chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy
Clinical narrative: Swollen left axillary lymph nodes; Very mild left arm discomfort.; This is a spontaneous report from a non-contactable other healthcare professional. A 54-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA (as reported)) via intramuscular route of administration in the left arm on 28Sep2021 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 other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. It was reported that the patient had vaccination in his left shoulder. On 29Sep2021, after 24 hours of the vaccination, the patient experienced swollen left axillary lymph nodes and very mild left arm discomfort. 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 left axillary lymph nodes and very mild left arm discomfort was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Fever 101 F; muscle & joint pain; Muscle & joint pain; Fatigue; Arm pain; Nausea; Headache; Chills; Booster; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 28Sep2021 at 14:30 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. 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 biotin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) both via an unspecified route of administration on an unknown date for covid-19 immunisation and had no adverse reactions. On 28Sep2021 at 18:30, the patient experienced arm pain, nausea, headache, chills, fever (101 F), muscle & joint pain and fatigue. The symptoms began about 4-12 hours after shot. The patient reported that first and second shots had no adverse reactions. 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 arm pain, nausea, headache, chills, fever (101 F), muscle & joint pain, fatigue was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever 101 F; muscle & joint pain; Muscle & joint pain; Fatigue; Arm pain; Nausea; Headache; Chills; Booster; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the left arm on 28Sep2021 at 14:30 (at the age of 75-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. 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 biotin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first and second dose of covid-19 vaccine (MANUFACTURER UNKNOWN) both via an unspecified route of administration on an unknown date for covid-19 immunisation and had no adverse reactions. On 28Sep2021 at 18:30, the patient experienced arm pain, nausea, headache, chills, fever (101 F), muscle & joint pain and fatigue. The symptoms began about 4-12 hours after shot. The patient reported that first and second shots had no adverse reactions. 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 arm pain, nausea, headache, chills, fever (101 F), muscle & joint pain, fatigue was not resolved 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: Menstrual disorder
Clinical narrative: Bleeding since September 3rd. Have an IUD.; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Sep2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation and 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 27Sep2021 at 18:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), sucralfate (MANUFACTURER UNKNOWN) and amoxicillin, clavulanate potassium (AMOX-CLAV 875) and unspecified IUD; for unknown indications, from unknown dates and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 03Sep2021 at 11:30, the patient experienced bleeding. The patient had an IUD and did not get periods, so that was odd for her. 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 bleeding since 11:30 on 03Sep2021 and did not get periods was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Following booster shot:Swollen lymph nodes near site of injection; Painful lymph nodes near site of injection; Pain at injection site; Discomfort at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 (at the age of 36-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. Concomitant medications were not reported. On 30Sep2021, following booster shot, the patient experienced swollen painful lymph nodes near site of injection, pain and discomfort at injection site. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen painful lymph nodes near site of injection, pain at injection site and discomfort 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pyrexia, Rhinorrhoea
Clinical narrative: Feeling tired; Had a "foggy like" sensation; "I" started running a low grade fever; Chills; Runny nose; This is a spontaneous report from a contactable pharmacist, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 28Sep2021 at 09:30 (at the age of 37-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 were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Sep2021 at 09:30, shortly after getting the vaccine, the patient started feeling tired and had a foggy like sensation. Towards the later part of the evening, the patient started running a low grade fever followed by chills and a runny nose which lasted about 48 hours and then fully subsided. The patient woke up 48 hours after and all symptoms resolved. 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 taken as a result of the events and included treatment with paracetamol (TYLENOL). The clinical outcome of the events started feeling tired, foggy like sensation, started running a low grade fever followed by chills and a runny nose was resolved on 30Sep2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Immunisation, Off label use
Clinical narrative: Extreme chills; Extreme shaking; Headache; Weakness; Off label use/ Dose number: 3; Dose number 3; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 30Sep2021 at 10:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation ( A fib) and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 30Sep2021 at 22:00, the patient experienced extreme chills and shaking, headache and weakness. 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 extreme chills and shaking, headache and weakness was unknown at the time of this report.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Extreme chills; Extreme shaking; Headache; Weakness; Off label use/ Dose number: 3; Dose number 3; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the right arm on 30Sep2021 at 10:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation ( A fib) and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 30Sep2021 at 22:00, the patient experienced extreme chills and shaking, headache and weakness. 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 extreme chills and shaking, headache and weakness was unknown at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: A swollen, painful lymph node with each injection on top of my left collar bone.; A swollen, painful lymph node with each injection on top of my left collar bone.; 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: UNKNOWN) via an unspecified route of administration in the left arm on 03Mar2021 at 12:00 (at the age of 31-year-old) and also 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 23Mar2021 at 12:00 (at the age of 31-year-old); both as a single dose for COVID-19 immunisation. Medical history included borderline personality disorder, major depressive disorder, generalized anxiety disorder and known allergy to sulfa. 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 were not reported. On 06Mar2021 at 00:00, the patient experienced a swollen lymph node and painful lymph node with each injection on top of the left collar bone. After the second injection, the patient had two swollen lymph nodes total, one on top of the other on top of left collar bone. The event 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 been tested for COVID-19. On 30Apr2021, the patient underwent lab tests and procedures which included COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events a swollen lymph node and painful lymph node with each injection was resolved on an unknown date in 2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 75-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 00:00 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included heart bypass. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Oct2021, the patient experienced sore arm. 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 sore arm was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a non-contactable consumer. A 37-year-old non-pregnant female patient received booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Sep2021 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 30Sep2021, the patient experienced body aches. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches 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: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Ever since receiving the second shot I have had headaches daily. I have never suffered from headaches like this before.; This is a spontaneous report from a non-contactable consumer, the patient. A 15-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 13Jul2021 at 14:00 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 22Jun2021 at 14:00 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. On 13Jul2021 at 14:00, ever since receiving the second shot, the patient experienced headaches daily. The patient had never suffered from headaches like that before. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported event, which included treatment with paracetamol (TYLENOL) and ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headaches daily was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Menstruation irregular, Off label use
Clinical narrative: Started period 6 days after getting vaccine. last day of previous period was the day I received the booster; Off label use; Booster/ Dose received: 3; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non-pregnant  female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Sep2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously 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 as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01Oct2021, the patient started period 6 days after getting vaccine. The last day of previous period was the day she received the booster. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started period 6 days after getting vaccine, last day of previous period was the day received the booster was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Headache, Immunisation
Clinical narrative: Severe pain across shoulders; Had severe pain across shoulders and down leftarm to the middle of hand; Severe pain across my shoulders and down my left arm to the middle of my hand; Chills; Nausea; Severe headache; Upset stomach; Muscles in my right shoulder were hard as a brick; Booster; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 30Sep2021 at 19:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included vitamin d nos (MANUFACTURER UNKNOWN) and vitamin b nos (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. The patient previously took morphine sulfate (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 29Jan2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 19Feb2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. After the booster shot (third vaccine), 23 hours later on 01Oct2021 (also reported as at 16:00), the patient had severe pain across her shoulders and down her left arm to the middle of her hand, chills, nausea, severe headache, upset stomach. The pain in her arm was so severe that she was crawling on the floor in tears. The muscles in her right shoulder were hard as a brick and her shoulder joint felt like it was being disarticulated. 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 and included treatment with ondansetron (ZOFRAN) (reported as zofram) and paracetamol (TYLENOL). The clinical outcome of the events severe pain across her shoulders and down her left arm to the middle of her hand, chills, nausea, severe headache, upset stomach; the pain in her arm was so severe that she was crawling on the floor in tears; the muscles in her right shoulder were hard as a brick and her shoulder joint felt like it was being disarticulated was resolving at the time of this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: Severe pain across shoulders; Had severe pain across shoulders and down leftarm to the middle of hand; Severe pain across my shoulders and down my left arm to the middle of my hand; Chills; Nausea; Severe headache; Upset stomach; Muscles in my right shoulder were hard as a brick; Booster; This is a spontaneous report from a contactable nurse, the patient. A 66-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 30Sep2021 at 19:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included vitamin d nos (MANUFACTURER UNKNOWN) and vitamin b nos (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. The patient previously took morphine sulfate (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 29Jan2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation and second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 19Feb2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. After the booster shot (third vaccine), 23 hours later on 01Oct2021 (also reported as at 16:00), the patient had severe pain across her shoulders and down her left arm to the middle of her hand, chills, nausea, severe headache, upset stomach. The pain in her arm was so severe that she was crawling on the floor in tears. The muscles in her right shoulder were hard as a brick and her shoulder joint felt like it was being disarticulated. 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 and included treatment with ondansetron (ZOFRAN) (reported as zofram) and paracetamol (TYLENOL). The clinical outcome of the events severe pain across her shoulders and down her left arm to the middle of her hand, chills, nausea, severe headache, upset stomach; the pain in her arm was so severe that she was crawling on the floor in tears; the muscles in her right shoulder were hard as a brick and her shoulder joint felt like it was being disarticulated was resolving at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Migraine, Myalgia, Nausea
Clinical narrative: Body aches; muscle aches; extreme fatigue; nausea; joint pains; headaches that become migraines; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 12Sep2021 at 12:00 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and did not usually have known allergies. The patient did not take any concomitant medications. 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. On 13Sep2021, the patient experienced body aches, muscle aches, extreme fatigue, nausea, joint pains and headaches that became migraines. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events body aches, muscle aches, extreme fatigue, nausea, joint pains and headaches that became migraines was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; muscle aches; extreme fatigue; nausea; joint pains; headaches that become migraines; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 12Sep2021 at 12:00 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. The patient did not have any medical history and did not usually have known allergies. The patient did not take any concomitant medications. 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. On 13Sep2021, the patient experienced body aches, muscle aches, extreme fatigue, nausea, joint pains and headaches that became migraines. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events body aches, muscle aches, extreme fatigue, nausea, joint pains and headaches that became migraines was not resolved 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: Ageusia, Immunisation, Off label use
Clinical narrative: Loss of taste; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 07:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 19Sep2021 for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and 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, as a single dose for COVID-19 immunisation. The patient received flu vaccine within four weeks prior to the COVID-19 vaccine. On 02Oct2021, the patient experienced loss of taste. 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 loss of taste was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via intramuscular route of administration in the right arm on 01Oct2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and 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, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Oct2021, the patient experienced below the injection site was red, warm, hard and tender. 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 below the injection site was red, warm, hard and tender was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Below the injection site is red, warm, hard and tender.; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer. A 40-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via intramuscular route of administration in the right arm on 01Oct2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and 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, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 03Oct2021, the patient experienced below the injection site was red, warm, hard and tender. 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 below the injection site was red, warm, hard and tender was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Maintained heart rate of 140-150 BPM the day after vaccination for approximately 12 hours; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included obstructive sleep apnea. The patient had no known allergies. 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 vaccine. The patient previously received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021 at 07:00, the day after vaccination, the patient's heart rate was maintained at 140-150 beats per minute (BPM) for approximately 12 hours. On the same day, the patient underwent heart rate measurement and the result was 140-150 beats per minute. The event did not result in a 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event maintained heart rate of 140-150 BPM the day after vaccination for approximately 12 hours was resolved on 02Oct2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, SARS-CoV-2 test
Clinical narrative: Right eye swollen; eye pain (slightly); eye feels itchy; 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: FD0809) via an unspecified route of administration in the arm left on 30Sep2021 at 09:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic and high cholesterol. It was reported that the patient was not aware of her 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 other medications within two weeks of vaccination. On 01Oct2021 at 16:30, the patient experienced right eye swollen, eye pain (slightly) and eye feels itchy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 03Sep2021, the patient underwent nasal swab test and the result was found to be negative. The clinical outcome of the events right eye swollen, eye pain (slightly) and eye feels itchy was unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Immunisation, Nausea, Off label use
Clinical narrative: This progressed to nausea by about noon the day following the vaccine; Ate a light supper and felt ok except tired; Within 12 hours post vaccine hadbody aches; Then had to get up around 1 am due to abdominal pain epigastric and upper quadrant; dry heaving; vomiting small amount clear liquid; Patient was administered Booster dose 3, BNT162b2; Patient was administered Booster dose 3, BNT162b2; This is a spontaneous report from a contactable physician, the patient. A 63-year-old non-pregnant female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 01Oct2021 at 16:00(at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 29Jan2021 at 09:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 08:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient previously took influenza vaccine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 02Oct2021 at 04:00, within 12 hours post vaccine, the patient had body aches and no fever. On 02Oct2021 at 12:00, the patient reported that this progressed to nausea by about noon the day following the vaccine, ate a light supper and felt ok except tired. On 03Oct2021 at 01:00, the patient had to get up due to abdominal pain epigastric and upper quadrant, severe nausea, dry heaving and vomiting small amount clear liquid, this lasted until about 10:30 on 03Oct at which pain subsided and nausea much better allowed her to eat a light breakfast. The patient reported that she was a gastroenterologist and she could attest that she never had nausea or vomiting. 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 took some tums. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within 12 hours post vaccine had body aches. This progressed to nausea by about noon the day following the vaccine. Ate a light supper and felt ok except tired. The patient had to get up due to abdominal pain epigastric and r upper quadrant, severe nausea, dry heaving and vomiting small amount clear liquid were recovered on 03Oct2021 at 10:30.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Retching, Vomiting
Clinical narrative: This progressed to nausea by about noon the day following the vaccine; Ate a light supper and felt ok except tired; Within 12 hours post vaccine hadbody aches; Then had to get up around 1 am due to abdominal pain epigastric and upper quadrant; dry heaving; vomiting small amount clear liquid; Patient was administered Booster dose 3, BNT162b2; Patient was administered Booster dose 3, BNT162b2; This is a spontaneous report from a contactable physician, the patient. A 63-year-old non-pregnant female patient received the third dose (BOOSTER DOSE) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the left arm on 01Oct2021 at 16:00(at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 29Jan2021 at 09:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 26Feb2021 at 08:00(at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient previously took influenza vaccine (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. On 02Oct2021 at 04:00, within 12 hours post vaccine, the patient had body aches and no fever. On 02Oct2021 at 12:00, the patient reported that this progressed to nausea by about noon the day following the vaccine, ate a light supper and felt ok except tired. On 03Oct2021 at 01:00, the patient had to get up due to abdominal pain epigastric and upper quadrant, severe nausea, dry heaving and vomiting small amount clear liquid, this lasted until about 10:30 on 03Oct at which pain subsided and nausea much better allowed her to eat a light breakfast. The patient reported that she was a gastroenterologist and she could attest that she never had nausea or vomiting. 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 took some tums. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events within 12 hours post vaccine had body aches. This progressed to nausea by about noon the day following the vaccine. Ate a light supper and felt ok except tired. The patient had to get up due to abdominal pain epigastric and r upper quadrant, severe nausea, dry heaving and vomiting small amount clear liquid were recovered on 03Oct2021 at 10:30.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nodule, Pruritus, Skin warm
Clinical narrative: I had a knot in my arm for about 2 and a half weeks after the first dose.; The knot was red, warm, and itchy for most of that time; My underarms were also very itchy with no visible signs of irritation/itchy for most of that time; The knot was red, warm, and itchy for most of that time; This is a spontaneous report from Non-contactable consumer (patient). A 41-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was unknown) via an unspecified route of administration, administered in Arm Left on 12Sep2021 (41-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included allergy from an unknown date and unknown if ongoing. The concomitant medications were reported as none. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 13Sep2021 05:00, the patient experienced knot in my arm for about 2 and a half weeks after the first dose, the knot was red, warm, and itchy for most of that time, underarms were also very itchy with no visible signs of irritation/itchy for most of that time. The patient received no treatment for the events. Patient was not hospitalised for the events. The outcome of the events was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Dyspnoea, Flushing
Clinical narrative: Immediately following injection: rapid heartbeat.; Dizziness/Weakness; Dizziness/Weakness; Flushed feeling; Severe headache that traveled from base of neck to forehead.; Shortness of breath; Difficulty swallowing; 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: EW0298) via an unspecified route of administration in the left arm on 05Jul2021(at the age of 41-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. The patient did not receive any medication within two weeks of vaccination. The patient previously received azithromycin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 05Jul2021, immediately after vaccination the patient experienced rapid heartbeat, dizziness, weakness, flushed feeling and severe headache that travelled from base of neck to forehead. On 05Jul2021, 10 min after vaccination the patient experienced shortness of breath and difficulty swallowing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent SARS-COV2 test via nasal swab and the result was negative. The clinical outcome of the events rapid heartbeat, dizziness, weakness, flushed feeling, severe headache that travelled from base of neck to forehead, shortness of breath and difficulty swallowing were resolved with sequelae on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.