chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site pain; Tiredness/ feeling extremely tired; Headache; Muscle pain; Injection site swelling; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW6204) via an unspecified route of administration in the left arm on 02Mar2021 at 09:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes II, high cholesterol, Obese, HBP (blood pressure high) and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient received doxycycline (MANUFACTURER UNKNOWN) and metaxalone (SKELAXIN) on unknown date for an unspecified indication and experienced drug allergy. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 02Mar2021 at 09:00, the patient experienced injection site pain, tiredness, headache, muscle pain, injection site swelling, nausea and feeling extremely tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, injection site swelling, nausea and feeling extremely tired were recovered on an unknown date in 2021. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 06Apr2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Disturbance in attention, Fatigue, Influenza like illness
Clinical narrative: Fever; Chills; Fatigue; Exhaustion; Trouble concentrating; feel run over; like flu; Extreme arm pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 13:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies, anxiety, polycystic ovarian syndrome (PCOS) and COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 22:00, the patient experienced extreme arm pain in evening of vaccine day, then day after on 09Apr2021, around 11:00, the patient experienced fever, chills, fatigue and exhaustion, trouble concentrating, feel run over, like flu. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme arm pain, fever, chills, fatigue, exhaustion, trouble concentrating and feel run over, like flu were not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; Exhaustion; Trouble concentrating; feel run over; like flu; Extreme arm pain; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 at 13:15 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included allergies, anxiety, polycystic ovarian syndrome (PCOS) and COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 22:00, the patient experienced extreme arm pain in evening of vaccine day, then day after on 09Apr2021, around 11:00, the patient experienced fever, chills, fatigue and exhaustion, trouble concentrating, feel run over, like flu. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events extreme arm pain, fever, chills, fatigue, exhaustion, trouble concentrating and feel run over, like flu were not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Tingling in  tongue; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN 6202) via an unspecified route of administration in the left arm on 12Mar2021 at 11:30 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any medications within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 12:15, the patient experienced tingling in tongue. The patient did not receive any treatment for the reported event. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event tingling in tongue was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Nausea, Pain in extremity
Clinical narrative: Slightly sore arm; Very slight queasy stomach; very slight stinging sensation in eye; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158), via unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to medications, food, or other products. The patient did not receive any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 10:45, the patient experienced slightly sore arm, very slight queasy stomach and very slight stinging sensation in eye. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse event. The clinical outcome of the events slightly sore arm, very slight queasy stomach and very slight stinging sensation in eye was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product preparation issue
Clinical narrative: Pt was given a dose of 0.3ml but the vial was not diluted properly, it was only diluted with 0.8mls; Vial was not diluted properly, it was only diluted with 0.8mls; This is a spontaneous report from a non-contactable pharmacist. A 74-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151, 0.3mL) via intramuscular route of administration in the left arm on 09Apr2021 (at the age of 74-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. It was unknown whether the patient had taken any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient was given a dose of 0.3ml but the vial was not diluted properly, it was only diluted with 0.8ml as reported. 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 these events. The clinical outcome of the reported events inappropriate dilution of medication and overdose was recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Peripheral swelling
Clinical narrative: Fever (up to 100.5),; Chills; Muscle Aches; Fatigue; Headache; Swelling in left arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 AM (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included none. The concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30 AM as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, on the same day of second dose of vaccination at 20:00 the patient experienced Fever (up to 100.5), chills, muscle aches, fatigue, headache and swelling in left arm. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Fever (up to 100.5), chills, muscle aches, fatigue, headache and swelling in left arm was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever (up to 100.5),; Chills; Muscle Aches; Fatigue; Headache; Swelling in left arm; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 AM (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included none. The concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30 AM as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, on the same day of second dose of vaccination at 20:00 the patient experienced Fever (up to 100.5), chills, muscle aches, fatigue, headache and swelling in left arm. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Fever (up to 100.5), chills, muscle aches, fatigue, headache and swelling in left arm was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: that night I woke up at 4 am and started throwing up violently; This is a spontaneous report from a non-contactable consumer, the patient. A 21-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 on an unknown date (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN) and duloxetine hydrochloride (CYMBALTA); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, after receiving the first dose in the morning and that night the patient woke up at 04:00 and started throwing up violently. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event throwing up violently was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Insomnia
Clinical narrative: on/off chills; Patient woke up around 8am with a pounding headache; Had two spoonful of grits and vomited.; He was freezing cold all night; He could not sleep; This is a spontaneous report from a contactable pharmacist. A 17-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included hemophilia A. The patient had no known allergies to medications, food or other products. Concomitant medications included emicizumab (HEMLIBRA) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 18Mar2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, the patient could not sleep because he was freezing cold all night. Temp was normal. On 09Apr2021 around 08:00, the patient woke up with pounding headache, the patient had two spoonful of grits and vomited. On 09Apr2021, as of 17:30, the patient was complaining of pounding headache and on/off chills. Therapeutic measures were taken as a result of reported events which included treatment with paracetamol (TYLENOL) on 09Apr2021 at 08:30. The clinical outcome of freezing cold all night, could not sleep, pounding headache, vomited and on/off chills was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: on/off chills; Patient woke up around 8am with a pounding headache; Had two spoonful of grits and vomited.; He was freezing cold all night; He could not sleep; This is a spontaneous report from a contactable pharmacist. A 17-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included hemophilia A. The patient had no known allergies to medications, food or other products. Concomitant medications included emicizumab (HEMLIBRA) from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an intramuscular route of administration in the left arm on 18Mar2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, the patient could not sleep because he was freezing cold all night. Temp was normal. On 09Apr2021 around 08:00, the patient woke up with pounding headache, the patient had two spoonful of grits and vomited. On 09Apr2021, as of 17:30, the patient was complaining of pounding headache and on/off chills. Therapeutic measures were taken as a result of reported events which included treatment with paracetamol (TYLENOL) on 09Apr2021 at 08:30. The clinical outcome of freezing cold all night, could not sleep, pounding headache, vomited and on/off chills was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Severe body aches; Chills; 102.7 F temp; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09April2021 at 10:30(at the age of 52-year-old) as a single dose for COVID-19 immunisation.  Medical history included fibromyalgia, osteoarthritis, degenerative disc disease, degenerative joint disease, asthma, depression. Concomitant medication included meloxicam (MELOXICAMUM), tizanidine hydrochloride (TIZANIDINE), pregabalin (LYRICA) and duloxetine hydrochloride (CYMBALTA) all started on unknown dates and for an unspecified indications. The patient was allergic to TRAZADONE, NAPROXENE. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 18March2021 at 10:30(at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient experienced severe body aches, chills, 102.7 F temp. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic and emergency room/department or urgent care. The clinical outcome of the events severe body aches, chills, 102.7 F temp was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My left Lymp node is still a bit swollen a week after the vaccine. Both lymp nodes were swollen but the right lymp node went down.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient 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 an unknown date in Apr2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles, varicella zoster.  The patient had known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications included metoprolol 25mg (MANUFACTURER UNKNOWN), omeprazole 20mg (OMEPRAZOL) and aciclovir sodium 400 (ACYCLOVIR) all from unknown dates, for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Apr2021 at 19:00, the patient experienced both lymph nodes were swollen, left lymph node is still a bit swollen a week after the vaccine. But the right lymph node went down. It was unknown, therapeutic measures were taken as a result of reported event. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left both lymph nodes were swollen was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Ear pain
Clinical narrative: Ears became blocked about 15 minutes after the 2nd injection. Stayed blocked for approximately 24 hours.; now have an earache that will not subside; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the right arm on 31Mar2021 at 13:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6203) via an unspecified route of administration in the left arm on 09Mar2021 at 16:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient ears became blocked about 15 minutes after the 2nd injection. Stayed blocked for approximately 24 hours and had an earache that did not subside. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events ears became blocked about 15 minutes after the 2nd injection. Stayed blocked for approximately 24 hours and had an earache that did not subside were not resolved at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Vaccination site pain
Clinical narrative: Bruising; Sore at injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-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 08Apr2021 at 12:45 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included syncope vasovagal, anxiety, depression and fruit allergy (Strawberries). Concomitant medications included fludrocortisone acetate (FLORINEF), and duloxetine hydrochloride (CYMBALTA) from an unknown date for an unspecified indication. The patient previously took cabergoline (MANAFACTURER UNKNOWN) from an unknown date for an unspecified indication, and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 21:00, the patient experienced sore at injection site, bruising. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore at injection site, bruising was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Nine days following shot a large red spot appeared at the injection site on arm. I thought it Was a spider bite, but realized it was at the exact spot where my shot was given; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 31Mar2021 at 15:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications included bio identical hormones (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 15:00, the patient experienced nine days following shot a large red spot appeared at the injection site on arm. The patient thought it was a spider bite, but realized it was at the exact spot where the shot was given. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event a large red spot appeared at the injection site on the arm, the patient thought it was a spider bite, but realized it was at the exact spot where the shot was given was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electric shock sensation, Paraesthesia, Tension headache
Clinical narrative: Dizziness CTCAE v 4.03 grade 1 as initial symptom similar to dose 1 with also feeling of scalp tightness and with a feeling of electric zaps persistent at this ti; Feeling of electric zaps; Feeling of scalp tightness; Tingling of mild to moderate nature; This is a spontaneous report from a contactable physician, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via intramuscular route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any concomitant medications. The patient was allergic to iodine contrast. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via intramuscular route of administration in the left arm on 14Mar2021 at 16:15 as a single dose for COVID-19 immunisation and experienced dizziness on an unspecified date in 2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 at 10:30, the patient experienced dizziness (Common Terminology Criteria for. Adverse Events, v 4.03) CTCAE grade 1 as initial symptom similar to dose 1 with also feeling of scalp tightness and tingling of mild to moderate nature with a feeling of electric zaps persistent at the time of entry still as of 09Apr2021. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events dizziness, scalp tightness, tingling and electric zaps 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
Symptoms: Body temperature, Body temperature increased, Dizziness, Pain in extremity
Clinical narrative: temperature was up at 99 until April3 in the late evening.; Light headedness; Sore arm; 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: ER8732) via an unspecified route of administration in the right arm on 30Mar2021 at 14:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus, blood pressure high, vertigo. Concomitant medications included magnesium (MANUFACTURER UNKNOWN), (CALM) all from an unknown date for an unspecified indication. Patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 14:30, the patient experienced lightheaded as soon as she sat down for 15 min watch right after getting the vaccine before leaving the hospital. Arm was sore the same day and became more and more sore as the day progressed. On 02Apr2021, the patient experienced temperature was up at 99(UNSPECIFIED UNITS) until April3 in the late evening. Patient also stated that she felt lightheaded all day and until about 10:30pm the same day. She didn't eat much before getting vaccine and did drink coffee before-hand, carried heavy items afterwards so that might have something to do with it. The day after getting the vaccine, 31March she did not feel lightheaded but her arm was more-sore.  The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event lightheaded as soon as she sat down for 15 min watch right after getting the vaccine before leaving the hospital was recovered on 30Mar2021 at 22:30. Clinical outcome of arm was sore the same day and became more and more sore as the day progressed was recovered on 01Apr2021. Whereas, that of temperature was up at 99 recovered on 03Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Lymphadenopathy
Clinical narrative: Axillary lymphadenopathy presents at day 2.; Rapid heartbeat for 2-3 minutes after vaccination, then resolved itself.; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received the unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) in the left arm on 01Apr2021 at 11:00 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took pseudoephedrine and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 the patient had experienced rapid heartbeat for 2-3 minutes after vaccination, then resolved itself. On 02Apr2021, the patient had experienced axillary lymphadenopathy presented (at day 2), which was improving but mildly present even after seven days. No therapeutic measures were taken as the result of adverse events. The clinical outcome of the event rapid heartbeat was recovered on 01Apr2021. The clinical outcome of the event axillary lymphadenopathy was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: developed a red itchy rash on my wrist (on the arm which received the injection); developed a red itchy rash on my wrist (on the arm which received the injection); This is a spontaneous report from a contactable consumer, the patient. A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 12Mar2021 at 08:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included terbinafine (MANUFACTURER UNKNOWN) and fluconazole (MANUFACTURER UNKNOWN), both for unknown indications from unknown dates. The patient previously took erythromycin (MANUFACTURER UNKNOWN) for unknown indication on unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021 at 08:00, after the first dose, the patient developed a red itchy rash on the wrist (on the arm which received the injection). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event red itchy rash on the wrist (on the arm which received the injection) was not recovered at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the left arm on 09Apr2021 at 08:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hot flush
Clinical narrative: Chills; Hot flashes; Headache; Tired; Sore arm; Low grade fever (<100); This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 16Mar2021 at 09:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Apr2021 at 22:00, the patient experienced chills, hot flashes, headache, tired, sore arm, low grade fever (less than 100). 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. The clinical outcome of the events chills, hot flashes, headache, tired, sore arm, low grade fever (less than 100) were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills; Hot flashes; Headache; Tired; Sore arm; Low grade fever (<100); This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 16Mar2021 at 09:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 08Apr2021 at 22:00, the patient experienced chills, hot flashes, headache, tired, sore arm, low grade fever (less than 100). 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. The clinical outcome of the events chills, hot flashes, headache, tired, sore arm, low grade fever (less than 100) were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: "started to notice myself feeling itchy"; "I got home from work, changed out of my work clothes and noticed a rash in several locations on my body where I was itching"; normal sore arm at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. Medical history included peanut allergy, allergy to nuts, allergy to grains (sesame seeds and corn) and mite allergy (dust mite allergy). The patient did not receive any other medications within two weeks of vaccination. The patient previously took amoxicillin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 12:00, the following day after the second dose of vaccination, the patient started to notice himself feeling itchy. He did not think too much about it until he got home from work, changed out of his work clothes and noticed a rash in several locations on his body where he was itching. Other than that, just the normal sore arm at the injection site but that had gone away. He was not sure if he should take any antihistamines or something to reduce the itching and to see if it would go away on its own after a few days. 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 adverse events. The clinical outcome of the event "started to notice myself feeling itchy" and "I got home from work, changed out of my work clothes and noticed a rash in several locations on my body where I was itching" was unknown. The clinical outcome of the event normal sore arm at the injection site was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: woke up feeling exhausted; experienced light headedness; Fever 100 at noon; Arm soreness overnight; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included HIV and high blood pressure. Concomitant medications included emtricitabine, elvitegravir, cobicistat, tenofovir alafenamide fumarate (GENVOYA), lisinopril (MANUFACTURER UNKNOWN), rosuvastatin (ROSUVASTATINE) and acetylsalicylic acid (ASPIRIN 81). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 14:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient previously received ciprofloxacin (MANUFACTURER UNKNOWN) and AUGMENTIN were taken for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, overnight, the patient experienced arm soreness. On 09Apr2021 at 06:00 the patient woke up feeling exhausted and experienced light headedness. On 09Apr2021, at noon, the patient experienced fever 100. No therapeutic measures were taken as a result of the events. The clinical outcome of the events arm soreness, fever 100, feeling exhausted and light headedness were recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Nausea; Vomiting; Stomach cramps; Fever; Chills; Sweats; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8127) in the left arm on 26Mar2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to "all meat". The patient did not receive any medication within two weeks of the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Mar2021 at 05:30, the patient had experienced nausea, vomiting, stomach cramps, fever, chills, sweats and headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, vomiting, stomach cramps, fever, chills, sweats and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Stomach cramps; Fever; Chills; Sweats; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8127) in the left arm on 26Mar2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to "all meat". The patient did not receive any medication within two weeks of the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 30Mar2021 at 05:30, the patient had experienced nausea, vomiting, stomach cramps, fever, chills, sweats and headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, vomiting, stomach cramps, fever, chills, sweats and headache was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 04Apr2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not available. The patient had no known allergies to medications, food or other products. Concomitant medication included desogestrel, ethinylestradiol (APRI), from an unknown date for unknown indication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021, the patient experienced cough. No therapeutic measures were taken as a result of the reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of cough was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.