chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out into hives; This is a spontaneous report from a contactable consumer or other non hcp. This is a spontaneous report from sponsored program SUPPORT. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced broke out into hives on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Hot flush, Myalgia
Clinical narrative: Metallic taste; Hot flashes; Headache; Muscle aches; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 10May2021 at 13:15 (at the age of 36-year-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 lisdexamfetamine mesilate (VYVANSE) for unknown indication from an unknown date and unknown if ongoing. The patient previously received clarithromycin (BIAXIN) for unknown indication from an unknown date and experienced drug allergy and 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 05Apr2021 at 09:00 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. On 10May2021 at 17:00, the patient experienced metallic taste, headache, hot flashes and muscle aches. 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 events metallic taste, headache, muscle aches and hot flashes was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cyanosis, Dyspnoea, Heart rate, Hypoaesthesia
Clinical narrative: Numbness in bilateral hands/fingers; About 45 min she developed cyanosis of her right hand and fingers, same side were she received the vaccine.; Denies pain; SOB or chest pain.; SOB or chest pain.; This is a spontaneous report from a non-contactable healthcare professional. A 44-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 05May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The medical history included gastroesophageal reflux disease (GERD), asthma and seafood allergy. 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. The concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) and multivitamin(unspecified), all for unknown indications from unspecified dates and unknown if ongoing. On 05May201, about 45 minutes after the first dose vaccination, the patient developed cyanosis of her right hand and fingers, same side where she received the vaccine. On 10May2021, 5 days after the administration of the vaccine, the patient was still having the cyanosis and some numbness in bilateral hands/ fingers. The bilateral pulses were intact and oxygen saturation (O2) at room air was at 98%. On an unknown date in May2021, the patient denied pain, shortness of breath (SOB) or chest pain. On an unknown date in May2021, the patient underwent venous duplex test of right upper extremity and result was not reported. On an unknown date in May2021, the patient also underwent pulse rate check and the result revealed that it was intact and an oxygen saturation test at room air showed a result of 98%. The adverse events resulted 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 cyanosis of right hand and fingers, same side where she received the vaccine and numbness in bilateral hands/fingers were not  resolved, while the clinical outcome of pain, shortness of breath (SOB) or chest pain were 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: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Pain, Ultrasound Doppler
Clinical narrative: Numbness in bilateral hands/fingers; About 45 min she developed cyanosis of her right hand and fingers, same side were she received the vaccine.; Denies pain; SOB or chest pain.; SOB or chest pain.; This is a spontaneous report from a non-contactable healthcare professional. A 44-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 05May2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The medical history included gastroesophageal reflux disease (GERD), asthma and seafood allergy. 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. The concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) and multivitamin(unspecified), all for unknown indications from unspecified dates and unknown if ongoing. On 05May201, about 45 minutes after the first dose vaccination, the patient developed cyanosis of her right hand and fingers, same side where she received the vaccine. On 10May2021, 5 days after the administration of the vaccine, the patient was still having the cyanosis and some numbness in bilateral hands/ fingers. The bilateral pulses were intact and oxygen saturation (O2) at room air was at 98%. On an unknown date in May2021, the patient denied pain, shortness of breath (SOB) or chest pain. On an unknown date in May2021, the patient underwent venous duplex test of right upper extremity and result was not reported. On an unknown date in May2021, the patient also underwent pulse rate check and the result revealed that it was intact and an oxygen saturation test at room air showed a result of 98%. The adverse events resulted 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 cyanosis of right hand and fingers, same side where she received the vaccine and numbness in bilateral hands/fingers were not  resolved, while the clinical outcome of pain, shortness of breath (SOB) or chest pain were 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.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Hypersensitivity
Clinical narrative: Bronchitis; had an allergic reaction on Saturday; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated that she experienced bronchitis and has taken an antibiotic regarding her condition and wanted to know how long she needs to wait to get the COVID 19 vaccine second shot after this since she was originally scheduled on 12May2021 or would it be fine for her to take the vaccine. Caller stated she received an antibiotic on Thursday and had an allergic reaction on Saturday and she stopped taking it so she has lost two days not being on an antibiotic and so she probably will not be ready on Wednesday to get the vaccine. Caller stated all she wanted to know was what is the time frame for her to get the second shot and how can she reschedule her appointment. Therapeutic measures were taken as a result of bronchitis in the form of antibiotic. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hot flush, Influenza, Oestrogen receptor assay, Pain
Clinical narrative: fever; chills; aches; hot flashes; felt like "bad flu"; This is a spontaneous report from a contactable nurse. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Pregnant at time of event reported as not available. Medical history included estrogen receptor positive status [er+], secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck, thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm, toxic diffuse goiter without crisis, unspecified bone and cartilage disorder allergy: penicillin, sulfa. Concomitant medication(s) included letrozole (LETROZOLE). The patient experienced fever, chills, hot flashes, aches and felt like bad flu on 15Apr2021 after receiving second covid vaccination. Patient is feeling better. Physician is aware. Lab test included: estrogen receptor positive status [er+]. The outcome of event was recovered on unspecified date 2021.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; aches; hot flashes; felt like "bad flu"; This is a spontaneous report from a contactable nurse. A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Pregnant at time of event reported as not available. Medical history included estrogen receptor positive status [er+], secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck, thyrotoxicosis with diffuse goiter without thyrotoxic crisis or storm, toxic diffuse goiter without crisis, unspecified bone and cartilage disorder allergy: penicillin, sulfa. Concomitant medication(s) included letrozole (LETROZOLE). The patient experienced fever, chills, hot flashes, aches and felt like bad flu on 15Apr2021 after receiving second covid vaccination. Patient is feeling better. Physician is aware. Lab test included: estrogen receptor positive status [er+]. The outcome of event was recovered on unspecified date 2021.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: Injection site pain; Swollen lymph nodes under left armpit..inject site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever 100.1; Nausea; Slight breathlessness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO173) via an unspecified route of administration in the left arm on 08May2021 at 14:00 (at the age of 62-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 medication taken within two weeks of vaccination included daily vitamins (MANUFACTURER UNKNOWN), from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 17Apr2021, at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 00:00, the patient experienced injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness. 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. Therapeutic measures were not taken as a result of events. The clinical outcome of the events injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: Injection site pain; Swollen lymph nodes under left armpit..inject site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever 100.1; Nausea; Slight breathlessness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO173) via an unspecified route of administration in the left arm on 08May2021 at 14:00 (at the age of 62-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 medication taken within two weeks of vaccination included daily vitamins (MANUFACTURER UNKNOWN), from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 17Apr2021, at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 00:00, the patient experienced injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness. 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. Therapeutic measures were not taken as a result of events. The clinical outcome of the events injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Swollen lymph nodes under left armpit..inject site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever 100.1; Nausea; Slight breathlessness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO173) via an unspecified route of administration in the left arm on 08May2021 at 14:00 (at the age of 62-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 medication taken within two weeks of vaccination included daily vitamins (MANUFACTURER UNKNOWN), from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 17Apr2021, at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 00:00, the patient experienced injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness. 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. Therapeutic measures were not taken as a result of events. The clinical outcome of the events injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgia
Clinical narrative: Symptoms included intermittent nerve pain throughout the body with both dose 1 & 2; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 37-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 06May2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included cholecystectomy, premature at birth (birth premature), penicillin allergy, allergy to gluten and dairy intolerances. 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 cetirizine hydrochloride (ZYRTEC), metagenics sinuplex (MANUFACTURER UNKNOWN) for unknown indications and birth control (unspecified); all from an unknown date and unknown if ongoing. The patient previously took cefaclor (CECLOR) for unknown indication on an unknown date and experienced drug allergy.  On an unknown date in 2021 (also reported as 06May2021 at 15:30), the patient experienced intermittent nerve pain throughout the body with both dose 1 and 2 as well as joint pain. 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 intermittent nerve pain throughout the body and joint pain were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dehydration, Feeling cold, Feeling hot, Nausea
Clinical narrative: I work nights and when I got home at 0600 I started having severe chills and felt very cold; I work nights and when I got home at 0600 I started having severe chills and felt very cold; Sore arm for 12 hours; Fell asleep at 0810 and woke up feeling hot and dehydrated. And nauseas; Fell asleep at 0810 and woke up feeling hot and dehydrated. And nauseas; Fell asleep at 0810 and woke up feeling hot and dehydrated. And nauseas; This is a spontaneous report from a contactable consumer, the patient. A 25-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 10May2021 at 16:00 (at the age of 25-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. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10May2021 at 16:15, the patient experienced sore arm for 12 hours. On 11May2021 at 06:00, the patient experienced severe chills and felt very cold. On an unknown date in May2021, the patient fell asleep at 08:10 and woke up feeling hot, dehydrated and nauseous. 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 sore arm for 12 hours was resolved on 11May2021 at 04:15, after the duration of 12 hours; while that of the events woke up feeling hot, dehydrated and nauseous, severe chills and felt very cold was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I work nights and when I got home at 0600 I started having severe chills and felt very cold; I work nights and when I got home at 0600 I started having severe chills and felt very cold; Sore arm for 12 hours; Fell asleep at 0810 and woke up feeling hot and dehydrated. And nauseas; Fell asleep at 0810 and woke up feeling hot and dehydrated. And nauseas; Fell asleep at 0810 and woke up feeling hot and dehydrated. And nauseas; This is a spontaneous report from a contactable consumer, the patient. A 25-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 10May2021 at 16:00 (at the age of 25-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. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10May2021 at 16:15, the patient experienced sore arm for 12 hours. On 11May2021 at 06:00, the patient experienced severe chills and felt very cold. On an unknown date in May2021, the patient fell asleep at 08:10 and woke up feeling hot, dehydrated and nauseous. 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 sore arm for 12 hours was resolved on 11May2021 at 04:15, after the duration of 12 hours; while that of the events woke up feeling hot, dehydrated and nauseous, severe chills and felt very cold was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Extreme dizziness; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 01May2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mango. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive 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: EW0151) via an unspecified route of administration in the left arm on 04Apr2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 16:00, the patient experienced extreme dizziness. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme dizziness was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Menstruation irregular
Clinical narrative: Menstrual cycle started 2 days late. It ended after 6 days which is normal.; Then it started again 2 days later. It is very weird. I bleed from around 2pm until 7pm, then stop. I wake up the next morning thinking my cycle is over, but it starts again later inthe day; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730, also reported as EN6205) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported for the patient. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medication was reported as not applicable. On 10May2021, the patient's menstrual cycle started 2 days late. It ended after 6 days which was normal. Then it started again 2 days later which was very weird. The patient bleeding from around 14:00 until 19:00, then it stopped. The patient woke up the next morning thinking cycle was over, but it started again later in the day. 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 menstrual cycle started 2 days late, started again 2 days later which was very weird, bleeding from around 14:00 until 19:00, then it stopped was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen mph node I left armpit and back of neck; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left shoulder on an unknown date in 2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced swollen mph node I left armpit and back of neck. 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 swollen mph node I left armpit and back of neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 04May2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. 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 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 14:00, the patient experienced chest pain. The event chest pain 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 chest pain was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Pain, Toothache
Clinical narrative: Severe tooth pain.  Especially sensitivity to cold in all four quadrants.; Severe tooth pain.  Especially sensitivity to cold in all four quadrants.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 02May2021 at 10:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO); bupropion hydrochloride (WELLBUTRIN); omega-3-acid ethyl ester (LOVAZA) and fexofenadine (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EE0161) via an unspecified route of administration in the right arm on 11Apr2021 at 11:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03May2021 at 09:00, the patient experienced severe tooth pain, especially sensitivity to cold in all four quadrants. It was reported as 9.9 out of 10 pain. The events resulted in a visit to the doctors or other healthcare professional office/clinic. 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 tooth pain, especially sensitivity to cold in all four quadrants was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Rash, Vertigo
Clinical narrative: Light headed, dizzy; Vertigo; Rash on lower arm of injection site; Extreme fatigue; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 05May2021 at 10:30 (at the age of 55-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 previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On 07May2021, the patient had rash on lower arm of injection site and extreme fatigue at the beginning of the same day. On 08May2021, the patient experienced light headedness, dizzy and vertigo. 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 rash on lower arm of injection site, extreme fatigue, light headedness, dizzy and vertigo was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Very itchy; Skin rashes appeared around the site. There are several bumps.; The area is red; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 10:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included trigeminal neuralgia and high cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included carbamazepine (CARBATROL) and simvastatin (MANUFACTURER UNKNOWN); both for unknown indications, from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 13Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 01:00, skin rashes appeared around the site. The area was red. On 09May2021, the day of report, the area was still red and very itchy and also there were several bumps. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events skin rashes appeared around the site, the area was red and very itchy, there were several bumps were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Menstruation delayed
Clinical narrative: delayed menstrual period late by 1 week and light; delayed menstrual period late by 1 week and light; This is a spontaneous report from a contactable consumer, the patient. A 47-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 10Apr2021 at 09:30 (at the age of 47-year-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 unspecified birth control medications 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: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced delayed menstrual period late by 1 week and light. 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 delayed menstrual period late by 1 week and light was resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Swelling below (distally) injection site; Lump below (distally) injection site (2 inch by 2 inch lump); Mild itching on swollen area; Redness on swollen area/mild redness over area of lump; Mild fever x 2 days.; Pain below (distally) injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 64-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 right arm on 01Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, complex regional pain disorder and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced pain and swelling/lump below (distally) injection site, (2 inch by 2 inch lump) that started immediately. There was mild itching and redness on swollen area and mild redness over the area of the lump. Swelling was still there for 8 days and mild fever for 2 days. 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 pain and swelling/lump below (distally) injection site, (2 inch by 2 inch lump) started immediately, mild itching and redness on swollen area, mild redness over area of lump and swelling still there  for 8 days and mild fever  for 2 days were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Swelling below (distally) injection site; Lump below (distally) injection site (2 inch by 2 inch lump); Mild itching on swollen area; Redness on swollen area/mild redness over area of lump; Mild fever x 2 days.; Pain below (distally) injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 64-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 right arm on 01Mar2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, complex regional pain disorder and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 17Apr2021 at 09:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced pain and swelling/lump below (distally) injection site, (2 inch by 2 inch lump) that started immediately. There was mild itching and redness on swollen area and mild redness over the area of the lump. Swelling was still there for 8 days and mild fever for 2 days. 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 pain and swelling/lump below (distally) injection site, (2 inch by 2 inch lump) started immediately, mild itching and redness on swollen area, mild redness over area of lump and swelling still there  for 8 days and mild fever  for 2 days were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Lethargy, Malaise
Clinical narrative: Became very ill; Chills; Headache; Nausea; Body aches; Lethargic/did not get out of bed; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 51-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 08May2021 at 09:00 (at the age of 51-year-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 other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08May2021 at 19:00, within 10 hours after taking the second dose of the vaccine, the patient became very ill. The patient experienced chills, headache, nausea, body aches, lethargic, loss of appetite and did not get out of bed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events became very ill, chills, headache, nausea, body aches, lethargic, loss of appetite and did not get out of bed was recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Became very ill; Chills; Headache; Nausea; Body aches; Lethargic/did not get out of bed; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 51-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 08May2021 at 09:00 (at the age of 51-year-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 other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08May2021 at 19:00, within 10 hours after taking the second dose of the vaccine, the patient became very ill. The patient experienced chills, headache, nausea, body aches, lethargic, loss of appetite and did not get out of bed. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events became very ill, chills, headache, nausea, body aches, lethargic, loss of appetite and did not get out of bed was recovering at the time of report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dizziness, Headache, Malaise
Clinical narrative: Headache; Muscle pain in armpits; muscle pain ~4 inches from injection site; Loss of smell for 2 hrs; loss of  taste for 2 hrs; Body aches; Malaise; Approx 30 minutes after vaccine got intense wave ofnausea; Approx 30 minutes after vaccine got intense wave oflightheadedness; Almost passed out; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 14:30 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19 and known allergy to penicillin. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included levocetirizine dihydrochloride (XYZAL), bupropion hydrochloride (WELLBUTRIN), montelukast sodium (SINGULAIR), salbutamol (VENTOLIN), fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) and sp (as reported); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN), levofloxacin (LEVOQUIN), doxycycline (MANUFACTURER UNKNOWN) and paracetamol; oxycodone hydrochloride (PERCOCET); all for unknown indication from an unknown date and experienced drug allergy. On 17Apr2021 at 15:15, the patient experienced headache, muscle pain in armpits, muscle pain approximately 4 inches from injection site (felt like muscle tearing), loss of smell and taste for 2 hours, body aches, malaise. Approximately 30 minutes after vaccine, the patient got intense wave of nausea, light-headedness and almost passed out. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events loss of smell and loss of taste was resolved on 17Apr2021, after the duration of approximately 2 hours. The clinical outcome of the events headache, muscle pain in armpits, muscle pain 4 inches from injection site, body aches, malaise, intense wave of nausea, lightheadedness and almost passed out was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.