chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large swollen lymph node in armpit of shot; 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: UNKNOWN) via an unspecified route of administration in the left arm on 15Jan2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, hypothyroidism and depression. The patient had history of allergy to several antibiotics (unspecified). The patient received other prescribed medications (unspecified) within 2 weeks of vaccination for an unknown indication and 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 COVID vaccine. On 18Jan2021, the patient experienced large swollen lymph node in armpit of shot. The patient reported that the swollen lymph node went away after 2 weeks. The 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 05Feb2021 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient reported that 2 months later after the second dose of vaccination, he experienced swollen, red lymph node in the same armpit and reported it to be inflamed one week to date. 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 reported event. The clinical outcome of the event large swollen lymph node in armpit was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: Soreness at the injection site as well as a light pink color; Soreness at the injection site as well as a light pink color; This is a spontaneous report received from a contactable consumer, the patient. A 28-year-old male patient 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 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to food, medications, or other products. The patient did not receive any medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 31Mar2021 at 15:00 (three weeks after first shot), the patient began to feel soreness at the injection site as well as a light pink color. There was no other side effects or reactions. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received treatment for the reported events. The clinical outcome of the event soreness at the injection site as well as a light pink color was unknown at the time of this report.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain in left arm; Pain in neck and head/face on left side; Pain in neck and head/face; Left side has pain and a little throbbing.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient 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 30Mar2021 at 17:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical vertebra injury (yes, I am also experiencing some nerve issues due to damage in cervical vertebrae). The patient had no allergies to medications, food or other products. Concomitant medications included heme iron (MANUFACTURER UNKNOWN), lorazepam (ATIVAN), TYLENOL (MANUFACTURER UNKNOWN) and spiranolactone (MANUFACTURER UNKNOWN); all from on an unknown date for unspecified indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 30Mar2021 at 18:00, the patient experienced pain in left arm, also on left side of neck and head or face, pain and a little throbbing on left side but not on right side. The patient did not receive any treatment for the reported events. The adverse 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 events pain in arm, pain in neck and face, pain and throbbing left side were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Chills, Cough
Clinical narrative: Started to feel unwell; fever of 100.7; muscles and body aches; back pain; chills; cough; headache; weak; muscles and body aches; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 19Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to PCP hair dye. The patient did not receive any concomitant medications within two weeks of vaccination. 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 19Mar2021 at 13:00, the patient started to feel unwell, got a fever of 100.7 (unspecified units), muscles and body aches, back pain, chills, cough, and headache through the next day. After 2 days the patient still felt unwell and weak. On 20Mar2021, the patient had undergone PCR via nasal swab test for COVID-19 and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever of 100.7, muscles and body aches, back pain, chills, cough, felt unwell, weakness and headache were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pain, Pyrexia
Clinical narrative: Started to feel unwell; fever of 100.7; muscles and body aches; back pain; chills; cough; headache; weak; muscles and body aches; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 19Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to PCP hair dye. The patient did not receive any concomitant medications within two weeks of vaccination. 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 19Mar2021 at 13:00, the patient started to feel unwell, got a fever of 100.7 (unspecified units), muscles and body aches, back pain, chills, cough, and headache through the next day. After 2 days the patient still felt unwell and weak. On 20Mar2021, the patient had undergone PCR via nasal swab test for COVID-19 and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever of 100.7, muscles and body aches, back pain, chills, cough, felt unwell, weakness and headache were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Started to feel unwell; fever of 100.7; muscles and body aches; back pain; chills; cough; headache; weak; muscles and body aches; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 19Mar2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to PCP hair dye. The patient did not receive any concomitant medications within two weeks of vaccination. 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 19Mar2021 at 13:00, the patient started to feel unwell, got a fever of 100.7 (unspecified units), muscles and body aches, back pain, chills, cough, and headache through the next day. After 2 days the patient still felt unwell and weak. On 20Mar2021, the patient had undergone PCR via nasal swab test for COVID-19 and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events fever of 100.7, muscles and body aches, back pain, chills, cough, felt unwell, weakness and headache were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Pain, Sneezing
Clinical narrative: Sneezing; Congestion; Fatigue; Achy body; Tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non- pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 08:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no allergies to medications, food or other products. Concomitant mediation included fluoxetine hydrochloride (PROZAC) for an unknown indication from unknown date. 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 20Mar2021 at 16:00, the patient experienced sneezing, congestion, fatigue, tiredness and achy body which continued for 5 days after vaccination with no fever, no loss of taste or smell. The patient did not receive any treatment for the events of sneezing, nasal congestion, fatigue, tiredness and achy body. The clinical outcome of the events sneezing, nasal congestion, fatigue, tiredness and achy body were resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Tremor
Clinical narrative: Serious chills; Had a 101 degree fever; Shaking; Yawning constantly (very weird); Creeping body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-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 25Mar2021 at 10:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food 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. The patient did not receive any other medications within 2 weeks of vaccination. On 29Mar2021 at 20:30, four days after getting first vaccine shot, the patient had sudden and severe reaction of side effects. At 8:30 PM, the patient was fine and then within minutes, the patient was having serious chills (the patient had a 101-degree fever), shaking, yawning constantly (very weird) and having creeping body aches. The patient struggled to bed and thankfully, the worst of it had receded within a couple of hours and patient had recovered in about 36 hours. While the patient cannot be 100 percent sure this was vaccine related. The adverse 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 patient did not receive any treatments for the events of general body pain, yawning, shaking, fever and chills. The clinical outcomes of the events general body pain, yawning, shaking, fever and chills were resolved in 31Mar2021 at 08:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Yawning
Clinical narrative: Serious chills; Had a 101 degree fever; Shaking; Yawning constantly (very weird); Creeping body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-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 25Mar2021 at 10:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food 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. The patient did not receive any other medications within 2 weeks of vaccination. On 29Mar2021 at 20:30, four days after getting first vaccine shot, the patient had sudden and severe reaction of side effects. At 8:30 PM, the patient was fine and then within minutes, the patient was having serious chills (the patient had a 101-degree fever), shaking, yawning constantly (very weird) and having creeping body aches. The patient struggled to bed and thankfully, the worst of it had receded within a couple of hours and patient had recovered in about 36 hours. While the patient cannot be 100 percent sure this was vaccine related. The adverse 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 patient did not receive any treatments for the events of general body pain, yawning, shaking, fever and chills. The clinical outcomes of the events general body pain, yawning, shaking, fever and chills were resolved in 31Mar2021 at 08:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Vaginal haemorrhage
Clinical narrative: Increased menstruation; Abnormal vaginal bleeding.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and asthma. The patient was allergic to shellfish. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 18:00, the patient experienced increased menstruation during her regular cycle and her cycle was over but she was experiencing abnormal vaginal bleeding. The patient did not receive any treatment for the reported events. The clinical outcome of the events increased menstruation and abnormal vaginal bleeding was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Muscle ache; fever; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 at 11:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unknown date in 2021, the patient experienced headache, muscle ache and fever. 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 events headache, muscle ache and fever were recovering at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling in the lymph nodes in my right arm pit; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old adult male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Lot Number: Er2613) via an unspecified route of administration in the arm right on 29Mar2021 at 16:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 06:00 the patient experienced swelling in the lymph nodes in right arm pit. The adverse 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 patient did not receive any treatment for the adverse event. The clinical outcome of swelling in the lymph nodes in right arm pit was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; chills; body aches; pain under left arm pit; headache; This is a spontaneous report received 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: EL3247), via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 60-years) as a single dose for COVID-19 immunisation. The medical history of the patient included high blood pressure. The patient did not receive any concomitant medications with in 2 weeks of vaccination. The patient had no known allergies to food, medications, or other products. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3247) via an unspecified route of administration in the left arm on 10Mar2021 at 10:00 (at the age of 60- years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 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 31Mar2021 at 17:00, the patient experienced the events sore arm, chills, body aches, pain under left arm pit and headache. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events sore arm, chills, body aches, pain under left arm pit and headache was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Pain in extremity
Clinical narrative: numbness of half left face; numbness of tongue; headache; pain on left arm; This is a spontaneous report from a contactable consumer, the patient. A 48-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 31Mar2021 at 12:00(at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included gout and high cholesterol. Concomitant medications included pyridoxine hydrochloride, biotin, folic acid, cholecalciferol, cyanocobalamin, phytomenadione, nicotinamide, sodium ascorbate, calcium pantothenate, thiamine mononitrate, zinc oxide, potassium iodide, manganese sulfate, chromic chloride, dl-alpha tocopherol acetate, sodium selenate, sodium molybdate dihydrate (CENTRUM VITAMINTS). No known allergies were reported. 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 12:30 the patient experienced numbness of tongue, headache, pain on left arm and numbness of half left face. Therapeutic measures were taken as a result of adverse events and included treatment with TYLENOL 500 MG. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events numbness of half left face, numbness of tongue, headache, pain on left arm were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody nose; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En7534) via an unspecified route of administration in the arm left on 01Apr2021 at 14:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 04Mar2021 at 14:45 (at the age of 37-years-old). On 04Mar2021, (after receiving first dose of Covid-19 vaccination), the patient experienced first episode of a bloody nose and was resolved on an unknown date. On 01Apr2021, (after receiving second dose of Covid-19 vaccination), the patient experienced second episode of a bloody nose. 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 does not normally had bloody noses at all. The patient did not receive any treatment for the event. The adverse 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 for the second episode of the event bloody nose was resolved on 01Apr2021.     No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Headaches; fever; chills; tiredness; nausea; general feeling of being unwell; muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 10:15 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included elevated cholesterol, bladder and basal cell cancer and COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), lactobacillus acidophilus (FLORAJEN) and MULTIVITA, all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 05Mar2021 at 10:30 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 18:30, the patient experienced headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain. The adverse events did not result in a visit to the 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 headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain. The clinical outcomes of the events headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headaches; fever; chills; tiredness; nausea; general feeling of being unwell; muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 71-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 10:15 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included elevated cholesterol, bladder and basal cell cancer and COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), lactobacillus acidophilus (FLORAJEN) and MULTIVITA, all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the right arm on 05Mar2021 at 10:30 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 18:30, the patient experienced headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain. The adverse events did not result in a visit to the 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 headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain. The clinical outcomes of the events headaches, fever, chills, tiredness, nausea, general feeling of being unwell and muscle pain were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nightmare, SARS-CoV-2 test
Clinical narrative: nightmares; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 49-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 12Mar2021 at 09:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy NOS. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) and over-the-counter (OTC) unspecified medication for allergy, from unknown dates. 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 13Mar2021, the patient experienced extreme fatigue and nightmares. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 17Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the events extreme fatigue and nightmares. The clinical outcomes of the events extreme fatigue and nightmares were not resolved at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: A bad headache; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old male patient received unknown dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm  on 1Apr2021 at 08:45 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) , fexofenadine hydrochloride (ALLEGRA) ,H2-Blockers (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 12:00 the patient experienced a bad headache. The event did not result in doctors 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. The clinical outcome of the event a bad headache was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchial irritation, Chest discomfort, Dyspepsia, Heart rate irregular, Heart sounds abnormal
Clinical narrative: By day 6, there was a friction run upon acscultation of heart sounds; Felt to be most likely PVC's; irregular heartbeats; sub sternal burning sensation; had mild bronchial irritation; chest congestion symptoms; a sense of inflammation in the heart; This is a spontaneous report from a contactable other hcp. A 64-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6203) via an intramuscular route of administration in Arm Left on 03Mar2021 08:30 (Age at vaccination 64years old, Pregnant at Time of Vaccination no) as single dose for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive list of any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID. The patient experienced chest congestion symptoms, a sense of inflammation in the heart, sub sternal burning sensation, had mild bronchial irritation on 06Mar2021 12:00, irregular heartbeats, felt to be most likely pvc's on 07Mar2021 12:00, by day 6, there was a friction run upon acscultation of heart sounds on 09Mar2021 12:00. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Ventricular extrasystoles
Clinical narrative: By day 6, there was a friction run upon acscultation of heart sounds; Felt to be most likely PVC's; irregular heartbeats; sub sternal burning sensation; had mild bronchial irritation; chest congestion symptoms; a sense of inflammation in the heart; This is a spontaneous report from a contactable other hcp. A 64-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6203) via an intramuscular route of administration in Arm Left on 03Mar2021 08:30 (Age at vaccination 64years old, Pregnant at Time of Vaccination no) as single dose for covid-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered in Doctor's office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive list of any other medications within 2 weeks of vaccination. Since the vaccination, the patient has not been tested for COVID. The patient experienced chest congestion symptoms, a sense of inflammation in the heart, sub sternal burning sensation, had mild bronchial irritation on 06Mar2021 12:00, irregular heartbeats, felt to be most likely pvc's on 07Mar2021 12:00, by day 6, there was a friction run upon acscultation of heart sounds on 09Mar2021 12:00. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: received the 1st and 2nd dose on 20Jan2021; tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reporting for his 24 years old granddaughter. A 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on 20Jan2021 (Batch/Lot number was not reported) and second dose on 20Jan2021 (Batch/Lot number was not reported); both via an unspecified route of administration as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient tested positive for COVID on 08Apr2021. The outcome of the events was unknown.  The reporter had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE on 09Apr2021. He was asking how much protection and what was the duration of protection once he got the 1st dose of the vaccine. He also wanted to know how much of the population were protected after getting the doses. The reporter was provided with Table 6: Vaccine Efficacy-first COVID-19 occurrence from 7 days after dose 2, by age subgroup -participants without evidence of infection and participants with or without evidence of infection prior to 7 days after dose 2 - evaluable efficacy (7 days) population. The reporter was asking if the COVID 19 vaccine might cause a false positive test and if the vaccine would give COVID 19 to patients.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Movement disorder, Pain, Pain in extremity, Rash erythematous
Clinical narrative: Pain seems to be in shoulder area and bicep area; aching/ stabbing pain; Bump reappeared with red itchy rash; Extreme pain and mobility issues with left arm that lasted from time I received vaccine but  really worsened on 4/2/21./ Could not even lift my arm any distance from body in any direction; mobility issues/ did not had full mobility; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 30Mar2021 at 12:30 (Lot Number: EN6208) at the age of 60-year-old as single dose for COVID-19 immunization. Medical history included allergies to medications and food. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol, antihistamines, vitamins and progesterone. The patient experienced extreme pain and mobility issues with left arm that lasted from time received vaccine but really worsened on 02Apr2021. On 04Apr2021, the patient went to urgent care. Went again to primary care doctor 4/8/21. It was gotten better each day but still did not had full mobility and had some pain. The patient could not event lift arm any distance from body in any direction. Extreme pain on scale of 1-10, a definite 10. Aching, stabbing pain. Bump reappeared with red itchy rash on the 07Apr2021, but was not severe. And improved today the 10Apr2021. Still not able to fully extend arm up above head. Pain seems to be in shoulder area and bicep area. At 2nd application, they prescribed Prednisone as treatment for events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abscess, Circumstance or information capable of leading to medication error, Vomiting
Clinical narrative: experiencing abscess and throwing up.; experiencing abscess and throwing up.; if they can reschedule her husband's 2nd dose.; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She stated her husband was scheduled to have his 2nd dose today but unfortunately, her husband was experiencing abscess and throwing up, asked if they can reschedule her husband's 2nd dose. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: blood pressure was very high; This is a spontaneous report from a contactable consumer reporting for herself. A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203, Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 28Feb2021 15:00 as single dose (at age of 65-years old) for covid-19 immunization. Medical history included High Blood Pressure, diabetes mellitus, cardiac pacemaker insertion from an unknown date and unknown if ongoing, penicillin allergy, COVID-19 from an unknown date and unknown if ongoing (if covid prior vaccination: Yes). The patient received other medications within 2 weeks of vaccination (unspecified). 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 experienced blood pressure was very high on 11Mar2021. Patient stated, sent her to the Emergency Room. She had to switch medicines and still trying to get it under control. Patient received treatment of IV, Tests and monitoring. The patient underwent lab tests and procedures which included Blood pressure measurement: very high on 11Mar2021, SARS-COV-2 test: positive on unknown date. The outcome of the event was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Pain, Peripheral swelling, Pruritus
Clinical narrative: Fever; fatugue; body aches for 36 hours; swollen and itchy arm for 3 days which later resolved into swollen; swollen and itchy arm for 3 days which later resolved into swollen; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:15 (at the age of 50-years-old) as dose 2, single for covid-19 immunization. Medical history included allergy to arthropod bite from an unknown date (fire ant allergy). Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (MINASTRIN 24 FE). cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin, amoxicillin, neosporin bacitracin neomycin sulfate polymyxin b sulfate] and experienced allergy. The patient took first dose of bnt162b2 (Lot number: EP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:15 as dose 1, single for covid-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 14Apr2021, the patient experienced Fever, fatigue, and body aches for 36 hours, swollen and itchy arm for 3 days which later resolved into swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks. The patient did not received treatment for adverse events. Outcome of events was recovered on unspecified date of Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site abscess, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Fever; fatugue; body aches for 36 hours; swollen and itchy arm for 3 days which later resolved into swollen; swollen and itchy arm for 3 days which later resolved into swollen; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks; This is a spontaneous report from a contactable consumer (Patient). A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0161), dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 10:15 (at the age of 50-years-old) as dose 2, single for covid-19 immunization. Medical history included allergy to arthropod bite from an unknown date (fire ant allergy). Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (MINASTRIN 24 FE). cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin, amoxicillin, neosporin bacitracin neomycin sulfate polymyxin b sulfate] and experienced allergy. The patient took first dose of bnt162b2 (Lot number: EP6955), via an unspecified route of administration, administered in Arm Left on 23Mar2021 10:15 as dose 1, single for covid-19 immunization. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 14Apr2021, the patient experienced Fever, fatigue, and body aches for 36 hours, swollen and itchy arm for 3 days which later resolved into swollen, red, hot, itchy, and hard palm-sized area at injection site that became a bruise after 2 weeks. The patient did not received treatment for adverse events. Outcome of events was recovered on unspecified date of Apr2021.  No follow-up attempts are needed. No further information is expected.