chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus
Clinical narrative: Itching under arm and right breast; Pain in shoulder blade; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 08Apr2021 at 13:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. 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 not been tested for COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 09Apr2021 at 17:00, the patient experienced itching under arm and right breast and pain and shoulder blade. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itching under arm and right breast and pain in shoulder blade was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the head; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have a history of allergies to any food or medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date the patient experienced ringing in the head. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in the head was unknown at the time of report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Body temperature, Confusional state, Disorientation, Gait disturbance
Clinical narrative: Confusion; Swollen face; Swollen lips; Swollen ankles; Swollen right arm; Fever 100.0 F for a few days.; Memory loss for few days; Disorientation; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney transplant, lupus, rheumatoid arthritis and vasculitis; all from unknown dates. The patient had known allergies to sulfa and ciprofloxacin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), prednisone (MANUFACTURER UNKNOWN) and unspecified heart medications and immunosuppressive; all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 08:15, the patient experienced confusion, swollen face and lips, swollen ankles and right arm, fever 100.0 F (Fahrenheit) for a few days, memory loss for a few days, disorientation and difficulty walking. On 09Apr2021, the patient's body temperature was found to be 100.0 F. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events confusion, swollen face and lips, swollen ankles and right arm, fever 100.0 F for few days, memory loss for few days, disorientation and difficulty walking was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Lip swelling, Peripheral swelling, Pyrexia, Swelling face
Clinical narrative: Confusion; Swollen face; Swollen lips; Swollen ankles; Swollen right arm; Fever 100.0 F for a few days.; Memory loss for few days; Disorientation; Difficulty walking; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: TW0151) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney transplant, lupus, rheumatoid arthritis and vasculitis; all from unknown dates. The patient had known allergies to sulfa and ciprofloxacin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (ASPIRIN), prednisone (MANUFACTURER UNKNOWN) and unspecified heart medications and immunosuppressive; all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 08:15, the patient experienced confusion, swollen face and lips, swollen ankles and right arm, fever 100.0 F (Fahrenheit) for a few days, memory loss for a few days, disorientation and difficulty walking. On 09Apr2021, the patient's body temperature was found to be 100.0 F. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events confusion, swollen face and lips, swollen ankles and right arm, fever 100.0 F for few days, memory loss for few days, disorientation and difficulty walking was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination site pain
Clinical narrative: Chills; Headache; Muscle aches; Pain at the injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm  on 10Apr2021(at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. The patient did not have any allergies to medications, food, or other products Concomitant medications included losartan (MANUFACTURER UNKNOWN) for an unknown indication received within 2 weeks of vaccination. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the  left arm on 20Mar2021 at 11:15 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 12:00 the patient experienced chills, headache, muscle aches and pain at the injection site. No therapeutic measures were taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, headache, muscle aches and pain at the injection site were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in left back shoulder blade after 2 days; This is a spontaneous report from a contactable consumer, the patient. A 61-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 10Apr2021 at 16:15(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Relevant medical history included rheumatoid arthritis (RA) and asthma. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), furosemide (FUROSIMIDE) and spironolactone (SPIRONOLACTON); all for unknown indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 20Mar2021 at 17:00 (at the age of 61-year-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 16:00, the patient experienced pain in left back shoulder blade after 2 days. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in left back shoulder blade after 2 days was not recovered at the time this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Had sore arm with first dose, hurt when sleeping on my left arm/Second shot, the left arm was very sort, hurting to use my arm for 2 days.; Felt a little dizzy/some dizziness.; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 19Mar2021 at 07:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 09Apr2021 at 07:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patients' medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in 2021, after the first dose the patient reported that he had a sore arm that hurt when he slept on his left arm. The patient also felt a little dizzy. On 10Apr2021, after the second shot the patient reported that the "left arm was very sort" and it hurt when he used his arm for 2 days. The patient also experienced some dizziness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events' sore arm that hurt when he slept on his left arm and felt a little dizzy were resolved on an unspecified date in 2021. The clinical outcomes of the events "left arm was very sort" and some dizziness were resolved on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Whole face was numb; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Mar2021 at 08:30(at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included fluoxetine hydrochloride (PROZAC), multi-vitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. 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 not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021 at 08:45, the patient's whole face was numb. Therapeutic measures were taken as a result of events and included treatment with BENADRYL & two days in bed. The clinical outcome of the event whole face was numb was recovered on an unknown date in April2021 at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Papule
Clinical narrative: Raised, red bumps on arms, legs and torso; Raised, red bumps on arms, legs and torso; Body aches; This is a spontaneous report from a contactable other healthcare professional. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733) via an unspecified route of administration in left arm on 01Apr2021 at 10:15 (at an age of 48-year-old) as single dose for COVID-19 immunisation.  Medical history included whipple surgery from pancreatic tumor, diabetes, depression and COVID-19. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), pioglitazone (MANUFACTURER UNKNOWN), dapagliflozin propanediol monohydrate (FARXIGA), insulin detemir (LEVEMIR) and semaglutide (OZEMPIC), all from unknown dates and for unknown indications. The patient previously received sulfamethoxazole, trimethoprim (BACTRIM) on an unknown date and experienced allergy. 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 09Apr2021 at 06:30 seven days after receiving the first dose of vaccine, the patient experienced raised red bumps on arms, legs, torso. On 09Apr2021 the same night, the patient also experienced body aches when bumps appeared. The patient did not receive any 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 raised red bumps on arms, legs, torso and body aches were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Swelling left eyelid; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) in the arm right on 09Apr2021 at 15:45 as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) in the arm left on an unknown date, as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, after first COVID-19 vaccine the patient experienced left eyelid swelled up for four days. After the second vaccine, on an unknown date his left eye swelled up again and went on day four at the time of report and it was not got any better. Therapeutic measures were not taken as a result of this event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling left eyelid was unknown 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: Lymphadenopathy
Clinical narrative: Swollen axillary lymph node left arm pit; This is a spontaneous report from a 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: ER8737) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included histoplasmosis, COVID-19. The patient's concomitant medications included adalimumab (HUMIRA), methotrexate (MANUFACTURER UNKNOWN), folinic acid (LEUCOVORIN) and levothyroxine (MANUFACTURER UNKNOWN) all for unknown indications on started on an unknown date and unknown if ongoing. The patient previously received Macrobid and fluorescein dye and experienced allergy. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 23:00, the patient experienced swollen axillary lymph node in the left armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen axillary lymph node left armpit was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Skin odour abnormal
Clinical narrative: Quickly developed awful, sour smelling body odor; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 12Apr2021 at 15:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic autoimmune urticaria since an unspecified date. Concomitant medications included cetirizine hydrochloride (ZYRTEC), hydroxyzine (MANUFACTURER UNKNOWN), pregabalin (MANUFACTURER UNKNOWN), famotidine (MANUFACTURER UNKNOWN) and vitamin d (MANUFACTURER UNKNOWN) all for an unknown indication started on unspecified dates and unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 22Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 15:45, the patient experienced nothing severe but quickly developed awful, sour-smelling body odor. The event did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of this adverse event. The clinical outcome of the event quickly developed awful, sour-smelling body odor was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness; tingling on left side, left leg and foot; This is a spontaneous report from a contactable non-health care professional. A 33-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 on an unknown date in Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included zinc (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication on an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, three days after first vaccine, the patient experienced numbness, tingling on left side, left leg and foot, it had moved to fingers and right side now. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events and included treatment with unspecified medication. It was reported that the patient had MRI of neck and brain. The clinical outcome of the events numbness and tingling on left side, left leg and foot was not recovered at the time of this report.   No follow up attempts needed. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Gastric disorder, Heart rate increased, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: my heart rate went up; rapid deep breaths; tingling and numbness in my lips; tingling and numbness in my lips; mild stomach weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 08:30 (age at the time of vaccination was 42-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took aspirin (E.C.) and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at time of vaccination. Patient did not receive other medications within 2 weeks of vaccination. On 24-MAR-2021 08:30, "approximately 3-5 minutes after 1st dose of covid vaccine, my heart rate went up, I began to have rapid deep breaths, tingling and numbness in my lips and mild stomach weakness. I had two more episodes of these symptoms within 1 hour after receiving the shot. The fire rescue on site took my heart rate and blood pressure during the first episode of my symptoms. I am scheduled to take the second shot on 15Apr and I would like to know if after experiencing these symptoms I should still take the second dose". The patient did not receive any treatment for AEs. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Migraine, Polymenorrhoea, Vertigo
Clinical narrative: Extreme virtigo. The virtigo is constant anddoesnt change if I sit, stand, or laydown.; Migraine; Stomach sickness; So dizzy cant function; Period 3 times in the last 5 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic daily migraines and ovarian cysts. Concomitant medications included mirtazapine (REMERON) 30 mg once daily and buprenorphine hydrochloride (SUBTEX) 2mg sublingual tablets twice daily; both from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration in the left arm on 15Mar2021 at 12:45 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient previously took tramadol hydrochloride (ULTRAM) and codeine (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. The patient did not receive any other vaccines within 4 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 06Apr2021 at 15:00, the patient experienced extreme virtigo for over 1 week which caused a migraine and stomach sickness, so dizzy can't function. The virtigo is constant and doesn't change if the patient sit, stand or lay down. The patient also had period 3 times in the last 5 week. It was reported that the patient had no side effects after the first dose. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with antivert and zofran. The clinical outcome of the events extreme virtigo, the virtigo is constant and doesn't change if I sit, stand, or lay down, migraine, stomach sickness, dizzy can't function and period 3 times in the last 5 week were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Computerised tomogram, Diarrhoea
Clinical narrative: About 2 days after receiving the second shot, diarrhea and horizontal burning in lower left side of abdomen.; Horizontal burning in lower left side of abdomen; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included diverticulosis. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) 100mg and multi-vitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient received codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 14Feb2021, about 2 days after receiving the second shot the patient experienced diarrhea and horizontal burning in lower left side of abdomen. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with computerized tomography (Cat) scan, blood work and upper Gastrointestinal (GI). The clinical outcome of the events diarrhea and horizontal burning in lower left side of abdomen were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Rapid heartbeat.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included depression, low thyroid, herpes simplex virus (HSV), migraine, sleep apnea and arthritis, seasonal allergies and  known allergies to penicillin, sulfa and latex. The patient received unspecified medications within two weeks of vaccination and reported that there was not enough room for all medications. The patient previously received tetracycline (MANUFACTURER UNKNOWN) for unspecified indication from unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 14:00, the patient experienced rapid heartbeat. The patient underwent lab tests and procedures which included hear rate on 23Mar2021 and the result was rapid heartbeat. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rapid heartbeat was recovered on an unknown date of 2021.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Muscle twitching
Clinical narrative: Twitching/muscle spasm in left leg; Menstrual period started 2.5 weeks early; Menstrual period heavy; This is a spontaneous report from a contactable consumer, the patient. A 29-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 06Apr2021 at 15:30 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as not available and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25 milligrams XR, vitamin b12 nos (MANUFACTURER UNKNOWN) and ascorbic acid; biotin; minerals nos; nicotinic acid; retinol; tocopherol; vitamin b nos; vitamin d nos (PRENATAL VITAMINS) for an unknown indication from an unknown date. The patient did not receive any other vaccines within 4 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 06Apr2021 at 16:00, 30 minutes after the shot the patient experienced twitching or muscle spasm in left leg which went away within an hour, menstrual period started 2.5 weeks early and heavy. It was reported that last period was 4 days from 25Mar-28Mar and patient's cycle was regular and period always starts in the morning, but this period started in the evening and no PMS signs or symptoms. No therapeutic measures were taken for the events. The 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 events twitching or muscle spasm in left leg, menstrual period started 2.5 weeks early and heavy were recovered with sequelae on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Nausea, SARS-CoV-2 test
Clinical narrative: Delayed dizziness; fatigue; Brain fog; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 30Mar2021 at 14:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had nil known allergies to medications, food, or other products. Concomitant medications included creatine monohydrate 5 mg (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 05Apr2021 at 07:00, 6 days after first dose of vaccine, the patient experienced symptoms of delayed dizziness, fatigue, brain fog and nausea. Therapeutic measures were taken as a result of the event which included treatment with anti nausea drug and unspecified intravenous drug. On 07Apr2021, the patient underwent nasal swab test and the result was negative. The events resulted in emergency room/department visit or urgent care. The clinical outcome of the event dizziness, fatigue, brain fog and nausea was resolved with lasting effects on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in left arm, hand, leg and foot; This is a spontaneous report from a contactable consumer, the patient. A 38-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 10Apr2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and doxylamine succinate (UNISOM). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took 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 14:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 20:00, the patient experienced tingling in left arm, hand, leg and foot. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event tingling in left arm, hand, leg and foot was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pain, Pyrexia
Clinical narrative: She has body aches; Chilling with temperature of 102.1; Not feeling the best and feeling lousy; This is a spontaneous report from a contactable consumer. A 37-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 08Apr2021 at 11:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 18Mar2021 at 16:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021, the patient experienced body aches, chilling with temperature of 102.1 and not feeling the best and feeling lousy. Therapeutic measures were not taken as a result of reported events. The clinical outcome of the events body aches, chilling with temperature of 102.1 and not feeling the best and feeling lousy was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash just below vaccine site; This is a spontaneous report from a contactable consumer, the patient. A 17-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 right arm on 12Apr2021 at 16:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included peanut allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patent did not receive any medication within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in Apr2021, the patient experienced rash just below vaccine site. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event rash just below vaccine site was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: "node still quite enlarged. A bit painful"; very enlarged lymph node neck/collarbone; fingers tingling; hands/feet/scalp itchy; Chills; Fever 101.3F; Headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 15:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included irritable bowel syndrome with constipation, seasonal allergy and sulfonamide allergy. Concomitant medications included levonorgestrel (MIRENA) and psyllium hydrophilic mucilloid (METAMUCIL) from unknown start dates for unknown indications and unknown if ongoing. The patient previously took Keflex and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on an unknown date at 15:30 (at the age of 39-years-old) as a 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 four weeks prior to the vaccination. Lab tests and procedures included body temperature test on 06Apr2021 and the result was found to be 101.3F. On 06Apr2021 the patient had "normal" side effects in first two days which included chills (8 hours after vaccine) followed by fever (101.3F) and headache. On 09Apr2021, third day after vaccine, the patient developed very enlarged lymph node on neck/collarbone; fingers tingling and hands/feet/scalp itchy. On 12Apr2021, 6 days post vaccine, itchiness had declined but node still quite enlarged and bit painful. Since the vaccination, the patient had not been tested for COVID-19. 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 chills, fever 101.3F, headache, very enlarged lymph node neck/collarbone, fingers tingling and "node still quite enlarged. A bit painful" was recovering. The clinical outcome of the event hands/feet/scalp itchy was recovered on 12Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Pyrexia
Clinical narrative: "node still quite enlarged. A bit painful"; very enlarged lymph node neck/collarbone; fingers tingling; hands/feet/scalp itchy; Chills; Fever 101.3F; Headache; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 15:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included irritable bowel syndrome with constipation, seasonal allergy and sulfonamide allergy. Concomitant medications included levonorgestrel (MIRENA) and psyllium hydrophilic mucilloid (METAMUCIL) from unknown start dates for unknown indications and unknown if ongoing. The patient previously took Keflex and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on an unknown date at 15:30 (at the age of 39-years-old) as a 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 four weeks prior to the vaccination. Lab tests and procedures included body temperature test on 06Apr2021 and the result was found to be 101.3F. On 06Apr2021 the patient had "normal" side effects in first two days which included chills (8 hours after vaccine) followed by fever (101.3F) and headache. On 09Apr2021, third day after vaccine, the patient developed very enlarged lymph node on neck/collarbone; fingers tingling and hands/feet/scalp itchy. On 12Apr2021, 6 days post vaccine, itchiness had declined but node still quite enlarged and bit painful. Since the vaccination, the patient had not been tested for COVID-19. 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 chills, fever 101.3F, headache, very enlarged lymph node neck/collarbone, fingers tingling and "node still quite enlarged. A bit painful" was recovering. The clinical outcome of the event hands/feet/scalp itchy was recovered on 12Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Fatigue, Hot flush, Hyperhidrosis, Influenza like illness
Clinical narrative: Hot flashes/About 30 minutes into after my vaccination, I started getting hot flashes.; Began to sweat; I apparently forgot that I had said some things.; The day ended with exhaustion; Flu or allergy-like symptoms; Stuffy yet also runny nose; Warm feverish face; Eyes that were watery; Eyes burning; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS729) via an unspecified route of administration in the left arm on 11Apr2021 at 17:00(at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, blood pressure high, porphyria, anxiety, sulfonamide allergy and MRI Contrast Media dye allergy. The patient did not receive any other medicines within two 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 17:30 about 30 minutes after vaccination, the patient started getting hot flashes. It was not hot in the room, but the patient began to sweat. Following that, the patient apparently forgot that he had said some things. The day ended with exhaustion and flu or allergy-like symptoms, stuffy yet also runny nose, warm feverish face, and eyes that were watery and burning. The clinical outcome of the events hot flashes, began to sweat, forgot had said something, exhaustion, flu or allergy-like symptoms, stuffy yet also runny nose, warm feverish face and eyes that were watery and burning was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Memory impairment, Rhinorrhoea, Skin warm
Clinical narrative: Hot flashes/About 30 minutes into after my vaccination, I started getting hot flashes.; Began to sweat; I apparently forgot that I had said some things.; The day ended with exhaustion; Flu or allergy-like symptoms; Stuffy yet also runny nose; Warm feverish face; Eyes that were watery; Eyes burning; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERS729) via an unspecified route of administration in the left arm on 11Apr2021 at 17:00(at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, blood pressure high, porphyria, anxiety, sulfonamide allergy and MRI Contrast Media dye allergy. The patient did not receive any other medicines within two 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 17:30 about 30 minutes after vaccination, the patient started getting hot flashes. It was not hot in the room, but the patient began to sweat. Following that, the patient apparently forgot that he had said some things. The day ended with exhaustion and flu or allergy-like symptoms, stuffy yet also runny nose, warm feverish face, and eyes that were watery and burning. The clinical outcome of the events hot flashes, began to sweat, forgot had said something, exhaustion, flu or allergy-like symptoms, stuffy yet also runny nose, warm feverish face and eyes that were watery and burning was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.