chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Friday morning I work up with a terrible headache, that worsened tremendously when I opened my eyes; Could hardly move; Everything hurt; Nauseated; Injection site was swollen; The injection site was red; Injection site was hot; Chills; This is a spontaneous report from a contactable consumer, the patient. A 65-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 15Apr2021 at 10:15 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (RA), fibromyalgia, osteoarthritis and COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient take concomitant medications quite a few, but no room to put them was reported by the patient. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 06:30 (she had the shot Thursday morning), on friday morning she woke up with a terrible headache, that worsened tremendously when she opened her eyes. she could hardly move. Everything hurt. she was nauseated. The injection site was swollen and was red and hot. She had chills, no fever. But she think she would have to die to feel better. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19 The clinical outcome of the event terrible headache, could hardly move, everything hurt, nauseated, vaccination site was swollen, vaccination site was red, vaccination site was hot and chills were recovering at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fatigue; swelling and redness at and around injection site, the area is also warm to the touch.; swelling and redness at and around injection site, the area is also warm to the touch.; swelling and redness at and around injection site, the area is also warm to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 10:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia, asthma, asthma, acid reflux (esophageal), blood pressure high and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acebutolol hydrochloride (SECTRAL), omeprazole (MANUFACTURER UNKNOWN), formoterol fumarate, mometasone furoate (DULERA), montelukast sodium (SINGULAIR) and fexofenadine hydrochloride (ALLEGRA) and vi (MANUFACTURER UNKNOWN), all from unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 27Mar2021 at 10:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation and took doxycycline (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 21:00, the patient experienced fatigue, swelling and redness at and around injection site, the area was also warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, swelling and redness at and around injection site, the area was also warm to the touch was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Herpes zoster
Clinical narrative: Shingles; Headaches; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Mar2021 at 03:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer. The patient had known allergies to penicillin and bees. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021, at 15:45 the patient experienced the events shingles (reported as shiggles) and headaches. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unknown medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shingles and headache were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Carpal tunnel syndrome, Condition aggravated, Hypoaesthesia, Paraesthesia
Clinical narrative: Periodic numbness and tingling (pins and needles) in hands and feet, particularly right hand and right foot.; Worsening of pre-existing inflammation or "carpal tunnel" symptoms in the right hand.; Periodic numbness; Worsening of pre-existing inflammation or "carpal tunnel" symptoms in the right hand.; This is a spontaneous report from a contactable consumer, the patient. A 35-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 right arm on 14Apr2021 at 11:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. The patient previously received sulfamethoxazole; trimethoprim (BACTRIM), desogestrel; ethinylestradiol (APRI) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included postpartum mood support and standard process adrenal on unknown dates, for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced periodic numbness and tingling (pins and needles) in hands and feet, particularly right hand and right foot and on an unknown date in Apr2021, patient experienced worsening of pre-existing inflammation or carpal tunnel symptoms in the right hand. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of these events. These events did not result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events worsening carpal tunnel symptoms, tingling (pins and needles) in hands and feet and period numbness were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pallor, Urticaria
Clinical narrative: Felt dizzy; Tired; Pale; Felt exhausted; Hives all over the back of neck and back; This is a spontaneous report from a contactable consumer. A 16-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm right on 18Apr2021 at 11:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included eczema and egg allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of receiving the vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Apr2021 at 11:10, within 10 minutes after the vaccine, the patient felt dizzy and tired and was pale. A few hours after the vaccine, the patient felt exhausted and had hives all over the back of her neck and back. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events felt dizzy, tired, pale, felt exhausted and hives all over the back of her neck and back were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Headache, Lymphadenopathy, Swelling face
Clinical narrative: Swollen lymph nodes under left arm pit and left breast; Currently having tenderness of the breast; Headaches lasting 3-4 days; Slight face swelling 3-4 days; This is a spontaneous report from a contactable consumer, the patient. A 35-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 09Apr2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 06:00, the patient experienced swollen lymph nodes under left arm pit and left breast. The patient was currently having tenderness of the breast. The patient also experienced headaches lasting three-four days and slight face swelling three-four days. Therapeutic measures were not taken as a result of the 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 event headaches lasting three-four days and slight face swelling three-four days was resolved on an unknown date in Apr2021. The clinical outcome of the event swollen lymph nodes under left arm pit and left breast; currently having tenderness of the breast was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pins and needles in areas of right arm and leg/foot; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included A-Fib heart. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included apixaban (ELIQUIS) 5mg, diltiazem 120mg (MANUFACTURER UNKNOWN) and rosuvastatin 5mg (MANUFACTURER UNKNOWN); all for unspecified 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 31Mar2021 at 07:00, the patient experienced pins and needles in areas of right arm and leg/foot the day after vaccination. Pins and needles had occurred non-stop for the past month (as per the date of this report). 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 event pins and needles in areas of right arm and leg/foot the day after vaccination was not recovered at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear congestion, Facial pain, Nasal congestion
Clinical narrative: Nose stuffed up; Face hurts; Ears stuffed up; Cough; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO161) via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and ankylosing spondylitis. The patient had known allergies to penicillin. Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), lamotrigine (LAMOTROGINE), levothyroxine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received celecoxib (CELEBREX) taken for unknown indication and experienced drug 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. On 14Apr2021 at 16:00, the patient's nose was stuffed up, her face did hurt, ears were stuffed up and had cough. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No 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 nose stuffed up, cough, face hurts and the event ears stuffed up were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Very sore arm (right side); Swollen axillary lymph node (right side); Intermittent headaches x 1 day; Fatigue; Mild joint and muscular pain; Mild joint and muscular pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm right on 16Apr2021 at 13:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa (Sulfonamide allergy). The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6213) via an unspecified route of administration in the arm right on 27Mar2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. 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. On 16Apr2021, the patient experienced very sore arm (right side), swollen axillary lymph node (right side), intermittent headaches x 1 day, fatigue, mild joint pain and muscular 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 event intermittent headache recovered on 17Apr2021, while that of the events very sore arm (right side), swollen axillary lymph node (right side), fatigue, mild joint pain and muscular pain was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore arm (right side); Swollen axillary lymph node (right side); Intermittent headaches x 1 day; Fatigue; Mild joint and muscular pain; Mild joint and muscular pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm right on 16Apr2021 at 13:15 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa (Sulfonamide allergy). The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER6213) via an unspecified route of administration in the arm right on 27Mar2021 at 14:00 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. 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. On 16Apr2021, the patient experienced very sore arm (right side), swollen axillary lymph node (right side), intermittent headaches x 1 day, fatigue, mild joint pain and muscular 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 event intermittent headache recovered on 17Apr2021, while that of the events very sore arm (right side), swollen axillary lymph node (right side), fatigue, mild joint pain and muscular pain was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Was dizzy. Still dizziness a few days after vaccine.; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ED6955) via an unspecified route of administration in the left arm on 16Mar2021 at 10:30 (at the age of 69-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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), atorvastatin calcium (LIPITOR), amlodipine besilate (AMLODIPINE BESYLATE) and losartan (MANUFACTURER UNKNOWN); all from an unknown date and for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 16Mar2021 at 22:00, the evening after taking the vaccine the patient felt dizzy and still dizziness was there a few days after vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event which included treatment with meclizine (MANUFACTURER UNKNOWN) of 25mg. The clinical outcome of event felt dizzy was recovering 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: Arthralgia, Decreased appetite, Fatigue, Feeling cold, Myalgia
Clinical narrative: Little appetite; Stabbing joint pain; Fever; Tired all day/ tired; slept on/off every 2 hours; Aching muscles/ Sore muscles; Fatigue; Woke up Cold; Woke every 2 hours that night with aches/ fewer aches/ achy all day; This is a spontaneous report from a 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: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 11:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and allergy to penicillin and related. 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 levothyroxine sodium (SYNTHROID), ethinylestradiol, etynodiol diacetate (ZOVIA), vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and ascorbic acid, tocopheryl acetate, zinc oxide, cupric oxide, betacarotene (VITEYES), all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 11:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 18:00, the patient experienced aching muscles and fatigue started that evening. On an unknown date in Apr2021, she woke every 2 hours in night with aches and woke up with cold (not feverish feeling) around midnight. On 12Apr2021, the patient experienced fever in morning. She was tired and achy all day and slept on/off every 2 hours. On 13Apr2021, the patient had sore muscles, stabbing joint pain and little appetite. She was still feverish sore muscles and tired and took TYLENOL at 18:00. On 14Apr2021, the patient had fever broke overnight. Tired but no fever, fewer aches. The patient fully recovered on 19Apr2021. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events and included treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever recovered on 14Apr2021 ; while that of aching muscles, fatigue, woke every 2 hours in night with aches, woke up with cold (not feverish feeling), tired, achy all day, slept on/off every 2 hours, sore muscles, stabbing joint pain and little appetite was recovered on 19Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: Little appetite; Stabbing joint pain; Fever; Tired all day/ tired; slept on/off every 2 hours; Aching muscles/ Sore muscles; Fatigue; Woke up Cold; Woke every 2 hours that night with aches/ fewer aches/ achy all day; This is a spontaneous report from a 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: ER8737) via an unspecified route of administration in the left arm on 11Apr2021 at 11:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism and allergy to penicillin and related. 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 levothyroxine sodium (SYNTHROID), ethinylestradiol, etynodiol diacetate (ZOVIA), vitamin d nos (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B12) and ascorbic acid, tocopheryl acetate, zinc oxide, cupric oxide, betacarotene (VITEYES), all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 11:45 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 11Apr2021 at 18:00, the patient experienced aching muscles and fatigue started that evening. On an unknown date in Apr2021, she woke every 2 hours in night with aches and woke up with cold (not feverish feeling) around midnight. On 12Apr2021, the patient experienced fever in morning. She was tired and achy all day and slept on/off every 2 hours. On 13Apr2021, the patient had sore muscles, stabbing joint pain and little appetite. She was still feverish sore muscles and tired and took TYLENOL at 18:00. On 14Apr2021, the patient had fever broke overnight. Tired but no fever, fewer aches. The patient fully recovered on 19Apr2021. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events and included treatment with TYLENOL. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever recovered on 14Apr2021 ; while that of aching muscles, fatigue, woke every 2 hours in night with aches, woke up with cold (not feverish feeling), tired, achy all day, slept on/off every 2 hours, sore muscles, stabbing joint pain and little appetite was recovered on 19Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face, neck, chest, back, and lower arm, appeared 11 days after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) in the arm left on 04Apr2021 at 10:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin and cephalosporin. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL) taken 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 COVID vaccine. On 15Apr2021, 11 days after vaccination, the patient experienced rash on face, neck, chest, back, and lower arm. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with creams for  the rash. The clinical outcome of the event rash on face, neck, chest, back, and lower arm was recovering 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: Asthenia, Cough, Fatigue, Headache, Pain
Clinical narrative: Body aches specifically in legs; Cough; Exhausted; Body aches specifically in legs; Headache; Feel like cannot get out of bed.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-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 16Apr2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021 at 11:00, the patient experienced exhausted, cough, body aches specifically in her legs, headache, and felt like she could not get out of bed. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event which included treatment with OTC pain relievers. The clinical outcomes of event exhausted, cough, body aches specifically in legs, headache, and felt like could not get out of bed were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Body aches specifically in legs; Cough; Exhausted; Body aches specifically in legs; Headache; Feel like cannot get out of bed.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 53-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 16Apr2021 at 11:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 18Apr2021 at 11:00, the patient experienced exhausted, cough, body aches specifically in her legs, headache, and felt like she could not get out of bed. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event which included treatment with OTC pain relievers. The clinical outcomes of event exhausted, cough, body aches specifically in legs, headache, and felt like could not get out of bed were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Cold sweat, Cough, Dysphonia, Ear pain
Clinical narrative: Started at 6-7 mins,, coughing - could not clear throat; Pain in ears; Red blotches on chest too; Hoarse voice; Tiny blisters formed all across my forehead; Tingling in feet, lower legs and fingers; One leg felt like it fell asleep; Then clammy sweaty all over; Then like a sudden rush up both sides of my neck followed by sudden blow up of lymph glands; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EWO162) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic, hysterectomy 18 months ago, sensitivity to bee stings, allergy to caffeine and any kind of stimulant. 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 alprazolam (XANAX), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) and phenylephrine hydrochloride (SINEX) all for unknown indications, on unknown dates and unknown if ongoing. The patient previously received nicotinic acid (NIACIN) for unknown indication on unknown date and experienced drug allergy. On 17Apr2021 at 14:00, 6-7 mins after vaccine, the patient experienced  coughing, she could not clear throat. Then clammy sweaty all over, then tingling in feet, lower legs and fingers, one leg felt like it fell asleep, then like a sudden rush up both sides of her neck followed by sudden blow up of lymph glands, pain in ears, red blotches on chest too, hoarse voice. During that time the patient looked in the mirror and saw tiny blisters had formed all across her forehead, she was not sure when that started in the timeline. The other symptoms occurred in quick succession over a 30 minute period. Therapeutic measures were taken as a result of the reported events and included treatment with BENEDRYL shot and 2 PEPCID pills. The events resulted in emergency room/department or urgent care. On 17Apr2021, the patient was taken to emergency room, vitals were monitored for 5 hours and the result was found to be unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events coughing, clammy sweaty, tingling in feet, lower legs and fingers, one leg felt like it fell asleep, sudden rush up both sides of her neck followed by sudden blow up of lymph glands, pain in ears, red blotches on chest, hoarse voice and blisters all across her forehead were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Paraesthesia, Rash macular, Vital signs measurement
Clinical narrative: Started at 6-7 mins,, coughing - could not clear throat; Pain in ears; Red blotches on chest too; Hoarse voice; Tiny blisters formed all across my forehead; Tingling in feet, lower legs and fingers; One leg felt like it fell asleep; Then clammy sweaty all over; Then like a sudden rush up both sides of my neck followed by sudden blow up of lymph glands; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EWO162) via an unspecified route of administration in the left arm on 17Apr2021 at 14:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic, hysterectomy 18 months ago, sensitivity to bee stings, allergy to caffeine and any kind of stimulant. 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 alprazolam (XANAX), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) and phenylephrine hydrochloride (SINEX) all for unknown indications, on unknown dates and unknown if ongoing. The patient previously received nicotinic acid (NIACIN) for unknown indication on unknown date and experienced drug allergy. On 17Apr2021 at 14:00, 6-7 mins after vaccine, the patient experienced  coughing, she could not clear throat. Then clammy sweaty all over, then tingling in feet, lower legs and fingers, one leg felt like it fell asleep, then like a sudden rush up both sides of her neck followed by sudden blow up of lymph glands, pain in ears, red blotches on chest too, hoarse voice. During that time the patient looked in the mirror and saw tiny blisters had formed all across her forehead, she was not sure when that started in the timeline. The other symptoms occurred in quick succession over a 30 minute period. Therapeutic measures were taken as a result of the reported events and included treatment with BENEDRYL shot and 2 PEPCID pills. The events resulted in emergency room/department or urgent care. On 17Apr2021, the patient was taken to emergency room, vitals were monitored for 5 hours and the result was found to be unknown. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events coughing, clammy sweaty, tingling in feet, lower legs and fingers, one leg felt like it fell asleep, sudden rush up both sides of her neck followed by sudden blow up of lymph glands, pain in ears, red blotches on chest, hoarse voice and blisters all across her forehead were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lip pain, Lip swelling, Pruritus
Clinical narrative: Some fatigue for a few days; Very light lip swelling; Very light lip swelling and sensitivity.; Slight itching on forearms and scalp.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 11:30 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma. Concomitant medications included escitalopram (ESCITALOPRAMUM), clonazepam (MANUFACTURER UNKNOWN), dexamfetamine (DEXTROAMPHETAMINE) and naproxen sodium (ALEVE) for unknown indication from an unknown date. The patient previously received rituximab (RITUXAN) for unknown indication on unknown date and experienced drug 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. On 28Mar2021, the patient experienced some fatigue for a few days, very light lip swelling and sensitivity. The patient also experienced slight itching on forearms and scalp. 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 some fatigue for a few days, very light lip swelling, lip sensitivity, slight itching on forearms and scalp were recovered on an unspecified date in 2021. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 18Apr2021 at 11:45 (at the age of 59-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: woke up with the worst tinnitus...so loud...currently still louder than what I had prior; woke up with the worst tinnitus...so loud...currently still louder than what I had prior; This is a spontaneous report from a contactable consumer, the patient. A 60-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 19Mar2021 at 11:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to dairy, legumes some food intolerance. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and omeprazole (PRILOSEC); both from unknown date for unknown indication and unknown if on going. The patient previously took propylene glycol (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 05:00, the patient experienced the worst tinnitus...so loud. On unknown date in Apr2021,currently still the patient experienced louder than what she had prior. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event of worst tinnitus so loud, currently still louder than what she had prior 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: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Disturbance in attention, Formication, Insomnia, Tinnitus
Clinical narrative: Terrible persistent high-pitched ringing in right ear perhaps both ears, but loudest in right ear.; Terrible persistent high-pitched ringing in right ear perhaps both ears but loudest in right ear.; Hard to sleep, concentrate; Feels very annoying but bearable other times feel like crawling out of skin; Hard to sleep, concentrate; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 08Apr2021 at 15:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, anxiety, depression, and occasionally experienced tinnitus, but it would come and go and not last for very long which was not ongoing. The patient had an allergy to sulfa. 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 COVID vaccine. Concomitant medications included clonazepam (MANUFACTURER UNKNOWN) and lamotrigine (MANUFACTURER UNKNOWN) both were taken for unknown indications from unknown dates (as long-term medications) and unknown if ongoing. Since an unknown date in Apr2021, not long after receiving the first vaccine, the patient was experiencing a terrible, persistent, high-pitched ringing in the right ear, perhaps it was both ears, but it was loudest in the right ear. It was hard to sleep, concentrate, etc. Sometimes it felt very annoying, but bearable, other times the patient felt like crawling out of the skin with it. It was with the patient when she woke up and goes to sleep. Every now and then, the patient felt it was much quieter, or that it had stopped, but then it would start right up again. The patient was supposed to get the second vaccine on 29Apr2021 but was not sure what to do. 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 a result of the events. The clinical outcome of the events terrible persistent high-pitched ringing in right ear perhaps both ears but loudest in right ear, hard to sleep, concentrate and feels very annoying but bearable other times feel like crawling out of skin were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 17Apr2021 at 16:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. On 25Mar2021, the patient underwent COVID-19 test (Rapid test) via nasal swab and the result was positive. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included sertraline hydrochloride (ZOLOFT), ibuprofen (ADVIL) and remdesivir (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. On 19Apr2021, the patient experienced lump on collarbone. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of event lump on collarbone was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Consistent headache; Nausea (carsick type nausea, gaggy, not stomach); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in left arm on 30Mar2021 at 12:15 (at the age of 30-years old) as a single dose for COVID-19 immunisation. The patient did not have any other relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication within two weeks of the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 19:00, the patient experienced consistent headache and nausea (carsick type nausea, gaggy, not stomach) for last 3 weeks. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in a visit to the doctors or other healthcare professional office/clinic. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events, consistent headache and nausea were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Influenza like illness, Pain
Clinical narrative: Flu-like symptoms; Body ache; Joint pain; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 17Apr2021 at 09:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and graves disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 27Mar2021 at 09:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 17Apr2021 at 21:30, the patient experienced headache, chills, body aches, joint pain and flu-like symptoms. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, chills, body aches, joint pain and flu-like symptoms were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.