chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: pain gets excruciating at times as flex the muscle; pain in my left calf sincethe afternoon of the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7553) via an unspecified route of administration in the left arm on 05Apr2021 at 12:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) and erythromycin (MANUFACTURER UNKNOWN) for unknown indication and unknown date and experienced drug allergy. Concomitant medications included venlafaxine hydrochloride (EFFEXOR SR), spironolactone (MANUFACTURER UNKNOWN) and birth control medicines (UNSPECIFIED) all for an unknown indication from an unknown date. 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 12:30, the patient experienced pain in left calf since the afternoon of the vaccination and the mild pain got excruciating at times as patient flexed the muscle. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events pain in left calf and pain got excruciating at times as flex the muscle was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches; Arm soreness and tenderness; Low-grade fever; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 06Apr2021 at 10:30 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient did not have any history of allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination which included ibuprofen (ADVIL) for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 17Mar2021 at 10:30 (at the age of 27-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 06Apr2021 at 15:00, the patient experienced arm soreness and tenderness, low-grade fever, body aches, fatigue and headache. 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 for the events. The clinical outcome of the events arm soreness and tenderness, low-grade fever, body aches, fatigue and headache were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Large egg-sized swelling at injection site; injection site hot and red for 48 hours; injection site hot and red for 48 hours; body aches; chills; fever of 102.9; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid nodule and mild hypertension. Concomitant medications included levothyroxine sodium (UNITHROID) and metoprolol (MANUFACTURER UNKNOWN), both on unknown dates for unspecified indications. The patient had no allergies to medications, food, or other products. Patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 12:45 (at the age of 44-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 vaccine. On 05Apr2021 at 15:45, the patient experienced large egg-sized swelling at injection site, injection site hot and red for 48 hours, body aches, chills, fever of 102.9 and fatigue. 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 events. The clinical outcome of the events injection site hot and red for 48 hours was recovered on 07Apr2021 while the outcomes of large egg-sized swelling at injection site, body aches, chills, fatigue and fever of 102.9 (unspecified units) was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Large egg-sized swelling at injection site; injection site hot and red for 48 hours; injection site hot and red for 48 hours; body aches; chills; fever of 102.9; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid nodule and mild hypertension. Concomitant medications included levothyroxine sodium (UNITHROID) and metoprolol (MANUFACTURER UNKNOWN), both on unknown dates for unspecified indications. The patient had no allergies to medications, food, or other products. Patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 12:45 (at the age of 44-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 vaccine. On 05Apr2021 at 15:45, the patient experienced large egg-sized swelling at injection site, injection site hot and red for 48 hours, body aches, chills, fever of 102.9 and fatigue. 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 events. The clinical outcome of the events injection site hot and red for 48 hours was recovered on 07Apr2021 while the outcomes of large egg-sized swelling at injection site, body aches, chills, fatigue and fever of 102.9 (unspecified units) was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Tightness of the chest\heart area.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 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 05Apr2021 at 23:30, the patient experienced tightness of the chest\heart area. The patient did not receive any treatment for the reported events. The adverse event 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 tightness of the chest\heart area was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: The second shot was on day 2 of my period - my period has now lasted 9 days.  Usually my period is 3-5 days.; 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: er8734), via an unspecified route of administration on 01Apr2021 at 14:30 (at the age of 52-year-old), as a single dose for COVID-19 immunisation. The patient received antibiotics within two weeks of vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6206), via an unspecified route of administration on 11Mar2021 at 14:30 (at the age of 52-year-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 an unknown date in Apr2021, the patient second shot was on day 2 of the period. The period had now lasted 9 days. Usually, period was 3-5 days. The patient did not receive any treatment for the event. The clinical outcome of the event prolonged period which had lasted 9 days was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 2 hours after receiving the second vaccine, began itching on  lower left side back and buttock, then started seeing blisters and it became very painful the next morning spoke to primary doctor and he diagnosed it to be shingles.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 01Apr2021 at 11:00 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included cancer, colon surgery, breast surgery and hernia surgery. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and paracetamol, hydrocodone bitartrate (HYDROCODONE/ACETAMINOPHEN) all started from unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration in left arm on 10Mar2021 at 11:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 01Apr2021 at 13:00 (2 hours after receiving the second vaccine), the patient began itching on her lower left side back and buttock, then she started noticing blisters and it became very painful, the next morning the patient spoke to her primary doctor and he asked the patient to send a photo and he diagnosed it to be shingles. The patient received treatment for the event shingles which included treatment with Famciclovir. The adverse event 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 shingles was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypoaesthesia, Paraesthesia
Clinical narrative: Left side of face became numb; Left side of face became tingly; Left side of face became hot; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Mar2021 at 20:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient did not report any other health issues. The patient had no known allergies to medications, food or other products. The patient received unspecified 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 COVID-19 vaccination. On an unspecified date in Mar2021, the patient reported that the left side of the face became tingly, hot and numb. The events did not result in a 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 left side of the face became tingly, hot and numb. The clinical outcome of the event left side of the face became tingly, hot and numb was resolved with sequelae on an unspecified date in 2021.   No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dermatitis allergic, Pain, Pruritus, Pyrexia
Clinical narrative: Got an allergic rash itchy hives all over my body 3 days later.; Got an allergic rash itchy hives all over my body 3 days later.; Got an allergic rash itchy hives all over my body 3 days later.; Got mild fever; chills; body pains the next day after taking 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. This 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) on 02Apr2021 at 16:30 (at the age of 30-years-old) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient did not have COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported she experienced mild fever, chills, and body pains the next day after taking the first dose of the vaccine; and an allergic rash and itchy hives all over her body 3 days later on 05Apr2021 at 14:00. The events required a doctor or other healthcare professional visit and the patient reported treatment with prednisone and dexamethasone 4 mg shot. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Got an allergic rash itchy hives all over my body 3 days later.; Got an allergic rash itchy hives all over my body 3 days later.; Got an allergic rash itchy hives all over my body 3 days later.; Got mild fever; chills; body pains the next day after taking 1st dose of vaccine; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. This 30-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) on 02Apr2021 at 16:30 (at the age of 30-years-old) via an unspecified route of administration as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient did not have COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported she experienced mild fever, chills, and body pains the next day after taking the first dose of the vaccine; and an allergic rash and itchy hives all over her body 3 days later on 05Apr2021 at 14:00. The events required a doctor or other healthcare professional visit and the patient reported treatment with prednisone and dexamethasone 4 mg shot. The clinical outcomes of the events were recovering. Since vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Dizziness; Swelling at injection site; Pain at injection site; Tired/fatigue; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 12:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient had received other medication within two weeks of vaccination. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021 at 15:00, the patient experienced swelling at the injection site, pain at the injection site that worsened into the night, dizziness and tired/fatigue. 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 events. The clinical outcome of the events swelling at the injection site, pain at the injection site, dizziness and tired/fatigue was recovering at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: 102 degree fever; sweats; chills; body aches; fatigue; lack of appetite; sever gastrointestinal issues; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration  on 14Mar2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications included apremilast (OTEZLA) 30 mg for an unknown indication from an unknown date.  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. The patient did not had any known allergies to medications, food, or other products. The patient underwent lab test and procedure which included body temperature on 15Mar2021 and the result was shown as 102. On 15Mar2021 at 01:00, the patient experienced 102 degree fever, sweats, chills, body aches, fatigue, lack of appetite, and severe gastrointestinal issues, which lasted about 36 hours and was once every 1-2 hours occurrence. The patient did not receive any treatment for the reported events. 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. The clinical outcome of the events of  fever, sweaty, chills, general body pain, fatigue, appetite lost and gastrointestinal discomfort was recovered on an unknown date in Mar2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER3784) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation and experienced no events.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: 102 degree fever; sweats; chills; body aches; fatigue; lack of appetite; sever gastrointestinal issues; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206) via an unspecified route of administration  on 14Mar2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. Concomitant medications included apremilast (OTEZLA) 30 mg for an unknown indication from an unknown date.  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. The patient did not had any known allergies to medications, food, or other products. The patient underwent lab test and procedure which included body temperature on 15Mar2021 and the result was shown as 102. On 15Mar2021 at 01:00, the patient experienced 102 degree fever, sweats, chills, body aches, fatigue, lack of appetite, and severe gastrointestinal issues, which lasted about 36 hours and was once every 1-2 hours occurrence. The patient did not receive any treatment for the reported events. 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. The clinical outcome of the events of  fever, sweaty, chills, general body pain, fatigue, appetite lost and gastrointestinal discomfort was recovered on an unknown date in Mar2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER3784) via an unspecified route of administration in the left arm on 14Apr2021 at 13:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation and experienced no events.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peripheral coldness
Clinical narrative: When circulation is cut off and numb.; Hand turned cold; Arm began tingling/ my hand went tingly/ extremity falls asleep; This is a spontaneous report from a contactable consumer, the patient. A 30-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 arm right on 07Apr2021 at 09:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and birth control. Concomitant medications included sertraline 50 mg (MANUFACTURER UNKNOWN) from an unknown date for unknown indication and norethisterone (NORLYDA) from an unknown date for birth control. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm right on 15Mar2021 at 16:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and cefaclor (CECLOR) on an unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines 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 at 09:35, about 20 minutes after, the patient experienced tingling in arm and then her hand went tingly like when an extremity falls asleep. Her hand then turned cold like when circulation is cut off and numb. This symptom remained for 4 hours after the shot. 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 events. The clinical outcomes of arm began tingling, hand turned cold and numb were recovered with sequelae on 07Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Mild fever (<100); Body ache; tiredness; sore joints; headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea. Patient reported allergy to shellfish. Concomitant medications included escitalopram oxalate (LEXAPRO) loteprednol etabonate (LOTREL) simvastatin (MANUFACTURER UNKNOWN) and vitamins(unspecified); all from an unknown date and for an unknown indication. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 14:00 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 vaccine. On 31Mar2021 at 14:00, the patient experienced mild fever (<100), body ache, tiredness, sore joints 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. The patient did not receive any treatment for the events. The clinical outcome of the events mild fever, body ache, tiredness, sore joints and headache were recovered on an unknown date in 2021 at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, SARS-CoV-2 test
Clinical narrative: Tips of toes turning red; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6201) via an unspecified route of administration in the left arm on 13Feb2021 at 13:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic and stage 3 kidney disorder. The patient did not have a history of allergies to medications, food, or other products. Concomitant medication included acetyl salicylic acid (ASPIRIN), atorvastatin (MANUFACTURER UNKNOWN), ezetimibe (MANUFACTURER UNKNOWN), fenofibrate (MANUFACTURER UNKNOWN)  and more (unspecified) all started on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021 at 12:00 the patient experienced tips of toes turning red (localised erythema). On an unknown date, the patient underwent lab test and procedure which included COVID-19 virus test and the result was found to be negative. No therapeutic measures  were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event tips of toes turning red was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Bronchospasm, Condition aggravated, Dyspnoea exertional, Foreign body sensation in eyes
Clinical narrative: have primary Sjogrens; had a mild flare in my joints; my eyes became very gritty; Mild bronchospasm; Slightly sob on exertion; Mild seasonal asthma; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8734, first dose) solution for injection intramuscular in the left arm on 29Mar2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included Sjogrens, mild seasonal asthma, CRPS (complex regional pain syndrome), and allergies to oranges and tomatoes. Concomitant medications included pregabalin (LYRICA), baclofen, levothyroxine, and prednisone. Past drug history included known allergy: SSRI's and codeine and all derivatives. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I have primary Sjogrens, and mild seasonal asthma and within 3 hours of injection, I had a mild flair in my joints and my eyes became very gritty. I also had mild bronchospasm that responded to use of albuterol inhaler. I have not had to use inhaler in 2 years prior to this, and I had not had a joint flair in 2 years. These symptoms lasted about 72 hours. I needed to use inhaler several times, I was slightly SOB (shortness of breath) on exertion" on 29Mar2021 at 13:00. Treatment for the events included albuterol inhaler and increased prednisone (by the patient). The outcome of the events was recovered in Apr2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sjogren's syndrome
Clinical narrative: have primary Sjogrens; had a mild flare in my joints; my eyes became very gritty; Mild bronchospasm; Slightly sob on exertion; Mild seasonal asthma; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8734, first dose) solution for injection intramuscular in the left arm on 29Mar2021 at 10:00 (at the age of 59-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included Sjogrens, mild seasonal asthma, CRPS (complex regional pain syndrome), and allergies to oranges and tomatoes. Concomitant medications included pregabalin (LYRICA), baclofen, levothyroxine, and prednisone. Past drug history included known allergy: SSRI's and codeine and all derivatives. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient stated, "I have primary Sjogrens, and mild seasonal asthma and within 3 hours of injection, I had a mild flair in my joints and my eyes became very gritty. I also had mild bronchospasm that responded to use of albuterol inhaler. I have not had to use inhaler in 2 years prior to this, and I had not had a joint flair in 2 years. These symptoms lasted about 72 hours. I needed to use inhaler several times, I was slightly SOB (shortness of breath) on exertion" on 29Mar2021 at 13:00. Treatment for the events included albuterol inhaler and increased prednisone (by the patient). The outcome of the events was recovered in Apr2021. Since the vaccination, the patient has not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Overall achiness.; This is a spontaneous report from a contactable consumer, the patient. A 52-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 06Apr2021 at 16:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic migraines. The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL), camphor, diphenhydramine hydrochloride, zinc oxide (BENADRYL) and  sumatriptan succinate (SUMATRIPTAN) for unknown indication and on unknown date 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 07Apr2021 at 07:00, the patient experienced overall achiness. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event overall achiness was 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: Haematoma, Vein disorder
Clinical narrative: impact from jumping and kicking many veins in lower legs are apparently weakened.; Incurred manyhematomas. These were not fromdirect contact to bruised area, thesewere in the veins surrounding; This is a spontaneous report from a contactable consumer. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 24Feb2021(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history details are not available and patient did not had a history of allergies to food, medications, or other products. The patient received unspecified vitamin supplements within two weeks of vaccination. The patient previously took 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 04Feb2021 at 16:00 (at the age of 44-year-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 24Mar2021, in late March the patient experienced upon impact from jumping and kicking many veins in lower legs are apparently weakened and incurred many hematomas. These were not from direct contact to bruised area, these were in the veins surrounding, and above impact. This was not a typical ailment for patient and experienced same in early April. No therapeutic measures were taken as a result of 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 impact from jumping and kicking many veins in lower legs are apparently weakened and incurred many hematomas in the veins surrounding were recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E96955) via an unspecified route of administration in the arm right on 02Apr2021 at 19:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) and piroxicam (PAXIL) both from unknown date for unknown indication taken within 2 weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm right on 05Mar2021 at 19:15 (at the age of 34-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 04Apr2021 at 23:00 the patient experienced severe nausea. No therapeutic measures are taken as a result of the event. The clinical outcome of the event severe nausea  was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm was extremely sore to any movement; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 30Mar2021 at 08:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medications within two weeks of vaccination. Patient had no allergies to food, medication or other products. 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 31Mar2021 at 08:00, the patient had pain in arm. Its reported that the patient had right arm which was extremely sore to any movement and had not gotten it better in 8 days. The patient did not receive any treatment for the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of pain in arm 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: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Soreness around the injection site; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 06Apr2021 at 09:30(at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity. The patient did not report any allergies to food, medications or other product. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) from unknown date, for unknown indication and unknown if it was 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 06Apr2021 at 21:00, the patient experienced soreness around the injection site. On 07Apr2021, the patient experienced fatigue the day following the injection. 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 events. The clinical outcome of the events soreness around the injection site and fatigue were recovering at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint noise, Ligamentitis
Clinical narrative: soreness in wrist and elbow; soreness in wrist and elbow; forearm ligament is inflamed; wrist was making a clicking sound; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male 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 23Mar2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic and thyroid. The patient previously took internal iodine for unknown indication and unknown start date and experienced iodine allergy. Concomitant medications included Insulin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and simvastatin (MANUFACTURER UNKNOWN) all from an unknown date and for unknown indication within two weeks of vaccination. 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 left arm on 02Mar2021 (at the age of 45-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, it was unknown whether the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021 at 06:00 approximately after 36 hours of vaccination, patient woke up in the morning and experienced clicking sound in the left outer wrist every time he did the movement, this was ongoing for two weeks and had not gone away. On 25Mar2021, the patient also experienced soreness in wrist and elbow. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient went to the chiropractor twice to get help and the chiropractor stated that the forearm ligament was inflamed. Therapeutic measures were taken as a result of the reported events which included treatment with massage, manipulation and taping of arm and wrist. The clinical outcome of the event clicking sound in the left outer wrist, soreness in wrist and elbow were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on arms and legs; This is a spontaneous report from a contactable consumer, the patient. A 28-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8733) via an unspecified route of administration, in the left arm on 27Mar2021 at 14:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and depression. The patient had known allergies to iodine dye. Concomitant medications included birth control (MANUFACTURER UNKNOWN) and duloxetine hydrochloride (CYMBALTA) from unknown dates, for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Apr2021, the patient experienced itchy rash on arms and legs. 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 reported events. The clinical outcome of the event's itchy rash on arms and legs were not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy within an hour of vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 61-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 on 07Apr2021 at 10:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included was not reported. Patient had no allergies to medications, food, or other products. Concomitant medications included hydrochlorothiazide (MANUFACTURER UNKNOWN) 25 mg, daily, from an unknown date for an unspecified indication 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 vaccination. On 07Apr2021 at 11:15 within an hour of vaccine, the patient became dizzy. The patient did not receive any treatment for 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 the event of dizzy was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Extreme fatigue; Persistent nausea.; Immediate lightheadedness; This is a spontaneous report from a contactable consumer, the patient. A 32-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 07Apr2021 at 11:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical and concomitant medications were not reported. The patient previously received penicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced penicillin 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 07Apr2021 at 11:30, the patient experienced immediate light-headedness and immediate dizziness, both persisting all day and into the night. Three hours after the vaccination (at 14:30), the patient experienced extreme fatigue and persistent nausea. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events immediate light-headedness, immediate dizziness, extreme fatigue and persistent nausea was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.