chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain in extremity
Clinical narrative: Arm soreness; Headache; Weakness; This is a spontaneous report from a contactable other health-care professional. A 27-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm left on 10Mar2021 at 13:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced allergy to antibiotic. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the arm left on 17Feb2021 at 13:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. On 10Mar2021 at 14:30, the patient experienced arm soreness, headache and weakness. 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events arm soreness, headache and weakness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a non-contactable consumer. A 80-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left  arm on 06Mar2021 at 18:15 (at the age of 80-year-old) as a single dose for COVID-19 immunisation. Medical history included edema, chronic obstructive pulmonary disease (COPD) and multiple sclerosis (MS). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) both from an unknown indication on an unknown date and unknown if ongoing. On 06Mar2021 at 22:00, the patient experienced severe headache. The events did not result in doctor or other healthcare professional office or clinic visit and 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 event severe headache was recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Muscle soreness at injection site; fatigue on the day of the vaccine administration; This is a spontaneous report from a non-contactable pharmacist, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 08Mar2021, the patient experienced muscle soreness at injection site and fatigue on the day of the vaccine administration. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle soreness at injection site and fatigue on the day of the vaccine administration was resolved on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: On the middle left side of my back I feel a painful radiating heat/burning with simultaneous pins and needles sensation.; On the middle left side of my back I feel a painful radiating heat/burning with simultaneous pins and needles sensation; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies 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 included amoxicillin (MANUFACTURER UNKNOWN) taken for an unknown indication on an unknown date and unknown if ongoing. On 09Mar2021 at 20:15, the patient experienced on the middle-left side of her back, the patient felt a painful radiating heat/burning with simultaneous pins and needles sensation. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any 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 painful radiating heat/burning with simultaneous pins and needles sensation were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; Lightheadedness; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 08Mar2021 at 09:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to Con. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 15Feb2021 at 09:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient previously also received pethidine hydrochloride (DEMEROL) and doxycycline (MANUFACTURER UNKNOWN) and experienced drug allergy on an unknown date. On 09Mar2021 at 21:00, the patient experienced vertigo and lightheadedness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events vertigo and lightheadedness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: Experiencing body soreness / soreness experiencing is all over body; Congestion; This is a spontaneous report from a contactable consumer, the patient. A 27-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 09Mar2021 at 15:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome, hypothyroidism and obesity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included methylphenidate hydrochloride (CONCERTA), levothyroxine (MANUFACTURER UNKNOWN) and spironolactone (MANUFACTURER UNKNOWN); all 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. On 09Mar2021 at 22:00, after receiving the first dose of vaccine, the patient experienced body soreness and congestion. Patient felt it was worth mentioning that her period started two days ago and was usually accompanied with body soreness in the lower abdominal area that can be quite severe, however the body soreness that she experienced then was all over her body which was not common for that monthly event. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body soreness and congestion was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysgeusia, Hypoaesthesia oral
Clinical narrative: Strong metal taste in mouth area within 10 mins of receiving the vaccine.; Ever so slight numb feeling around "my" lip area that lasted for a couple of hours; Stomach ever so slightly off in the morning; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6202) via an unspecified route of administration in the left arm on 02Mar2021 at 16:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and one kidney (details unspecified) and allergy to shellfish. 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.  Concomitant medications included melatonin (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D 3) taken for unspecified indications, from an unknown date and unknown if ongoing. On 02Mar2021 at 17:00 the patient experienced strong metal taste in mouth area within 10 mins of receiving the vaccine and the taste lasted for two days. The patient also experienced slight numb feeling around lip area that was lasted for a couple of hours. Stomach was slightly off in the morning. Everything was calmed and fine. The events did not result in doctor or other healthcare professional office/clinic, 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 strong metal taste in mouth area, slight numb feeling around lip area and stomach ever so slightly off in the morning were recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Headache, Lymph node pain, Lymphadenopathy, Swelling
Clinical narrative: Tender lymphnode in the clavicle/neck region of the left side.; swollen lymphnode in the clavicle/neck region of the left side.; Tenderness below the clavicle in the chest area above the breast, below the clavicle.; swelling below the clavicle in the chest area above the breast, below the clavicle.; Pain in left side of face when I laugh or bite down; Headache on left side; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 11:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included acoustic neuroma on the left side of skull or ear. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included phendimetrazine (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); for an unknown indication from an unknown date and unknown if ongoing. On 15Mar2021 at 22:00, the patient experienced tender and swollen lymph node in the clavicle or neck region of the left side. Tenderness and swelling below the clavicle in the chest area above the breast, below the clavicle. Pain in left side of face when the patient laughs or bites down and headache on left side. Therapeutic measures were not taken as a result of the reported events. The event did not result in a visit to the doctors 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 tender and swollen lymph node in the clavicle/neck region of the left side. Tenderness and swelling below the clavicle in the chest area above the breast, below the clavicle. Pain in left side of face when the patient laughs or bites down and headache on left side were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tender lymphnode in the clavicle/neck region of the left side.; swollen lymphnode in the clavicle/neck region of the left side.; Tenderness below the clavicle in the chest area above the breast, below the clavicle.; swelling below the clavicle in the chest area above the breast, below the clavicle.; Pain in left side of face when I laugh or bite down; Headache on left side; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 08Mar2021 at 11:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included acoustic neuroma on the left side of skull or ear. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included phendimetrazine (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL); for an unknown indication from an unknown date and unknown if ongoing. On 15Mar2021 at 22:00, the patient experienced tender and swollen lymph node in the clavicle or neck region of the left side. Tenderness and swelling below the clavicle in the chest area above the breast, below the clavicle. Pain in left side of face when the patient laughs or bites down and headache on left side. Therapeutic measures were not taken as a result of the reported events. The event did not result in a visit to the doctors 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 tender and swollen lymph node in the clavicle/neck region of the left side. Tenderness and swelling below the clavicle in the chest area above the breast, below the clavicle. Pain in left side of face when the patient laughs or bites down and headache on left side were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck base of skull limited backward motion; This is a spontaneous report from a contactable consumer, the patient. A 66-years-old patient of unspecified gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and depression. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included hydrochlorothiazide (HCTZ), lisinopril (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 09Mar2021 at 12:00, the patient experienced stiff neck base of skull limited backward motion. The events did not result in doctor or other healthcare professional office/clinic visits, 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 stiff neck base of skull and limited backward motion was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Influenza, Oropharyngeal pain, Pain
Clinical narrative: Flu symptoms started two days following injection; Body ache; Stomach upset.; Chills; Throat pain; This is a spontaneous report from a contactable health-care professional, the patient. A 42-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 02Mar2021 at 11:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, irritable bowel syndrome (IBS) and cancer gene carrier (BRCA+). Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included topiramate (TOPAMAX), rizatriptan benzoate (MAXALT), venlafaxine hydrochloride (VENLAFAXINE), cetirizine hydrochloride (ZYRTEC) and melatonin (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received lactulose (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 04Mar2021 at 16:00, the patient experienced flu symptoms started two days following injection, body ache, stomach upset, chills and throat pain. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu symptoms started two days following injection, body ache, stomach upset, chills and throat pain was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: The area around the injection site became red; The area around the injection became swollen; The area around the injection site became itchy; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration on 05Mar2021(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, 4 days post the 2nd shot, the patient reported that the area around the injection site became red, swollen and itchy. 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 the area around the injection site became red, swollen and itchy was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Temporary burning/itching at injection site; Temporary burning/itching at injection site; Headache; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 26-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 10Mar2021 at 13:30 (at the age of 26-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 vaccines within four weeks prior to vaccination. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), buspirone (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), naltrexone (MANUFACTURER UNKNOWN) and I (unspecified); all taken for unspecified indications from unknown dates and unknown if ongoing. On 10Mar2021 at 13:45, the patient experienced temporary burning/itching at injection site, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events temporary burning/itching at injection site, headache and fatigue was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site reaction
Clinical narrative: Injection site raised up, became red; Injection site raised up, became red and hard as is painful to touch, bump or rub.; Injection site raised up, became red and hard as is painful to touch, bump or rub; The injection site raised up; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Feb2021 at 08:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA), buspirone hydrochloride (BUSPAR) and eszopiclone (LUNESTA), all for an unknown indication, from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 08:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 09Mar2021(also reported as 06Mar2021 at 08:00), approximately 10 days after the second dose, the patient experienced injection site raised up, became red and hard as it was painful to touch, bump or rub. The event resulted in doctor or other healthcare professional office/clinic visit. 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 events injection site raised up, became red and hard as is painful to touch, bump or rub was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Metallic taste; Metallic smell; 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: UNKNOWN) via an unspecified route of administration in the arm right on 15Mar2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and Minerals nos, Vitamins nos (PRENATAL VITAMINS) since an unknown date for an unknown indication and unknown if ongoing. On 15Mar2021 at 15:15 the patient experienced metallic taste and smell. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events metallic taste and smell were recovered on an unknown date in Mar2021.   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: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old 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 09Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. The patient previously took ampicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VITAMIN D), cetirizine hydrochloride (ZYRTEC), amlodipine besilate (AMLODIPINE BESYL) and multi-vitamin (MANUFACTURER UNKNOWN); all from unknown date and for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 05Feb2021 at 13:00 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. On 10Mar2021 at 13:30 the patient experienced diarrhea. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event diarrhea was recovered on 10Mar2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance
Clinical narrative: Unable to get out of bed, stand, or walk unassisted; Lower back pain mostly on left side at hip/spine.; 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: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 18:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included reactive airways and general seasonal allergies. The patient had no known allergies to medications, food, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 13:00, within 12-18 hours after vaccination, the patient developed lower back pain mostly on left side at hip/spine. On 10Mar2021, by next morning, the patient was unable to get out of bed, stand, or walk unassisted. It was reported that online doctor visit suggested this was unrelated to the vaccine and was dismissive of the idea when raised. Differential diagnosis was performed to eliminate obvious neurological issues and the doctor concluded none. Review of the database,  data appeared to suggest the possibility existed the back pain could be related. The patient had no prior or recent trauma to the back, heavy lifting or other physical strain recalled in past (more than)2 weeks that might account for this type of back pain. The patient had never experienced this under any other circumstance. It was reported that proximity to vaccination somewhat suspect, but hard to know, hence this report. The patient was still in pain but was able to get around with care. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events lower back pain mostly on left side at hip/spine and unable to get out of bed, stand, or walk unassisted which included treatment with heat, lidocaine (MANUFACTURER UNKNOWN) pad (in absence of heat), alternating paracetamol (TYLENOL) 1000 mg (milligram) and ibuprofen (MANUFACTURER UNKNOWN) 600mg plus rest. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lower back pain mostly on left side at hip/spine and unable to get out of bed, stand, or walk unassisted was resolving at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: Headache; Upset stomach; This is a spontaneous report from a non-contactable consumer (patient). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 02Mar2021 20:30 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunization at pharmacy or drug store. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. 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 an unspecified date in Mar2021, the patient experienced headache and had upset stomach. The reporter considered the event as non-serious. The patient treatment received was unknown. The outcome of events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My tinnitus is much louder and has not stopped since the first shot. Usually my tinnitus comes and goes quickly and its never this loud.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 23Feb2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included grave's disease, endometriosis, vitiligo, fuch's dystrophy, cataracts, osteoarthritis, spinal stenosis, morton's neuromas, spinal fusion, parathyroid tumour removal, carpal tunnel release left hand, carpal tunnel right hand, cubital tunnel left and right, tinnitus mild comes and goes until the COVID vaccine, right hip replacement and known allergies to tide laundry detergent, some types of make-up and highly scented soaps. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included levothyroxine sodium (LEVOXYL), quetiapine fumarate (SEROQUEL), alprazolam (XANAX), fish oil (FISH OIL OMEGA 3) and vitamins (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 26Feb2021, the patient experienced tinnitus was much louder and had not stopped since the first shot, usually the patient's tinnitus came and went quickly and it was never that loud. It started within a few days of getting the first shot. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus was much louder and had not stopped since the first shot was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Lateral lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 07Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, diabetes and allergy to iodine in vein (Iodine allergy). Prior to vaccination it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 09Mar2021 at 09:00, the patient experienced lateral lower back pain. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of lateral lower back pain and included treatment with Hydrocodone-Acetaminophen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lateral lower back pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea, Pain
Clinical narrative: Pain in injection site.; Headache; Nausea; Odd feeling; Pale in color; Light headed; Minor harm pain; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history included irritable bowel, known allergies to shellfish, nickel and minor hives to most antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021, the patient experienced headache, light headed, pale in colour, nausea, odd feeling and minor harm pain. On the same day, at 10:00, 2 hours after the vaccination, the patient experienced pain in injection site and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, light headed, pale in colour, nausea, odd feeling, minor harm pain and pain in injection site was resolved on 10Mar2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Vaccination site pain
Clinical narrative: Pain in injection site.; Headache; Nausea; Odd feeling; Pale in color; Light headed; Minor harm pain; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 10Mar2021 at 08:00 as a single dose for COVID-19 immunisation. Medical history included irritable bowel, known allergies to shellfish, nickel and minor hives to most antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 10Mar2021, the patient experienced headache, light headed, pale in colour, nausea, odd feeling and minor harm pain. On the same day, at 10:00, 2 hours after the vaccination, the patient experienced pain in injection site and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, light headed, pale in colour, nausea, odd feeling, minor harm pain and pain in injection site was resolved on 10Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes under left arm pit; body aches; headache; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 31-years-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6205) via an unspecified route of administration in the left arm on an unknown date in 2021(at the age of 31-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 mediations were not reported. On an unknown date in 2021, the patient experienced swollen lymph nodes under left arm pit, body aches, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events swollen lymph nodes under left arm pit, body aches, headache and fatigue were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Thirst
Clinical narrative: Within about 3+ hours after receiving the second shot, I began to experience extreme thirst, foggy headed feelings and slight nausea; Within about 3+ hours after receiving the second shot, I began to experience extreme thirst, foggy headed feelings and slight nausea; Within about 3+ hours after receiving the second shot, I began to experience extreme thirst, foggy headed feelings and slight nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included weak immune system in the past and asthma as a teenager that he outgrew. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 16Feb2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation and had no side effects. On 10Mar2021 at 04:30, within about 3 plus hours after receiving the second shot, the patient began to experience extreme thirst, foggy headed feelings and slight nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any 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 within about 3 plus hours after receiving the second shot, he began to experience extreme thirst, foggy headed feelings and slight nausea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.  .
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Flatulence, Interchange of vaccine products, Middle insomnia, Off label use
Clinical narrative: Severe left lower quadrant abdominal pain; Awakened me from sleep; Flatulence; Received moderna vaccine as dose 1 and BNT162B2 as dose 2; Off-label use; This is a spontaneous report from a contactable physician, the patient. A 64-year-old female patient received the second dose (initial Pfizer dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 14:00 (at the age of 64-years-old) and third dose (reported as 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 09Mar2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension-controlled, diverticulosis, and allergies to certain plastics or blue dye during childhood. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) in the left arm on 11Jan2021 as a single dose for immunisation. Concomitant medications included nifedipine (MANUFACTURER UNKNOWN) at a dose of 60 mg, hypericum perforatum (ST. JOHN'S WORT), colecalciferol/apoaequorin (PREVAGEN), and colecalciferol (VIT D3); all were taken for an unknown indication from an unknown date and unknown if ongoing. On 07Feb2021 at 00:30, after the 1st dose of Pfizer vaccine, the patient developed severe left lower quadrant abdominal pain which awakened the patient from sleep at 00:30, lasting 1.5 to 2 hours. The pain was rated 8-9/10 with no nausea, vomiting, or fever. The pain improved associated with flatulence and somewhat relieved with bowel. The patient had developed the same events on 2nd dose of Pfizer vaccine as well and recovered. 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 a modified diet and no medications were accepted. Since the vaccination, the patient had been tested for COVID-19. On 11Mar2021, the patient underwent a SARS-CoV-2 antigen test via nasal swab and the result was negative. The clinical outcome of the events severe left lower quadrant abdominal pain, awakened from sleep, and flatulence was recovered on an unknown date in Feb2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe left lower quadrant abdominal pain; Awakened me from sleep; Flatulence; Received moderna vaccine as dose 1 and BNT162B2 as dose 2; Off-label use; This is a spontaneous report from a contactable physician, the patient. A 64-year-old female patient received the second dose (initial Pfizer dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Feb2021 at 14:00 (at the age of 64-years-old) and third dose (reported as 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 09Mar2021 at 14:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension-controlled, diverticulosis, and allergies to certain plastics or blue dye during childhood. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) in the left arm on 11Jan2021 as a single dose for immunisation. Concomitant medications included nifedipine (MANUFACTURER UNKNOWN) at a dose of 60 mg, hypericum perforatum (ST. JOHN'S WORT), colecalciferol/apoaequorin (PREVAGEN), and colecalciferol (VIT D3); all were taken for an unknown indication from an unknown date and unknown if ongoing. On 07Feb2021 at 00:30, after the 1st dose of Pfizer vaccine, the patient developed severe left lower quadrant abdominal pain which awakened the patient from sleep at 00:30, lasting 1.5 to 2 hours. The pain was rated 8-9/10 with no nausea, vomiting, or fever. The pain improved associated with flatulence and somewhat relieved with bowel. The patient had developed the same events on 2nd dose of Pfizer vaccine as well and recovered. 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 a modified diet and no medications were accepted. Since the vaccination, the patient had been tested for COVID-19. On 11Mar2021, the patient underwent a SARS-CoV-2 antigen test via nasal swab and the result was negative. The clinical outcome of the events severe left lower quadrant abdominal pain, awakened from sleep, and flatulence was recovered on an unknown date in Feb2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.