chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hot flush, Malaise
Clinical narrative: Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 12Mar2021 at 10:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and grave's disease. The patient had unspecified allergy to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 10:15, the patient experienced severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. It was reported that, the headache was absolutely severe to the point that it was hard to keep eyes open and see. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. The clinical outcome of events severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea were resolved on an unknown date in Mar2021 (lasted 3 and half days).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 12Mar2021 at 10:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and grave's disease. The patient had unspecified allergy to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 10:15, the patient experienced severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. It was reported that, the headache was absolutely severe to the point that it was hard to keep eyes open and see. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. The clinical outcome of events severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea were resolved on an unknown date in Mar2021 (lasted 3 and half days).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Muscle tightness, Swelling, Vaccination site pain
Clinical narrative: muscles in arm began to tighten; bruising  arm extending from my shoulder to my elbow; bumps and puffiness on my arm extending from my shoulder to my elbow; tenderness at the site of the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old-non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via unspecified route of administration on 26Mar2021 at 12:30 (at the age of 32-years-old) as a single dose for Covid-19 immunisation. The patient's medical history included asthma. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication on 26Mar2021(2 hours prior the vaccination). The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On 26Mar2021, the patient experienced tenderness at the site of the vaccine, within a few hours muscles in arm began to tighten then began to see bruising, bumps and puffiness on arm extending from shoulder to elbow. These bumps and puffiness lasted for about a week. No therapeutic measures were taken as a result of the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the tenderness at the site of the vaccine, muscle tightness, bruising on arm extending from shoulder to elbow was recovering and bumps and puffiness on arm extending from shoulder to elbow was recovered on an unknown date.    No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Palpitations, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: Racing heart; Dizziness; Headache; Hives; Mild throat swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot m100003243928, first dose) solution for injection intramuscular in the left arm on 29Mar2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: shellfish, soy, nuts, sunflower seeds, sesame, mustard, bananas, apricots, peaches; and COVID-19 on an unknown date. Concomitant medications included salbutamol sulfate (PROAIR DIGIHALER) and over the counter allergy medication. Lab test on an unknown date included COVID-19 was positive. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Mar2021 at 10:30, the patient experienced racing heart, dizziness, headache, hives, mild throat swelling. Treatment for the events racing heart, dizziness, headache, hives, mild throat swelling included diphenhydramine (BENADRYL), epinephrine (EPIPEN), and inhaler. The outcome of the events racing heart, dizziness, headache, hives, mild throat swelling was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Racing heart; Dizziness; Headache; Hives; Mild throat swelling; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot m100003243928, first dose) solution for injection intramuscular in the left arm on 29Mar2021 at 10:15 (at the age of 40-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: shellfish, soy, nuts, sunflower seeds, sesame, mustard, bananas, apricots, peaches; and COVID-19 on an unknown date. Concomitant medications included salbutamol sulfate (PROAIR DIGIHALER) and over the counter allergy medication. Lab test on an unknown date included COVID-19 was positive. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Mar2021 at 10:30, the patient experienced racing heart, dizziness, headache, hives, mild throat swelling. Treatment for the events racing heart, dizziness, headache, hives, mild throat swelling included diphenhydramine (BENADRYL), epinephrine (EPIPEN), and inhaler. The outcome of the events racing heart, dizziness, headache, hives, mild throat swelling was recovered in 2021. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, SARS-CoV-2 test
Clinical narrative: went to get out of bead and fell to the floor. Unable to get up; Chills; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 17Mar2021 at 10:00 (at the age 0f 64-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On unknown date in Mar2021, the patient experienced chills that night and woke at about 07:00 on 18Mar2021 and went out of bed and fell on the floor and was unable to get up which lasted for 12 hours. Since the vaccination, patient had been tested for COVID-19. On 24Mar2021, the patient underwent nasal swab test and result was negative. The patient did not receive any treatment for the events. The clinical outcome of the events chills was recovered on unknown date in Mar2021 and fell on floor and unable to get up was recovered on 18Mar2021.  No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Headaches; Body Aches; Excessive Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6205), via an unspecified route of administration in the left arm on 09Mar2021 at 11:50 and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8732), via an unspecified route of administration in the left arm on 31Mar2021 at 00:15 as a single dose for COVID-19 immunisation. Medical history included osteo-arthritis and high blood pressure. The patient had a history of allergy to nickel. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) 12.5 milligrams and losartan (MANUFACTURER UNKNOWN) 50 milligrams. 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 09Mar2021 at 14:00,  after the first dose of vaccine, the patient experienced headaches, body aches and excessive fatigue daily. After the second dose of vaccination these symptoms persist with increased body aches. Therapeutic measures were taken as a result of events which included treatment with consultation, ibuprophen, exercise for neck, left shoulder/arm. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events headaches, body aches and fatigue were not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Pain in extremity
Clinical narrative: HSV1 outbreak; left thigh stabbing pain; This is a spontaneous report from a contactable consumer, the patient. A 56-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 15Mar2021 at 10:00 (at the age of 56 years-old) as a single dose for COVID-19 immunisation. Medical history included melanoma in situ, osteomyelitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium, zinc, calcium (CALCIUM MAGNESIUM ZINC), collagen (MANUFACTURER UNKNOWN) and vitamin b complex (B COMPLEX); all for unknown indication from an unknown date. On 19Mar2021 at 19:00, the patient experienced left thigh stabbing pain and after 10 days of vaccination, On 25Mar2021, the patient experienced herpes simplex virus type-1 (HSV1) outbreak. The patient did not receive any treatment for the events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event left thigh stabbing pain and HSV1 was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Respiratory tract infection, SARS-CoV-2 test
Clinical narrative: inflamed airway; Tested Positive for COVID 19 5 days after second shot and then again on 01Apr2021; Tested Positive for COVID 19 5 days after second shot and then again on 01Apr2021/ trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered on the right arm on 02Feb2021 at 16:30 (Lot number: EL9264) as dose 1, single and on 27Feb2021 04:30 (lot number: EN6202) as dose 2, single for COVID-19 immunisation. Medical history included Parkinson's Disease and Kidney Disease. Concomitant medication included Parkinson's Disease medications. The patient tested positive for COVID 19 5 days after second shot (03Mar2021) and then again on 01Apr2021. With the second positive diagnosis, the only symptom he had was trouble breathing and had to call # for assistance (they said he had an inflamed airway on 01Apr2021 03:00). The event inflamed airway resulted in Emergency room/department or urgent care visit and therapeutic measure was taken as a result of the event which included steroid shot. COVID test type post vaccination: Nasal Swab: positive on 01Apr2021 and 03Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event inflamed airway was recovering while unknown for the other event.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort
Clinical narrative: Burning sensation in outer edge of left ear; This is a spontaneous report from a contactable other healthcare professional, the patient. A 44-year-old male 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 30Mar2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to any medications, food, or other products. Concomitant medication included naproxen (MANUFACTURER UNKNOWN). 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 an unknown date in Mar2021, the patient experienced burning sensation in outer edge of left ear. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. The patient did not receive any treatment for the event. The clinical outcome of the event burning sensation in outer edge of left ear was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in right ear starting night of vaccination; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8734) via unspecified route of administration in left arm on 03April2021 as a single dose for COVID-19 immunisation (at 27-year-old). The patient medical history and concomitant medications were not reported. The patient reported allergies to nuts and garbanzo beans. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03April2021, at 23:00 the patient experienced event of tinnitus in right ear starting night of vaccination. The patient did not receive treatment for the reported event. The clinical outcome of events tinnitus in right ear was not recovered 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: Erythema, Fatigue, Headache, Nausea, Pruritus
Clinical narrative: Arm was red; itching alot; Nauseated; Exhausted; Headache; This is a spontaneous report from a contactable consumer, the patient. A 62-years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 30Mar2021 at 12:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient medical history included vegan and lactose intolerance. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient was unsure if she had any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for 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 2 weeks prior to the vaccination. On 30Mar2021, the patient felt nauseated and totally exhausted with a headache on the first night. On 31Mar2021 (next morning) her arm was red and itching a lot. The patient only has the arm being the problem now (at the time of this report). The patient asked for guidance and she does not have insurance. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the events nauseated, totally exhausted, headache, arm was red and arm was itching was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon pain, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Lump at the injection site; Redness at the injection site; Tenderness at the injection site; Right Achilles tendon began to hurt; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old 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 31Mar2021 at 15:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included reactive airway disease, allergic to certain trees, weeds, grasses, molds, rodents and cats. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 31Mar2021 within 30 minutes of receiving the vaccine, the patient's right achilles tendon began to hurt and it never hurt before in her life. On 01Apr2021 approximately 15 hours after receiving the vaccine, the patient experienced redness, tenderness and lump at the injection site which persisted 48 hours after the injection. The patient received ibuprofen and ice packs as a treatment for the event right achilles tendon hurt. The patient did not receive any treatment for the events redness, tenderness and lump at the injection site. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event right achilles tendon hurt was recovered on 02Apr2021, while that of lump at the injection site, redness at the injection site and tenderness at the injection site was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the right arm on 02Apr2021 at 11:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. The patient was receiving unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 11:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021 at 21:00, the patient experienced insomnia. The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event insomnia. The clinical outcome of the event insomnia was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Muscle tightness, Pain in extremity
Clinical narrative: RIGHT FOOT LEG AND INNER THIGH HAS BRUISES; Right foot, leg and inner thigh has bruise and soar with tightness; Right foot, leg and inner thigh has bruise and tightness; Right foot, leg and inner thigh has bruise and tightness; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 27Mar2021 at 08:00 (at the age of 64-year-old), as a single dose for COVID-19 immunisation. Medical history included sarcoidosis. Concomitant medications were not reported. The patient did not have any known allergy to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 30Mar2021 at 07:00 the patient was not sure but experienced right foot, leg and inner thigh had bruises and sore with tightness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events right foot, leg and inner thigh had bruises and sore with tightness were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 03Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. 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 03Apr2021, the patient experienced diarrhea. Adverse events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event diarrhea was unknown at the time of report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Tremendous headache; Injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old male 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 01Apr2021 at 12:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had drug allergy to amoxicillin. Concomitant medications were reported as not available. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:00, the patient experienced tremendous headache and injection site pain. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of headache and vaccination site pain was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Brain fog; Fatigue; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 28-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 30Mar2021, (at the age of 28 years old), as a single dose for COVID-19 immunization.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient experienced brain fog and fatigue on 30Mar2021. Details were as follows: on 30Mar2021, after getting vaccination (Tuesday), the patient experienced brain fog and fatigue; this was noted as lasting through Saturday. The other unspecified symptoms had resolved. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. Since the vaccination, the patient underwent a COVID test on 02Apr2021 and the results were unknown and pending. The clinical outcome of brain fog and fatigue was unknown.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Menustral bleeding commenced; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant, female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; (Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 15:45(at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 02Apr2021 at 18:45, the patient experienced intermenstrual bleeding. The patient reported about 3 hours after having the vaccine administered, menstrual bleeding commenced. The patient had a very regular cycle (every 28 days), and had her last cycle only 9 days ago. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event menstrual bleeding commenced was not recovered at the time of report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain
Clinical narrative: chills; shaking; body aches; joint pain; mild fever; awful headache; felt nauseous; This is a spontaneous report from a contactable pharmacist. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP-6955) via an unspecified route of administration in the left arm on 02Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease.  Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL 3247) via an unspecified route of administration in the right arm on 11Mar2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021 after receiving the second dose, the patient felt fine initially and went to sleep. On 03Apr2021 at 01:00, the patient woke up with chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous. It was lasted all through the day and the patient slept all day. The patient was feeling better at the time of the report. The patient received treatment for the reported events which included tylenol. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: chills; shaking; body aches; joint pain; mild fever; awful headache; felt nauseous; This is a spontaneous report from a contactable pharmacist. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP-6955) via an unspecified route of administration in the left arm on 02Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease.  Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unknown indication and from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL 3247) via an unspecified route of administration in the right arm on 11Mar2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021 after receiving the second dose, the patient felt fine initially and went to sleep. On 03Apr2021 at 01:00, the patient woke up with chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous. It was lasted all through the day and the patient slept all day. The patient was feeling better at the time of the report. The patient received treatment for the reported events which included tylenol. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events chills, shaking, body aches, joint pain, mild fever, awful headache and felt nauseous were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Motion sickness, Pain in extremity
Clinical narrative: lightheaded and dizzy; Severe motion sickness; loss of appetite; sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to sulfa (sulfonamide allergy). Concomitant medications included ethinylestradiol and norethisterone acetate (JUNEL), desvenlafaxine succinate monohydrate (PRISTIQ) and buspirone hydrochloride (BUSPAR). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. 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 22Mar2021, the patient experienced sore arm. On 23Mar2021 at 12:00, the patient was very lightheaded and dizzy and also experienced severe motion sickness and loss of appetite. Next day after that, the patient felt fine and ok. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm, lightheaded, severe motion sickness and loss of appetite was resolved on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Tired; Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration on an unknown date (at the age of 44-years-old) as a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were reported. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date, the patient felt tired and experienced soreness at injection site. The patient did not receive any treatment for the reported events. The clinical outcome of the events tired and soreness at injection site was unknown.    No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Wheezing
Clinical narrative: heavy wheezing; coughing; left side of back hurts; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration, in the left arm on 02Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux and seasonal allergies, and the patient was allergic to dyes, and a kind of antibiotic. Concomitant medications included bisoprolol celecoxib (CELEBREX), amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate (ADDERALL), esomeprazole magnesium (NEXIUM), and multivitamin (MANUFRATURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Apr2021 at 03:00, the patient woke up with heavy wheezing and a lot of coughs. He had tried and breathed shallow to not cough. Coughing lasted about an and couldn't controlled it. He took an over-the-counter allergy pill that seemed to help after about 40 minutes. He had to call in sick to work because excessive movement would get coughing again. It was reported that, at 11:00 he was breathing better. His left side of back was hurting from all the coughing. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. As the result of adverse events an unknown over-the-counter allergy pill was taken as therapeutic measure. The clinical outcome of the events wheezing, coughing and back pain were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Sensitive skin
Clinical narrative: Fatigue mentally and physically; Sensitive skin similar to when havethe flu but less pronounced.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not have medical history. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the COVID-19 vaccine. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 15:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 09:00, the patient experienced fatigue mentally and physically and sensitive skin similar to when had the flu but less pronounced. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue mentally and physically and sensitive skin similar to when have the flu but less pronounced were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: body aches; fatigue; fever; left arm was very sore and hurt to pick up; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old patient of unknown gender 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 02Apr2021 at 09:30(at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma and anxiety. Concomitant medications included fluoxetine hydrochloride (PROZAC) for an unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that the patient felt fine until about 4 hours after the vaccine on 02Apr2021. At 13:00, the patient experienced left arm was very sore and hurt to pick up. On 03Apr2021, when the patient woke up in the morning, the patient experienced body aches, fatigue and fever. The patient still does not feel great at the time of this report. The patient could function and arm hurts less, but all the symptoms were remained in a less intense form at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events left arm was very sore and hurt to pick up, body aches, fatigue and fever was resolving at the time of this report.  No follow-up attempts are possible; information about lot/ batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Very sore upper left arm and unable to lift the whole arm to touch top of head; tingles down the left arm; This is a spontaneous report from a contactable consumer, the patient. A 34-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 02Apr2021 at 11:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. On 02Apr2021 at 11:45, the patient experienced very sore upper left arm,almost was unable to lift the whole arm to touch top of head and had tingles down the left arm. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcomes of the events very sore upper left arm, unable to lift the whole arm to touch top of head and tingles down the left arm was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Disequilibrium / moving head back or down; Dizziness upon laying down; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration on 29Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included heart valve disease. Concomitant medications were not reported. The patient previously received tetracycline (MANUFACTUER UNKNOWN) on an unknown date and experienced drug allergy. 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 unknown date in 2021, the patient experienced disequilibrium and dizziness upon laying down, moving head back or down. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events disequilibrium/moving head back or down and dizziness upon laying down. The clinical outcome of the events disequilibrium/moving head back or down and dizziness upon laying down were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph nodes in armpits swollen to the size of a baseball; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 26-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. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced lymph nodes in armpits swollen to the size of a baseball. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event lymph nodes in armpits swollen was not recovered at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.