chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Right (opposite) arm and hand felt a little numb; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 17:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously took bupropion hydrochloride (WELLBUTRIN), itraconazole (SPORANOX) for an unknown indication on an an 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 19:00, the patient experienced right (opposite) arm and hand felt a little numb a couple of hours after the vaccination, and still felt that way the next day, but to a lesser degree. The patient felt like the feeling when she get a limb "falls asleep". 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 right (opposite) arm and hand felt a little numb was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on face and neck 3 days after first dose.; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on13Apr2021 at 12:30 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and alpha thalassemia. 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 ethinylestradiol, levonorgestrel (JOLESSA) taken for birth control from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 11:15, 3 days after the first dose, the patient experienced rash on face and neck. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash on face and neck was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dysgeusia, Headache, Heart rate increased
Clinical narrative: Headache; Taste of metal in mouth; Ringing in the ears; Elevated heart rate; Blurry vision; Arms soreness; Muscle, bone and joint pain.; Muscle, bone and joint pain.; Muscle, bone and joint pain.; This is a spontaneous report from a contactable healthcare professional, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 03Apr2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and bi lateral mastectomy. The patient had known allergies to iodine, all antibiotics, shellfish, latex and gadolinium. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:30, the patient experienced headache that lasted a week, taste of metal in mouth that lasted a week, ringing in the ears, elevated heart rate, blurry vision, arms soreness, muscle, bone and joint 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 headache and taste of metal in mouth was recovered on 10Apr2021; while that of the ringing in the ears, elevated heart rate, blurry vision, arms soreness, muscle, bone and joint pain was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Tinnitus, Vision blurred
Clinical narrative: Headache; Taste of metal in mouth; Ringing in the ears; Elevated heart rate; Blurry vision; Arms soreness; Muscle, bone and joint pain.; Muscle, bone and joint pain.; Muscle, bone and joint pain.; This is a spontaneous report from a contactable healthcare professional, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 03Apr2021 at 11:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer and bi lateral mastectomy. The patient had known allergies to iodine, all antibiotics, shellfish, latex and gadolinium. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 12:30, the patient experienced headache that lasted a week, taste of metal in mouth that lasted a week, ringing in the ears, elevated heart rate, blurry vision, arms soreness, muscle, bone and joint 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 headache and taste of metal in mouth was recovered on 10Apr2021; while that of the ringing in the ears, elevated heart rate, blurry vision, arms soreness, muscle, bone and joint pain was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Joint swelling, Pain assessment
Clinical narrative: Excruciating pain in the right knee joint; Could barely walk; Knee joint swelled, so right knee measured 1 inch greater than left knee.; Left knee was sore; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GL8982) via an unspecified route of administration in the left arm on 11Feb2021 at 09:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 09:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included angelica sinensis root (DONG QUAI), tocopheryl acetate (VITAMIN E), vitamin b complex (VITAMIN B), calcium (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and hormone replacement therapy; all from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Feb2021 at 16:30, the day of the first shot, the patient experienced excruciating pain in the right knee joint, pain was 9 on the pain scale of 10, the patient could barely walk, knee joint swelled, the patient's right knee measured 1 inch greater than left knee. For four weeks the patient was in pain, just walked to the car, went up and down stairs one leg at a time. The patient's right knee got better after five weeks. On an unknown date in 2021, the patient experienced left knee was sore. Pain level was about a 4 on the scale of 10. Before the shot, the patient was walking regularly about 10 miles a week but walking was now limited to several blocks' maximum. Since the right knee improved over 5 weeks, the patient had to assume the left knee would also improve. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with multiple acupuncture, chiropractic, physical therapy treatments, ice, salonpas patches and ibuprofen. On 11Feb2021, the patient underwent pain scale assessment and the result was 9 on the pain scale of 10. On an unknown date in 2021, the patient underwent pain scale assessment and the result was 4 on the pain scale of 10. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events excruciating pain in the right knee joint, could barely walk, right knee joint swelled and left knee was sore was recovering 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: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; chills; achy joints; sore throat; upset stomach; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 at 13:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included tachycardia. 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 amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL), vitamin b12 nos (VITAMIN B12), cetirizine hydrochloride (ZYRTEC) and ethinylestradiol, drospirenone (NIKKI) all from an unknown date and unknown if ongoing for an unknown indication. The patient previously took hydrocodone (MANUFACTURER UNKNOWN) and experienced allergy. On 14Apr2021 at 07:00, the patient experienced fever, chills, achy joints, sore throat, upset stomach. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, achy joints, sore throat, upset stomach was not recovered at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain in extremity
Clinical narrative: Sore arm; tired; foggy; chills; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30(at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included allergy medicines  and ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 23Mar2021 at 16:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 20:30 the patient experienced sore arm, tired, foggy, chills. Since the vaccination, the patient had not been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcomes of the events sore arm, tired, foggy, chills were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Pyrexia, Vaccination site erythema
Clinical narrative: Within 6 hours of the 2nd vaccine the injection site swelled up/ a "knit the size of a quarter"; Turned feverish; Within 6 hours of the 2nd vaccine. the injection site hurt/ arm hurts where "knit" is located.; "The redness is gone."; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER732) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included hypothyroidism and arthritis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN) and montelukast (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient previously took codeine and experienced a drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6299) via an unspecified route of administration in the left arm on 19Mar2021 at 13:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 19:00, within 6 hours of the second vaccine the patient reported that the "injection site swelled up, turned feverish, and hurt." The patient reported that on 14Apr2021, 6 days after the vaccination (at the time of this report) she had a "knit the size of a quarter." The redness had gone and her arm hurt where the "knit was located." Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events redness was resolved on 14Apr2021; while the clinical outcome of the events injection site swelled up, turned feverish, and hurt, she had a "knit the size of a quarter", arm hurt where the "knit was located" were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Muscular weakness, Pain, Pain in extremity
Clinical narrative: tingling lips; swelling sensation in throat; sore arm; headache; chills and fever; chills and fever; achy; arm tired; This is a spontaneous report from a non-contactable consumer. A 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 in the left arm on 13Apr2021 at 09:00, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 09:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced tingling lips, swelling sensation in throat, sore arm, headache, chills and fever, achy and arm tired. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling lips, swelling sensation in throat, sore arm, headache, chills and fever, achy and arm tired was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal swelling, Pyrexia
Clinical narrative: tingling lips; swelling sensation in throat; sore arm; headache; chills and fever; chills and fever; achy; arm tired; This is a spontaneous report from a non-contactable consumer. A 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 in the left arm on 13Apr2021 at 09:00, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Mar2021 at 09:00, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021, the patient experienced tingling lips, swelling sensation in throat, sore arm, headache, chills and fever, achy and arm tired. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling lips, swelling sensation in throat, sore arm, headache, chills and fever, achy and arm tired was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Arm pain (injection site); Fever; tiredness; Muscle ache; Joint pain; Headache; 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: EOW158) via an unspecified route of administration on the left arm on 13Apr2021 at 10:15(at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 13:00 the patient experienced  arm pain (injection site), fever, headache, tiredness, muscle ache and joint pain. 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. The clinical outcome of the events vaccination site pain, fever, headache, tiredness, muscle ache and joint pain was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain (injection site); Fever; tiredness; Muscle ache; Joint pain; Headache; 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: EOW158) via an unspecified route of administration on the left arm on 13Apr2021 at 10:15(at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 13:00 the patient experienced  arm pain (injection site), fever, headache, tiredness, muscle ache and joint pain. 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. The clinical outcome of the events vaccination site pain, fever, headache, tiredness, muscle ache and joint pain was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Papule, Pruritus
Clinical narrative: Itchy bumps on skin; Itchy bumps on skin; This is a spontaneous report from a non-contactable consumer. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021 and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021, as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient received any other medications in two weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced itchy bumps on skin. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event itchy bumps on skin was unknown at the time of reporting.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Parotid gland enlargement
Clinical narrative: Parotid gland swelling; This is a spontaneous report from a contactable physician, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), nifedipine (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), vitamin d nos (MANUFACTURER UNKNOWN) and curcuma longa (TURMERIC) all for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 00:00, the patient experienced parotid gland swelling. The event did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event parotid gland swelling was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Vaccination site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; Dizzy; This is a spontaneous report from a non-contactable consumer. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 10Apr2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and unspecified allergy. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6Z06) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 05:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint, pain, fever, nausea, feeling unwell and dizzy. 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 events of vaccination site pain tiredness, headache, muscle pain, chills, joint, pain, fever, nausea, feeling unwell and dizzy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Vaccination site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; Dizzy; This is a spontaneous report from a non-contactable consumer. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 10Apr2021 at 15:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and unspecified allergy. The patient did not receive any other medications within 2 weeks of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6Z06) via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 05:30, the patient experienced vaccination site pain, tiredness, headache, muscle pain, chills, joint, pain, fever, nausea, feeling unwell and dizzy. 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 events of vaccination site pain tiredness, headache, muscle pain, chills, joint, pain, fever, nausea, feeling unwell and dizzy was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Fatigue; body ache; chills; This is a spontaneous report from a non-contactable consumer. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 09:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 13Apr2021 at 17:00, the patient experienced fatigue, body aches and chills. 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. The clinical outcome of the events fatigue, body ache and chills were recovering 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: bouts of depression within a week after shot; This is a spontaneous report from a contactable consumer, the patient. A 36-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 07Apr2021 at 12:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of taking the COVID-19 vaccine. On 11Apr2021, the patient experienced bouts of depression within a week after the shot similar to postpartum depression, no history of depression or mental illness. The event 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 event. The clinical outcome of the event bouts of depression within a week after the shot similar to postpartum depression was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Huge migraine; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 13Apr2021 at 18:00(at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food, or other product. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 13Apr2021 at 18:30, the patient experienced huge migraine. The patient stated that migraine was getting worse. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event huge migraine was ongoing at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 08:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of the COVD-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 14Apr2021 at 09:30, the patient woke up with a horizontal rash along the side of the upper right torso. It stretched from just below the side of her right breast toward the center of her back. On 16Apr2021, it was diagnosed as shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with VALTREX EQ and pain medication. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Occipital neuralgia, Poor quality sleep, Skin burning sensation
Clinical narrative: Left side sensation skin is burning gets hoter if I was with water also; occipital neuralgia; 2nd and third day I've been tired; 12 hours after 2nd dose woke up at 4am; This is a spontaneous report from a contactable consumer, the patient. A 42-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 14Apr2021 at 16:15 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient was allergic to sulfa. Concomitant medications included prednisone (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN) and magnesium (MANUFACTURER UNKNOWN) 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: EP7534) via an unspecified route of administration in the left arm on 24Mar2021 at 04:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Apr2021 at 04:00,12 hours after vaccination the patient woke up at 4 am. On 16Apr2021 the patient experienced tired, left side sensation of skin burning gets hotter if was with water also and had occipital neuralgia. These events occurred on second and third day of vaccination. 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 12 hours after vaccination the patient woke up at 4 am, tired, left side sensation of skin burning gets hotter if was with water also and had occipital neuralgia was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Woke up sweating; Feeling hot but my body felt cool. Felt like I had icy hot all over my body.; 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 16Apr2021 at 13:00 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient was allergic to latex and iodine. 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 17Apr2021 at 04:00, the patient woke up sweating, felt hot but her body felt cool. The patient felt like she had icy hot all over her body. 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 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 woke up sweating, felt hot but her body felt cool and felt like she had icy hot all over her body was unknown at the time of the report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: PCR Nasal Swab: Positive/ stuffy nose, general ache, diarrhea and loss of taste; PCR Nasal Swab: Positive/ stuffy nose, general ache, diarrhea and loss of taste; This is a spontaneous report from a contactable nurse. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 31-years-old, intramuscular in right arm on 15Feb2021 at 13:00 at dose 1, single (lot number: EL3248) and intramuscular in right arm on 08Mar2021 at 12:45 at dose 2, single (lot number: EL3248) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Known allergies were unknown. The patient has no COVID prior to vaccination. It was unknown if the patient received any other vaccines in four weeks. The patient's concomitant medications were not reported. Facility type was reported as a workplace clinic. On 15Apr2021, the patient began to experience stuffy nose, general ache, diarrhea, and loss of taste. His PCR nasal swab for COVID on the same day was positive. Treatment for the events was unknown. The outcome of the events was recovering.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Migraine, Tinnitus
Clinical narrative: Excessive ringing in both ears louder each day; increase in migraine headaches; disease recurrence; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 15Mar2021 at 09:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medication included propranolol (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received codeine (MANUFACTURER UNKNOWN) taken for unknown indication and experienced drug allergy. 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 left arm on 20Feb2021 at 10:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021, the patient experienced excessive ringing in both ears - louder each day. It did not go away and the patient wished there was something she could do to stop it. The patient also had an increase in migraine headaches. 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 excessive ringing in both ears louder each day and increase in migraine headaches were not resolved 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: Asthenia, Paraesthesia
Clinical narrative: right arm and hand intermittently tingles; right arm and hand feels very weak; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 05:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, Raynauds syndrome and spondylolisthesis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril dihydrate (LISINOPRIL), amlodipine besilate (AMLOR), ascorbic acid, levoglutamide, biotin, folic acid, tyrosine, cyanocobalamin, choline bitartrate, acetylcarnitine, docosahexaenoic acid, panax ginseng root, phosphatidyl choline, phosphatidyl serine, resveratrol, ginkgo biloba leaf, bacopa monnieri herb (PROVASIL), cod-liver oil (FISH OIL) and acetylsalicylic acid (SPRIN); all taken for unknown indication on unknown date, unknown if ongoing. The patient previously took hydrocodone (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) and experienced drug allergy as itch. 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 right arm on 24Mar2021 at 05:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 15Apr2021, at 06:00, 1day after receiving the vaccine and subsequent days afterwards, the patient experienced right arm and hand intermittently tingles and right arm and hand feels very weak. 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 adverse events right arm and hand intermittently tingles and right arm and hand feels very weak. The clinical outcome of the event right arm and hand intermittently tingles were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: I have had blurred vision since I got home from getting my first shot; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 07Apr2021 at 09:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as patient was diabetic and had asthma. The patient had previously taken Barbiturates and experienced drug allergy. The patient previously took ciprofloxacin (MANUFACTURER UNKNOWN), chlorhexidine (MANUFACTURER UNKNOWN), styrax benzoin tincture (BENZOIN TINCTURE), theophylline(MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN); all on unknown date for unknown indication and experienced drug allergy. The patient had received other prescribed medications (unspecified) 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. The patient has had blurred vision from 07Apr2021 at 10:30, since she got home from getting her first shot on 07Apr2021 at 09:45. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event had blurred vision since she got home from getting her first shot was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleeds; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0158) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid cancer and thyroidectomy. The patient had no known allergies to medications, food, or other products. Concomitant medications included thyroid (ARMOUR THYROID), ethinylestradiol, etonogestrel (NUVARING) and unspecified vitamins; all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 16Apr2021 at 18:00, the patient had nosebleeds. The event 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 event. The clinical outcome of the event nosebleeds was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# ER8732), at the age of 67, via an unspecified route of administration, left arm, on Mar 29, 2021, single dose, for COVID-19 immunisation. Medical history not available. The patient has no allergies to medications, food or other products. Prior to the vaccination, 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 Mar 29, 2021, patient experienced pain in upper left arm for three weeks. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of pain in upper left arm: not resolved. No follow-up attempts needed. No further information expected.