chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Paraesthesia
Clinical narrative: L arm 2 hours after vaccination with paresthesia from shoulder into the L hand medial side; Motion in shoulder slightly limited; This is a spontaneous report from a contactable physician. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via intramuscular route of administration in the left arm on 30Mar2021 at 12:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension and gastroesophageal reflux disease (GERD). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR), salbutamol (ALBUTEROL), atorvastatin calcium (LIPITOR), fluticasone propionate (FLONASE), hydrochlorothiazide/lisinopril (LISINOPRIL/HCTZ) and pantoprazole (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 30Mar2021 at 14:00, 2 hours after vaccination, the patient experienced left arm paresthesia from shoulder into the left-hand medial side and motion in shoulder slightly limited. The patient reported that symptoms had not improved for 4 weeks after vaccination and the patient got second vaccine without incident. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm paresthesia from shoulder into the left-hand medial side and motion in shoulder slightly limited were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Arm soreness; Lymph node inflammation; Fever up to 101.8F; Head and body aches; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 15:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN); taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 right arm on 02Apr2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 16:00, the patient experienced arm soreness, lymph node inflammation, fever up to 101.8 F and head and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 27Apr2021, the patient underwent body temperature and the result was fever up to 101.8 degrees Fahrenheit. 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 arm soreness, lymph node inflammation, fever up to 101.8F and head and body aches was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Arm soreness; Lymph node inflammation; Fever up to 101.8F; Head and body aches; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 15:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN); taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 right arm on 02Apr2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 16:00, the patient experienced arm soreness, lymph node inflammation, fever up to 101.8 F and head and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 27Apr2021, the patient underwent body temperature and the result was fever up to 101.8 degrees Fahrenheit. 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 arm soreness, lymph node inflammation, fever up to 101.8F and head and body aches was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Distractibility, Tinnitus
Clinical narrative: Ringing in the ears is loud, unabated and distracting; Ringing in the ears is loud, unabated and distracting; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on an unknown date (at the age of 61-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER87729) via an unspecified route of administration in the left arm on an unknown date (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. On 11Mar2021 at 06:00, the patient experienced ringing in the ears is loud, unabated and distracting. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in the ears is loud, unabated and distracting was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Period irregularity; Menstrual cycle was extremely heavier and more painful (in intensity & duration) than normal; Menstrual cycle was extremely heavier and more painful (in intensity & duration) than normal; "My" cycle is always regular and consistent, so this was abnormal; 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: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 11:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 25Apr2021, the patient experienced period irregularity, menstrual cycle was extremely heavier and more painful (in intensity and duration) than normal. The patient's cycle was always regular and consistent, so that was abnormal. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period irregularity, menstrual cycle was extremely heavier and more painful (in intensity and duration) than normal and "my" cycle is always regular and consistent, so this was abnormal was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting multiple times; Severe headache; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 20Apr2021 at 13:00 at the age of 30-year-old as a single dose for COVID-19 immunisation. The patient did not have any 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 vaccine within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 at the age of 30-year-old as a single dose for COVID-19 immunisation. On 21Apr2021 at 03:00, the patient experienced nausea, vomiting multiple times, severe headache, and fever. The events did not result in doctor or other healthcare professional office or clinic, emergency room, or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting multiple times, severe headache, and fever were not recovered at the time of this report.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal discomfort, Productive cough, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 37, via an unspecified route of administration, in the left arm, on Mar 1, 2021, at 12:00, single dose, for COVID-19 immunisation. Medical history reported as not applicable. The patient has no known allergies. Prior to the vaccination, 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 vaccination. On Mar 5, 2021, at 12:00,  patient felt like there was something constantly in his throat. The patient had a lot of phlegm and also got headaches regularly. He never had headaches before. This has not stopped since the first 5 days of the vaccination. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures taken as a result of the events. On Mar 12, 2021, patient underwent COVID-19 (nasal swab) test with negative result. Since the vaccination, patient has tested for COVID-19. The clinical outcome of felt like there was something constantly in throat, had a lot of phlegm and headaches regularly recovered with lasting effects on an unknown date in 2021. No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Muscle twitching, Pain in extremity, Vaccination site pruritus
Clinical narrative: Extreme arm pain; Unable to straighten or lift the arm; Sporadic itching at the injection site; Sporadic twitching in the bicep, tricep and shoulder; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 13:30 (at the age of 39-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 to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks were not reported. On an unknown date in Apr2021, the patient experienced extreme arm pain and unable to straighten or lift the arm, for the 2 weeks after sporadic itching at the injection site and sporadic twitching in the bicep, tricep, and shoulder. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or 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 extreme arm pain and unable to straighten or lift the arm, sporadic itching at the injection site and sporadic twitching in the bicep, tricep and shoulder was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test
Clinical narrative: Red spotted rash on both arms; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male 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 06Apr2021 at 11:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 18Apr2021 at 00:00, the patient experienced red spotted rash on both arms. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with prednisone (MANUFACTURER UNKNOWN) and clobetasol (MANUFACTURER UNKNOWN) cream. Since the vaccination, the patient had been tested for COVID-19. On 26Apr2021, the patient underwent SARS-COV-2 test (nasal swab) and the result was negative. The clinical outcome of the event red spotted rash on both arms was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Rash erythematous
Clinical narrative: Red welted rash on inside elbow of injected arm; Red welted rash on inside elbow of injected arm; Headache; Chills; Fatigue; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 61-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 06Apr2021 at 17:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021 at 08:00, within 15 hours, the patient experienced headache, chills, fatigue, joint pain. On 08Apr2021 at 17:00, 48 hours after, the patient experienced red welted rash on inside elbow of injected arm and lasted for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of reported events. The clinical outcome of events headache, chills, fatigue and joint pain was recovered on Apr2021, while that of red welted rash on inside elbow of injected arm was recovered on 13Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Red welted rash on inside elbow of injected arm; Red welted rash on inside elbow of injected arm; Headache; Chills; Fatigue; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 61-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 06Apr2021 at 17:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had known allergies to dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 07Apr2021 at 08:00, within 15 hours, the patient experienced headache, chills, fatigue, joint pain. On 08Apr2021 at 17:00, 48 hours after, the patient experienced red welted rash on inside elbow of injected arm and lasted for 5 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of reported events. The clinical outcome of events headache, chills, fatigue and joint pain was recovered on Apr2021, while that of red welted rash on inside elbow of injected arm was recovered on 13Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes on the left side of lower chin and on the left side of my collar bone.; This is a spontaneous report from a contactable consumer, the patient. A 45-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 15Apr2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included BP pills (unspecifed) and bc pills (unspecified) from an unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 25Mar2021 at 08:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 27Apr2021, 12th day post second vaccination, the patient experienced swollen lymph nodes on the left side of her lower chin and on the left side of her collar bone. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes on the left side of her lower chin and on the left side of her collar bone 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: F
Vaccine: COVID19
Symptoms: Blood test, Breast pain, Lymphadenopathy, Magnetic resonance imaging, Ultrasound scan
Clinical narrative: Large swollen lymph node in the left groin; Both breasts hurt terribly; Swollen lymph nodes in both armpits and sides of both breasts; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN620S) via an unspecified route of administration on 15Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within 2 weeks of vaccination. On 16Mar2021, after receiving the second vaccine, the patient experienced that both breasts hurt terribly with swollen lymph nodes in both armpits and sides of both breasts. On 26Mar2021, she noticed a large swollen lymph node in the left groin which resulted in medical care including visits to her Primary Care Physician (PCP), a surgeon, an MRI, ultrasound and blood work. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date in 2021, the patient underwent MRI, ultrasound and blood work and the results were unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events both breasts hurt terribly, swollen lymph nodes in both armpits and sides of both breasts and large swollen lymph node in the left groin were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Low grade fever; Chills; Achy; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 07Apr2021 at 16:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical and breast cancer, high cholesterol and pre-diabetic. The patient was allergic to latex. 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 rivaroxaban (XARELTO), exemestane (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and 50+ daily vitamin (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin; clavulanate potassium (AMOXICILLIN;CLAVULANATE POTASSIUM) and experienced drug allergy. The patient previously received the first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:; EN6207) via an unspecified route of administration in the right arm on 17Mar2021 at 17:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 06:00, next morning after the shot the patient experienced low grade fever, chills and achy which had lasted for 24 hours and was gone. 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. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, chills and achy was recovered on 09Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Muscular weakness, Nausea
Clinical narrative: Nausea; Chills; Headache -  headache as bad if not worse than my brain tumor headache except in back of head; Fatigue - still fatigued beyond belief/ Still very tired since last dose and it's been over a month; Legs so weak when ''I'' got out of bed, legs buckled; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 03Mar2021 at 11:30 (at the age of 69-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included brain tumor, diabetes, congestive heart failure, lichen sclerosis, hypertension, high cholesterol and had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included metformin (MANUFACTURER UNKNOWN), mirabegron (MYRBETRIQ), amiloride (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) and other unspecified medication; all for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021 at 14:00, the patient experienced chills, headache - headache as bad if not worse than her brain tumor, headache except in back of head, fatigue-still fatigued beyond belief, legs so weak when she got out of bed, her legs were buckled. On 08Mar2021, five days after first dose, the patient experienced nausea when she was in bed. It was reported that, the patient was still very tired since last dose and it had been over a month. Honestly thought the public needed to know more information about adverse side effects instead of describing it as flu. She had flu many times and the flu shot. That did not compare as to how this vaccine made her feel. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event fatigue - still fatigued beyond belief/ still very tired since last dose and it had been over a month was not resolved; whereas the events chills, headache, legs so weak when she got out of bed, legs buckled and nausea was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Therapeutic response unexpected
Clinical narrative: When I had my last shot I had some anticipated reactions including fatigue which lasted about 24 hours; When I had my last shot I had some anticipated reactions including headache which lasted about 24 hours; I had a positive reaction that was not expected; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 25Apr2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified multivitamins, metoprolol tartrate (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and sertraline hydrochloride (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 04Apr2021 at 10:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, the patient had a positive reaction that was not expected. For the last 18 months or, he had muscle pain and difficulty getting up and down from sitting, bending over, picking things up, walking down steps sideways because he did not have the leg strength. When he had his last shot, he had some anticipated reactions including headache and fatigue which lasted about 24 hours. His shot was on 25Apr2021. By 27Apr2021, those side effects dissipated. However, so did his normal muscle pain to the extent he can much more easily move and traverse steps. It was quite remarkable. He was not sure if it was related to the vaccine but the timing was very coincidental. There were no changes in his daily routine other than the vaccine and thereafter a very positive improvement in his ability to move. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event when he had his last shot he had some anticipated reactions including headache and fatigue which lasted about 24 hours was recovered on 27Apr2021; while that of the event had a positive reaction that was not expected was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Teeth chattering shivers; Extreme fatigue; Body aches; Fever; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 10:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 10:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021 at 20:15, the patient experienced teeth chattering shivers, extreme fatigue, body aches and fever. The events did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events teeth chattering shivers, extreme fatigue, body aches and fever were not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated
Clinical narrative: PT RECEIVED HER FIRST COVID VACCINE ON 03/10/2021 AND EXPERIENCED A FLARE UP WHILE OFF XELJANZ; This is a spontaneous report from a contactable Pharmacy report from a contactable other hcp. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 10Mar2021 (at the age of 61-years-old) as single dose for COVID-19 immunisation and was taking tofacitinib citrate (XELJANZ, Batch/Lot number was not reported), via an unspecified route of administration from an unspecified date to Mar2021 and restarted on Apr2021, at 5 mg, 2x/day for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient reported that she was off of xeljanz for a week for each covid vaccine. Patient received her first covid vaccine on 10Mar2021 and experienced a flare up while off xeljanz for that week. Patient stated she received her second dose of covid vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 24Mar2021 (at the age of 61-years-old) as single dose for COVID-19 immunisation and had no issues. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Hypersomnia
Clinical narrative: Dizziness; Headache (oppressive); Fatigue; Loopy feeling; Sleep for hours at a time during the day and full night sleep when not disturbed by headache; This is a spontaneous report from a contactable consumer, the patient. A 54-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 25Apr2021 at 12:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. Medical history included becker's muscular dystrophy carrier, weight (overweight) seasonal allergy, and allergy to dogs, cats other small animals. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included naproxen sodium (ALEVE) and loratadine (reported as generic claritin); for unknown indications from unknown start dates and unknown if ongoing. On 25Apr2021 at 12:45, the patient experienced dizziness within 15 minutes of shot, oppressive headache, fatigue, loopy feeling and slept for hours at a time during the day and full night sleep when not disturbed by headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (ADVIL), respiratory evaluation and heart monitoring. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness, oppressive headache, fatigue, loopy feeling and sleep for hours at a time during the day and full night sleep was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Gastric disorder, Headache, Lymphadenopathy
Clinical narrative: Tremors for 4 days; Very swollen neck glands; Headache 3 days; Weakness 2 weeks; Heart palpitations on going; Stomach problems ongoing; Dizziness 2 weeks; Overall unwell feelings ongoing; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (afib) and sulfa allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included diltiazem hydrochloride (CARTIA XT) for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. From 06Apr2021 at 00:00, the patient experienced tremors for 4 days; very swollen neck glands; headache for 3 days, weakness for 2 weeks, heart palpitations on going, stomach problems ongoing, dizziness for 2 weeks and overall unwell feelings ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache for 3 days was resolved on 03Apr2021 and tremors for 4 days was resolved on 10Apr2021. The clinical outcome of the events weakness for 2 weeks and dizziness for 2 weeks was resolved on an unknown date in Apr2021. The clinical outcome of the event very swollen neck glands was resolving, while that of heart palpitations on going, stomach problems ongoing and overall unwell feelings ongoing was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Palpitations, Tremor
Clinical narrative: Tremors for 4 days; Very swollen neck glands; Headache 3 days; Weakness 2 weeks; Heart palpitations on going; Stomach problems ongoing; Dizziness 2 weeks; Overall unwell feelings ongoing; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (afib) and sulfa allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included diltiazem hydrochloride (CARTIA XT) for unknown indication on unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. From 06Apr2021 at 00:00, the patient experienced tremors for 4 days; very swollen neck glands; headache for 3 days, weakness for 2 weeks, heart palpitations on going, stomach problems ongoing, dizziness for 2 weeks and overall unwell feelings ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache for 3 days was resolved on 03Apr2021 and tremors for 4 days was resolved on 10Apr2021. The clinical outcome of the events weakness for 2 weeks and dizziness for 2 weeks was resolved on an unknown date in Apr2021. The clinical outcome of the event very swollen neck glands was resolving, while that of heart palpitations on going, stomach problems ongoing and overall unwell feelings ongoing was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Fatigue, Lymphadenopathy, Pain in extremity
Clinical narrative: 9 days after, swollen armpit with lump.; Significant pain in armpit area; Significant pain in armpit area and arm; Fatigue; 9 days after, swollen armpit with lump.; This is a spontaneous report from a contactable consumer, the patient. A 33-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 19Apr2021 at 10:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 28Apr2021 at 00:15, 9 days after, the patient experienced swollen armpit with lump, significant pain in armpit area and arm and fatigue. 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. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events swollen armpit with lump, significant pain in armpit area and arm and fatigue was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Sinus congestion
Clinical narrative: Nausea after 12 hours; Fatigue for two weeks; sinus congestion 24 hours; 2-3 headaches a week; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 16Mar2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease(COPD).Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included umeclidinium bromide/vilanterol trifenatate (ANORO) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 23Feb2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 17Mar2021 at 3:00, the patient experienced nausea after 12 hours, fatigue for two weeks, sinus congestion 24 hours, 2-3 headaches a week since the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, fatigue, sinus congestion and 2-3 headaches were resolved with sequelae on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Pain in extremity, Ultrasound scan, X-ray
Clinical narrative: It looks like a gout flare up; Left foot big toe started hurting; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included atorvastatin (LIPTOR) for an unknown indication from an unknown date and unknown if ongoing. On 11Apr2021 at 08:00, next day after the shot, the patient's left foot big toe started hurting. Each day after that it got worse and by fourth day, he called his doctor. The patient had X-ray and ultrasound in left leg to check for blood clot but both were normal. It looked like a gout flare up which the patient never had gout before. It had been 2 weeks now (at the time of reporting) and the patient's foot was getting better but not normal yet. The patient believed that the vaccine caused this. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with indomethacin (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events it looks like a gout flare up and left foot big toe started hurting was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in my right ear; This is a spontaneous report from a contactable consumer, the patient. A 71-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 22Feb2021 at 12:45 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, esophageal acid reflux (acid reflux disease) and the patient had known allergy to nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included losartan potassium (LOSARTIN), omeprazole (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and naproxen (MANUFACTURER UNKNOWN); all from an unknown date for unknown indications and unknown if ongoing. On 01Mar2021, the patient experienced tinnitus in the right ear. 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 tinnitus in the right ear was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.