chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Feeling abnormal, Hypoaesthesia
Clinical narrative: Side of left toe had gone numb; Pain in upper back muscles; Slept the first half of the day; Felt like had a major surgery done; Muscles hurt; Hurt to breathe; Dizzy; Fatigued/exhausted; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 11May2021 at 08:45 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included borderline personality disorder, degenerative disc disease, have had 2 previous surgeries on L5-S1, also possibly suffered from small fiber neuropathy, fibromyalgia, and/or silent migraines. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3); both for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERE734) via an unspecified route of administration in the left arm on 20Apr2021 at 08:45 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient previously took gabapentin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021, within an hour, the patient experienced sore arm and on 11May2021 by 22:00, the patient felt like she had a major surgery done, all of muscles were hurt, it was even hurting to breathe, felt dizzy and fatigued. On 12May2021, the next day, the patient was exhausted and slept the first half of the day and by the end of the day, at 22:00, the side of her left toe had gone numb and to the day of reporting, the patient could only feel pressure, and the pain in her upper back muscles was awful and had not gone away. The stretching and physical therapy exercises for the back (exercises taught from previous back issues), had not corrected the issue. The pain and numbness did not get better or worse and pain killers had no effect either. The patient was still fatigued. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events sore arm, hurt to breathe, pain in upper back muscles, muscles hurt and side of left toe had gone numb and included treatment with pain killers (unspecified) and stretching and physical therapy exercises. The clinical outcome of the events sore arm, felt like had a major surgery done, hurt to breathe, pain in upper back muscles, dizzy, muscles hurt, fatigued/exhausted, slept the first half of the day and side of left toe had gone numb were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Painful respiration, Somnolence
Clinical narrative: Side of left toe had gone numb; Pain in upper back muscles; Slept the first half of the day; Felt like had a major surgery done; Muscles hurt; Hurt to breathe; Dizzy; Fatigued/exhausted; Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 11May2021 at 08:45 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included borderline personality disorder, degenerative disc disease, have had 2 previous surgeries on L5-S1, also possibly suffered from small fiber neuropathy, fibromyalgia, and/or silent migraines. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3); both for an unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERE734) via an unspecified route of administration in the left arm on 20Apr2021 at 08:45 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient previously took gabapentin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021, within an hour, the patient experienced sore arm and on 11May2021 by 22:00, the patient felt like she had a major surgery done, all of muscles were hurt, it was even hurting to breathe, felt dizzy and fatigued. On 12May2021, the next day, the patient was exhausted and slept the first half of the day and by the end of the day, at 22:00, the side of her left toe had gone numb and to the day of reporting, the patient could only feel pressure, and the pain in her upper back muscles was awful and had not gone away. The stretching and physical therapy exercises for the back (exercises taught from previous back issues), had not corrected the issue. The pain and numbness did not get better or worse and pain killers had no effect either. The patient was still fatigued. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events sore arm, hurt to breathe, pain in upper back muscles, muscles hurt and side of left toe had gone numb and included treatment with pain killers (unspecified) and stretching and physical therapy exercises. The clinical outcome of the events sore arm, felt like had a major surgery done, hurt to breathe, pain in upper back muscles, dizzy, muscles hurt, fatigued/exhausted, slept the first half of the day and side of left toe had gone numb were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in right ear.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10May2021 at 08:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included micrographically oriented histographic surgery (Mohs surgery on face). The patient previously received silicone (MANUFACTURER UNKNOWN) on an unspecified date for an unspecified indication and experienced drug allergy. The patient took unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left  arm on 17Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12May2021, the patient experienced tinnitus in right ear. 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 adverse event. The clinical outcome of the event tinnitus in right ear was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle tightness, Pain in extremity
Clinical narrative: tightening of neck muscles, including swallowing muscles; Sore arm; fatigue; This is a spontaneous report from a 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: EWO150) via an unspecified route of administration in the left arm on 07Apr2021 at 13:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included occasional irregular heartbeat and caffeine allergy. The patient previously took epinephrine (MANUFACTURER UNKNOWN) for unknown indication and from unknown date and experienced allergy. Concomitant medications included fish oil (MANUFACTURER UNKNOWN), curcuma longa (TURMERIC) and multi vitamins (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 19:30, six hours after the first dose, the patient experienced tightening of neck muscles including swallowing muscles, sore arm and fatigue. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcomes of the events tightening of neck muscles including swallowing muscles, sore arm and fatigue was recovered on unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: slight headache around 4:00 p.m.; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727) via an unspecified route of administration on 19May2021 at 14:45(at the age of 22-year-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. Since the vaccination, the patient had not been tested for COVID-19. On 19May2021, at 16:00 the patient experienced slight headache. The clinical outcome of the event slight headache was recovered on unknown date May2021.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Medical history reported as none. Concomitant medications included cod-liver oil (COD LIVER OIL), unspecified probiotic and prenatal vitamins; all for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 11May2021, the patient experienced pityriasis rosea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with prednisone. The clinical outcome of the event pityriasis rosea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: high fever; Chills; severe body aches; This is a spontaneous report from a contactable consumer (patient husband). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH VACCINE FOR COVID-19, solution for injection, lot number was not reported), dose 2 via an unspecified route of administration on may2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date, the patient received the second shot and after 24 hours she experienced a high fever, her fever was 101.7. Patient also had chills and severe body aches. The outcome of the event was unknown.   No follow-up attempts were completed; information about lot/batch number could not be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20May2021 at 11:45 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient has no known allergies. Concomitant medications included aripiprazole (ABILIFY), escitalopram oxalate (LEXAPRO), vitamin d nos (VITAMIN D), tocopheryl acetate (VITAMIN E) and acetylsalicylic acid (ASPIRIN) all for unspecified indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Apr2021 at 16:00 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 12:00 the patient experienced shortness of breath. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event shortness of breath was recovering at the time of this report.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Teething
Clinical narrative: Extreme chills; 101.5 F fever; Headache; Pain in teeth and upper palate.; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male 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 18May2021 at 10:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The medical history not reported. The patient had known allergies to tree nuts and penicillin. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the right arm on an unspecified date 2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19May2021 at 08:00, the patient experienced extreme chills, 101.5 F (body temperature) fever, headache and later pain in teeth and upper palate. No therapeutic measures were taken as the result of adverse events. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the event's extreme chills, 101.5 F fever, headache and later pain in teeth and upper palate was recovering at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia oral, Pain in extremity, Pyrexia
Clinical narrative: numbness in the tip of my tongue; exhaustion; headache; low grade fever; arm pain; itching of arm of injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8736) on 17May2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to eurythymacin. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 13:30, the patient experienced numbness in the tip of her tongue, exhaustion, headache, low grade fever, arm pain and  itching of arm of injection site. 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. The clinical outcome of the events numbness in the tip of tongue, exhaustion, headache, low grade fever, arm pain, itching of arm of injection site was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: numbness in the tip of my tongue; exhaustion; headache; low grade fever; arm pain; itching of arm of injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8736) on 17May2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to eurythymacin. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 13:30, the patient experienced numbness in the tip of her tongue, exhaustion, headache, low grade fever, arm pain and  itching of arm of injection site. 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. The clinical outcome of the events numbness in the tip of tongue, exhaustion, headache, low grade fever, arm pain, itching of arm of injection site was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Myalgia
Clinical narrative: Sore muscle, tender to touch; Strong metallic taste in mouth; 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: EW0176) via an unspecified route of administration in the arm left on 19May2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 at 21:00, 7 hours after vaccination, the patient experienced sore muscle which was tender to touch and strong metallic taste in mouth like had nickels on her tongue. The event was present even after almost 24 hours of vaccination. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the events sore muscle, tender to touch and strong metallic taste in mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Light spotting for 7 days straight 1 week after taking the vaccine. Period was not due for another 3 weeks. I never spot randomly for 7 days, nor experience an early period 1 week after last one; This is a spontaneous report from a contactable consumer, the patient. A 30-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 02May2021 at 15:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not received. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021 the patient experienced Light spotting for 7 days straight 1 week after taking the vaccine, period was not due for another 3 weeks. The patient had never spotted randomly for 7 days, nor experienced an early period 1 week after finishing the last one, so the timing was no coincidence. 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 Light spotting for 7 days, period was not due was unknown at the time of this report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Severe headache. Headache moved to different parts of the head and face, including sinus area, jaw, and top of the head; severe aches; fatigue; fever; chills; This is a spontaneous report from a non- contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18May2021 at 15:00 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS), GERD, seasonal allergy and vestibular disorder (vestibular weakness). Patient previously took bactrim and nitrofurantoin on an unknown date for unknown indication and experienced drug allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 for (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Apr2021 at 15:30 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 18:00, the patient experienced Severe headache that did not respond to treatment and lasted more than 48 hours. Headache moved to different parts of the head and face, including sinus area, jaw, and top of the head. Accompanied by severe aches, fatigue, fever, chills. Therapeutic measures were taken for the reported event of severe headache and treatment was not specified. No therapeutic measures were taken for the events of severe aches, fever, fatigue and chills. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of severe headache, headache moved to different parts of the head and face, including sinus area, jaw, and top of the head, severe aches, fatigue, fever and chills were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Severely swollen lymph nodes under left arm; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19May2021 at 12:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 08:00 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. On 20May2021 at 15:00, the patient experienced severely swollen lymph nodes under left arm. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severely swollen lymph nodes under left arm was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Influenza like illness, Oral herpes, Pain, Rash pruritic
Clinical narrative: Cold sores on mouth; Itchy, painful shingles like rash; Shingles like rash; Flu like symptoms; Achy; Back felt on fire; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 12May2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBSD), celiac disease, depression, anxiety and penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA), lactulose (MANUFACTURER UNKNOWN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), diazepam (VALIUM) and folic acid (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 08:15, the patient woke up with cold sores on her mouth. On an unknown date in May2021, several days later vaccination, the patient experienced itchy, painful shingles like rash which appeared on her back. The patient was also achy with flu like symptoms, but no fever and back felt on fire. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events included treatment with anti-viral medications (unspecified) and prednisone. The clinical outcome of events cold sores on mouth, itchy, painful shingles like rash on back, achy with flu like symptoms and back felt on fire were not resolved, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: Cold sores on mouth; Itchy, painful shingles like rash; Shingles like rash; Flu like symptoms; Achy; Back felt on fire; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 12May2021 at 14:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), irritable bowel syndrome (IBSD), celiac disease, depression, anxiety and penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included citalopram hydrobromide (CELEXA), lactulose (MANUFACTURER UNKNOWN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL), diazepam (VALIUM) and folic acid (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown start date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13May2021 at 08:15, the patient woke up with cold sores on her mouth. On an unknown date in May2021, several days later vaccination, the patient experienced itchy, painful shingles like rash which appeared on her back. The patient was also achy with flu like symptoms, but no fever and back felt on fire. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events included treatment with anti-viral medications (unspecified) and prednisone. The clinical outcome of events cold sores on mouth, itchy, painful shingles like rash on back, achy with flu like symptoms and back felt on fire were not resolved, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chronic pigmented purpura, Constipation, Lymphadenopathy, Vaccination site pain
Clinical narrative: Enlarged lymph nodes both armpits, painful to the touch; Schamberg's disease: discoloration on both lower and upper legs; Sore arm where vaccine was administered; Upset stomach; Constipation; This is a spontaneous report from a non-contactable consumer (patient). This is first of the two cases. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the arm on 05Apr2021 at 14:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not provided. Concomitant medication included spironolactone, 100 mg (MANUFACTURER UNKNOWN) for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On an unknown date in Apr2021, one week after first dose of vaccine, the patient experienced enlarged lymph nodes in both armpits which lasted a few days and was painful to touch. On an unknown date in Apr2021, shortly after first dose of vaccine, the patient experienced Schamberg's disease: which included discoloration on both lower and upper legs and sore arm where vaccine was administered. On an unknown date in Apr2021, in the second to third week after the first dose, the patient experienced upset stomach and constipation. Therapeutic measures were not taken as a result of adverse events. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events enlarged lymph nodes in both armpits which was painful to touch, Schamberg's disease- discoloration on both lower and upper legs, sore arm where vaccine was administered, upset stomach and constipation was recovered with sequelae. (outcome of event Schamberg's disease also reported as not recovered)  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic pigmented purpura, Constipation, Fatigue, Migraine, Myalgia
Clinical narrative: Migraine; soreness in muscles; Continued discoloration (Schmaberg's) after second dose.; Constipation; tiredness; This is a spontaneous report from a non-contactable consumer reported for herself. A 30-years-old female patient received BNT162B2, via an unspecified route of administration on 26Apr2021 14:30 (Lot Number: EW0150), at the age of 30-years-old, as dose 2, single, for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included spironolactone taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient previously received 1st dose of BNT162B2 on 05Apr2021 at 02:45 PM (Lot number: EW0175) for COVID-19 immunization. Adverse event after 1st dose included enlarged lymph nodes both armpits 1 week after 1st vaccine. Lasted a few days. Painful to the touch. Schambergs disease: discoloration on both lower and upper legs shortly after 1st dose. Sore arm (where vaccine was administered). Upset stomach/constipation 2nd - 3rd week after 1st dose. The events after 2nd dose included: Migraine and increased soreness in muscles that were generally stiff due to non-vaccine related causes. Went away with 2 x Advil. Continued discoloration (Schmabergs) after second dose. Discoloration did not go away as of this writing (3.5 week post 2nd dose). Constipation & tiredness for 1-2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of migraine and soreness in muscles which included 2 x Advil. No treatment was received for the other events. The patient was recovered with lasting effects. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Tenderness
Clinical narrative: lump in left breast under the arm pit.  It was tender to the touch; It is tender to the touch and about the size of a small pea; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 12May2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis (Non-Surgically Diagnosed Endometriosis). The patient was allergic to penicillin. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021, the patient experienced a lump in the left breast under the armpit. It was tender to the touch and about the size of a small pea. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lump in the left breast under the armpit and it was tender to the touch and about the size of a small pea were unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature
Clinical narrative: Temperature; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date the patient experienced temperature. The clinical outcome of the event temperature was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: allergic reaction bump at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication was not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date the patient had allergic reaction bump at injection site. The clinical outcome of the event allergic reaction bump at injection site was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea developed within 2 weeks of vaccination.; This is a spontaneous report from a contactable healthcare professional, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 31Mar2021 at 15:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation.  The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Mar2021 at 17:30 (at the age of 26-year-old) as a single dose for COVID-19 immunization.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient developed pityriasis rosea within 2 weeks of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event pityriasis rosea and included treatment with antihistamine and triamcinolone acetonide (MANUFACTURER UNKNOWN) cream. The clinical outcome of the event pityriasis rosea was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; body aches; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy to squash. Concomitant medications included loratadine from an unknown date for an unknown indication 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 as a single dose for COVID-19 immunisation. The patient previously took levofloxacin for an unknown indication and experienced allergy. On 27Apr2021 at 10:00 the patient experienced chills, body aches, fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of chills, body aches and fever included treatment with acetaminophen. The clinical outcome of the events chills, body aches and fever were resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness, Tremor
Clinical narrative: Dizziness; shakey hands and feet; weak legs; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 17May2021 at 09:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history included cholesteatoma. The patient did not receive any medication within two weeks of vaccination. The patient previously took amoxicillin; clavulanate potassium (AUGMENTIN) from an unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17May2021 at 18:00, the patient experienced dizziness, shakey hands and feet, weak legs. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizziness, shakey hands and feet, weak legs was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: "It resurfaced again May 19, 2021 if like just had the shot again. Arm is very sore and tender to the touch at injection site"; "Sore arm at injection site and when moving arm, as if patient just got the vaccine"; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 19Apr2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included congestive heart failure (CHF), histoplasmosis, thyroid disease, diabetic, penicillin allergy and sulfonamide allergy. The patient did receive unknown medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient previously received BYDUREON for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 the patient experienced, sore arm at injection site and when moving arm, as if the patient just got the vaccine. It resurfaced about 2 weeks after 2nd shot and lasted 3-4 days and then went away. It resurfaced again on 19May2021, as if the patient just had the shot again. Arm was very sore and tender to the touch at injection site. There were no other symptoms. 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. The clinical outcome of the event "sore arm at injection site and when moving arm, as if patient just got the vaccine" was recovered on an unknown date in May2021. The clinical outcome of the event "It resurfaced again May 19, 2021 if like just had the shot again. Arm was very sore and tender to the touch at injection site" was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Migraine; Fever; Dizziness; Drowsiness; Arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 20-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 15May2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included just mental illnesses, ADHD and mood disorder. The patient had no known allergies to medications, food or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lamotrigine (LAMICTAL) and atomoxetine hydrochloride (STRATTERA). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021, the patient experienced migraine, fever, dizziness, drowsiness and arm pain. 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. The clinical outcome of the events migraine, fever, dizziness, drowsiness and arm pain were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: constant tinnitus; This is a spontaneous report from a contactable consumer (patient). A 19-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Right arm on an unspecified date at the age of 19-years-old as dose number unknown, single for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included crisaborole (EUCRISA) taken for an unspecified indication, start and stop date were not reported and unspecified topical steroids taken for an unspecified indication from an unspecified date received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Device Date : 19May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced constant tinnitus that started within 24 hours of vaccination. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Doctors were unable to find a solution. The patient did not receive treatment for adverse event. The patient underwent lab tests and procedures which included Nasal Swab (sars-cov-2 test): negative on an unspecified date. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The outcome of event was not recovered.  Information on the lot/batch number has been requested  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.