chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash papular
Clinical narrative: The day after receiving vaccine, a sore dime-sized red raised area developed.  Each day the area has increased. Today the area is about the size of a slice of bread, red, slightly raised and tender to touch; The day after receiving vaccine, a sore dime-sized red raised area developed.  Each day the area has increased. Today the area is about the size of a slice of bread, red, slightly raised and tender to touch; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the right arm on 25Feb2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included ovarian cancer, thyroidectomy and wasp bites. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), rucaparib camsylate (RUBRACA), warfarin sodium (COUMADIN), exemestane (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 04Feb2021 at 16:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation and received cefaclor (CECLOR) and  chlorhexidine topical scrub (MANUFACTURER UNKNOWN); both on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021 at 12:00, the day after receiving vaccination, the patient experienced a sore dime-sized red raised area developed. Each day the area had increased and at the day of reporting (Today) the area was about the size of a slice of bread, red, slightly raised and tender to touch. It looks similar to a response to wasp bites she had several years ago. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events a sore dime-sized red raised area and the area was about the size of a slice of bread, red, slightly raised and tender to touch was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue
Clinical narrative: "I" was very light headed; "I" had chills; "I" felt fatigued; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 3248) via an unspecified route of administration in the left arm on 01Mar2021 at 14:30 (at the age of 45-year-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 medication included lisinopril 10 mg (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. On 02Mar2021 at 14:30, about 24 hours after the shot, the patient experienced very light headed and had chills. The patient felt fatigued as well. The events did not result in doctor or other healthcare professional office/clinic visit/emergency 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 outcomes of the events very light headed, chills and felt fatigued were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Sore left side of left breast; This is a spontaneous report from a contactable consumer, the patient. A 61-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 left arm on 23Feb2021 at 12:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), multivitamin (MANUFACTURER UNKNOWN) and vitamin B complex (VITAMIN B) supplement, 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 24Feb2021, the patient experienced sore left side of left breast. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore left side of left breast 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced arm pain. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 47-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 02Mar2021 at 14:45 (at the age of 47-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to sulfa drugs and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included salbutamol (ALBUTEROL), levocetirizine dihydrochloride (XYZAL), montelukast (MANUFACTURER UNKNOWN) and unspecified vitamins; all taken for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Mar2021, at 21:00 the patient experienced soreness in left arm. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the event soreness in left arm was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Hands and face burning; This is a spontaneous report from a contactable consumer, the patient. A 62-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 02Mar2021 at 09:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial flutter, asthma, meniere's disease, blood pressure high and allergy to artificial dyes, penicillin, and yeast. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included PROPAFENONE, VERELAN, BENICAR, and CLOPIDOGREL, all for unknown indication from unknown date and unknown if ongoing. The patient previously received ASPIRIN, CIPRO, and LEVAQUIN, all on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021 at 09:47, 17 minutes after vaccination, the patient experienced hands and face burning that lasted about 3 minutes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hands and face burning was recovered on 02Mar2021.   No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; dizziness accompanied by being light headed; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in the left arm on 09Feb2021 at 14:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. 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 atorvastatin (MANUFACTURER UNKNOWN), chlortalidone (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), vitamin d not otherwise specified (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 19Jan2021 at 14:15 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. On 23Feb2021 at 05:30, the patient experienced vertigo and dizziness accompanied by being light headed started 14 days after the second dose. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo and dizziness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Neck stiffness; Soreness at injection site; Tiredness; Stomach cramping; Diarrhea; 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: EN6199) via an unspecified route of administration in the right arm on 02Mar2021 at 15:30 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included myasthenia gravis, fibromyalgia, osteoarthritis (OA), rheumatoid arthritis (RA), heart arrhythmia, asthma and allergy to bee venom. 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. The concomitant medications included gabapentin (MANUFACTURER UNKNOWN), flecainide (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN) and clotrimazole (MYCO) for unknown indications from unknown dates and unknown if ongoing. The patient previously took hydrocodone(MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 02Mar2021 at 19:45, the patient experienced neck stiffness, soreness at injection site, tiredness, stomach cramping and diarrhea. The adverse 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events neck stiffness, soreness at injection site, tiredness, stomach cramping and diarrhea was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder area of injection is moderately sore; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 25Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Feb2021, the patient's shoulder area of injection was moderately sore. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shoulder area of injection is moderately sore 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: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal
Clinical narrative: Sore area on back near spinal cord; Just an unusual feeling and uncomfortable when sat back; This is a spontaneous report from a contactable nurse, the patient. An 89-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 right arm on 02Mar2021 at 14:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and arthritis. The patient had no known allergies to food, medications or other products. Concomitant medications included acetylsalicylic acid (ASPIRIN) and hydrochorize; both for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the right arm on 09Feb2021 at 15:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. 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 02Mar2021, at 19:00 the patient experienced sore area on back near spinal cord; no marks, redness, or itchy. It was not a sharp pain, just an unusual feeling and uncomfortable when the patient sat back. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore area on back near spinal cord and just an unusual feeling and uncomfortable when sat back were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site soreness; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm right on 19Feb2021 at 14:30 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included raised blood pressure and facial pain. The patient did not had allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included tramadol (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021 at 17:00, the patient experienced injection site soreness. 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 event injection site soreness was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight soreness at vaccination site; 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: EN6198) via an unspecified route of administration in the left arm on 25Feb2021 at 11:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and increased cholesterol controlled with medications. The patient did not have any 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 included pravastatin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN) and unspecified vitamins (MANUFACTURE UNKNONWN); all for unknown indications, from an unknown date and unknown if ongoing. On 25Feb2021 at 23:00, the patient experienced slight soreness at vaccination site. 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 outcome of the event slight soreness at vaccination site was unknown 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: Breast swelling
Clinical narrative: After about four hours after receiving the vaccine, my right breast implant swelled.  I am a breast cancer survivor and after one week, the breast is still swollen. Going in for an ultrasound on 3/8.; This is a spontaneous report from a contactable consumer, the patient. A 57-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 24Feb2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, breast cancer and atrial fibrillation (AFib). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021 at 16:00, after about four hours after receiving the vaccine, the patient experienced her right breast implant swelled. The patient reported that she was a breast cancer survivor and after one week, the breast was still swollen. The patient reported that she will be going in for an ultrasound on 08Mar2021.The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with steroids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right breast implant swelled 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Product administered at inappropriate site
Clinical narrative: Swollen lymph node in left arm pit; vaccine location=Left leg; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM3247) via an unspecified route of administration in the leg left on 15Feb2021 (at the age of 36-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 17Feb2021, 48 hours after the vaccination, the patient experienced swollen lymph node in left arm pit. 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 swollen lymph node in left arm pit was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue
Clinical narrative: Tiredness; Mild temperature elevation 1.5 degrees; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 02Mar2021 at 09:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, diabetes type 2, penicillin allergy, and sulfonamide allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 03Mar2021 at 07:00, the patient experienced tiredness and mild temperature elevation of 1.5 degrees. 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 reported events. On 03Mar2021, the patient underwent body temperature test and the result was mild temperature elevation 1.5 degrees (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tiredness and mild temperature elevation was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, swollen, warm-to-touch arm; Red, swollen, warm-to-touch arm; Red, swollen, warm-to-touch arm; This is a spontaneous report from a contactable consumer, the patient. A 50-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 17Feb2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received morphine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) and pantoprazole sodium sesquihydrate (PROTONIX) all from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, 8 days after vaccination, the patient experienced red, swollen and warm-to-touch arm. It was reported that welcome to contact her doctor but she did not go to show her reaction on her arm. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the events red, swollen, warm-to-touch arm 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: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Dull headache; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the right arm on 02Mar2021 at 15:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), liothyronine (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and zinc (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. 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 02Mar2021 at 19:00, the patient experienced sore arm, dull headache and tiredness. 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 sore arm, dull headache and tiredness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: ''I'' had a very violent episode of vertigo; Continued on and off dizziness since then but not as bad as the first day; This is a spontaneous report from a non-contactable consumer, the patient. A 68-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration on 08Feb2021 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 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 bimatoprost (LUMIGAN), for an unknown indication from an unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the right arm on 18Jan2021 as a single dose for COVID-19 immunisation. On 14Feb2021, about 6 days after vaccination, the patient had a very violent episode of vertigo. Continued on and off dizziness since then but not as bad as the first day (day 1 on 09Feb2021). She still had dizziness on and off throughout the day. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events very violent episode of vertigo and continued on and off dizziness were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Eye inflammation, Eye pain, Photophobia, Sunburn, Vision blurred
Clinical narrative: Woke up the next morning with left eye ball pain; Eye felt sunburned; Vision is slightly off; Eye felt sunburned, vision is slightly off, light sensitive; Saw eye doctor at 3:15, symptoms were still present, mild inflammation was visible during exam; This is a spontaneous report from a contactable consumer, the patient. A 48-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 02Mar2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis, vitamin b12 deficiency, allergy to latex, banana and avocado. The patient did not receive any medication within two weeks of vaccination. The patient previously received prednisone (MANUFACTURER UNKNOWN) and cortisone (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. The patient woke up the next morning on 03Mar2021 at 07:15, with left eye ball pain. Eye felt sunburned, vision was slightly off, light sensitive. The events resulted in doctor or other healthcare professional office/clinic visit. The patient saw eye doctor at 15:15, symptoms were still present, mild inflammation was visible during examination. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL) for pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left eye ball pain; eye felt sunburned, vision was slightly off, light sensitive; mild inflammation was visible during examination were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Oropharyngeal pain
Clinical narrative: Hoarseness; a slight soar throat; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right upper arm on 25Feb2021 at 13:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic asthma under control with medication. The patient was not aware of any 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 ADVAIR and SPIRIVA inhalers for asthma, from an unknown date.  On 25Feb2021 at 14:45, the patient experienced hoarseness and a slight sore throat, much better on reported day (01Mar2021) and hoarseness was not as bad as the first day. It was reported that the patient wanted to know if she would have the same problem when she receives the 2nd dose which was set for 18Mar2021. 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 hoarseness and a slight sore throat was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: Arms hurts; "I" m starting to feel as if "Im getting a cold; This is a spontaneous report from a contactable consumer, the patient. A 59-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 25Feb2021 at 16:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy, contrast media allergy (allergy to contrast dye), food allergy (feed) and allergy to animal (hyena). 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 took other medication in two weeks (Reg meds). The patient reported that he was fine until that day, 02Mar2021. On 02Mar2021, the patients arm hurts and the patient started to feel as if he was getting a cold. 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 events arm hurts and "I' m starting to feel as if I'm" getting a cold 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Nausea
Clinical narrative: Pain at injection site; Chills; Body aches; Diarrhea; Nausea; Extreme fatigue; Stabbing pain in right lower abdomen; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6200) via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 69-years old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 02Mar2021 at 02:00, the patient experienced pain at injection site, chills, body aches, diarrhea, nausea, extreme fatigue and stabbing pain in right lower abdomen. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, chills, body aches, diarrhea, nausea, extreme fatigue and stabbing pain in right lower abdomen was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Pain at injection site; Chills; Body aches; Diarrhea; Nausea; Extreme fatigue; Stabbing pain in right lower abdomen; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6200) via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 69-years old) as a single dose for COVID-19 immunisation. Medical history included osteoporosis and COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 02Mar2021 at 02:00, the patient experienced pain at injection site, chills, body aches, diarrhea, nausea, extreme fatigue and stabbing pain in right lower abdomen. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, chills, body aches, diarrhea, nausea, extreme fatigue and stabbing pain in right lower abdomen was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache
Clinical narrative: Earache; Mild headache; This is a spontaneous report from a contactable consumer, the patient. A 49-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 02Mar2021 at 16:00 (at the age of 49-year-old), as a single dose for COVID-19 immunisation. The patient's medical history was unknown. 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 were not reported. The patient previously received oseltamivir phosphate (TAMIFLU) and sulfur (MANUFACTURER UNKNOWN); both for unspecified indications from unknown dates and experienced drug allergy. On 02Mar2021 at 17:15, the patient experienced earache and mild headache. Since the vaccination, the patient had not been tested for COVID-19. 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. The clinical outcome of the events earache and mild headache 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: This is a spontaneous report from a noncontactable consumer (patient). A 49-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 49, via an unspecified route of administration, on Mar 2, 2021, at 13:30, single dose, for COVID-19 immunisation. No medical history reported. No known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not have any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the vaccination. On Mar 2, 2021, patient experienced a very deep sleep at the night after the vaccine. The day after the vaccine, patient felt sleepy as though like jetlagged. The events did not result in doctor or other healthcare professional office/clinic/emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of the event. The outcome of feeling sleepy: not recovered (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Migraine that will not go away along with nausea; Migraine that will not go away along with nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 22-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 right arm on 26Feb2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Feb2021, the patient experienced migraine that would not go away along with nausea. 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 migraine that would not go away along with nausea was not resolved 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.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: terrible vertigo; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 as a single dose for COVID-19 immunisation. Medical history included symptoms of having COVID-19, including muscle tremors, chills without (w/o) fever, joint pain and cough from an unspecified date in Feb2021 and unknown if ongoing. It was unknown if the patient had 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. It was unknown if the patient had received other medications in two weeks. On 26Feb2021, the patient experienced terrible vertigo. 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 event terrible vertigo was recovered on 01Mar2021, after the duration of 72 hours.   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: Pain in extremity
Clinical narrative: Sore arm for approximately 30 hours - peak soreness at about 12-14 hours after injection; 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: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 15:45 (at the age of 54-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 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 ibuprofen (MANUFACTURER UNKNOWN), valsartan (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. On 01Mar2021 at 20:00, the patient experienced sore arm for approximately 30 hours - peak soreness at about 12-14 hours after injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was resolved on 03Mar2021 at 02:00.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Somnolence
Clinical narrative: Severe muscle pain; Very sleepy; Tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265) via an unspecified route of administration in the right arm on 16Feb2021 at 10:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included LDL cholesterol-high and known allergies only to lactose or caffeine. Concomitant medications included colecalciferol (VIT D3), ascorbic acid (VITAMIN C), menaquinone (VITAMIN K2) and zinc (MANUFACTURER UNKNOWN); all medications from an unknown date and unknown if ongoing for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283) via an unspecified route of administration in the right arm on 19Jan2021 at 10:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 23Feb2021 at 04:00, the patient experienced severe muscle pain, very sleepy, tiredness and feeling unwell after the first week of the second dose. 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 events severe muscle pain, very sleepy, tiredness and feeling unwell were not resolved 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: Lymphadenopathy
Clinical narrative: Swollen lymph node on injection arm (left side); This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Feb2021 at 09:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not received any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and water pill (unspecified); both for unknown indication from unknown date and unknown if ongoing. On 01Mar2021 at 07:00, the patient experienced swollen lymph node on injection arm (left side). The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node on injection arm (left side) 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.