chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: chills; Fever 101.5; sore at injection site; slight swelling at injection site; Achiness; This is a spontaneous report received from a contactable consumer, the patient. A 65-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via unspecified route of administration on left arm on 19Mar2021 at 15:15 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had known allergies with sulfa drugs and zest bar soap. 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 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamins (MANUFACTURER UNKNOWN), ZESTRIL, HYDRODIURIL started from an unknown date for an unknown indication. On 20Mar2021 at 12:15, the patient experienced chills, achiness, fever at 101.5(units unspecified), soreness and slight swelling at injection site. Lab tests and procedures included body temperature test on 20Mar2021 at 12:15 and the result was 101.5 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. No therapeutic measures taken for the reported events. The clinical outcome of the events chills, ache, fever, vaccination site pain and vaccination site swelling were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Irregular heart beat developed  few hours after injection of the vaccine.; This is a spontaneous report received from a contactable consumer, the patient. A 85-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8730) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 85-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, type 2 diabetes, gout and glaucoma. Concomitant medication included High blood pressure medicines and Diabetic medicine. The patient previously took quinidine and diamox for unknown indication and experienced an drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 19Mar2021, the patient experienced Irregular heart beat developed few hours after injection of the vaccine. The patient did not receive any treatment for the adverse events. The clinical outcome of the event Irregular heart beat was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, SARS-CoV-2 test
Clinical narrative: Losing smell; This is a spontaneous report received from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534,) via an unspecified route of administration in the left arm on 19Mar2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to 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 COVID vaccine. On 19Mar2021 at 21:00, the patient was losing smell. The adverse event 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 20Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the event losing smell. The clinical outcome of the event losing smell was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Petechiae, Vaccination site pain
Clinical narrative: arm soreness around the injection site; petechial rash on the underside of toes on both feet; This is a spontaneous report received from a contactable consumer, the patient. A 25-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 19Mar2021 at 12:15 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included aplastic anemia (treated successfully with equine atg) on an unknown date. The patient did not have any 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 concomitant medications within the two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to COVID vaccination. On 19Mar2021 at 17: 00, the patient experienced arm soreness around the injection site and a petechial rash on the underside of toes on both feet. 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 treatment for the events. The clinical outcome of the events soreness around the injection site and a petechial rash on the underside of toes on both feet was recovering. No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Dysgeusia, Fatigue, Headache
Clinical narrative: Low grade headache; chills; Body aches; dark bruise-like area on the skin outside each eye; extreme tiredness; food tasted bitter for 24 hours; This is a spontaneous report received from contactable consumer, the patient. A 74-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6207) via an unspecified route of administration in the left arm on 16Mar2021 at 15:00 (at the age of 74-years-old), as single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. On 16Mar2021 at 16:15, the patient experienced low grade headache (almost immediately), chills, body aches, dark bruise-like area on the skin outside each eye (side of eye not over or under), extreme tiredness, food tasted bitter for 24 hours. The patient did not receive any treatment for the reported events. 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 low grade headache, chills, body aches, dark bruise-like area on the skin outside each eye (side of eye not over or under), extreme tiredness, food tasted bitter for 24 hours was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Low grade headache; chills; Body aches; dark bruise-like area on the skin outside each eye; extreme tiredness; food tasted bitter for 24 hours; This is a spontaneous report received from contactable consumer, the patient. A 74-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6207) via an unspecified route of administration in the left arm on 16Mar2021 at 15:00 (at the age of 74-years-old), as single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications (unspecified) within 2 weeks of vaccination. On 16Mar2021 at 16:15, the patient experienced low grade headache (almost immediately), chills, body aches, dark bruise-like area on the skin outside each eye (side of eye not over or under), extreme tiredness, food tasted bitter for 24 hours. The patient did not receive any treatment for the reported events. 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 low grade headache, chills, body aches, dark bruise-like area on the skin outside each eye (side of eye not over or under), extreme tiredness, food tasted bitter for 24 hours was resolved in Mar2021. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state
Clinical narrative: Lack of energy; Feeling of not being able to think clearly; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 18Mar2021 at 17:45 (at the age of 59-years-old) as single dose for COVID-19 immunisation. The patient had no medical history and allergies to medications, food, or other products. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 19Mar2021 at 18:00, the patient experienced lack of energy and a feeling of not being able to think clearly. No therapeutic measures were taken for the reported events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of lack of energy and feeling of not being able to think clearly were recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling in right foot and leg; Numbness in right foot and leg; This is a spontaneous report from a contactable consumer, patient. A 33-year-old non-pregnant female patient received BNT162b2(PFIZER-BIONTECH COVID19 mRNA VACCINE; Lot number: ep7534) on the right arm as a first dose on 20Mar2021 at 12.45(at the age of 33 years old) for COVID-19 vaccination. The patients medical history was not reported. No concomitant medication was reported. The patient did not have any allergies to medication, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 20Mar2021, the patient developed tingling and numbness on right foot and leg that come and go away . 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 outcome of the event tingling and numbness on right foot and leg was unknown at the time of report.    No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Hyperhidrosis, Paraesthesia oral
Clinical narrative: Tingling Lips and face; Sweating; Fast Heart Rate; Tongue Swelling; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 20Mar2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), zolpidem (AMBIEN), montelukast (SINGULAIR), lisdexamfetamine (VYVANSE) and cetirizine (ZYRTEC), all for unknown indications from unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received hepatitis B vaccine (MANUFACTURER UNKNOWN) on 26Feb2021 as immunisation, 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient experienced tingling lips and face, sweating, fast heart rate, tongue swelling and headache.  The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events tingling lips and face, sweating, fast heart rate, tongue swelling and headache. The clinical outcomes of the events tingling lips and face, sweating, fast heart rate, tongue swelling and headache were not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Tingling Lips and face; Sweating; Fast Heart Rate; Tongue Swelling; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 20Mar2021 at 12:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), zolpidem (AMBIEN), montelukast (SINGULAIR), lisdexamfetamine (VYVANSE) and cetirizine (ZYRTEC), all for unknown indications from unknown dates. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received hepatitis B vaccine (MANUFACTURER UNKNOWN) on 26Feb2021 as immunisation, 4 weeks prior to the COVID vaccine. On 20Mar2021, the patient experienced tingling lips and face, sweating, fast heart rate, tongue swelling and headache.  The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events tingling lips and face, sweating, fast heart rate, tongue swelling and headache. The clinical outcomes of the events tingling lips and face, sweating, fast heart rate, tongue swelling and headache were not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Continued Severe right ear pain; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EN6198), via an unspecified route of administration in the left arm on 17Mar2021 10:10 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications included LEXAPRO and ZYRTEC. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 17Mar2021 at 16:00, the patient experienced continued severe right ear pain. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the event ear pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm where vaccine was injected,; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in left arm on 06Mar2021 at 00:00 (at the age of 64-years-old), as a single dose, for COVID-19 immunisation. Medical history and concomitant medication were not reported. 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 4 weeks prior to the COVID-19 vaccine. On 06Mar2021, at 12.00am the patient experienced sore arm where vaccine was injected which lasted about 7days. No therapeutic measures were taken as a result of adverse event. The clinical outcome of the event vaccination site pain was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Short term rapid racing of heart; This is a spontaneous report received from a contactable consumer, the patient. A 52-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 20Mar2021 at 14:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes and colitis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included metformin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) for unknown indications from unknown dates. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Mar2021 at 15:15, the patient experienced short term rapid racing of heart after the 15-minute wait time, around the 30-minute mark after the first dose, like being over caffeinated. 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 short term rapid racing of heart. The clinical outcome of the event short term rapid racing of heart was recovered on 20Mar2021.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: fever of 101; flu like symptoms; chills; headache; This is a spontaneous report received from a contactable consumer, the patient. A 73-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on the right arm on 19Mar2021 at 11:00 (at the age of 73-years-old) for COVID-19 immunisation. Medical history included blood pressure high (BPH).  The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included terazosin (MANUFACTURER UNKNOWN) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) unspecified route of administration on the right arm on 26Feb2021 at 14:00 as a single dose for COVID-19 immunisation. Additionally, the patient previously took unspecified pill for blood pressure. On 19Mar2021 the body temperature was measured and was found to be 101 (unspecified unit). On 19Mar2021 at 23:00 the patient experienced with fever of 101 unspecified unit, flu like symptoms and at night in bed the patient had chills and headache. Therapeutic measures were taken as a result of events and included treatment with ibuprofen. The clinical outcome of the events fever of 101, flu like symptoms, chills and headache was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Severe abdominal pain located right hand side below navel toward hip; This is a spontaneous report received from a contactable patient. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6207) via an unspecified route of administration in the left arm on 18Mar2021 at 12:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure but under control with medication. The patient was allergic to nuts, some fish, melons. Concomitant medications received (unspecified medication). 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 4 weeks prior to the COVID vaccine. The patient had not tested positive for COVID-19 since having the vaccine. On 12Mar2021 at 01: 00, the patient experienced severe abdominal pain located right hand side below navel toward hip. The patient did not receive treatment for the event. Adverse event not resulted in doctor health care visit. The clinical outcome of severe abdominal pain located right hand side below navel toward hip was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph node,; Pain in whole arm and underarm; pain in whole arm and underarm; This is a spontaneous report received from a contactable consumer, the patient. A 42-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 17Mar2021 at 23:30 as a single dose for COVID-19 immunisation. Medical history included COVID-19.  Concomitant medication included vitamins (MANUFACTURER UNKNOWN) for an unknown indication. The patient previously received flu vaccine [MANUFACTURER UNKNOWN] in the left arm on 12Oct2020. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. Since the vaccination, the patient had not tested for COVID-19. The patient experienced swollen lymph node and pain in whole arm and underarm, on 18Mar2021 at 08:00. The patient did not receive any treatment for 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 swollen lymph node and pain in whole arm and underarm was reported as recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node around left collarbone; This is a spontaneous report from a contactable consumer. A 49-year-old adult non-pregnant female 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 04Mar2021 at 17:15 (at the age of 49-years-old), as a single dose for COVID-19 immunisation. The patient medical history included obesity, arthritis and back stenosis. The patient had nuts allergy. Concomitant medications included unspecified antibiotic, vitamins and cough medicine from an unspecified date. The patient had not received 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 tested positive for COVID-19. On an unspecified date in Mar2021 at 12:00, the patient experienced swollen lymph node around left collarbone. No therapeutic measures were taken as a result of adverse events. The clinical outcome of swollen lymph node around left collarbone was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing ears (left ear more noticeable than the right ear); This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration on left arm on 17Mar2021 at 10:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to walnut from an unknown date. The patient was allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. On 20Mar2021 at 13:00 the patient experienced ringing in ears but left ear had more noticeable when compared to right ear. The patient did not receive any treatment for events. The clinical outcome of the event ringing ears (left ear more noticeable than the right ear) was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Night sweats
Clinical narrative: night sweats; Headache; chills; This is a spontaneous report received from a contactable consumer. A 45-years-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration on 17Mar2021(at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19, gout and fatty liver. The concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced headache, night sweats and chills for 3 days which was reported as ongoing. The patient did not receive any treatment for the reported events. The adverse 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 events headache, night sweats and chills were not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Bladder pain, Polyuria
Clinical narrative: Frequent urge to urinate; slight pain at lower abdomen; slight pain at bladder area; This is a spontaneous report received from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8727), via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves disease (hyperthyroidism), moderately cholesterol and sulpha 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. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), progesterone (MANUFACTURER UNKNOWN), estradiol (DIVIGEL), atorvastatin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6203), via an unspecified route of administration in the left arm on 25Feb2021 at 14:00 as a single dose (at the age of 58-years-old) for COVID-19 immunisation. On 20Mar2021 at 12:00, the patient experienced frequent urge to urinate with slight pain at lower abdomen/ bladder area. The patient did not receive any treatment for these 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 frequent urge to urinate with slight pain at lower abdomen/ bladder area was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Chemical taste in the back of throat taste of vaccine; This is a spontaneous report received from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration on the left arm on 18Mar2021 at 15:45 (at the age of 32-year-old), as single dose for COVID-19 immunisation. Medical history included celiac. The patient has allergic to latex. Concomitant medication included tramadol (MANUFACTURER UNKNWON) and multivitamin ritual (MANUFACTURER UNKNOWN) from an unknown date and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration on the left arm on 22Feb2021 at 15:00, as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not tested positive for COVID-19. On 18Mar2021 at 16:00 (for 2 hours after second dose), the patient experienced chemical taste in the back of throat taste of vaccine. On the following day, the patient had the same feeling which went away quickly. The patient described the event as it was similar to when she swallows a pill and it gets stuck or had not enough water. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event chemical taste was resolved on 19Mar2021.   No follow-up attempts possible. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Vaccination site pain, Viral test
Clinical narrative: Sore injection site; headache; fatigue; overall not feeling well feeling; This is a spontaneous report received from a contactable consumer, the patient. A 50-year-old-female non pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 05Mar2021 at 13:15 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history of the patient included high blood pressure, vitamin d deficiency, elevated cholesterol. Concomitant medications were not reported. The patient was allergic to sulfa. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient tested negative for COVID-19. The patient experienced sore injection site, headache, fatigue and overall, not feeling well on 05Mar2021 at 16:00. The patient underwent lab tests and procedures, which included nasal swab test on 12Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken for the reported events. The clinical outcome of the sore injection site, headache, fatigue and overall not feeling well feeling was resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in both hands and arms, likely tingling in feet too.; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 09:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included fluticasone (MANUFACTURER UNKNOWN) on an unknown date. Prior to 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 17Mar2021 at 07:00AM the patient experienced tingling in both hands and arms, likely tingling in feet too. The patient has not received any treatment for the events tingling in both hands and arms and likely tingling in feet. The clinical outcome of event tingling in both hands and arms, likely tingling in feet too was recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Rapid heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female 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 19Mar2021 at 11:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 had no allergies to medications, food, or other products. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. The patient experienced rapid heartbeat on 20Mar2021 at 23:00. The patient did not receive any treatment for heartbeat increased. The clinical outcome of the event heartbeat increased was unknown at the time of this report.  Information about lot number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: recurrent horrible migraine headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6199), via an unspecified route of administration in the right arm on 12Mar2021 at 10:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. It was reported that, the patient not had migraine in past 6 months and also not had two in a row before this time. The patient did not have any 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. Concomitant medications were not reported. On 14Mar2021 at 13:00 (two days after receiving the vaccine), the patient experienced horrible migraine headache that effected vision and had vomiting all night long. After getting better, the patient had another episode of migraine and spent night throwing up. Therapeutic measures were taken and included treatment with migraine medications (unspecified). The clinical outcome of the event recurrent migraine headache was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Oedema peripheral, Pain, Wheezing
Clinical narrative: Leg/feet swelling (edema); Aches; Wheezing; Difficulty catching my breath (like the patient had bronchitis); Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 16Mar2021 at 14:15 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetic, blood pressure, cholesterol, neuropathy and depression. The patient had allergic reaction to original MMR vaccine in 1965. Concomitant medications included insulin (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), LYRICA and ZOLOFT for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. On 17Mar2021 at 12:00, the patient had leg/feet swelling (edema), headache, aches, wheezing and difficulty catching breath (like she had bronchitis). The patient did not receive any treatment for the adverse 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 leg edema, headache, aches, wheezing and difficulty breathing was not recovered 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: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number {GB-MHRA-WEBCOVID-202106151223546340-NMY0H}, Safety Report Unique Identifier {GB-MHRA-ADR 25476963}. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route on 14Jun2021 as a single dose for COVID-19 immunisation and received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route on 14Jun2021 as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 18May2021, The patient underwent lab tests which included COVID-19 virus test and the result was found to be negative. On 14Jun2021, the patient experienced heart rate. On 15Jun2021, the patient experienced nosebleed. On an unknown date in Jun2021, the patient experienced tachycardia 20 minutes after jab and arm started to become more painful. The clinical outcome of the events heart rate and nosebleed were resolved. The clinical outcome of the events tachycardia 20 minutes after jab and arm started to become more painful were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: 2x2 inch dark bruising fever in shot arm; Swelling in shot arm around bruising; Redness in shot arm around bruising; Redness in shot arm around bruising and hurts; fever in shot arm; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 18Mar2021 at 13:15 (at the age of 74-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer in 1991, hysterectomy in 1995 and abdominal surgery in 2017. The patient did not have any allergies to medications, food, or other products. Concomitant medications included bupropion (WELLBUTRIN XL) tablet 150mg once a day from an unknown date for unknown indication and levothyroxine sodium (SYNTHROID) tablet 50 (unspecified units) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 25Feb2021 at 12:30 (at the age of 74-years-old), as a single dose for COVID-19 immunisation. 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 18Mar2021 at 16:45, the patient had 2x2 inch dark bruising fever in shot arm (vaccinated arm), swelling and redness around bruising and it hurts. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site bruising, fever, swelling, redness in shot arm around bruising and hurts were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Shortness of breath; Fatigue; This is a spontaneous report received from a contactable physician, reporting for the patient. A non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 had not received any other vaccine within four weeks prior to the vaccination. On 15Mar2021 (2 days after vaccination), the patient experienced shortness of breath and fatigue. The patient had not received any treatment for the adverse events. The patient had doctor or other healthcare professional office/clinic visit as a result of the adverse events. The clinical outcome of events shortness of breath and fatigue were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia
Clinical narrative: Intense muscle pain in left shoulder traveling down left side of back.; Painful to breathe at times. Lasting longer than expected.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route administration in left arm on 17Mar2021 at 02:45, as a single dose for COVID-19 immunisation. Medical history included depression and plantar fasciitis. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications received within 2 weeks of vaccination included meloxicam (MANUFACTURER UNKNOWN), PREVAGEN, AMBEREN and CLARITIN all from unknown dates for unknown indication. On 18Mar2021, at 05:00, the patient experienced intense muscle pain in left shoulder traveling down left side of back. The patient felt painful to breathe at times (breathing difficult) which was lasting longer than expected. The patient did not receive any treatment for events. The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of muscle pain and breathing difficult was not resolved. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Rash
Clinical narrative: Swollen eyes with rash; Swollen eyes with rash; This is a spontaneous report from a contactable consumer, the patient. A 38-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 left arm on 19Mar2021 at 10:45 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to amoxicillin-m. 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. Concomitant medications taken within two weeks of vaccination included CLARITIN-D and spironolactone (MANUFACTURER UNKNOWN) both for unknown indication and from an unknown date. The patient experienced swollen eyes with rash on 20Mar2021 at 15:00. No Therapeutic measures were taken for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen eyes and rash was not recovered. No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity
Clinical narrative: Migraine/headache through the night starting around 9pm and into the next day; Ache in arm; This is a spontaneous report received from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the right arm on 20Mar2021 at 13:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included bronchiectasis and migraines due to winter/pressure (haven't had a migraine in weeks as winter was over). The patient did not have any allergies to food, medications, or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. On 20Mar2021 at 21:30, the patient experienced migraine/headache throughout the night and into the next day (21Mar2021). The patient had no idea how long this would last. The patient also experienced ache in arm on 20Mar2021 but was not concerned. The events didn't 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 pain in arm and migraine headache was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.