chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Therapeutic response unexpected
Clinical narrative: "My" HDL that over the years ranged from mid 50's-mid 60's was elevated to 230; "My" HDL that over the years ranged from mid 50's-mid 60's was elevated to 230; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 08:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid and cholesterol. The patient reported that she was healthy except for needing medication for thyroid and cholesterol. The patient's blood pressure had been consistently good. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lisinopril 10mg (MANUFACTURER UNKNOWN), levothyroxine 88mcg (MANUFACTURER UNKNOWN) and thiamine (VITAMIN B1); all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 18Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient had no reaction to the vaccine. However, on 13Apr2021 (reported as 7 days later), the patient had routine bloodwork done and noticed her high-density lipoprotein (HDL) that over the years ranged from mid 50's-mid 60's was elevated to 230. This was considered extremely high and she had no explanation to explain what might be different (patient's weight was 103 (unit unspecified)) and she was very active so this made her wonder if it was because of the vaccine she received one week prior. The patient stated, perhaps she should not have had bloodwork done so soon. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 "my" HDL that over the years ranged from mid 50's-mid 60's was elevated to 230 was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: Sharp burning pain on the side of right breast; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 21Mar2021 at 15:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included atherosclerosis which was treated and healthy then. The patient did not have any known allergy. 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. Concomitant medications included ascorbic acid (VIT C), vitamin d nos (VIT D), rosuvastatin calcium (CRESTOR) and ezetimibe (ZETIA); from an unknown date for unknown indication and unknown if ongoing. On 04Apr2021 at 11:00, two weeks after first shot, the patient experienced sharp burning pain on the side of right breast, same side of vaccination. There were no lumps felt. The patient felt the pain randomly, when the patient laid on her breast, after someone hugged her, when her arm fell across the breast. The pain persisted at the same level for two weeks before lessening but pain albeit much less however was still there. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sharp burning pain on the side of right breast was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Broke out in hives; A rash in several places; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 21Apr2021 at 09:00(at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history and any other illness. The patient had known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks, prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 31Mar2021 at 09:00(at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 19:00 the patient experienced broke out in hives and a rash in several places. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events broke out in hives and a rash in several places was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Cough, Fatigue, Nasal congestion
Clinical narrative: Pressure in the chest; Arm pain; Chills; Fatigue; Congested coughing; congested; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 24Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. concomitant medications were not reported. It was unknown whether, the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced pressure in the chest, arm pain, chills, fatigue, congested and coughing. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events chest, arm pain, chills, fatigue, congested and coughing were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pressure in the chest; Arm pain; Chills; Fatigue; Congested coughing; congested; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration on 24Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. concomitant medications were not reported. It was unknown whether, the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced pressure in the chest, arm pain, chills, fatigue, congested and coughing. 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, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events chest, arm pain, chills, fatigue, congested and coughing were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Pain, Paraesthesia, Sensitive skin
Clinical narrative: Brain fog; Skin hypersensitivity- waves of painful prickling just under skin w/o rash, Headache, Fever; Skin hypersensitivity -waves of painful prickling just under skin; Painful prickling; Insomnia (inability to fall asleep); This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EW0158) via an unspecified route of administration in the arm left on 19Apr2021 at 09:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included esophageal acid reflux (acid reflux), sulfonamide allergy (Sulfa drugs allergy) and seasonal allergy (various plants). 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. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN), metronidazole (MANUFACTURER UNKNOWN) and fluticasone (MANUFACTURER UNKNOWN), all for an unknown indication from unknown date and unknown if ongoing. On 19Apr2021 at 22:00, the patient experienced insomnia (inability to fall asleep). On 20Apr2021, 1 day after the vaccination, 8 hours duration after waking up, the patient experienced skin hypersensitivity- waves of painful prickling just under skin w/o rash, headache and fever. On 21Apr2021, two days after vaccination, the patient experienced brain fog. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen (MANUFACTURER UNKNOWN) which was taken 8 hours post symptoms on 20Apr2021. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events insomnia (inability to fall asleep), skin hypersensitivity- waves of painful prickling just under skin w/o rash, headache, fever and brain fog were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 19Mar2021 at 13:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 12:00, approximately 7 days after first shot, the patient experienced ringing in both ears. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in both ears was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Herpes simplex
Clinical narrative: Herpes type 1 that has been dormant for years appeared 6 days after vaccine; Disease Recurrence; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 17Apr2021 at 13:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes type 1. The patient had known allergies to sulfa and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications were not reported. On 22Apr2021, the patient experienced herpes type 1 that has been dormant for years appeared 6 days after vaccine. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included treatment with acyclovir (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event herpes type 1 that has been dormant for years appeared 6 days after vaccine was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Lymphadenopathy, Nipple pain, Nipple swelling
Clinical narrative: Feeling discomfort; swelling and redness around left nipple/pectoral; swelling and redness around left nipple/pectoral; swelling and redness around left nipple/pectoral; my lymph nodes that are swelling; nipple of the breast does have discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left bicep on 23Apr2021 at 12:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Apr2021 at 10:00, roughly 72 hours later, the patient felt discomfort, swelling and redness around left nipple/pectoral. Within the last 24 hours symptoms remain and was not sure if this was common. The patient believed it was his lymph nodes that are swelling but by the nipple of the breast does had discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received any treatment for the events. The clinical outcome of the events felt discomfort, swelling and redness around left nipple/pectoral and believe it was his lymph nodes that are swelling but by the nipple of the breast does had discomfort was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Feeling discomfort; swelling and redness around left nipple/pectoral; swelling and redness around left nipple/pectoral; swelling and redness around left nipple/pectoral; my lymph nodes that are swelling; nipple of the breast does have discomfort; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left bicep on 23Apr2021 at 12:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Apr2021 at 10:00, roughly 72 hours later, the patient felt discomfort, swelling and redness around left nipple/pectoral. Within the last 24 hours symptoms remain and was not sure if this was common. The patient believed it was his lymph nodes that are swelling but by the nipple of the breast does had discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received any treatment for the events. The clinical outcome of the events felt discomfort, swelling and redness around left nipple/pectoral and believe it was his lymph nodes that are swelling but by the nipple of the breast does had discomfort was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Headache, Muscle twitching, Pruritus
Clinical narrative: 2 days after experienced eye soreness in right eye; 2 days after experienced eye soreness in right eye, headache caused by eye pain.; Continued swollen and twitching right eye even after 5 days of receiving vaccine.; Continued swollen and twitching right eye even after 5 days of receiving vaccine.; Itchiness & small rash clusters on several parts of the body occurred 1 hour after vaccine was administered; Itchiness & small rash clusters on several parts of the body occurred 1 hour after vaccine was administered; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 12:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease with hypothyroidism and known allergy to crab. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 13:15, 1 hour after vaccine was administered, the patient experienced itchiness and small rash clusters on several parts of the body and continued swollen and twitching right eye even after 5 days of receiving vaccine. On 24Apr2021, 2 days after vaccination, the patient experienced eye soreness in right eye and headache caused by eye pain. 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 itchiness, small rash clusters on several parts of the body, eye soreness in right eye, headache caused by eye pain and continued swollen and twitching right eye were resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 2 days after experienced eye soreness in right eye; 2 days after experienced eye soreness in right eye, headache caused by eye pain.; Continued swollen and twitching right eye even after 5 days of receiving vaccine.; Continued swollen and twitching right eye even after 5 days of receiving vaccine.; Itchiness & small rash clusters on several parts of the body occurred 1 hour after vaccine was administered; Itchiness & small rash clusters on several parts of the body occurred 1 hour after vaccine was administered; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 12:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease with hypothyroidism and known allergy to crab. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 13:15, 1 hour after vaccine was administered, the patient experienced itchiness and small rash clusters on several parts of the body and continued swollen and twitching right eye even after 5 days of receiving vaccine. On 24Apr2021, 2 days after vaccination, the patient experienced eye soreness in right eye and headache caused by eye pain. 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 itchiness, small rash clusters on several parts of the body, eye soreness in right eye, headache caused by eye pain and continued swollen and twitching right eye were resolved with sequelae on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Large Swollen lymph nodes above collar bone; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 26Apr2021 at 11:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history was not provided. The patient did not have any allergies to food, medications, or other products. 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. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the arm left on 05Apr2021 at 11:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 05:00 the patient experienced large swollen lymph nodes above collar bone. The event did not result 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 the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Large Swollen lymph nodes above collar bone was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Nasopharyngitis, Vaccination site pain
Clinical narrative: Muscle aches on left side of my body, started in hip and then down the back of the leg and my left foot feels like it is asleep; Muscle aches on left side of my body, started in hip and then down the back of the leg and my left foot feels like it is asleep; Soreness on left arm at injection site.; I have been cold today; 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: EW0167) via an unspecified route of administration in the left arm on 26Apr2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease, chronic migraine and known allergies to sensitivity to steroids- acne reaction. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide/triamterene (TRIAMTERENE HCTZ) 37.5-25 MG for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0163) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 16:45, the patient experienced muscle aches on left side of her body, started in hip and then down the back of the leg and her left foot felt like it was asleep, soreness on left arm at injection site and the patient had been cold that day. The events did not result 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 the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle aches on left side of her body, started in hip and then down the back of the leg and her left foot felt like it was asleep, soreness on left arm at injection site and had been cold that day was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Numerous outbreaks of cold sores that the patient had never experienced before; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EL3249) via an unspecified route of administration in the left arm on 03Feb2021 at 15:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and cold sores on unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 14Jan2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 05Apr2021 at 12:00, the patient experienced numerous outbreaks of cold sores that the patient had never experienced before. The patient usually got cold sore once a year. But for the past 3 weeks the patient reported to have had 4-5. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  Therapeutic measures were not taken as results of events. The clinical outcome of the event numerous outbreaks of cold sores that the patient had never experienced before was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Generalized nontender nonpruritic rash started at neck spreading down to trunk and extremities.; This is a spontaneous report from a contactable physician. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via intramuscular route of administration in the left arm on 24Apr2021 at 09:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease and allergic rhinitis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levocetirizine (MANUFACTURER UNKNOWN) and fluticasone propionate (FLONASE); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 07:00, the patient experienced generalized nontender nonpruritic rash started at neck spreading down to trunk and extremities. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event generalized nontender nonpruritic rash started at neck spreading down to trunk and extremities was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Body aches; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration on 06Apr2021 at 11:00 in left arm (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, cholesterol high, breast cancer, gluten intolerance(gluten allergy) and latex allergy. The patient previously received morphine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, at 11:00, the patient experienced fever that ran for 2 days, body aches, and fatigue. 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 of fever, body aches and fatigue were resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Paraesthesia, Stomatitis
Clinical narrative: Mouth sores; Tingling; Inflammation; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 23Apr2021 at 13:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medications included buspirone hydrochloride (BUSPAR), bupropion hydrochloride (WELLBUTRIN), sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE) and levonorgestrel (MIRENA); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021 at 15:00, the patient experienced mouth sores, tingling and inflammation. The events did not result 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 the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mouth sores, tingling and inflammation was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Pyrexia
Clinical narrative: My arm and underarm are killing me; My arm and underarm are killing me; I also have a fever; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and unknown if ongoing. On 27Apr2021 at 02:00, the patient's arm and underarm were killing. The patient also had a fever. 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 patient arm and underarm were killing and fever was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Migraine
Clinical narrative: Severe headache almost to a migraine on day 2 and 3.; Severe headache almost to a migraine on day 2 and 3.; Extreme tiredness on first day; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an unspecified route of administration in the left arm on 24Apr2021 at 13:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS), high cholesterol, depression, hypothyroidism and lactose intolerance. 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. The patient received unspecified concomitant medications and it was reported as too many to be listed. On 24Apr2021, on the first day of vaccination, the patient experienced extreme tiredness. On 25Apr2021 and 26Apr2021, on days 2 and 3, the patient had severe headache almost to a migraine. 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. 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 extreme tiredness and severe headache almost to a migraine was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Stick/sore neck; Stick/sore neck; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received 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 12:30 (at the age of 40-years-old) as a single dose and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 05Apr2021 at 11:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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. Concomitant medications included zinc (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), colecalciferol (VIT D), ascorbic acid (VIT C) and probiotics (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. On an unknown date in 2021, the patient experienced stick/sore neck after the first shot and it went away, and then a stick/sore neck after the second shot that the patient still had at the time of reporting. It got much worse with alcohol consumption. 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 stick/sore neck was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Oropharyngeal pain, Tinnitus
Clinical narrative: Pain in the injection site; Sore throat; Fatigue; Headache; Worsened tinnitus; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 23Apr2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus, temporomandibular joint disorder and bipolar disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) for urinary tract infection from an unknown date and unknown if ongoing and ferrous sulfate/folic acid/zinc (PRENATAL) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 the patient experienced pain in the injection site, sore throat, fatigue, headache, worsened tinnitus and dizziness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in the injection site, sore throat, fatigue, headache, worsened tinnitus and dizziness were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the injection site; Sore throat; Fatigue; Headache; Worsened tinnitus; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm left on 23Apr2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included tinnitus, temporomandibular joint disorder and bipolar disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amoxicillin (MANUFACTURER UNKNOWN) for urinary tract infection from an unknown date and unknown if ongoing and ferrous sulfate/folic acid/zinc (PRENATAL) for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 the patient experienced pain in the injection site, sore throat, fatigue, headache, worsened tinnitus and dizziness. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in the injection site, sore throat, fatigue, headache, worsened tinnitus and dizziness were resolving 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: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: After having the second shot, 24 hours later I'm running a 101.5 fever; chills; achiness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and bupropion hydrochloride (WELLBUTRIN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 05Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021, 24 hours later, the patient experienced fever of 101.5(unspecified units), along with chills and achiness. On 27Apr2021, the patient checked body temperature and the result was 101.5(unspecified units). 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 101.5 fever along with chills and achiness were not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Severe body aches; Chills; Low grade fever,; Lingering headache; This is a spontaneous report from a non-contactable consumer, the patient and also from a contactable consumer. An adult non-pregnant female patient of unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient experienced flu like symptoms, severe body aches, chills, low grade fever and lingering headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events flu like symptoms, severe body aches, chills, low grade fever and lingering headache was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Nausea; Mild vomiting; Diarrhea; Moderate abdominal pain; Sweating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and gluten. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), pseudoephedrine hydrochloride (SUDAFED), ethinylestradiol/ levonorgestrel (CAMRESE LO) and multi-vitamin (MANUFACTURER UKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in left arm on 31Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 23:30, the patient experienced nausea, mild vomiting, diarrhea, moderate abdominal pain and sweating-no fever. 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 nausea, mild vomiting, diarrhea, moderate abdominal pain and sweating were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe soreness in right arm. Difficult to move past parallel. Had to continue movement to loosen up.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-02) via an unspecified route of administration in the right arm on 21Apr2021 at 16:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. 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. Concomitant medications included fluticasone propionate (FLONASE) and multivitamin (MANUFACTURER UNKNOWN) both were taken for an unknown indication from an unknown date and unknown if ongoing. On 22Apr2021 at 06:30, the patient experienced severe soreness in right arm, difficult to move past parallel where he had to continue movement to loosen up. He also reported that he never experienced such soreness after an immunization in his life. 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 event severe soreness in right arm and difficult to move past parallel, had to continue movement to loosen up was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.