 28Apr2021 at 13:15(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. Patient had no known allergies to food, medication or other products. On 28Apr2021 at 16:45, the patient experienced feelings of dizziness, heavy fatigue, sweaty palms & feet, sore arm. The main symptom he was reporting was a sense of derealization. He felt like he was going to faint at certain times and it was hard to focus and concentrate. It felt like he was floating outside of his body and the only thing he could do was try to focus on not fainting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feelings of dizziness, sore arm, sense of derealization, hard to focus and concentrate, floating outside of my body, going to faint, heavy fatigue and sweaty palms & feet were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: Feelings of dizziness; sore arm; sense of derealization; hard to focus and concentrate; floating outside of my body; going to faint; heavy fatigue; sweaty palms & feet; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 28Apr2021 at 13:15(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Patient did not have any medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication was not reported. Patient had no known allergies to food, medication or other products. On 28Apr2021 at 16:45, the patient experienced feelings of dizziness, heavy fatigue, sweaty palms & feet, sore arm. The main symptom he was reporting was a sense of derealization. He felt like he was going to faint at certain times and it was hard to focus and concentrate. It felt like he was floating outside of his body and the only thing he could do was try to focus on not fainting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feelings of dizziness, sore arm, sense of derealization, hard to focus and concentrate, floating outside of my body, going to faint, heavy fatigue and sweaty palms & feet were 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: Confusional state, Fatigue, Headache, Memory impairment
Clinical narrative: Confusion; Memory issues; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 14:45 (at the age of 51-years-old), and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8735) via an unspecified route of administration in the left arm on 24Apr2021 at 14:30 (at the age of 51-years-old); both as a single dose for COVID-19 immunisation. Medical history included allergies to eggs, peanuts, wheat, soy, corn, tomatoes and peppers. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified multivitamin, paracetamol (TYLENOL), ibuprofen (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN SR); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN), tramadol (MANUFACTURER UNKNOWN) and ciprofloxacin (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021 at 12:00, the patient experienced confusion, memory issues, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of confusion, memory issues, fatigue and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Periodic chest tightness; This is a spontaneous report from a non-contactable consumer, the patient. A 30-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 on an unknown date in Apr2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 28Apr2021 at 02:00, approximately 36 hours after second dose of vaccine the patient experienced periodic chest tightness. These episodes lasted a second, and occurred randomly. It seemed to get worse when laying down. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as the result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event periodic chest tightness was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.