chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Poor quality sleep
Clinical narrative: Armpit lymph node major swelling; Chills; Fatigue; Difficulty concentrating; Slept poorly; Brain fog; Slight dizziness; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 04May2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, foot surgery, blood clotting and penicillin allergy. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 13Apr2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 23:00, Chills night of second dose. Slept poorly. Day after until day 11 after left armpit lymph node major swelling. Went away. Brain fog developed shortly after and was present 2weeks later. Fatigue/brain fog/difficultly concentrating/slight dizziness. Therapeutic measures were taken as a result of the events which included treatment with over-the-counter nose spray. The clinical outcome of armpit lymph node major swelling was recovered on an unknown date in May2021. The clinical outcome of the events chills night of second dose. Slept poorly. Brain fog developed shortly after and was present 2weeks later. Fatigue/brain fog/difficultly concentrating/slight dizziness were not resolved 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: Heavy menstrual bleeding, Lethargy, Menstruation irregular, Mood swings
Clinical narrative: 1 week after had menstrual cycle out of cycle; 7 days of heavy menstrual cycle; severe mood swings from crying to anger, very uncharacteristic; Lathergic and need to take several naps throughout day to function.; This is a spontaneous report from a non-contactable consumer, the patient. A 44-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 07May2021 at 13:15 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included gliclazide (CLARITIN), rubus idaeus leaf, sambucus nigra flower, sambucus nigra fruit (ELDERBERRY), mometasone furoate (ASMANEX), ketoprofen (TOP), cyanocobalamin, pyridoxine hydrochloride, thiamine hydrochloride (SUPER B) and fish oil (OMEGA 3); all for unspecified indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On 13May2021, the patient experienced 1 week after had menstrual cycle out of cycle, heavy cycle when normally it was light. Normal cycle lasted only 3-4 days, but (cycle started on 13May2021) was approaching 7 days of constant bleeding. The patient also experienced out of normal severe mood swings from crying to anger, very uncharacteristic and also felt lethargic and needed to take several naps throughout day to function. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event 1 week after had menstrual cycle out of cycle, heavy cycle when normally it was light, normal cycle lasted only 3-4 days, but (cycle started on 13May2021) was approaching 7 days of constant bleeding, out of normal severe mood swings from crying to anger, very uncharacteristic and lethargic and needed to take several naps throughout day to function was not recovered at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Pain, Vomiting
Clinical narrative: mild headache all day; body aches developed throughout the day; drenched in sweat; vomited; This is a spontaneous report from a contactable other healthcare professional, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 17May2021 at 15:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC); all for an unknown indication from an unknown date. The patient previously took Reglan, Tetanus and Ceftin on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 26Apr2021 at 17:30 (at the age of 64-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 18May2021, the morning after the 2nd vaccine the patient had a mild headache all day, body aches developed throughout the day, she woke up at midnight drenched in sweat and vomited. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the events. The clinical outcome of the events body aches developed throughout the day, drenched in sweat, mild headache all day and vomited was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Myalgia
Clinical narrative: Tiredness; Muscle pain; sour; 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: ER8731), via an unspecified route of administration on 17Apr2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had a history of allergy to broad bean and bezoar. Concomitant medications were 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. On 17Apr2021, the patient experienced tiredness, muscle pain and sour. No therapeutic measures were taken 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 the events tiredness, muscle pain and sour was resolved on an unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182), via an unspecified route of administration on 08May2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin G decreased
Clinical narrative: quantitative IgG level was very low; This is a spontaneous report from a contactable physician, the patient. A 67-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via intramuscular route of administration in the left arm on 12Jan2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis. The patient had no allergies to medications, food, or other products. Concomitant medications included ustekinumab (STELARA) taken from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 21Dec2020 (at the age of 67-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 an unknown date in Feb2021, one month after the second dose, the patient experienced that his quantitative Immunoglobulin G (IgG) level was very low. He feared whether Stelara had blunted the dose and if he had been fully vaccinated. The patient was still practicing medicine and at a risk for COVID, so he wondered if he can hold his Stelara and get a booster and he was willing to do it as research if needed. 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 low quantitative IgG level was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pain, Pyrexia
Clinical narrative: fever more than 24 hours after shot; chills; body aches; lethargy; This is a spontaneous report from a non-contactable healthcare professional. 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 left arm on 17May2021 at 14:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medication included birth control (unspecified); taken for an unknown indication from an unknown date. 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 18May2021 at 05:00, the patient experienced fever more than 24 hours after shot, chills, body aches and lethargy. 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 fever more than 24 hours after shot, chill, body aches and lethargy was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast pain
Clinical narrative: Very sore shoulder; Very sore shoulder and upper left back; spreading all the way to left breast; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0185) via an unspecified route of administration in the left arm on 14May2021 at 13:45 (at the age of 48-year-old) as a single dose for COVID-19immunisation.The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0172) via an unspecified route of administration in the left arm on 23Apr2021 at 15:45 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021, the patient experienced very sore shoulder and upper left back spreading all the way to left breast. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events very sore shoulder and upper left back spreading all the way to left breast was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Oral pain, Oropharyngeal pain
Clinical narrative: Mouth sore; throat sores; persistent cough; This is a spontaneous report from a non-contactable consumer, the patient. A unknown gender patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration on 05May2021 at 00:00, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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 vaccination. On 12May2021 at 01:00, the patient experienced mouth sore, throat sore and persistent cough. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as the result of adverse events. The clinical outcome of the events mouth sore, throat sore and persistent cough were not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: Menstrual cycle was late by 8 day; painful cramps; This is a spontaneous report from a non-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 04May2021 at 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (UNITHROID) and colecalciferol (VITAMIN D3) all from unknown date, for unspecified indication. 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 13Apr2021 at 13:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 07:00 the patient reported that menstrual cycle was late by 8 day, when it did start, it was accompanied by painful cramps, which was not normal for her. She usually did not have cramps with her cycle. The events did not result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events and included treatment with MOTRIN. The clinical outcome of the events delayed menstrual cycle and painful cramps were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: limited appetite for various food; This is a spontaneous report from a contactable Other health care professional (Patient). A 62-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot Number: EW0186), via an unspecified route of administration on 14May2021 at 16:15 (age at vaccination 62-years-old) as dose 2, single for covid-19 immunization. Medical history included hypertension and patient was allergic to penicillin, statin, sulfa, latex and hypertension. Concomitant medications within two weeks included blood pressure medicine + statin. There were no other vaccine within 4 weeks. The patient did not had Covid prior vaccination and did not test for Covid post vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 23Apr2021 at 16:30 (Batch/Lot Number: EW0172) as dose 1, single for covid-19 immunization and experienced hypersomnia. On 15May2021 at 13:00, after second vaccination, the patient experienced decreased appetite. It was reported that after second dose, the patient felt fine the next day until 1:00 pm and each day since. At 1:00 pm must lie down and rest for at least one hour. The patient had limited appetite for various foods which she usually eat, duration and intensity of these episodes is lessening (today was day 4 post inoculation) but still happened today. The patient did not received treatment for event. The patient was recovering from the event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Breast pain, Breast scan, Breast tenderness
Clinical narrative: left side under my arm and side of my left breast was painful and tender.; left side under my arm and side of my left breast was painful and tender.; could hardly lift my left arm; could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast; could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast; This is a spontaneous report from a contactable consumer (patient reported for self). A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 26Mar2021 (at the age of 44-years-old) as dose 2, single for COVID-19 immunisation. (Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion). Medical history included diabetes mellitus from an unknown date and unknown if ongoing; Known allergies: Mucinex DM patient previously took Mucinex DM and experienced drug hypersensitivity. Patient had earlier received first dose of BT162b2 for covid-19 immunisation on 05Mar2021 9:30 (at the age of 44-years-old) on arm left as dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included Semaglutide (OZEMPIC) shot once a week and Ascorbic Acid (VITAMIIN C) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported stating on 27Mar2021 09:00 "A day after receiving Pfizer's second dose the left side under my arm and side of my left breast was painful and tender. I could hardly lift my left arm. Left Breast was painful and sore feeling. I could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast." The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Left Breast Exam (breast scan): unknown results on an unspecified date in Mar2021. Diagnostic Left Breast Exam was taken as treatment for all the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae. Device Date : 19May2021.  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint movement impairment
Clinical narrative: left side under my arm and side of my left breast was painful and tender.; left side under my arm and side of my left breast was painful and tender.; could hardly lift my left arm; could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast; could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast; This is a spontaneous report from a contactable consumer (patient reported for self). A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 26Mar2021 (at the age of 44-years-old) as dose 2, single for COVID-19 immunisation. (Reason why batch/lot is Unknown: Not available/provided to reporter at the time of report completion). Medical history included diabetes mellitus from an unknown date and unknown if ongoing; Known allergies: Mucinex DM patient previously took Mucinex DM and experienced drug hypersensitivity. Patient had earlier received first dose of BT162b2 for covid-19 immunisation on 05Mar2021 9:30 (at the age of 44-years-old) on arm left as dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications the patient received within 2 weeks of vaccination) included Semaglutide (OZEMPIC) shot once a week and Ascorbic Acid (VITAMIIN C) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported stating on 27Mar2021 09:00 "A day after receiving Pfizer's second dose the left side under my arm and side of my left breast was painful and tender. I could hardly lift my left arm. Left Breast was painful and sore feeling. I could feel lumps the size of an egg near my left breast and under left arm as well as inside of left side cavity near my left breast." The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Left Breast Exam (breast scan): unknown results on an unspecified date in Mar2021. Diagnostic Left Breast Exam was taken as treatment for all the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered with sequelae. Device Date : 19May2021.  Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Left arm and side had numbness sensation for 3 days then went away, no other side affects; Left arm and side had numbness sensation for 3 days then went away, no other side affects; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0151, Expiration date were not reported) via an unspecified route of administration, administered on arm left on 28Apr2021 at 10:00 (age at vaccination was 40 years) as dose 1, single for COVID-19 immunization workplace clinic. No other vaccine in four weeks. On 28Apr2021 at 11:00 the patient developed Left arm and side had numbness sensation for 3 days then went away, no other side effects. No covid prior vaccination. No covid was tested post vaccination. No allergies were reported. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovered on an unspecified date 2021.   Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Somnolence
Clinical narrative: Drowsiness; Joint pain in left thigh; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 18May2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 27Apr2021 at 16:00 (at the age of 33-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 19May2021 at 05:00, the patient experienced joint pain in left thigh, drowsiness. 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 the events joint pain in left thigh, drowsiness was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Fatigue, Headache, Pain
Clinical narrative: Body body aches; Body discomfort; Pain in armpit; Extreme tiredness; Fever; Headache; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 24-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 arm left on 17May2021 (age at the time of vaccination 24-years-old, patient was not pregnant at the time of vaccination), as DOSE 2, SINGLE for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication included birth control medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme tiredness, body aches, fever, headache, pain in armpit, pain in arm and body discomfort on 18May2021. 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 was recovering at the time of this report.  The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Body body aches; Body discomfort; Pain in armpit; Extreme tiredness; Fever; Headache; Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 24-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 arm left on 17May2021 (age at the time of vaccination 24-years-old, patient was not pregnant at the time of vaccination), as DOSE 2, SINGLE for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication included birth control medication. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for COVID-19 immunisation. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced extreme tiredness, body aches, fever, headache, pain in armpit, pain in arm and body discomfort on 18May2021. 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 was recovering at the time of this report.  The lot number for the vaccine (PFIZER-BIONTECH COVID-19 mRNA VACCINE) was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, SARS-CoV-2 test, Skin reaction, Urticaria
Clinical narrative: I notice red itchy bumps on my neck, chest, stomach, back and legs; I notice red itchy bumps on my neck, chest, stomach, back and legs; Hives and dry patches of skin; Hives and dry patches of skin; This is a spontaneous report from a contactable other healthcare professional. A 61-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in May2021 (Batch/Lot number and Expiry date was not reported) (at the age of 61-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medications included vitamins nos (DAILY VITAMINS), ascorbic acid (VIT C), Coq 10 and cholecalciferol (COLECALCIFEROL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. On 04May2021 11:00, the patient experienced i notice red itchy bumps on my neck, chest, stomach, back and legs, hives and dry patches of skin. It was reported as Three days after the patient received the vaccine, she noticed red itchy bumps on her neck, chest, stomach, back and legs and they began to increase in number in the days following. She went to the clinic at the withheld Pharmacy where she got the vaccine and was prescribed a prednisone pack to take over 6 days. When she has completed the pack, the red bumps returned along with hives and dry patches of skin. She further stated that she was trying to decide whether to get the 2nd dose. Laboratory tests on an unspecified date included sars-cov-2 test: positive. The patient received treatment with prednisone. The clinical outcome of the events was not recovered.   Follow-up attempts completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Hot flush
Clinical narrative: Hot flashes; Abdominal pain; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0172) via an unspecified route of administration in the left arm on 11May2021 at 13:00(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history were not reported. The patient did not receive any medication within two weeks of vaccination. 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 14May2021 at 06:00, the patient experienced fatigue, chills, hot flashes and abdominal pain. 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 fatigue, chills, hot flashes and abdominal pain was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia oral, Urticaria
Clinical narrative: Mouth was numb; At 17 hours I broke out into hives all over my body, including my mouth; After 13 hours, I had chills; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 07May2021 at 13:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient only had a prior allergic reaction to airborne. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 15:00 (at the age of 46-year-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 four weeks prior to the vaccination. On 08May2021 at 02:00 the patient had chills after 13 hours and at 15 hours, the patient received Tylenol. At  17 hours, the patient broke out into hives all over body, including mouth at 06:00 . Mouth was numb and the hives were large enough that patient could not speak comfortably. The patient took Benadryl at 17 hours. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of chills which included treatment with Tylenol and hives and Mouth was numb which included treatment with Benadryl. The clinical outcome of the event hives was resolved on 08May2021 at 10:00. The clinical outcome of the mouth was numb was recovered on 08May2021. The clinical outcome of chills was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in right foot toes/Had similar sensation in left toes but to much losses extent; Tingling in right foot toes/Had similar sensation in left toes but to much losses extent; Short episode of disequilibrium; This is a spontaneous report from a contactable physician. A 49-years-old female Physician reported for herself that who received second dose of BNT162B2 (BNT162B2, solution for injection), intramuscular, administered in Vastus Lateral Right on 28Jan2021 15:55 (Batch/Lot Number: EL9262) (at the age of 49-years-old) as SINGLE for covid-19 immunization and was administered at hospital. Medical history included ongoing menstrual cycle management, ongoing general symptom, ongoing UCTD (undifferentiated connective tissue disease). Concomitant medication (received within 2 weeks of vaccination) included hydroxychloroquine sulfate (PLAQUENIL) at 300mg daily oral for undifferentiated connective tissue disorder, methotrexate at 2.5mg weekly oral for undifferentiated connective tissue disorder, mycophenolate mofetil (CELLCEPT) at 750mg twice a day oral for undifferentiated connective tissue disorder, folic acid daily and magnesium, ergocalciferol (VIT D) 5000 IU/week oral for general health, vitamin B complex (VITAMIN B) daily, vitamins magnesium 400mg daily oral for general health, multivitamin 2-3 times per week oral and oral contraceptive for cycle control 1 tab daily oral. The patient historical vaccine included received first dose of BNT162B2 (BNT162B2, solution for injection), intramuscular, administered in Deltoid left on 07Jan2021 15:55 (Batch/Lot Number: EK9231) as SINGLE for covid-19 immunization and experienced disequilibrium, left side of my face felt heavy, stiff, and was palpably warmer than the right side of my face, awoken by intense bilateral leg pain, left deltoid with prickly "itchy" sensation. Approximately one hour after second vaccine given on 28Jan2021, short episode of disequilibrium occurred, followed by numbness and tingling in right foot toes which lasted approximately 30 minutes. Had similar sensation in left toes but to much losses extent. The outcome of events was recovered on 28Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Venous thrombosis
Clinical narrative: Palmar digital vein thrombosis on my left index finger of the second digit; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0173) via an unspecified route of administration on 05May2021 at 08:30 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and allergy to pollen. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included amlodipine from an unknown date for an unknown indication. On 12May2021 the patient experienced palmar digital vein thrombosis on her left index finger of the second digit. The event was reported as non-serious. The patient was not hospitalized for the event. The patient visited a doctor or other healthcare professional office/clinic as a result of the event. The patient did not receive treatment for the event. The outcome of palmar digital vein thrombosis was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema
Clinical narrative: Large, red patchy area around vaccine site.; Very enlarged lymph node in left armpit; 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: EW0186) via an unspecified route of administration in the left arm on 15May2021 at 11:15 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included quetiapine (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN) and prazosin (MANUFACTURER UNKNOWN) all taken for unknown indication from an unknown date, taken within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 41-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 16May2021, the patient experienced Large, red patchy area around vaccine site, very enlarged lymph node in left arm pit. No therapeutic measures were taken as a result of 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 the events  Large, red patchy area around vaccine site, very enlarged lymph node in left arm pit were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 18May2021 at 13:30 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 20:00, the patient experienced headache. 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, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment Tylenol. The clinical outcome of the event headache 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: Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Irregular (extra) and heavy periods; Irregular (extra) and heavy periods; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in arm left on 22Apr2021 13:00 (at the age of 44-year-old) at dose 2, single for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. Patient had no Known allergies. Patient did not have covid prior vaccination. Patient has not tested for covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY); lamotrigine (LAMICTAL); sertraline hydrochloride (ZOLOFT); lithium (LITHIUM), all the drugs taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 25Mar2021 13:00 (at the age of 44-year-old) at dose 1, single for covid-19 immunisation. On 23Apr2021 the patient experienced irregular (extra) and heavy periods. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.   Follow-up (16Jul2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Pt developed erythematous macular rash across torso approx 1-1.5wks after the 2nd dose of vaccination; This is a spontaneous report from a contactable physician. A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 2 intramuscular, administered in Arm Left on 30Apr2021 (at the age of 37-years-old) as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on 09Apr2021 (at the age of 37-years-old) as a single dose for covid-19 immunization. Medical history included hypothyroidism, depression, hyperlipidemia. Concomitant medication(s) and received within 2 weeks of vaccination included atorvastatin, SYNTHROID, PAXIL, ORTHO TRI-CYCLEN. The patient had allergies with metaclazepam drug hypersensitivity. The patient had no other vaccine within four weeks. On 10May2021, the patient experienced erythematous macular rash across torso approximately 1-1.5wks after the 2nd dose of vaccination. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included nasal swab, sars-cov-2 test negative on May2021. The patient received treatment for the adverse event with betamethasone cream topically. Outcome of the event was not recovered. Device Date was 19May2021. Information regarding the lot/batch number has been requested. No new information was received.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Rash, Urticaria
Clinical narrative: Rash; hives over ears, face, neck, chest, and arm of injection at two hours; coughing; shortness of breath; This is a spontaneous report from a non-contactable consumer (patient).  A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 17May2021 10:00 (Batch/Lot Number: EWO171) (at the age of 44 years old) as dose 1, single for COVID-19 immunisation.  Medical history included asthma, migraines, allergy to latex, possible food allergies and allergy to sulfa. Concomitant medications included loratadine, pseudoephedrine sulfate (CLARITIN-D) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; and ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took fluoride and experienced drug allergy.  The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17May2021 12:00, the patient experienced rash, hives over ears, face, neck, chest, and arm of injection at two hours, then coughing and shortness of breath not responding to asthma medicine. The adverse event resulted in any Doctor or other healthcare professional office/clinic visit. Treatment was given for the events including stronger asthma inhaler and epi-pen prescription. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient  had not been tested for COVID-19. The reporter assessed the case as non-serious and no hospitalization. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.