chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Rash erythematous
Clinical narrative: I have two rashes on my left arm; Red rash on left arm specifically located in the left medial vein /several red rashes almost a pin point looking red rashes all over my chest and red rashes on left leg near my left knee; Severe headache for the last two 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: EW0167) via an unspecified route of administration in the left arm on 01May2021 at 14:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID 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: EP7533) via an unspecified route of administration in the left arm on 10Apr2021 at 14:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. On 10May2021 at 08:00, the patient noticed a red rash on left arm specifically located in the left medial vein. It was approximately a dime size. The patient had two rashes on left arm and had several red rashes almost a pin point looking red rashes all over chest and red rashes on left leg near left knee. The patient was not taking any medications and it was first time to have red rashes like this, it was not itchy however. The patient had a severe headache for the last two days. 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 red rash on left arm specifically located in the left medial vein, two rashes on left arm, several red rashes almost a pin point looking red rashes all over chest and red rashes on left leg near left knee, a severe headache was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Petechiae
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 32, via an unspecified route of administration, on May 6, 2021, at 14:15, single dose, for COVID-19 immunisation. Medical history not reported. The patient allergic to peanuts. Prior to the vaccination, 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 postnatal multivitamin since an unknown date for an unknown indication and unknown if ongoing. On May 7, 2021, patient experienced petechiae localized on abdomen (about one inch by two inches). The events did not result in doctor or other healthcare professional office, clinic visit/emergency room, department or urgent care. Therapeutic measures not taken as a result of the events petechiae localized on abdomen (about one inch by two inches). Since the vaccination, patient has not tested for COVID-19. The outcome of petechiae localized on abdomen: not resolved (at the time of report). No follow-up attempts required. Information about batch/lot number cannot be obtained. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing/humming in the right ear; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 10Apr2021 at 16:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified multivitamin from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced ringing/humming in the right ear that developed 3 days post the vaccine. It has not improved with time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing/humming in the right ear was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 01May2021 at 13:00 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph node in left armpit; Swollen lymph node in left armpit, tender to touch and movement; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 07May2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included mental health conditions. 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 ethinylestradiol, etonogestrel (NUVARING), topiramate (MANUFACTURER UNKNOWN) and duloxetine (MANUFACTURER UNKNOWN) all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 17Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. On 08May2021, the patient experienced swollen lymph node in left armpit, tender to touch and movement. Therapeutic measures were taken as a result of swollen lymph node in left armpit, tender to touch and movement and included treatment with ibuprofen from an unknown date to an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph node in left armpit, tender to touch and movement was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pain, Pyrexia
Clinical narrative: 101.5 fever; Nausea; Body aches; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 07May2021 at 10:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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. The patient did not receive any medication within two weeks of vaccination. On 07May2021 at 23:30, the patient experienced 101.5 fever, nausea, body aches and slight headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 07May2021 at 23:30, the patient underwent body temperature test and the result was found to be 101.5 (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 101.5 fever, nausea, body aches and slight headache was resolved on an unknown date in May2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstrual disorder, Menstruation delayed
Clinical narrative: Intermittent menstrual spotting; Late period; Cramping; Large menstrual clot; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Apr2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. It was not known if the patient was pregnant. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), gabapentin (MANUFACTURER UNKNOWN) and sertraline hydrochloride (ZOLOFT); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021, the patient experienced intermittent menstrual spotting, late period, large menstrual clot and cramping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intermittent menstrual spotting, late period, large menstrual clot and cramping was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: Migraines; Nausea; Fever; Chills; Aches; This is a spontaneous report from a non-contactable consumer, the patient. A 16-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 an unknown date in May2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021, the patient experienced migraines, nausea, fever, chills and aches. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraines, nausea, fever, chills and aches were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Mass, Pruritus
Clinical narrative: Itching; She has been breaking out on her arm, neck, and back; She found bumps on the side of her face; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that a 55-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 05May2021 (55-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The concomitant medications were reported as yes (not specified). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 14Apr2021 as dose 1, single for COVID-19 immunization. On an unspecified date of 2021, the patient experienced itching, she has been breaking out on her arm, neck, and back, ear and her arm and bumps on the side of her face. The patient took the second shot last week on 05May2021, and since she has been itching. She has been breaking out on her arm, neck, and back. It was off and on. The patient would come home from work, and undress and be itching. It was weird. The patient did not have a prescribing doctor. She had no side effects with the first shot. This itching was like 50/50, but it has not improved. It was annoying the patient. It comes and goes. Today she noticed it on her arm. Today it is on the back of her ear and her arm. When the patient gets undressed it was going down her leg. There are several places on her face that started itching today. She found bumps on the side of her face. Therapeutic measures were taken as a result of itching using calamine lotion on itchy spots, and she may go get some Benadryl. Her cousin works in the lab. The outcome of the event Itching was not recovered while other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder discomfort, Hypertonic bladder, Nocturia
Clinical narrative: Overactive bladder. No sign of infection or debris in urine after getting evaluated by a doctor.; Pressure in bladder.; Have to get up multiple times during night to urinate.; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 22-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 16Apr2021, the patient experienced overactive bladder. There was no sign of infection or debris in urine after getting evaluated by a doctor. The patient had to get up multiple times during night to urinate. The patient experienced pressure in bladder. Medication did not help. It was reported that many other people had also reported similar symptoms online. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with medications (unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events overactive bladder, got up multiple times during night to urinate and pressure in bladder were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Period came earlier by 1-2 weeks after first vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01May2021, the patient reported period came earlier by 1-2 weeks after first vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period came earlier 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Myalgia, Pyrexia
Clinical narrative: High grade fever of 104.2; Extreme muscle aches; Migraine for 4 days straight; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 04May2021 at 17:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 14:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 20:15, the patient experienced high grade fever of 104.2 (unspecified units), extreme muscle aches, migraine for 4 days straight. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events high grade fever of 104.2 and extreme muscle aches was recovering at the time of this report, whereas the outcome of migraine was recovered on 08May2021, after a duration of 4 days.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Friday evening body rash appeared; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05May2021 at 12:00 at the age of 41-years-old as a single dose for COVID-19 immunisation. Medical history included thyroid issues. It was unknown if the patient had any 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 patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 07May2021 at 21:00, Friday evening, the patient experienced body rash appeared. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body rash was not resolved at the time of this report.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Exacerbated and extensive nerve pain predominately on the left side of ''my'' body, face both arms, neck, lower back and entire length of ''my'' left leg. Present but not as significant pain on ''my'' right side; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included myofascial pain syndrome, attention deficit hyperactivity disorder (ADHD) inattention, chronic fatigue, fibromyalgia and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), rosuvastatin calcium (ROSUVASTIN), modafinil (MANUFACTURER UNKNOWN) and dexamfetamine (DEXTROAMPHETAMINE), all for an unknown indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 21Apr2021, the patient experienced exacerbated and extensive nerve pain predominately on the left side of her body, face both arms, neck, lower back and entire length of her left leg. Present but not as significant pain on her right side. The events 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. No therapeutic measures were taken as a result of reported event. The clinical outcome of the event exacerbated and extensive nerve pain predominately on the left side of her body, face both arms, neck, lower back and entire length of her left leg. Present but not as significant pain on her right side was not recovered 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: Arthralgia, Heart rate, Heart rate increased, Rash, SARS-CoV-2 test
Clinical narrative: Rash on Left lower extremity-lasted one week; over all joint pain for several hours; Elevated heart rate for 1 week over 100 BPM; This is a spontaneous report from a contactable other healthcare professional, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 09:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included prenatal (MANUFACTURER UNKNOWN) 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 at 10:00, the patient experienced rash on left lower extremity that lasted one week, over all joint pain for several hours and elevated heart rate for 1 week over 100 beats per minutes. On the same day, the patient underwent Heart rate and the result was 100 beats per minutes. On 20Apr2021, the patient underwent Nasal swab and the result was Negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events rash on left lower extremity that lasted one week and elevated heart rate for 1 week over 100 beats per minutes was resolved on an unknown date in Apr2021 and of the event over all joint pain for several hours was resolved on 12Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Muscle aches; Fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EV0162) via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 at the age of 37-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 to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 18Mar2021 at 10:45 at the age of 36-years-old as a single dose for COVID-19 immunisation. On 08Apr2021 at 22:00, the patient experienced muscle aches, fever, and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle aches, fever, and headache was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Myalgia
Clinical narrative: Fatigue; muscle soreness; Tightness in chest; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Apr2021 at 08:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on 02Apr2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, since second injection, the patient experienced fatigue, muscle soreness and tightness in chest. The adverse events did not result in doctors 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 fatigue, muscle soreness and tightness in chest were unknown at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme tiredness/fatigue set in six days after the shot, and lasted approximately one day. This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on an unknown date in May2021at 14:30  (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication 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 May2021, the patient experienced extreme tiredness/fatigue set in six days after the shot, and lasted approximately one day. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event extreme tiredness/fatigue was recovered on an unknown date in May2021. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Malaise, Nausea
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 07May2021 at 09:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included melanoma. 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 nivolumab (OPDIVO), ibuprofen (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN), hydrocodone bitartrate / paracetamol (NORCO), cyclobenzaprine hydrochloride (FLEXERIL) and colecalciferol (MANUFACTURER UNKNOWN) 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: EW0169) via an unspecified route of administration in the right arm on 16Apr2021 at 09:00 (age at vaccination-unknown) as a single dose for COVID-19 immunisation. On 08May2021 at 04:00, the patient experienced nausea, headache, chills, was feeling very sick and weak. 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 nausea, headache, chills, feeling very sick and weak were not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Dermal fillers swollen and painful after second dose.; Dermal fillers swollen and painful after second dose.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0179) via an unspecified route of administration in the left arm on 06May2021 at 14:30 (at the age of 40-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 to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included doxycycline (MANUFACTURER UNKNOWN), dermal fillers and botulinum toxin type a (BOTOX). The patient previously 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 15Apr2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 06May2021, the patient experienced, dermal fillers swollen and painful after second dose. The event 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 swelling and pain and included treatment with Benadryl, MD may rx prednisone. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dermal fillers swollen and painful after second dose was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My period came a week early, even though Im on birth control.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included severe anxiety, autism, post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD) and allergy to scallops. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included medication for birth control (unspecified) from unknown date and unknown if ongoing, desvenlafaxine succinate monohydrate (reported as generic: PRISTIQ) and drospirenone, ethinylestradiol betadex clathrate (reported as generic: YAZ), both for unknown indication from 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 the first dose of 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. On 03May2021 at 18:00, the patients period came a week early, even though she was on birth control. The event did not result in doctor or other health care 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 the event period came a week early, even though she was on birth control was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Tingling; Numbness on my tongue; Metallic taste; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, Grave's disease and allergic to a few foods. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. Any other vaccines received by the patient within four weeks prior to the COVID-19 vaccine was not reported. On 26Apr2021 at 10:30, the patient experienced tingling, numbness on her tongue and metallic taste. The events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling, numbness on tongue and metallic taste was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Vaccination site pain; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant adult 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 07May2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any medication within two weeks of vaccination. The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 21:00, the patient experienced fever, injection site pain, chills and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with paracetamol (TYLENOL) on an unknown date. The clinical outcome of the event fever, injection site pain, chills and body aches 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea, Oropharyngeal pain
Clinical narrative: Sore throat; coughing; nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06May2021 at 14:45 (at the age of 20-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified concomitant medications. On 07May2021, the patient experienced sore throat, coughing and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore throat, coughing and nausea was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chills, Headache, Pyrexia
Clinical narrative: Upper back pain; Chest tightness; Common fever; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 30Apr2021 at 12:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 12:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. On 01May2021 at 02:00, the patient experienced upper back pain for five days following the second dose, the patient also experienced chest tightness for 4 days following the second dose. Nothing critical, but it was unexpected. The patient also experienced common fever, chills and headache, for 48 hours following the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events common fever, chills and headache was resolved on 02May2021, after duration of 48 hours, chest tightness for 4 days was resolved on 04May2021 after the duration of 4 days and upper back pain for 5 days was resolved on 05May2021 after the duration of 5 days.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: Headache; Ear aches; Muscle pain; Skin sensitive to the touch; Sore throat; Malaise; 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: EL3302) via an unspecified route of administration in the left arm on 08May2021 at 14:30 at the age of 33-years-old as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19 and penicillin allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included XYZAL, SINGULAIR, WELLBUTRIN, VENTOLIN, and WIXELA, all 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 COVID vaccine. The patient previously took AMOXICIILIN, LEVOQUIN, DOXYCYCLINE, PERCOCET, and experienced drug allergy. The patient previously received the first dose of dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 14:30 at the age of 33-years-old as a single dose for COVID-19 immunisation. On 09May2021 at 06:00, the patient experienced headache, ear aches, muscle pain, skin sensitive to the touch, sore throat, and malaise. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, ear aches, muscle pain, skin sensitive to the touch, sore throat, and malaise 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: Sensitive skin
Clinical narrative: Headache; Ear aches; Muscle pain; Skin sensitive to the touch; Sore throat; Malaise; 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: EL3302) via an unspecified route of administration in the left arm on 08May2021 at 14:30 at the age of 33-years-old as a single dose for COVID-19 immunisation. Medical history included asthma, COVID-19 and penicillin allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included XYZAL, SINGULAIR, WELLBUTRIN, VENTOLIN, and WIXELA, all 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 COVID vaccine. The patient previously took AMOXICIILIN, LEVOQUIN, DOXYCYCLINE, PERCOCET, and experienced drug allergy. The patient previously received the first dose of dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 14:30 at the age of 33-years-old as a single dose for COVID-19 immunisation. On 09May2021 at 06:00, the patient experienced headache, ear aches, muscle pain, skin sensitive to the touch, sore throat, and malaise. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, ear aches, muscle pain, skin sensitive to the touch, sore throat, and malaise was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Mood swings
Clinical narrative: Mood swings; Crying for no reason; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 07May2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to English walnuts since an unknown date. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included apremilast (OTEZLA) for an unknown indication and unspecified birth control; both since 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: EW0158) via an unspecified route of administration in the left arm on 16Apr2021 at 09:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 01:30, the patient experienced mood swings and bouts of crying for no reason. The patient did not have previous condition of this occurring. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events mood swings and crying for no reason was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.