chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Severe uncontrollable chills and shivering; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0150) via an unspecified route of administration in the left arm on 03Apr2021 at 16:45 (at the age of 58-years) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient was allergic to shellfish. Concomitant medications in two weeks of vaccination included bupropion hydrochloride (WELLBUTRIN) and mirtazapine (REMERON) for unknown indications. The patient did not receive any other vaccines within 4 weeks prior to the COVID 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 04Apr2021 at 04:15, the patient experienced pain at injection site and 12 hours later, the patient experienced uncontrollable chills and shivering. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events pain at injection site, uncontrollable chills and shivering was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took amoxicillin on unknown date for an unspecified indication and experienced drug allergy. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021 at 16:00, the patient experienced sore arm and a little tired. Tiredness went away the next day and no other side effects. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm was resolved on an unknown date in Mar2021 and a little tired was resolved on 10Mar2021. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Head discomfort, Pain in extremity
Clinical narrative: slightly lack of energy.; Sore arm; a little tired; Stuffy head; This is a spontaneous report from a non-contactable consumer, the patient. A 58-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0150), via unspecified route of administration in the left arm on 02Apr2021 at 11:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation.  Medical history was reported as none and the patient had a history of allergy to amoxicillin. The patient did not receive any other medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 15:00, the patient experienced sore arm, a little tired and stuffy head. On 03Apr2021, on 2nd day after the shot the patient experienced slightly lack of energy and sore arm continued.  The 3rd day after the shot only sore arm was there.  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 receive any treatment for the events reported. The clinical outcome of the event sore arm was not recovered while the outcome of events stuffy head, a little tired and lack of energy was recovered on 04Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Tiredness; Temperature 99.6F higher than usually which is 96-97F; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 02Apr2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any known allergy to any medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021, the patient experienced tiredness and temperature (99.6F)(Fahrenheit) which was higher than usual which was 96-97F. 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 tiredness and temperature (99.6F). The clinical outcomes of the events tiredness and temperature (99.6F) were resolved on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report received from a contactable consumer. A female patient with unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date (at unknown age) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any medication within two weeks prior to the COVID-19 vaccine. 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 unknown date, the patient experienced fever. The clinical outcome of the event fever was unknown at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy rash at injection site; Itchy rash at injection site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 30Mar2021 at 09:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), alpha-1 antitrypsin deficiency and vasculitis. The patient had history of known allergies to medications, food or other products. The patient received unspecified concomitant medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267) via an unspecified route of administration in the left arm on 09Mar2021 at 09:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 17:00, the patient experienced itchy rash at injection site. 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 the event itchy rash at injection site was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot
Clinical narrative: Cold sweat; Feeling overheated; Sudden fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the left arm on 03Apr2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), acetylsalicylic acid;caffeine;paracetamol (EXCEDRIN) and melatonin (MANUFACTURER UNKNOWN), all from unknown dates for unknown indications. 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-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 03Apr2021 at 15:00, the patient experienced cold sweat though feeling overheated and sudden fatigue. 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 patient did not receive any treatment for the adverse events. The clinical outcome of the events cold sweat, feeling overheated and sudden fatigue were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory disturbance, Swelling face
Clinical narrative: Swelling and sensation in left cheek; Swelling and sensation in my left cheek; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the left arm on 03Apr2021 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included mefenamic acid (MEFTAL) pain killer taken for unknown indication from an unknown date. On 03Apr2021, the patient experienced swelling and sensation in left cheek. The patient did not receive any treatment for the events. The clinical outcome of the event swelling and sensation in left cheek was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasms
Clinical narrative: Leg cramps; Discomfort near the heel and calf; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the arm left on 03Apr2021 at 10:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS). The patient had no known allergies. Concomitant medications included MILK THISTLE 500 mg and QUNOL COQ-10 20 for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 09:00, the patient experienced leg cramp and discomfort near the heel and calf. 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 reported events. The clinical outcome of the events leg cramp and discomfort near the heel and calf was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 61-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included peripheral neuropathy, hypertension and migraines. The patient had history of allergies to lisinopril, amlodipine and Percocet. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), ASPIRIN, vitamin b1 (MANUFACTURER UNKNOWN) and vitamin D3 (MANUFACTURER UNKNOWN) 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 vaccination. On 31Mar2021 the patient experienced Inflamed left toe joint within 24 hours of vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with foot wrap and foot boot. The clinical outcome of the event inflamed left toe joint was not resolved. No follow-up attempts are needed. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach cramping; Diarrhea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 27Mar2021 at 13:30 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included medroxyprogesterone acetate (DEPO PROVERA), hydroxyzine (MANUFACTURER UNKNOWN) and lithium carbonate (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. 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, the patient experienced diarrhea and stomach cramping. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of diarrhea and stomach cramps was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 100.3; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the right arm on 03Apr2021 at 13:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known 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 been tested for COVID-19. On an unknown date, the patient underwent lab test and procedure which included nasal swab and tested negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 12:00, the patient experienced fever of 100.3 and arm pain. On 04Apr2021, the body temperature was reported as 100.3 (unit unspecified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events fever and arm pain was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Contusion, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and pinching on both hands/fingers; Numbness; Blisters on tips of fingers; Bruising under nails.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6199) via an unspecified route of administration in the left arm on 06Mar2021 at 13:45 (at the age of 42-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 14:45 (at the age of 42-years-old) as single doses for COVID-19 immunisation. Medical history included diabetes type 2. The patient did not have any allergies to medications, food, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 06Mar2021 at 17:30, the patient experienced tingling and pinching on both hands/fingers also numbness, blisters on tips of fingers and bruising under nails. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. Therapeutic measures were taken as a result of events tingling and pinching on both hands/fingers, numbness, blisters on tips of fingers and bruising under nails which included treatment with prednisone (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN). The clinical outcomes of the events tingling and pinching on both hands/fingers, numbness, blisters on tips of fingers and bruising under nails were not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Somnolence
Clinical narrative: extreme tiredness the following day; Sleepiness in the evening of the vaccine; Chills during the night; Headache; This is a spontaneous report from a non-contactable consumer. A 64-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the arm left on 02Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included threshold diabetes diagnosis (no medication) and high BMI (body mass index). The patient was allergic to fish, shellfish, nickel and latex upon prolonged contact. Concomitant medications included loratadine (CLARITIN), vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and baby aspirin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the arm left on an unspecified date in Mar2021 at 10:00 (at the age of 64-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-19 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 02Apr2021 at 20:00, the patient experienced sleepiness in the evening of the vaccine, chills during the night, headache and extreme tiredness the following day. The patient could only sleep through most of the next day. Overall, it was about 24 hours of feeling very sick, then it began to fade away. 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. Clinical outcome of sleepiness, chills, headache, tiredness was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder
Clinical narrative: Easy on right lower extemity; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737), via an unspecified route of administration in the right arm on 02Apr2021 at 10:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, hypertension, breast cancer (breast cancer survivor), anxiety and depression. The patient was not allergic to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included glipizide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and simvastatin (ZOCOR). Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID-19 vaccination. On 04Apr2021 at 03:30, the patient experienced easy on right lower extremity (Lower extremity dysfunction). The event did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event lower extremity dysfunction was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Feeling abnormal, Headache, Lip swelling, Malaise
Clinical narrative: mouth,throat and eyes feltweird; slightly itchy in eyes andmouth.; slightly itchy in eyes andmouth.; headache; low-grade fever; not feeling well; mouth swelled; lip swelled; This is a spontaneous report received from a contactable consumer, the patient. A 53-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 01Apr2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have a history of allergies to food, medications, or other products. The patient did not receive any medication within two weeks of COVID-19 vaccine. 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 03Apr2021 at 16:00, the patient experienced usual headache, low-grade fever and she was not feeling well. On 03Apr2021 (reported as last night at the time of report), left side of her mouth and lip swelled up which was hold up all night. The patient woke up in the next morning, it was swollen. Her mouth, throat felt weird and her eyes felt a little weird on 04Apr2021. Like she was going to have an allergic reaction. The patient felt slightly itchy in her eyes and mouth on 04Apr2021. She was worried about getting her second dose. 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 headache, low-grade fever, not feeling well, mouth swelled, lip swelled, mouth, throat and eyes felt weird and slightly itchy in eyes and mouth was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pruritus, Pyrexia
Clinical narrative: mouth,throat and eyes feltweird; slightly itchy in eyes andmouth.; slightly itchy in eyes andmouth.; headache; low-grade fever; not feeling well; mouth swelled; lip swelled; This is a spontaneous report received from a contactable consumer, the patient. A 53-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 01Apr2021 at 15:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have a history of allergies to food, medications, or other products. The patient did not receive any medication within two weeks of COVID-19 vaccine. 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 03Apr2021 at 16:00, the patient experienced usual headache, low-grade fever and she was not feeling well. On 03Apr2021 (reported as last night at the time of report), left side of her mouth and lip swelled up which was hold up all night. The patient woke up in the next morning, it was swollen. Her mouth, throat felt weird and her eyes felt a little weird on 04Apr2021. Like she was going to have an allergic reaction. The patient felt slightly itchy in her eyes and mouth on 04Apr2021. She was worried about getting her second dose. 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 headache, low-grade fever, not feeling well, mouth swelled, lip swelled, mouth, throat and eyes felt weird and slightly itchy in eyes and mouth was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Menstruation irregular, Vaccination site pain
Clinical narrative: Headache; Sore arm at injection site; Fatigue; Irregular Period/vaginal bleeding; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8737), via an unspecified route of administration in the left arm on 01Apr2021 at 19:00 (at the age of 30-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. Concomitant medication included birth control pills unspecified (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021, the patient experienced headache, sore arm at injection site, fatigue and irregular period or vaginal bleeding. 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 patient did not receive any treatment for the headache, sore arm at injection site, fatigue and irregular period or vaginal bleeding. The clinical outcome of the events headache, sore arm at injection site, fatigue and irregular period or vaginal bleeding were unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lacrimation increased
Clinical narrative: left eye got swollen; eye watery; This is a spontaneous report from a contactable consumer, the patient. A 24-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 04Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Patient did not have any relevant medical history. The patient had no known allergies. The concomitant medication was taken by the patient (birth control pill) within two 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 been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021 at 16:00, two hours after the injection, the patient experienced left eye swollen and watery. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and  emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events left eye swollen and watery was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hypoaesthesia, Pain in extremity, Palpitations
Clinical narrative: Slight temporary numbness in left arm; Odd feeling in pit of stomach; Palpitations while attempting to sleep; Sore left arm; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 17:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included glucose-6-phosphate dehydrogenase (G6PD) deficiency. The patient had an allergy to legumes. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), theanine (L-THEANINE), magnesium (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (MANUFACTURER UNKNOWN) all from an unknown date for unknown indication. The patient previously took aspirin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 18:00, the patient experienced a sore left arm where the vaccine was administered and slight temporary numbness in the left arm. The patient had an odd feeling in the pit of the stomach and had palpitations while attempting to sleep. 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 patient did not receive any treatment for the events. The clinical outcome of the events sore left arm, slight temporary numbness in left arm, odd feeling in pit of stomach and palpitations while attempting to sleep were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My period is normally very regular and was not due for 12 days at the time of the vaccine. However, I unexpectedly started my period the day after my first vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 30Mar2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer. Concomitant medications included tamoxifen (MANUFACTURER UNKNOWN) and levothyroxine sodium (SYNTHROID) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient experienced irregular periods. The patient reported that her period was normally very regular and was not due for 12 days at the time of the vaccine. However, she unexpectedly started her period the day after her first vaccination. 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 event. The clinical outcome of the event irregular periods was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Vision blurred, Vitreous floaters
Clinical narrative: left eye has blurry vision; A very large floater in the middle of the eye.; Throbbing migraine; Arm soreness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 29Mar2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included a heart attack 11 years ago due to Kawasaki virus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient previously received aspirin-based products and experienced sensitivity (but not bad as reported).  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 51-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 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced throbbing migraine and arm soreness a day after he received the vaccine. On 31Mar2021 at 06:00, the patient experienced blurry vision in left eye and a very large floater in the middle of his eye, two days after he received the vaccine. The events resulted in a doctor or other health care professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event throbbing migraine, arm soreness, floaters in eye and blurry vision was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Nausea; Headache; Fatigue; Sore arm; This is a spontaneous report from a contactable nurse. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and flu vaccine allergy. Concomitant medication included levothyroxine sodium (EUTHYROX) taken from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 13:00, the patient experienced nausea, headache, fatigue and sore arm(pain in arm). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, headache, fatigue and sore arm was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Body temperature increased, Chills, Pain
Clinical narrative: body aches; chills; Temperature 99.5; upset stomach; This is a spontaneous report from a contactable consumer, the patient.  A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 03Apr2021 at 08:45 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and obesity. The patient had no known allergies. Concomitant medications included amlodipine besilate; atorvastatin calcium (CADUET) and vitamin d nos (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 13Mar2021 at 08:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. 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 vaccine. On 03Apr2021 at 19:00, the patient experienced body aches, chills, temperature 99.5 (units unspecified) and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events body aches, chills, temperature 99.5 (units unspecified) and upset stomach were recovered with lasting effects on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness in lower neck-upper backareas; Stiffness in lower neck-upper backareas; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8737), via an unspecified route of administration in the left arm on 31Mar2021 at 10:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to ASPIRIN. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6288), via an unspecified route of administration in the left arm on 10Mar2021 at 11:00, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 12:00, the patient experienced stiffness in lower neck and in upper back areas. The patient did not receive treatment for the reported events. 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 stiffness in lower neck and upper back areas was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Urticaria
Clinical narrative: Both arms broke out in hives from shoulders to wrists (on on the underside though).Then it moved to my chest Thursday. Then it moved to my thighs Friday and to my lower legs by Sunday (today).; My shingles also flared back up; Tuesday (3/23) evening my shins started itching really bad. There were no visible signs of a rash or hives. They continued to itch through Saturday.; This is a spontaneous report from a contactable consumer, the patient. A 44-years-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 22Mar2021 at 15:45 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history included CREST Syndrome. The patient previously took codeine and experienced drug allergy. Prior to 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 vaccination. The patient received unspecified medications within 2 weeks of vaccination. On 23Mar2021 at 18:00, the patient experienced really bad itching and there were no visible signs of a rash or hives which continued to itch through Saturday. On 25Mar2021, the patient had shingles flaired back-up. On 31Mar2021, the patient's both arms broke out in hives from shoulders to wrists (on the underside though) and by thursday it moved to chest and by Friday to thighs and by Sunday to lower legs. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for itching, shingles and hives. The clinical outcome of the events itching, shingles and hives were not resolved at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: severe headache; shootingpain; slight pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 54-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 04Apr2021 at 14:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic severe asthma treated with mepolizumab (NUCALA) injection monthly and allergic to penicillin (PCN). Concomitant medications included mepolizumab (NUCALA) for asthma from an unknown date. The patient had known allergies to past drugs NSAIDs (non-steroid anti-inflammatory drugs), cyproheptadine hydrochloride (CYPRO) and zithromax (Z-PAK). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Apr2021 at 19:00, the patient experienced sudden severe headache, shooting pain and slight pain at injection site. 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 severe headache, shooting pain and injection site pain was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patient was allergic to penicillin, sulfa drugs and dairy. The patient previously 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 an unknown date, as a single dose for COVID-19 immunisation. Concomitant medications within 2 weeks of vaccination included ethinylestradiol, etonogestrel (NUVARING ), loratadine (CLARITIN) and ibuprofen (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. 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 4 weeks prior to the COVID vaccine. On 02Apr2021 at 23:00, 13 hours after the vaccination, the patient experienced chills which continued for about 45 minutes, fever which lasted for 12 hours and headache during the last final hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event chills and headache was resolved on 02Apr2021, while that of fever was resolved on 03Apr2021 at 11:00.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.