chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Severe headache; Jaw pain; Swollen lymph node left armpit; chest pain; Left pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. The patient had no 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 take concomitant medications. 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: EZ9262) via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 02:30, the patient experienced severe headache, jaw pain, swollen lymph node left armpit, chest pain and left pain. 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.  On an unknown date in 2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events severe headache, jaw pain, swollen lymph node left armpit, chest pain and left pain was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Fatigue, Lymph node pain, SARS-CoV-2 test
Clinical narrative: Sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection).; Tight chest/chest pain; Tight chest/chest pain; Tiredness; Pain at injection site on arm; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 16Apr2021 at 14:45 (at the age of 22-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 to medications, food, or other products. Concomitant medications included ethinylestradiol; ferrous fumarate; norethisterone acetate (LO LOESTRIN FE) for an unknown indication on an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, within first hour of vaccination, the patient experienced pain at injection site on arm. On 18Apr2021 at 08:00, the patient experienced sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection) and tight chest/chest pain and tiredness. 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 the events. Since the vaccination, the patient had been tested for COVID-19. On 22Apr2021, the patient underwent pixel lab Covid-19 test  test via nasal swab and the result was negative. The clinical outcome of the event pain at injection site on arm was resolved on 18Apr2021, after duration of 2 days, events sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection) and tight chest/chest pain was resolved on 23Apr2021, after the duration of 5 days, while that of tiredness was resolved on an unknown date in Apr2021 (also reported as after duration of about 7 days).  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection).; Tight chest/chest pain; Tight chest/chest pain; Tiredness; Pain at injection site on arm; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 16Apr2021 at 14:45 (at the age of 22-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 to medications, food, or other products. Concomitant medications included ethinylestradiol; ferrous fumarate; norethisterone acetate (LO LOESTRIN FE) for an unknown indication on an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, within first hour of vaccination, the patient experienced pain at injection site on arm. On 18Apr2021 at 08:00, the patient experienced sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection) and tight chest/chest pain and tiredness. 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 the events. Since the vaccination, the patient had been tested for COVID-19. On 22Apr2021, the patient underwent pixel lab Covid-19 test  test via nasal swab and the result was negative. The clinical outcome of the event pain at injection site on arm was resolved on 18Apr2021, after duration of 2 days, events sore/throbbing lymph nodes near bottom of throat near the chest and near the collar bone (mostly on the side of the injection) and tight chest/chest pain was resolved on 23Apr2021, after the duration of 5 days, while that of tiredness was resolved on an unknown date in Apr2021 (also reported as after duration of about 7 days).  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Heart rate increased, Heavy menstrual bleeding, Migraine
Clinical narrative: Teeth hurt; Fast near beats; Diarrhea; Migraine; Sleep; Heavy onset of period; Weakness; Leg pain; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 42-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 in the left arm on an unknown date in 2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer. 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 concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 14Apr2021 at 01:00, the patient experienced teeth hurt, fast near beats, diarrhea, migraine, sleep, heavy onset of period, weakness, leg pain and nausea. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events teeth hurt, fast near beats, diarrhea, migraine, sleep, heavy onset of period, weakness, leg pain and nausea were 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: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Somnolence, Toothache
Clinical narrative: Teeth hurt; Fast near beats; Diarrhea; Migraine; Sleep; Heavy onset of period; Weakness; Leg pain; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 42-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 in the left arm on an unknown date in 2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer. 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 concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 14Apr2021 at 01:00, the patient experienced teeth hurt, fast near beats, diarrhea, migraine, sleep, heavy onset of period, weakness, leg pain and nausea. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events teeth hurt, fast near beats, diarrhea, migraine, sleep, heavy onset of period, weakness, leg pain and nausea were 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 46-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 05Apr2021 at 15:45 (at the age of 46-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 had no allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 20:30, the patient experienced severe headache with onset within 4 hours and tapered off within 48 hours. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache was recovered on  an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Chills; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 11:00 (at the age of 38-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram 15mg (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 07Mar2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 29Mar2021 at 08:00, the patient experienced headache, chills, fever and fatigue. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with ibuprofen (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, chills, fever and fatigue recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain in extremity, Pyrexia
Clinical narrative: Chill; Sore arm; Fever; Diarrhea; 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: EW0162) via an unspecified route of administration in the left arm on 23Apr2021 at 13:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. 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 concomitant medications. The patient previously received penicillin V potassium (MANUFACTURER UNKNOWN), ciprofloxacin (MANUFACTURER UNKNOWN) and metronidazole hydrochloride (MANUFACTURER UNKNOWN) and had drug allergy. On 23Apr2021 at 16:00, the patient experienced chill, sore arm, fever and diarrhea. 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, chill, sore arm, fever and diarrhea was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Nervousness, Pyrexia
Clinical narrative: starting to get anxiety about it; little nervous with chills and crap; chills; fever; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient).   A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch no: not reported/Lot number: EW0153) via an unspecified route of administration, administered in Left arm on 20Apr2021 (age at the time of vaccination was 65 years old) as a dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no family medical history Relevant to AE. Historical vaccine included previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch no: not reported/Lot number: EP6955) via an unspecified route of administration, administered in Left arm on 22Mar2021 (age at the time of vaccination was 65 years old) as a dose 1, single dose for COVID-19 immunization and experienced his arm got sore and it made the caller sleepy. No Prior Vaccinations taken within 4 weeks. No adverse events following prior vaccinations. After the second dose on an unspecified date in Apr2021, the patient experienced with systemic side effects like chills and fever were observed within the first 1 to 2 days after receiving the vaccine and that have lasted 7 days now, it was ongoing and has worsened, constantly back-to-back. On an unspecified date, patient was starting to get anxiety and a little nervous with chills and crap. Patient was asking about how long the reported events that supposed to last. Investigation Assessment was provided as No. AE did not require a visit to Emergency room or Physician office. Relevant Tests were reported as none. Patient was referred to his physician for treatment recommendation. The clinical outcome of chills and fever was not recovered and starting to get anxiety about it, little nervous with chills and crap was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Feeling cold, Headache
Clinical narrative: Felt very cold; Dizziness; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 27Apr2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all from an unknown date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in left arm on 06Apr2021 at 17:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 22:45, the patient experienced chills, a fever of up to 100.9, headache, dizziness, and felt very cold. 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 chills, fever, headache, dizziness and felt very cold was not resolved 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: Pyrexia
Clinical narrative: Felt very cold; Dizziness; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 27Apr2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), triamterene (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all from an unknown date, for an unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in left arm on 06Apr2021 at 17:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 22:45, the patient experienced chills, a fever of up to 100.9, headache, dizziness, and felt very cold. 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 chills, fever, headache, dizziness and felt very cold was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica, Vision blurred
Clinical narrative: Severe sciatic left side back past hip down thigh just above the knee.; Foggy vision off difficulty focusing on distance is it 4 to 6ft.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: Er8729) via an unspecified route of administration in the arm left on 06Apr2021 at 08:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 14:00, 1 week after dose 1 the patient experienced severe sciatic left side back past hip down thigh just above the knee also had foggy vision off difficulty focusing on distance was it 4 to 6ft. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with Tbd. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe sciatic left side back past hip down thigh just above the knee also had foggy vision off difficulty focusing on distance was it 4 to 6ft were not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8736) via an unspecified route of administration in the arm left on 06Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; Body aches; Sore injection site; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 13:45 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included Covid-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Apr2021 the patient experienced fever, chills, body aches and sore injection site. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events fever, chills, body aches, sore injection site were unknown at the time of 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, Headache, Pain, Skin odour abnormal, Vaccination site pain
Clinical narrative: Sore injection site; Headache; Extreme fatigue; All over body aches; change in body scent; 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: EN 6204) via an unspecified route of administration in the arm left on 18Mar2021 at 09:45 as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease, hypertension and lung disease (hypersensitivity lung disease). 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 received other medications(unspecified) within two weeks prior to the vaccination. On 20Mar2021 the patient experienced sore injection site, headache, extreme fatigue, all over body aches and change in body scent. 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 event's sore injection site, headache, extreme fatigue, all over body aches and change in body scent was recovered on unknown date of 2021.    No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Migraine/ The patient deal with migraines and it progressively made it worse for 4 days after; headache; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported) via an unspecified route of administration on 19Apr2021 at 16:30 (at the age of 22 years old) as dose number unknown, single for COVID-19 immunisation. Medical history included migraine from an unknown date. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On 19Apr2021, the patient experienced migraine/headache. It was further reported that the patient deal with migraines and it progressively made it worse for 4 days after. Unspecified medical treatment/shots was received in response to the events. Events resulted to doctor or other healthcare professional office/clinic visit. Since vaccination, the patient has not been tested for COVID-19. The patient did not recover from migraine but was recovering for the event headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hot flush
Clinical narrative: Hot flashes; Insomnia; Mild headache; Weakness; Chills; Fatigue; Muscle pain; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 10:45 (at the age of 36-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. 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: EP6955) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 10:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021 at 12:00, the patient experienced mild headache, chills, hot flashes, fatigue, weakness, muscle pain, sore arm and insomnia. 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 not taken as a result of reported events. The clinical outcome of the mild headache, chills, hot flashes, fatigue, weakness, muscle pain, sore arm and insomnia was recovered on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain in extremity
Clinical narrative: Hot flashes; Insomnia; Mild headache; Weakness; Chills; Fatigue; Muscle pain; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 10:45 (at the age of 36-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. 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: EP6955) via an unspecified route of administration in the right arm on an unknown date in Mar2021 at 10:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021 at 12:00, the patient experienced mild headache, chills, hot flashes, fatigue, weakness, muscle pain, sore arm and insomnia. 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 not taken as a result of reported events. The clinical outcome of the mild headache, chills, hot flashes, fatigue, weakness, muscle pain, sore arm and insomnia was recovered on unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia
Clinical narrative: Insomnia; Fatigue; This is a spontaneous report from a contactable nurse, the patient. A 64-year-old non-pregnant female 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 22Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included meloxicam (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), multivitamin, vitamin d nos (VIT D) and ascorbic acid (VIT C); all from unknown date for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 01Apr2021 at 11:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 21:00 the patient experienced insomnia and fatigue. 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 insomnia and fatigue was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature fluctuation, Fatigue, Headache, Hypersomnia
Clinical narrative: Extreme headache, with a vise-like grip on the back of my brain.; Temperatures fluctuating between 101 and 103.5; Tired; Slept for 33 hours; This is a spontaneous report from a contactable consumer, the patient.  A 60-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 21Apr2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 13:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. On 22Apr2021 at 02:15, 13 hours after the vaccination, the patient had extreme headache, with a vise-like grip on the back of the brain and temperatures fluctuating between 101 and 103.5. The patient was tired and slept for 33 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On 22Apr2021, the patient underwent body temperature test and the result was found to be between 101 and 103.5 degrees. The clinical outcome of the events extreme headache, with a vise-like grip on the back of the brain, temperatures fluctuating between 101 and 103.5, tired and slept for 33 hours was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymphoedema, Myalgia, Neuralgia, Pain in extremity
Clinical narrative: Headache; Muscle pain; Lymphedema; Fever; Extreme pain in lower extremities that was still lingering two weeks later; Nerve like pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male 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 14Apr2021 at 12:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. It was reported by the patient that none known allergies to food, medication and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ramipril (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all from an unknown date for an unknown indication 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: EN6204) via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 18:00, the patient experienced headache, muscle pain, lymphedema, fever, extreme pain in lower extremities that was still lingering two weeks later and nerve like pain. 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 headache, muscle pain, lymphedema, fever, extreme pain in lower extremities that was still lingering two weeks later and nerve like pain were resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Muscle pain; Lymphedema; Fever; Extreme pain in lower extremities that was still lingering two weeks later; Nerve like pain; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male 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 14Apr2021 at 12:45 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. It was reported by the patient that none known allergies to food, medication and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ramipril (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all from an unknown date for an unknown indication 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: EN6204) via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 14Apr2021 at 18:00, the patient experienced headache, muscle pain, lymphedema, fever, extreme pain in lower extremities that was still lingering two weeks later and nerve like pain. 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 headache, muscle pain, lymphedema, fever, extreme pain in lower extremities that was still lingering two weeks later and nerve like pain were resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes (armpit); This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration on 26Apr2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mango. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hepatitis B vaccine (HEPATITIS B) for unknown indication on 30Mar2021. The patient received other vaccines within four weeks prior to the vaccination. On 27Apr2021 the patient experienced swollen lymph nodes (armpit). The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes (armpit) was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Myalgia
Clinical narrative: Arm muscle ache; This is a spontaneous report from a contactable other HCP. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization (Age at Vaccination was 48 years). Patient also received Thalidomide (THALOMID, formulation: capsules, Lot Number: 9802543), via an oral (PO) route of administration on an unspecified date in Sep2013 at 200 mg, 1 time a day and ongoing for erythema nodosum (off label use). Dose, Frequency and Route used: 2) 100-200 mg, 1 in 1 D, PO, 3) 150-100 mg, 1 in 1 D, PO., 4) 50-100 mg, 1 in 1 D, PO, 5) 150-100 mg, 1 in 1 D, PO 6) 50 mg, 28 in 28 D, PO. Therapy Dates (or duration): 2) Sep2014  Unknown, 3) Jul2015  Unknown, 4) May2018  Unknown, 5) Apr2019  Unknown, 6) Apr2021  Ongoing. The patient medical history included ongoing erythema nodosum. The patient concomitant medications were not reported. It was reported that patient had the event after taking Pfizer COVID vaccine. On an unspecified date, the patient experienced arm muscle ache. The outcome of the event was recovered on an unspecified date.    Follow up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Peripheral swelling
Clinical narrative: both his legs were swollen and also the middle of his foot; both legs around ankles were very swollen; sore shoulder; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. It was reported he received his 2nd dose of the covid vaccine yesterday, Pfizers (On 27Apr2021). Then went shopping and about 6 hours later, both legs around ankles were very swollen. When he got home, both his legs were swollen and also the middle of his foot. Patient questioned whether his side effect swollen legs was related to the covid vaccine. No other reaction other than a sore shoulder. He put feet his feet up on high pillows all night long were still present this morning. Slightly more pronounced on left side, which is also the side he received the vaccine (27Apr2021). He wanted to question the fact that the left side, non-dominant side, is more swollen than the right, and this is also where he received the vaccine and stated he would like to know about the countermeasure injury compensation program. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Diarrhoea, Dyspnoea, Ear pain
Clinical narrative: Joint pain; chest pain; difficulty breathing; headaches; diarrhea; swelling; hives; rash; watery eyes; ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP7534, Expiration date was not reported), via an unspecified route of administration in arm right on 20Mar2021 at 01:30 AM (at the age of 26-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications in two weeks were reported as no. The patient did not receive any other vaccines within 4 weeks. No covid prior vaccination and no covid tested post vaccination. On 15Apr2021 at 12:30 PM, the patient experienced joint pain, chest pain, difficulty breathing, headaches, diarrhea, swelling, hives, rash, watery eyes and ear pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received the second dose of Pfizer with Lot number: ER8734 in arm left. Treatment was not received for the events. The outcome of the events was recovered with sequel (recovered with lasting effects).   Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lacrimation increased, Rash, Swelling, Urticaria
Clinical narrative: Joint pain; chest pain; difficulty breathing; headaches; diarrhea; swelling; hives; rash; watery eyes; ear pain; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EP7534, Expiration date was not reported), via an unspecified route of administration in arm right on 20Mar2021 at 01:30 AM (at the age of 26-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was reported as none. The patient had no known allergies. The patient's concomitant medications in two weeks were reported as no. The patient did not receive any other vaccines within 4 weeks. No covid prior vaccination and no covid tested post vaccination. On 15Apr2021 at 12:30 PM, the patient experienced joint pain, chest pain, difficulty breathing, headaches, diarrhea, swelling, hives, rash, watery eyes and ear pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received the second dose of Pfizer with Lot number: ER8734 in arm left. Treatment was not received for the events. The outcome of the events was recovered with sequel (recovered with lasting effects).   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Skin reaction
Clinical narrative: Fourth toe on her left foot is swollen and red; redness of her toes on her left foot; pain on her toes on her left foot; swelling of her toes on her left foot; toe is red and swollen/Left big toe swollen and red; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 08Apr2021 (at the age of 59 years old) (Batch/Lot Number: EP7533; Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Medical history included ongoing hypothyroidism. The patient's concomitant medications included Synthroid for hypothyroidism (has been taking the medication for about a decade). Patient was scheduled for the second Pfizer Covid 19 Vaccine on 29Apr2021. On 12Apr2021, our days after the first vaccine, the caller experienced redness, pain & swelling of her toes on her left foot. She reported she had developed a side effect of the Pfizer COVID Vaccine, she was supposed to have her 2nd shot today (date of reporting) but, put it off due to her experience. She reported her left big toe was red and swollen (at night). She also noticed her fourth toe on her left foot was red and swollen. She read on the CDC website that this is a documented side effect of the vaccine, she knew its related to blood inflammation connected to the vaccine. She said she needed to contact her doctor because she was not sure she should get her next shot. She was not sure she should get the next shot due her toes being red and swollen. Her event happened 5 days after her shot. 08Apr2021 was when she got the shot. No events required a visit to emergency room or physician Office. She had not had any treatment yet. She was going to call her doctor today. She got the COVID Test before getting her shot and the result was negative. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Apr2021. She received no treatment for any of the events. The outcome of redness of her toes on her left foot, pain on her toes on her left foot, swelling of her toes on her left foot, fourth toe on her left foot is swollen and red was unknown and toe is red and swollen/Left big toe swollen and red was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.