chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Vaccination site pain
Clinical narrative: Injection site pain; swollen axillary lymph nodes; whole body joint pain; whole body muscle pain; whole body skin pain; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, peppers allergy, bananas allergy, latex allergy, dust allergy and boxelder pollen allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), multi vitamins (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and oxymetazoline hydrochloride (AFRIN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received clobetasol (MANUFACTURER UNKNOWN) and experienced drug allergy. 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 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021 at 11:00, the patient experienced injection site pain, swollen axillary lymph nodes, whole body joint pain, whole body muscle pain, whole body skin pain, fatigue and nausea. 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 outcomes of the events injection site pain, swollen axillary lymph nodes, whole body joint pain, whole body muscle pain, whole body skin pain, fatigue and nausea were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes swollen the size of an orange; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male 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 01Apr2021 (at the age of 57-year-old) as a single dose for COVID-19 immunisation and 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 22Apr2021 at 11:45 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date in Apr2021, the patient's lymph nodes swollen the size of an orange. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph nodes swollen the size of an orange was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding
Clinical narrative: Period cramps and spotting; Period cramps and spotting; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 13:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included salmon oil (MANUFACTURER UNKNOWN), docosahexaenoic acid (DHA), ergocalciferol (VIT D), ascorbic acid (VIT C) and multivitamins (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 03:00, the patient experienced period cramps and spotting. The patient was very regular and track her period using an application. It was reported that the patient was not expecting to get her period until 08May2021. 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 event period cramps and spotting was resolving at the time of this report. The 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 05Apr2021 at 09:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Severe shoulder pain in injection arm, to the point of almost not being able to use my arm for several days; Several days of moderate full body joint pain; Exhaustion for several days and challenging to complete low-energy activities without needing a break (i.e., gardening); This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Apr2021at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. Prior to 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 ethinylestradiol/ etonogestrel (NUVARING) and vitamin d nos (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. On an unknown date in Apr2021 at 20:00, the patient experienced severe shoulder pain in injection arm, to the point of almost not being able to use her arm for several days, several days of moderate full body joint pain and exhaustion for several days and challenging to complete low-energy activities without needing a break (i.e., gardening). The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shoulder pain in injection arm, to the point of almost not being able to use her arm for several days, moderate full body joint pain, exhaustion for several days and challenging to complete low-energy activities without needing a break were resolved with sequelae on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: I was mildly nauseous for about 1 entire week after the vaccine, mainly in the mornings; 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: ER8731) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and coarctaion of the aorta (repaired). The patient had known allergies to avocado and pineapple. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. On 09Apr2021, the patient was mildly nauseous for about 1 entire week after the vaccine, mainly in the mornings. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event was mildly nauseous for about 1 entire week after the vaccine, mainly in the mornings was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Swollen lymph nodes in both armpits; Swollen lymph nodes in both armpits that are painful; Whole body pain and aches; Fever up to 100.8; This is a spontaneous report from a contactable healthcare professional. A 40-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 arm right on 21Apr2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included possible inflammatory autoimmune 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 vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO150) via an unspecified route of administration in the arm left on 31Mar2021 at 14:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 10:00, the patient experienced swollen lymph nodes in both armpits that are painful, whole-body pain and aches fever up to 100.8. On an 22Apr2021, the patient underwent body temperature test and the result was fever up to 100.8 F. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes in both armpits that are painful, whole body pain and aches fever up to 100.8 F was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Pain, Pain in extremity
Clinical narrative: Severa arm pain; Body aches; Chills at times; It hurts to walk; Extreme fatigue even to shower; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 at 11:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included degenerative disc disease and had known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 23:00, the patient experienced severe arm pain and can't lift arm, body aches all over are at an 8 almost a 9, chills, it hurts to walk, extreme fatigue even to shower and had no fever. 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 severe arm pain and can't lift arm, body aches, chills, it hurts to walk and extreme fatigue 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Early onset of menstrual cycle even while taking hormonal birth control pills. Cycle stated a week and a half early.; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Apr2021 at 07:15 (at the age of 39-year-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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified birth control pill from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 07:00 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 20:00, the patient had an early onset of menstrual cycle even while taking hormonal birth control pills. The cycle stated a week and half early. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early onset of menstrual cycle even while taking hormonal birth control pills 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Fall, Fatigue, Hypoaesthesia
Clinical narrative: Extreme dizziness; Falling over; Inability to drive; Numbness in both arms and legs/ Couldn't feel legs from the calf down at one point; Arm weakness to pick things up; Involuntary left arm shaking; Memory issues, forgetting to complete tasks that I have started; Feeling of extreme itching inside my body; Crushing fatigue; This is a spontaneous report from a non-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: EW0151) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included Nickel allergy and food sensitivities. The patient did not take any concomitant medications. 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 08Apr2021, 1 hour after the vaccination, the patient experienced numbness in both arms and legs, couldn't feel legs from the calf down at one point. On 08Apr2021, the patient experienced extreme dizziness, caused falling over and  inability to drive, arm weakness to pick things up, involuntary left arm shaking, memory issues, forgetting to complete tasks that the patient had started, feeling of extreme itching inside body and crushing fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. 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 outcomes of the events extreme dizziness, falling over and inability to drive were resolved on an unspecified date in Apr2021, after a duration of almost 2 weeks; while that of the events numbness in both arms and legs, couldn't feel legs from the calf down at one point, arm weakness to pick things up, involuntary left arm shaking, memory issues, forgetting to complete tasks that the patient had started, feeling of extreme itching inside my body and crushing fatigue were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Memory impairment, Muscular weakness, Pruritus
Clinical narrative: Extreme dizziness; Falling over; Inability to drive; Numbness in both arms and legs/ Couldn't feel legs from the calf down at one point; Arm weakness to pick things up; Involuntary left arm shaking; Memory issues, forgetting to complete tasks that I have started; Feeling of extreme itching inside my body; Crushing fatigue; This is a spontaneous report from a non-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: EW0151) via an unspecified route of administration in the right arm on an unknown date in Apr2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included Nickel allergy and food sensitivities. The patient did not take any concomitant medications. 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 08Apr2021, 1 hour after the vaccination, the patient experienced numbness in both arms and legs, couldn't feel legs from the calf down at one point. On 08Apr2021, the patient experienced extreme dizziness, caused falling over and  inability to drive, arm weakness to pick things up, involuntary left arm shaking, memory issues, forgetting to complete tasks that the patient had started, feeling of extreme itching inside body and crushing fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. 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 outcomes of the events extreme dizziness, falling over and inability to drive were resolved on an unspecified date in Apr2021, after a duration of almost 2 weeks; while that of the events numbness in both arms and legs, couldn't feel legs from the calf down at one point, arm weakness to pick things up, involuntary left arm shaking, memory issues, forgetting to complete tasks that the patient had started, feeling of extreme itching inside my body and crushing fatigue were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Heavy menstrual bleeding, Pain
Clinical narrative: Chills; Stomach pain; Diarrhea; Aches; Heavy period; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 22Mar2021 (at the age of 44-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 COVID vaccine. Concomitant medications included iron (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and citalopram hydrobromide (CELEXA); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient previously took cefuroxime axetil (CEFTIN) and experienced drug allergy. On 23Mar2021, the patient experienced chills, stomach pain, diarrhea, aches and heavy period. 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 chills, stomach pain, diarrhea, aches and heavy period was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extremely itchy scalp/ Itching going down to behind ears; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Apr2021 at 07:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid 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 4 weeks prior to the COVID-19 vaccine. Concomitant medication included unspecified thyroid medication (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 22Apr2021 at 01:00, the patient experienced extremely itchy scalp and the itching was going down to behind ears at the time of reporting (reported as at the present time). No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely itchy scalp/ itching going down to behind ears 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Extreme pain in the left armpit area where lymph nodes are located; This is a spontaneous report from a non-contactable consumer, the patient. A 29-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 on 30Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and also the 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 13:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether 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 previously received ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On an unknown date in 2021, the patient experienced extreme pain in the left armpit area where lymph nodes are located. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extreme pain in the left armpit area where lymph nodes are located was not resolved 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Skin disorder
Clinical narrative: 6 chicken pox looking bumps on elbow and hand of the arm where the shot got in; 101 fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male 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 01Apr2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 19:00, the patient experienced 101 fever and headache about 6 hours after the shot for 24 hours. On 11Apr2021, 10 days after the shot the patient experienced 6 chicken pox looking bumps on elbow and hand of the arm where he got shot in. On 01Apr2021, the patient underwent body temperature test and the result was 101 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101 fever and headache were resolved on 02Apr2021 (reported as recovering). The clinical outcome of the event 6 chicken pox looking bumps on elbow and hand of the arm where he got shot in was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Vaccination site pain, Vomiting
Clinical narrative: Nausea; Injection site pain; Body ache; Muscle aches; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 in left arm (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, ADHD (attention deficit hyperactivity disorder) and auto immune disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination and included second dose of meningococcal vaccine (MANUFACTURER UNKNOWN) on 19Mar2021 in the left leg. Concomitant medication included amfetamine aspartate / amfetamine sulfate / dexamfetamine saccharate / dexamfetamine sulfate (ADDERAL), fluoxetine hydrochloride (PROZAC), colecalciferol (VIT. D), iron (FERRATE PILL) and medroxyprogesterone acetate (DEPOPROVERA); for unknown indications from an unknown date and unknown if ongoing. The patient previously received CEFZIL (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On 28Apr2021, the patient had typical symptoms expected like nausea, injection site pain, body / muscle aches, vomiting which had been pretty constant last 2 hours. It was unknown whether 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 of nausea, injection site pain, body ache, muscle aches and vomiting were 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Very tired feeling; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 28Apr2021 at 18:15 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included schizophrenia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included prazosin hydrochloride (PRAZOSIN), trazodone (MANUFACTURER UNKNOWN), olanzapine (ZYPREXA), sertraline (MANUFACTURER UNKNOWN) and benzatropine mesilate (COGENTIN); all for unknown indication from an unknown date and unknown if ongoing. On 28Apr2021 at 19:15, the patient experienced very tired feeling, chills and nausea. 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 very tired feeling, chills and nausea was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Musculoskeletal chest pain, Rash
Clinical narrative: Headaches; Weakness; Left side of rib cage hurts; Rash from neck to legs; This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm  on 18Apr2021 at 08:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 07:00 the patient experienced headaches, weakness, left side of rib cage hurts and rash from neck to legs. 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 adverse events and included treatment with unspecified medication.  The clinical outcome of the events headaches, weakness, left side of rib cage hurts and rash from neck to legs was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Eye pruritus, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Chest tightness within an hour of the shot; Severe nasal congestion; Sore throat; Hard heavy sneezing about 60-70 times a day; Red itchy eyes; Red itchy eyes; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 16:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had allergies to sulfa and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 17:00, the patient experienced chest tightness within an hour of the shot and then severe nasal congestion with red itchy eyes, sore throat and hard heavy sneezing about 60-70 times a day. Therapeutic measures were taken as a result of the events and included treatment with allergy medicine loratadine (CLARITIN) and over the counter co. Since the vaccination, the patient had been tested for COVID-19. On 16Apr2021, 19Apr2021, and 23Apr2021, the patient underwent unknown rapid test which was done at school via nasal swab and the result was negative. The clinical outcome of the events chest tightness within an hour of the shot and then severe nasal congestion with red itchy eyes, sore throat and hard heavy sneezing about 60-70 times a day were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: Chest tightness within an hour of the shot; Severe nasal congestion; Sore throat; Hard heavy sneezing about 60-70 times a day; Red itchy eyes; Red itchy eyes; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 16:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had allergies to sulfa and environmental allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within 2 weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 17:00, the patient experienced chest tightness within an hour of the shot and then severe nasal congestion with red itchy eyes, sore throat and hard heavy sneezing about 60-70 times a day. Therapeutic measures were taken as a result of the events and included treatment with allergy medicine loratadine (CLARITIN) and over the counter co. Since the vaccination, the patient had been tested for COVID-19. On 16Apr2021, 19Apr2021, and 23Apr2021, the patient underwent unknown rapid test which was done at school via nasal swab and the result was negative. The clinical outcome of the events chest tightness within an hour of the shot and then severe nasal congestion with red itchy eyes, sore throat and hard heavy sneezing about 60-70 times a day were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Headache, Hyperhidrosis
Clinical narrative: Extreme headache; nausea; sweating; shivering; back soreness; neck soreness; arm soreness; overall weakness; This is a spontaneous report from a contactable consumer, the patient. A 19-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 13:45 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis, gastroesophageal reflux disease (GERD) and allergic to gluten 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 vaccination. Concomitant medications were not reported. 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 12:15 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 23:00, the patient experienced extreme headache, nausea, sweating, shivering, back or neck or arm soreness and overall weakness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme headache, nausea, sweating, shivering, back or neck or arm soreness and overall weakness 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain in extremity
Clinical narrative: Extreme headache; nausea; sweating; shivering; back soreness; neck soreness; arm soreness; overall weakness; This is a spontaneous report from a contactable consumer, the patient. A 19-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 13:45 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis, gastroesophageal reflux disease (GERD) and allergic to gluten 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 vaccination. Concomitant medications were not reported. 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 12:15 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 23:00, the patient experienced extreme headache, nausea, sweating, shivering, back or neck or arm soreness and overall weakness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme headache, nausea, sweating, shivering, back or neck or arm soreness and overall weakness 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Fever 101.3; Headache; This is a spontaneous report from a contactable consumer, the patient. A 28-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 24Apr2021 at 09:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 01Dec2020, the patient underwent Siliva test for COVID-19 and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 at 21:30, the patient experienced chills, fever 101.3 (units unspecified) and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, fever 101.3 (units unspecified) and headache was unknown 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: The first test was on 3/10/21, 5 days after the firstvaccine dose, where my PSA was 6.05. On the second test on 4/21/21, almost 4 weeks after the second dose, it was 6.65/elevated PSA levels; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 12:15 (at the age of 68-years-old) and 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 26Mar2021 at 11:15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included moderate prostate enlargement and known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included MULTIVITAMIN, PROBIOTIC, FISH OIL, MAGNESIUM, CHONDROITIN, GLUCOSAMINE, GINGER ROOT EXTRACT, and VITAMIN D3, all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient reported possible vaccine effect Higher PSA test results following each COVID vaccine dose.  It was reported that the PSA in Oct2020 was 4.7, which was normal for patient's age (68), and had been around this level for the past several years. The patient recently had blood tests done for two different insurance applications. The first test was on 10Mar2021 at 12:00, 5 days after the first vaccine dose, where his PSA was 6.05. On the second test on 21Apr2021, almost 4 weeks after the second dose, it was 6.65. None of the symptoms he had for his moderate prostate enlargement had changed. The patient though this would be worth reporting in case other reports of elevated PSA levels had been made. He would very much like to know if other people had reported this, so that the patient could make the case with the insurance company that the higher PSA was likely due to the vaccine and not an indication of a potential for prostate cancer. The event resulted in doctor or other healthcare professional office/clinic visit. 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 elevated PSA levels was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: After the Pfizer vaccine I experienced irregular spotting and cramping; After the Pfizer vaccine I experienced irregular spotting and cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 25-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 15Apr2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had regular periods her entire life, she knew what day and what time of day it will arrive and for how long. After the Pfizer vaccine, she experienced irregular spotting and cramping on an unspecified date in Apr2021. 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 after the Pfizer vaccine she experienced irregular spotting and cramping was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Malaise, Vaccination site erythema, Vaccination site mass
Clinical narrative: Large red, itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole.; Large red, itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; Itchy, hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; Hot knot on the left arm.  The knot was where the injection was, but it was bigger than the injection hole; I didn't feel well, but not sick; Just weak and didn't want to eat.; Just weak and didn't want to eat.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, asthma and pseudotumor cerebri. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included furosemide (LASIX), hydrochlorothiazide (HYDRODIURIL), verapamil hydrochloride (CALAN-SR) and malus spp. vinegar extract (APPLE CIDER VINEGAR); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and azithromycin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. 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 left arm on 30Mar2021 at 17:30 (at the age of 29-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 20Apr2021 at 18:30, the patient experienced large red, itchy, hot knot on the left arm. The knot was where the injection was, but it was bigger than the injection hole. The patient did not feel well, but not sick, just weak and did not want to eat. The events did not result in doctor or other health care 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 large red, itchy, hot knot on the left arm, did not feel well, but not sick, just weak and did not want to eat were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.