chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgia
Clinical narrative: Joint pain in both shoulders; More intense nerve pain in legs; This is a spontaneous report from a contactable consumer, the patient. A 51-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 01Apr2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. 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 levetiracetam (MANUFACTURER UNKNOWN); taken for unspecified 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: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (also reported on 01Apr2021 at 08:15), as a single dose for COVID-19 immunisation. On 30Apr2021 at 06:00, the patient experienced joint pain in both shoulders. More intense nerve pain in legs than typical for a patient with multiple sclerosis. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events more intense nerve pain in legs and joint pain in both shoulders was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache; Fatigue; Hives; Bodyache; Arm soreness; Dizziness; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 11May2021 at 17:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC), prednisone (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL) and sertraline (MANUFACTURER UNKNOWN); all for an 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: EL3302) via an unspecified route of administration in the left arm on 20Apr2021 at 17:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 18:00, the patient experienced headache, fatigue, hives, body ache, arm soreness, dizziness, fever and chills. On an unknown date in 2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fatigue, hives, body ache, arm soreness, dizziness, fever and chills were resolving 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: Pain in extremity, Pyrexia, SARS-CoV-2 test, Urticaria
Clinical narrative: Headache; Fatigue; Hives; Bodyache; Arm soreness; Dizziness; Fever; Chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 11May2021 at 17:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC), prednisone (MANUFACTURER UNKNOWN), diphenhydramine hydrochloride (BENADRYL) and sertraline (MANUFACTURER UNKNOWN); all for an 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: EL3302) via an unspecified route of administration in the left arm on 20Apr2021 at 17:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 18:00, the patient experienced headache, fatigue, hives, body ache, arm soreness, dizziness, fever and chills. On an unknown date in 2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fatigue, hives, body ache, arm soreness, dizziness, fever and chills were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Ear haemorrhage, Epistaxis, Fatigue, Memory impairment
Clinical narrative: Patient having nose bleeds but only in the left nostril; Patient having blood in my right ear but looking at the fluid to come out just a little bit; Patient ridiculously forgetful; I was like really knocked out exhausted; Patient was like really knocked out exhausted; Shortness of breath; This is a spontaneous report from a contactable consumer (reported for self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 21Apr2021 at 08:45 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the consumer reported that the patient having nose bleeds but only in the left nostril and the patient having blood in right ear but looking at the fluid to come out just a little bit and patient been ridiculously forgetful. Patient was like really knocked out exhausted after the first shot and like now patient experiencing shortness of breath. So, the patient wondering should get the second shot. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: Body aches; Painful sinuses; Fatigue; Arm pain; Fever; Chills; Headache; Dose 1: 27Apr2021;Dose 2: 11May2021; This is a spontaneous report from a contactable consumer, the patient. A 16-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 11May2021 at 11:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and latex 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 COVID vaccine. Concomitant medications included iron (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. 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 27Apr2021 at 11:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, the patient experienced fever, chills, body aches, headache, fatigue, painful sinuses and arm pain. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, headache, fatigue, painful sinuses and arm pain were resolving at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sinus pain
Clinical narrative: Body aches; Painful sinuses; Fatigue; Arm pain; Fever; Chills; Headache; Dose 1: 27Apr2021;Dose 2: 11May2021; This is a spontaneous report from a contactable consumer, the patient. A 16-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 11May2021 at 11:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included shellfish allergy and latex 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 COVID vaccine. Concomitant medications included iron (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. 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 27Apr2021 at 11:00 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. On 11May2021 at 23:00, the patient experienced fever, chills, body aches, headache, fatigue, painful sinuses and arm pain. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, body aches, headache, fatigue, painful sinuses and arm pain were resolving at the time of this report.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: From the site of the vaccine there is tingling and numbness randomly shooting down the arm; From the site of the vaccine there is tingling and numbness randomly shooting down the 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: EW0170) via an unspecified route of administration in the right arm on 16Apr2021 at 09:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient previously received hydrocodone bitartrate; paracetamol (VICODIN) 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. Concomitant medications included etonogestrel (NEXPLANON); taken 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: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 08:00, from the site of the vaccine, the patient experienced tingling and numbness randomly shooting down her arm for the last 2 weeks (at the time of this report) and it seemed to be more frequent as time goes on. 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 from the site of the vaccine there is tingling and numbness randomly shooting down the arm were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in armpit; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 09May2021 at 09:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 18Apr2021 at 10:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 10May2021 at 07:00, the patient experienced swollen lymph nodes in armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of event swollen lymph nodes in armpit was resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchy skin/scalp; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0162) via an unspecified route of administration on 19Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 30Apr2021, the patient had itchy skin and scalp. 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 itchy skin and scalp was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Genital herpes, Herpes zoster
Clinical narrative: Shingles outbreak on back of neck; Genital herpes outbreak; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 15:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included shingles. 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 COVID-19 vaccine. The patient did not receive any medications within two weeks of the COVID-19 vaccine. On 04Apr2021 at 12:00, the patient experienced genital herpes outbreak within 24 hours of vaccination. The patient stated that he did not treat it with medication. On 19Apr2021, the patient experienced shingles outbreak on back of neck, 15 days after vaccination. Patient stated that he had shingles previously as an adult and also as a child. 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 the event shingles outbreak on back of neck and included treatment with valacyclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events genital herpes outbreak, shingles outbreak on back of neck was recovering at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 24Apr2021 at 15:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Fatigue, Headache, Pain
Clinical narrative: The day after the 2nd dose I had mild fever (100.1); Body aches that felt like my spine/bones hurt to move.; For several days i also would get random waves of feeling fatigued; Had a mild lingering headache that lasted for several hours.; 9 days after I had lower back pain from doing minimal activity that has now lasted a few days.; 9 days after I had lower back pain from doing minimal activity that has now lasted a few days.; 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: EW0176) via an unspecified route of administration in the arm left on 29Apr2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) for allergies from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8738) via an unspecified route of administration in the arm left on 08Apr2021 at 15:45 (at the age of 33-year-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 30Apr2021 at 03:00, day after the second dose the patient had mild fever 100.1(Unspecified units) and body aches that felt like the  spine/bones hurt to move. For several days, the patient also would get random waves of feeling fatigued or had a mild lingering headache that lasted for several hours. Nine days after the patient had lower back pain from doing minimal activity that had now lasted a few days. The patient was still in pain. The patient never had lower back pain before. 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 mild fever 100.1(Unspecified units), body aches that felt like my spine/bones hurt to move, random waves of feeling fatigued or had a mild lingering headache and lower back pain from doing minimal activity was resolving 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: Pyrexia
Clinical narrative: The day after the 2nd dose I had mild fever (100.1); Body aches that felt like my spine/bones hurt to move.; For several days i also would get random waves of feeling fatigued; Had a mild lingering headache that lasted for several hours.; 9 days after I had lower back pain from doing minimal activity that has now lasted a few days.; 9 days after I had lower back pain from doing minimal activity that has now lasted a few days.; 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: EW0176) via an unspecified route of administration in the arm left on 29Apr2021 at 15:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) for allergies from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8738) via an unspecified route of administration in the arm left on 08Apr2021 at 15:45 (at the age of 33-year-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 30Apr2021 at 03:00, day after the second dose the patient had mild fever 100.1(Unspecified units) and body aches that felt like the  spine/bones hurt to move. For several days, the patient also would get random waves of feeling fatigued or had a mild lingering headache that lasted for several hours. Nine days after the patient had lower back pain from doing minimal activity that had now lasted a few days. The patient was still in pain. The patient never had lower back pain before. 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 mild fever 100.1(Unspecified units), body aches that felt like my spine/bones hurt to move, random waves of feeling fatigued or had a mild lingering headache and lower back pain from doing minimal activity was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: 3x4 raised red hot oval shaped tender area at injection site; 3x4 raised red hot oval shaped tender area at injection site; 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: EW0150) via an unspecified route of administration in the right arm on 07Apr2021 at 12:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included type 2 diabetes and 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 vaccine within four weeks prior to the COVID vaccine. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and diltiazem (MANUFACTURER UNKNOWN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 17Mar2021 at 12:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. On 08Apr2021, the patient experienced "3x4" raised red hot oval shaped tender area at injection site which occurred on 1st day after 2nd vaccine. That was lasting and very slowly subsided over more than a week. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event "3x4" raised red hot oval shaped tender area at injection site was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Lymphadenopathy, Vaccination site pain
Clinical narrative: Fatigue; Pain in left armpit; swollen lymph node; Pain at injection site; Headache; 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: EW0164) via an unspecified route of administration in the left arm on 09May2021 at 08:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (ADVIL) which might be one week prior for an unknown indication and unknown if ongoing and nighttime tea. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 18Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 01:00, the patient experienced pain in the left armpit (swollen lymph node), pain at the injection site (left arm), headache, fatigue and dizziness. 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 pain in the left armpit, swollen lymph node, pain at the injection site (left arm), headache, fatigue and dizziness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Bloodshot right eye; This is a spontaneous report from a contactable physician. A 41-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration on 10May2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included fibroadenoma of right breast. It was unknown if the patient was pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks prior to the COVID-19 vaccination. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On 11May2021, the patient experienced a bloodshot right eye. The event did not result in doctor or other health care professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, it was unknown if the patient has been tested for COVID-19. The clinical outcome of the event bloodshot right eye 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Decreased immune responsiveness, Pain, Pharyngeal ulceration, SARS-CoV-2 test
Clinical narrative: Had a terrible outbreak of mouth ulcers (canker sores); There were many large ones in mouth/ throat and were very painful; These were many large ones in my mouth/throat and were very painful; UTI; It felt like the immune system had completely shut down/been weakened; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 05May2021 at 14:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19), mouth ulcer and urinary tract infection (UTI). The patient had no known allergies. Concomitant medications included birth control pills daily (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 06May2021, within a day of receiving the vaccine, the patient had experienced a terrible outbreak of mouth ulcers (canker sores). The patient reported that she rarely got mouth ulcers, might be one time, once or twice a year. These were many large ones in her mouth, throat and were very painful. The patient never had an outbreak like that before. The patient also developed a urinary tract infection (UTI) within a day of receiving the vaccine and reported that she rarely ever got a UTI and it was usually from wearing a bathing suit too long or a specific reason. Both of these reactions were out of the blue and the patient could not think of any other reasons that they would have occurred other than receiving this vaccine. The patient felt like her immune system had completely shut down or weakened for those reactions to occur. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with prescription medications and mouthwash (unspecified). On 06May2021, the patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) and the result was negative. The clinical outcome of the events outbreak of mouth ulcers (canker sores), throat ulcers, large ones in mouth, throat and were very painful, urinary tract infection (UTI) and felt like immune system had completely shut down/been weakened was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Had a terrible outbreak of mouth ulcers (canker sores); There were many large ones in mouth/ throat and were very painful; These were many large ones in my mouth/throat and were very painful; UTI; It felt like the immune system had completely shut down/been weakened; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168) via an unspecified route of administration in the right arm on 05May2021 at 14:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, the patient was diagnosed with COVID-19), mouth ulcer and urinary tract infection (UTI). The patient had no known allergies. Concomitant medications included birth control pills daily (unspecified) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. On 06May2021, within a day of receiving the vaccine, the patient had experienced a terrible outbreak of mouth ulcers (canker sores). The patient reported that she rarely got mouth ulcers, might be one time, once or twice a year. These were many large ones in her mouth, throat and were very painful. The patient never had an outbreak like that before. The patient also developed a urinary tract infection (UTI) within a day of receiving the vaccine and reported that she rarely ever got a UTI and it was usually from wearing a bathing suit too long or a specific reason. Both of these reactions were out of the blue and the patient could not think of any other reasons that they would have occurred other than receiving this vaccine. The patient felt like her immune system had completely shut down or weakened for those reactions to occur. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events which included treatment with prescription medications and mouthwash (unspecified). On 06May2021, the patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) and the result was negative. The clinical outcome of the events outbreak of mouth ulcers (canker sores), throat ulcers, large ones in mouth, throat and were very painful, urinary tract infection (UTI) and felt like immune system had completely shut down/been weakened was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad, consistent headaches to date since a couple days after receiving the second vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0162) via an unspecified route of administration in the left arm on 27Apr2021 at 10:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. The medical history included environmental 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. The concomitant medications included topiramate (TROKENDI), omeprazole (MANUFACTURER UNKNOWN) and levocetirizine dihydrochloride (XYZAL), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 06Apr2021 at 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient previously took metoclopramide (REGLAN) and sumatriptan (IMITREX) and experienced allergy. On 29Apr2021, a couple of days after receiving the second vaccine, the patient experienced bad, consistent headaches till date (at the time of the report). It had not gone away, even with medication. The patient received medication (unspecified) for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bad, consistent headaches was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Neck pain, Pain, Thyroid function test, Thyroiditis subacute
Clinical narrative: subacute hyperthyroidism/fatigue; neck pain; achiness; Fatigue; This is a spontaneous report from a contactable consumer (patient) via COVAES. This non-pregnant 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Mar2021 (at 55-years-old) as a single dose for COVID-19 immunisation. Medical history included mild hypertension which was treated from an unknown date. Concomitant medications included losartan from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number EI9264) in the left arm on 05Feb2021 at 09:45 (at 55-years-old) for COVID-19 immunisation. Prior to vaccination the patient had not received any other vaccines in four weeks, was not diagnosed with COVID-19 and had no allergies. On 22Mar2021, two weeks after the second dose, the patient developed neck pain, achiness, and fatigue, and was diagnosed with subacute hyperthyroidism. The event resulted in a doctor's office visit; no treatment was provided for the event. The clinical outcomes of the events were recovering. Since vaccination, the patient had not been tested for COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Insomnia, Myalgia, Peripheral coldness
Clinical narrative: Insomnia; muscle aches; joint pain; cold extremities; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. The patient previously had peanuts and experienced peanut allergy. Concomitant medication received within two weeks of vaccination 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 07May2021, the patient experienced insomnia, muscle aches, joint pain, cold extremities, fatigue. 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. The clinical outcome of the events insomnia, muscle aches, joint pain, cold extremities, fatigue was resolved on an unknown date in May2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia, Urticaria
Clinical narrative: Hives on face and arm; Fever of 102 F; Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0173) via an unspecified route of administration in the left arm on 09May2021 at 13:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient had no 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 vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729), via an unspecified route of administration in the left arm on 19Apr2021, at 13:30, (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 10May2021 at 01:00, the patient experienced hives on face and arm, fever of 102 F (Fahrenheit) and flu like symptoms. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events hives on face and arm, fever of 102 Fahrenheit and flu like symptoms were resolved on unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site vesicles
Clinical narrative: Acne-like blisters on upper left arm (injection site) spreading to shoulder, neck, back and forearm; Soreness; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 22-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03May2021 at 11:00 (at the age of 22-year-old) both as a single dose for COVID-19 immunisation. The patient had no relevant medical history and 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 concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced acne-like blisters on the upper left arm (injection site) which was spreading to the shoulder, neck, back and forearm and some soreness after a week. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events acne-like blisters on the upper left arm (vaccination site) and soreness were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional. A female patient of unknown age 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 and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 06May2021, the patient experienced lymph node under armpit swelling. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event lymph node under armpit swelling was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: Began experiencing chills; Fever of 101.7; Fatigue/exhaustion; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 03May2021 at 12:45 (at the age of 45-years old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), EMERGEN C IMMUNE SUPPORT, OLLY GLOWING SKIN; all for unknown indications from an unknown start date and unknown if ongoing. The patient had no known allergies. 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 12Apr2021 at 11:45 (at the age of 45-years old) as a single dose for COVID-19 immunisation. On 04May2021 at 04:00, after 16 hours of the vaccination, the patient experienced chills, a fever of 101.7 (units unspecified), fatigue or exhaustion and nausea that lasted about 24 hours. The events did not result in doctors or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events, which included treatment with OTC ibuprofen (MANUFACTURER UNKNOWN) to reduce fever and symptoms. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, chills, a fever of 101.7 (units unspecified), fatigue or exhaustion and nausea was recovered on 05May2021.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes in the left axilla; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 10May2021 at 10:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 18-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. On 11May2021, the patient experienced lymph nodes in the left axilla. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as a result of the event. The clinical outcome of the event lymph nodes in the left axilla was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Vomiting
Clinical narrative: Vomiting after second vaccine,; Headache; Soreness of arm starting day of second vaccine approximately 8 hours after injection; 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: UNKNOWN) via an unspecified route of administration in the arm right on 10May2021 at 09:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs (sulfonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and bupropion (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 19Apr2021 at 09:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 11May2021 at 23:00 approximately 38 hours after second vaccine the patient had vomiting and as well as headache. On 10May2021 at 17:30, starting day of second vaccine approximately 8 hours after injection, the patient had soreness of arm. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vomiting as well as headache and soreness of arm, was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.