chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Temperature fluctuations (fluctuating fairly quickly with multiple degree differences within minutes of each other); Severe nausea worsening at nigh; Menstruation bleeding was heavier than normal; Severe cramps; Migraines; Chills; Hot flashes; 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: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 08:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, scoliosis, generalized anxiety. The patient was allergic to dairy and bird dandruff. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) and women's multivitamin (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 starting at 17:00 (estimated), the patient experienced chills and hot flashes and continuing until 18Apr2021. No temperature measured except the 16Apr2021 when temperature fluctuations measured between 94-98 degrees Fahrenheit throughout the day (fluctuating fairly quickly with multiple degree differences within minutes of each other, thermometer was correct when compared with a second thermometer's readings). On 13Apr2021 (reported as tuesday), the patient had migraines all the day. On 14Apr2021 (reported as wednesday) with severe nausea worsening at night, stayed laying or sitting down to keep from throwing up. Period (menstruation) started this day as well, and bleeding was heavier than normal with severe cramps which she never experienced. Migraines are also never experienced as a symptom of menstruation. Migraines continued until Monday 19Apr2021 but were much lighter and without nausea or stomach cramping. Period ended on 21Apr2021 (reported as today), the blood having been heavy the entire time. The patient reported that she was still getting headaches but nothing was as severe. 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.  On 16Apr2021, the patient underwent Body temperature test and the result was found to be 94-98 degrees Fahrenheit. The clinical outcome of the events chills and hot flashes was resolved on 18Apr2021.The clinical outcome of the events temperature fluctuations, severe nausea worsening at night and stomach cramping was resolved on an unknown date in Apr2021. The clinical outcome of the events menstruation bleeding was heavier than normal was resolved on 21Apr2021; while that of the event migraines was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Migraine, Nausea
Clinical narrative: Temperature fluctuations (fluctuating fairly quickly with multiple degree differences within minutes of each other); Severe nausea worsening at nigh; Menstruation bleeding was heavier than normal; Severe cramps; Migraines; Chills; Hot flashes; 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: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 08:15 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, scoliosis, generalized anxiety. The patient was allergic to dairy and bird dandruff. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d (MANUFACTURER UNKNOWN) and women's multivitamin (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Apr2021 starting at 17:00 (estimated), the patient experienced chills and hot flashes and continuing until 18Apr2021. No temperature measured except the 16Apr2021 when temperature fluctuations measured between 94-98 degrees Fahrenheit throughout the day (fluctuating fairly quickly with multiple degree differences within minutes of each other, thermometer was correct when compared with a second thermometer's readings). On 13Apr2021 (reported as tuesday), the patient had migraines all the day. On 14Apr2021 (reported as wednesday) with severe nausea worsening at night, stayed laying or sitting down to keep from throwing up. Period (menstruation) started this day as well, and bleeding was heavier than normal with severe cramps which she never experienced. Migraines are also never experienced as a symptom of menstruation. Migraines continued until Monday 19Apr2021 but were much lighter and without nausea or stomach cramping. Period ended on 21Apr2021 (reported as today), the blood having been heavy the entire time. The patient reported that she was still getting headaches but nothing was as severe. 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.  On 16Apr2021, the patient underwent Body temperature test and the result was found to be 94-98 degrees Fahrenheit. The clinical outcome of the events chills and hot flashes was resolved on 18Apr2021.The clinical outcome of the events temperature fluctuations, severe nausea worsening at night and stomach cramping was resolved on an unknown date in Apr2021. The clinical outcome of the events menstruation bleeding was heavier than normal was resolved on 21Apr2021; while that of the event migraines was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: After the first dose tinnitus got noticeably louder and is now in both ears/ My tinnitus used to be noticeable to me only at bedtime, but now I hear it all the time, day and night.; It is causing me significant anxiety.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history included tinnitus, high cholesterol and enlarged prostate. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. On an unknown date in Apr2021, 3 or 4 days after the first dose, the patient experienced tinnitus got noticeably louder and was felt in both ears. The patient had mild tinnitus in right ear for some time. The tinnitus was noticeable only at bedtime (earlier to vaccine), but currently could hear it all the time, day and night. It caused the patient significant anxiety. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus got noticeably louder and was felt in both ears was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Tinnitus
Clinical narrative: After the first dose tinnitus got noticeably louder and is now in both ears/ My tinnitus used to be noticeable to me only at bedtime, but now I hear it all the time, day and night.; It is causing me significant anxiety.; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 13:00 (at the age of 62-year-old), as a single dose for COVID-19 immunisation. Medical history included tinnitus, high cholesterol and enlarged prostate. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), escitalopram (MANUFACTURER UNKNOWN), tamsulosin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. On an unknown date in Apr2021, 3 or 4 days after the first dose, the patient experienced tinnitus got noticeably louder and was felt in both ears. The patient had mild tinnitus in right ear for some time. The tinnitus was noticeable only at bedtime (earlier to vaccine), but currently could hear it all the time, day and night. It caused the patient significant anxiety. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus got noticeably louder and was felt in both ears was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Head to toe rash/hives all over her body. Very itchy NOT affecting her breathing, airway or lungs.; Head to toe rash/hives all over her body. Very itchy NOT affecting her breathing, airway or lungs.; Head to toe rash/hives all over her body. Very itchy NOT affecting her breathing, airway or lungs.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 18Apr2021 at 15:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included TRI LO ESTARYLLA for birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 07:00, the patient experienced head to toe rash/hives all over her body and very itchy not affecting her breathing, airway or lungs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with over the counter allergy medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events head to toe rash/hives all over her body and very itchy not affecting her breathing, airway or lungs were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Head to toe rash/hives all over her body. Very itchy NOT affecting her breathing, airway or lungs.; Head to toe rash/hives all over her body. Very itchy NOT affecting her breathing, airway or lungs.; Head to toe rash/hives all over her body. Very itchy NOT affecting her breathing, airway or lungs.; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 18Apr2021 at 15:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included TRI LO ESTARYLLA for birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 07:00, the patient experienced head to toe rash/hives all over her body and very itchy not affecting her breathing, airway or lungs. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with over the counter allergy medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events head to toe rash/hives all over her body and very itchy not affecting her breathing, airway or lungs were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Balance disorder, Dizziness, Feeling abnormal, Injection site pain
Clinical narrative: Six days after I received the vaccine I was abruptly awaken at 6:30 am with severe vertigo; It took me 45 minutes to get out of bed.; I was very dizzy; Off balance and barely able to move around; I also have a headache that remains and brain fog; I also have a headache that remains and brain fog; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, anxiety and panic attacks. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications in two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 07Apr2021 at 06:30, six days after the patient received the vaccine, she was abruptly awakened with severe vertigo. It took her 45 minutes to get out of bed. She was very dizzy and off balance and barely able to move around. She experienced vertigo for 3 days and had remained dizzy ever since and it's been two weeks. On 07Apr2021, she also had a headache that remains and brain fog. She had never had vertigo in her entire life until she got the vaccine. As per her doctor's advisement and her personal feelings, she will not get the second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab rapid COVID test and the result was negative. The clinical outcome of the events also had a headache that remains and brain fog, six days after she received the vaccine was abruptly awakened at 06:30 with severe vertigo, it took 45 minutes to get out of bed, she was very dizzy and off balance and barely able to move around was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, SARS-CoV-2 test negative, Sleep disorder, Vertigo positional
Clinical narrative: Six days after I received the vaccine I was abruptly awaken at 6:30 am with severe vertigo; It took me 45 minutes to get out of bed.; I was very dizzy; Off balance and barely able to move around; I also have a headache that remains and brain fog; I also have a headache that remains and brain fog; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, anxiety and panic attacks. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications in two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 07Apr2021 at 06:30, six days after the patient received the vaccine, she was abruptly awakened with severe vertigo. It took her 45 minutes to get out of bed. She was very dizzy and off balance and barely able to move around. She experienced vertigo for 3 days and had remained dizzy ever since and it's been two weeks. On 07Apr2021, she also had a headache that remains and brain fog. She had never had vertigo in her entire life until she got the vaccine. As per her doctor's advisement and her personal feelings, she will not get the second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab rapid COVID test and the result was negative. The clinical outcome of the events also had a headache that remains and brain fog, six days after she received the vaccine was abruptly awakened at 06:30 with severe vertigo, it took 45 minutes to get out of bed, she was very dizzy and off balance and barely able to move around was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Feeling abnormal, Headache, SARS-CoV-2 test
Clinical narrative: Six days after I received the vaccine I was abruptly awaken at 6:30 am with severe vertigo; It took me 45 minutes to get out of bed.; I was very dizzy; Off balance and barely able to move around; I also have a headache that remains and brain fog; I also have a headache that remains and brain fog; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, anxiety and panic attacks. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications in two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 07Apr2021 at 06:30, six days after the patient received the vaccine, she was abruptly awakened with severe vertigo. It took her 45 minutes to get out of bed. She was very dizzy and off balance and barely able to move around. She experienced vertigo for 3 days and had remained dizzy ever since and it's been two weeks. On 07Apr2021, she also had a headache that remains and brain fog. She had never had vertigo in her entire life until she got the vaccine. As per her doctor's advisement and her personal feelings, she will not get the second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab rapid COVID test and the result was negative. The clinical outcome of the events also had a headache that remains and brain fog, six days after she received the vaccine was abruptly awakened at 06:30 with severe vertigo, it took 45 minutes to get out of bed, she was very dizzy and off balance and barely able to move around was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence, Vertigo
Clinical narrative: Six days after I received the vaccine I was abruptly awaken at 6:30 am with severe vertigo; It took me 45 minutes to get out of bed.; I was very dizzy; Off balance and barely able to move around; I also have a headache that remains and brain fog; I also have a headache that remains and brain fog; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines, anxiety and panic attacks. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications in two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 07Apr2021 at 06:30, six days after the patient received the vaccine, she was abruptly awakened with severe vertigo. It took her 45 minutes to get out of bed. She was very dizzy and off balance and barely able to move around. She experienced vertigo for 3 days and had remained dizzy ever since and it's been two weeks. On 07Apr2021, she also had a headache that remains and brain fog. She had never had vertigo in her entire life until she got the vaccine. As per her doctor's advisement and her personal feelings, she will not get the second shot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab rapid COVID test and the result was negative. The clinical outcome of the events also had a headache that remains and brain fog, six days after she received the vaccine was abruptly awakened at 06:30 with severe vertigo, it took 45 minutes to get out of bed, she was very dizzy and off balance and barely able to move around was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Eyelid function disorder, Rash, Rash pruritic
Clinical narrative: The next morning elbow swelling and itchiness subsided and right ear began to itch.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the arm left on 18Apr2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medication included sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and cefalexin (MANUFACTURER UNKNOWN); both on unknown dates and experienced allergy. On 20Apr2021 at 08:00, the patient experienced itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness. On 21Apr2021, the next morning elbow swelling and itchiness subsided and right ear began to itch. The patient reported that the upper lip became more swollen and itchier the same morning that the elbow discomfort subsided. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy and swollen right elbow was recovered on 21Apr2021, while the clinical outcome of the events right ear began to itch, itchy and swollen upper lip accompanied by small bumps at sites of itchiness was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pruritus, Joint swelling, Lip pruritus, Lip swelling, Pruritus
Clinical narrative: The next morning elbow swelling and itchiness subsided and right ear began to itch.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the arm left on 18Apr2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medication included sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and cefalexin (MANUFACTURER UNKNOWN); both on unknown dates and experienced allergy. On 20Apr2021 at 08:00, the patient experienced itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness. On 21Apr2021, the next morning elbow swelling and itchiness subsided and right ear began to itch. The patient reported that the upper lip became more swollen and itchier the same morning that the elbow discomfort subsided. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy and swollen right elbow was recovered on 21Apr2021, while the clinical outcome of the events right ear began to itch, itchy and swollen upper lip accompanied by small bumps at sites of itchiness was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin lesion
Clinical narrative: The next morning elbow swelling and itchiness subsided and right ear began to itch.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; Itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness.; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the arm left on 18Apr2021 at 15:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medication included sertraline (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) and cefalexin (MANUFACTURER UNKNOWN); both on unknown dates and experienced allergy. On 20Apr2021 at 08:00, the patient experienced itchy and swollen upper lip and right elbow accompanied by small bumps at sites of itchiness. On 21Apr2021, the next morning elbow swelling and itchiness subsided and right ear began to itch. The patient reported that the upper lip became more swollen and itchier the same morning that the elbow discomfort subsided. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy and swollen right elbow was recovered on 21Apr2021, while the clinical outcome of the events right ear began to itch, itchy and swollen upper lip accompanied by small bumps at sites of itchiness was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Breast pain, Burning sensation, Discomfort, Lymph node pain
Clinical narrative: Missed menstrual cycle; discomfort down entire length of right side.; Body muscle [and joint] aches; Joint aches; Lymph node in under arm of right arm became swollen.; Both arms have on/ off tingling from shoulder to fingers.; Burning feeling across back from shoulder to shoulder.; Arm pain; Heat near injection area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient did not receive any other medications within two weeks, prior to the vaccination. On 07Apr2021, the patient experienced arm pain and heat near injection area. On 08Apr2021, next day after vaccination the patient had lymph node in under arm of right arm became swollen. Both arms had on/off tingling from shoulder to fingers. Burning feeling across back from shoulder to shoulder. On 09Apr2021 (Day 3), the patient had body muscle and joint aches and discomfort down entire length of right side. Lymph nodes in both armpits swollen. On 22Apr2021 (Day 16), the patient had lymph node under armpit was still size of thumb and had not gone down, area of lymph node had constant pain. Pressure/ discomfort moving to right breast. The patient also missed menstrual cycle in the month of reporting. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, heat near injection area (skin warmth), lymph node in under arm of right arm became swollen (swollen lymph node), both arms have on/ off tingling from shoulder to fingers (tingling), burning feeling across back from shoulder to shoulder (burning sensation), body muscle aches, Joint aches,  discomfort down entire length of right side and missed menstrual cycle (absence of menstruation) were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Menstrual disorder, Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: Missed menstrual cycle; discomfort down entire length of right side.; Body muscle [and joint] aches; Joint aches; Lymph node in under arm of right arm became swollen.; Both arms have on/ off tingling from shoulder to fingers.; Burning feeling across back from shoulder to shoulder.; Arm pain; Heat near injection area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient did not receive any other medications within two weeks, prior to the vaccination. On 07Apr2021, the patient experienced arm pain and heat near injection area. On 08Apr2021, next day after vaccination the patient had lymph node in under arm of right arm became swollen. Both arms had on/off tingling from shoulder to fingers. Burning feeling across back from shoulder to shoulder. On 09Apr2021 (Day 3), the patient had body muscle and joint aches and discomfort down entire length of right side. Lymph nodes in both armpits swollen. On 22Apr2021 (Day 16), the patient had lymph node under armpit was still size of thumb and had not gone down, area of lymph node had constant pain. Pressure/ discomfort moving to right breast. The patient also missed menstrual cycle in the month of reporting. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, heat near injection area (skin warmth), lymph node in under arm of right arm became swollen (swollen lymph node), both arms have on/ off tingling from shoulder to fingers (tingling), burning feeling across back from shoulder to shoulder (burning sensation), body muscle aches, Joint aches,  discomfort down entire length of right side and missed menstrual cycle (absence of menstruation) were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Missed menstrual cycle; discomfort down entire length of right side.; Body muscle [and joint] aches; Joint aches; Lymph node in under arm of right arm became swollen.; Both arms have on/ off tingling from shoulder to fingers.; Burning feeling across back from shoulder to shoulder.; Arm pain; Heat near injection area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient did not receive any other medications within two weeks, prior to the vaccination. On 07Apr2021, the patient experienced arm pain and heat near injection area. On 08Apr2021, next day after vaccination the patient had lymph node in under arm of right arm became swollen. Both arms had on/off tingling from shoulder to fingers. Burning feeling across back from shoulder to shoulder. On 09Apr2021 (Day 3), the patient had body muscle and joint aches and discomfort down entire length of right side. Lymph nodes in both armpits swollen. On 22Apr2021 (Day 16), the patient had lymph node under armpit was still size of thumb and had not gone down, area of lymph node had constant pain. Pressure/ discomfort moving to right breast. The patient also missed menstrual cycle in the month of reporting. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, heat near injection area (skin warmth), lymph node in under arm of right arm became swollen (swollen lymph node), both arms have on/ off tingling from shoulder to fingers (tingling), burning feeling across back from shoulder to shoulder (burning sensation), body muscle aches, Joint aches,  discomfort down entire length of right side and missed menstrual cycle (absence of menstruation) were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Arthralgia, Burning sensation, Discomfort, Lymphadenopathy
Clinical narrative: Missed menstrual cycle; discomfort down entire length of right side.; Body muscle [and joint] aches; Joint aches; Lymph node in under arm of right arm became swollen.; Both arms have on/ off tingling from shoulder to fingers.; Burning feeling across back from shoulder to shoulder.; Arm pain; Heat near injection area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient did not receive any other medications within two weeks, prior to the vaccination. On 07Apr2021, the patient experienced arm pain and heat near injection area. On 08Apr2021, next day after vaccination the patient had lymph node in under arm of right arm became swollen. Both arms had on/off tingling from shoulder to fingers. Burning feeling across back from shoulder to shoulder. On 09Apr2021 (Day 3), the patient had body muscle and joint aches and discomfort down entire length of right side. Lymph nodes in both armpits swollen. On 22Apr2021 (Day 16), the patient had lymph node under armpit was still size of thumb and had not gone down, area of lymph node had constant pain. Pressure/ discomfort moving to right breast. The patient also missed menstrual cycle in the month of reporting. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, heat near injection area (skin warmth), lymph node in under arm of right arm became swollen (swollen lymph node), both arms have on/ off tingling from shoulder to fingers (tingling), burning feeling across back from shoulder to shoulder (burning sensation), body muscle aches, Joint aches,  discomfort down entire length of right side and missed menstrual cycle (absence of menstruation) were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia, Vaccination site warmth
Clinical narrative: Missed menstrual cycle; discomfort down entire length of right side.; Body muscle [and joint] aches; Joint aches; Lymph node in under arm of right arm became swollen.; Both arms have on/ off tingling from shoulder to fingers.; Burning feeling across back from shoulder to shoulder.; Arm pain; Heat near injection area; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 07Apr2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks, prior to the vaccination. The patient did not receive any other medications within two weeks, prior to the vaccination. On 07Apr2021, the patient experienced arm pain and heat near injection area. On 08Apr2021, next day after vaccination the patient had lymph node in under arm of right arm became swollen. Both arms had on/off tingling from shoulder to fingers. Burning feeling across back from shoulder to shoulder. On 09Apr2021 (Day 3), the patient had body muscle and joint aches and discomfort down entire length of right side. Lymph nodes in both armpits swollen. On 22Apr2021 (Day 16), the patient had lymph node under armpit was still size of thumb and had not gone down, area of lymph node had constant pain. Pressure/ discomfort moving to right breast. The patient also missed menstrual cycle in the month of reporting. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain, heat near injection area (skin warmth), lymph node in under arm of right arm became swollen (swollen lymph node), both arms have on/ off tingling from shoulder to fingers (tingling), burning feeling across back from shoulder to shoulder (burning sensation), body muscle aches, Joint aches,  discomfort down entire length of right side and missed menstrual cycle (absence of menstruation) were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Ear pain
Clinical narrative: Fever; Aches; Chills; Sore throat; Ear ache; Cough; Loss of smell; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included severe plaque psoriasis. 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 medication included apremilast (OTEZLA); taken for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021 at 07:00, the patient developed a fever, aches, chills, sore throat, ear ache, cough, that lasted a week, loss of smell and taste lasted 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events reported which included treatment with paracetamol (TYLENOL) and an unspecified antihistamine. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent nasal swab polymerase chain reaction (PCR) and rapid COVID test and the result was negative. The clinical outcome of the events loss of smell and taste was recovered on 19 Apr2021 and events fever, aches, chills, sore throat, ear ache and cough was recovered on 24Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test negative, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Fever; Aches; Chills; Sore throat; Ear ache; Cough; Loss of smell; Loss of taste; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 15:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included severe plaque psoriasis. 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 medication included apremilast (OTEZLA); taken for an unknown indication from an unknown date and unknown if ongoing. On 17Apr2021 at 07:00, the patient developed a fever, aches, chills, sore throat, ear ache, cough, that lasted a week, loss of smell and taste lasted 2 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events reported which included treatment with paracetamol (TYLENOL) and an unspecified antihistamine. Since the vaccination, the patient had been tested for COVID-19. On 20Apr2021, the patient underwent nasal swab polymerase chain reaction (PCR) and rapid COVID test and the result was negative. The clinical outcome of the events loss of smell and taste was recovered on 19 Apr2021 and events fever, aches, chills, sore throat, ear ache and cough was recovered on 24Apr2021.  No follow-up attempts are needed. No further information is expected.