chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable nurse, the patient. A 54-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 right arm on 27Mar2021(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism (reported as hypothyroid) and back pain. Concomitant medications taken within two weeks prior to vaccination included levothyroxine (MANUFACTURER UNKNOWN), pantoprazole sodium sesquihydrate (PROTONIX), vitamin d nos (VITAMIN D), ibuprofen (MOTRIN) and calcium (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: eng6198) via an unspecified route of administration in the right arm on 04Mar2021 at 09:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pyrexia, Urticaria
Clinical narrative: Hives; Chills; Fever; Sharp lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 15:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medication included lansoprazole (MANUFACTURER UNKNOWN) dose of 30 mg from an unknown date for an unknown indication and was unknown if ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 07Apr2021 at 10:30 the patient experienced chills, fever and sharp lower back pain. On 08Apr2021 the patient experienced hives. The clinical course was as follows: At 10:30 of 07Apr2021, the patient started to have chills, fever and sharp lower back pain. By 08Apr2021, chills and fever went away, but hives appeared and back pain persisted. As per PCP, the patient took Tylenol, Cyclobenzaprine, Benadryl but no change to the back pain. Hives were slowly going away. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events included treatment with tylenol, cyclobenzaprine, benadryl for 5 days. The clinical outcome of the events chills and fever were resolved on 08Apr2021. The clinical outcome of the event hives was recovering. The clinical outcome of the event sharp lower back pain was not recovered at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depression, Night sweats, Nodule, Pain
Clinical narrative: Rash at the injection site; Swollen fluid-filled nodule above collarbone; Chills; Body aches; Night sweats; Mental state was considerably negative/depressive; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included multivitamin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously 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 16Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 16:00, the patient experienced rash at the injection site, a swollen fluid-filled nodule above collarbone, chills, body aches, night sweats for 3 nights and the patient's mental state was considerably negative/depressive. The patient stated negative/depressive mental state was unrelated to any circumstances other than the vaccine. 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 rash at the injection site, swollen fluid-filled nodule above collarbone, chills, body aches, night sweats and the mental state was considerably negative/depressive were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Rash at the injection site; Swollen fluid-filled nodule above collarbone; Chills; Body aches; Night sweats; Mental state was considerably negative/depressive; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Concomitant medication included multivitamin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously 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 16Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 06Apr2021 at 16:00, the patient experienced rash at the injection site, a swollen fluid-filled nodule above collarbone, chills, body aches, night sweats for 3 nights and the patient's mental state was considerably negative/depressive. The patient stated negative/depressive mental state was unrelated to any circumstances other than the vaccine. 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 rash at the injection site, swollen fluid-filled nodule above collarbone, chills, body aches, night sweats and the mental state was considerably negative/depressive were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: constant sense of smelling smoke/ new smell developed in its place; This smell was so strong that at times, I could even taste it/ tastes like soured oil.; 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) in the right arm on 18Mar2021 at 04:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 08Apr2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included clogged, full-feeling ear for which the treatment was ongoing. The patient had no allergies to medications, food, or other products. Concomitant medications included guaifenesin (MUCINEX), allergy pills (MANUFACTURER UNKNOWN), nose spray (MANUFACTURER UNKNOWN) and nasal saline rinse (MANUFACTURER UNKNOWN), for indication of clogged ear from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, after the first vaccination, the patient developed a constant sense of smelling smoke. The smell was so strong that at times, the patient could even taste it. This continued the entire 3 weeks until the second vaccine. On 09Apr2021, after the second vaccine, the smoke smell noticeably decreased, disappearing the second day after the second vaccine. But a new smell developed in its place; a smell that was more difficult to label. The patient described it as soured olive oil. This new smell was much more problematic, because everything she ate, tasted like soured oil. Like those who sell perfume had cleared their sense of smell with a sachet of coffee beans, the patient experimented the same and took a whiff of some ground coffee but it only smelled like a stronger version of the sour oil. She could taste nothing spicy nor savory. It all tasted like the dull, almost rancid taste of oil. Since there was no third vaccine to change her smell/taste, she wondered how long she should expect this condition to last. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events smell and taste alterations were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 27Feb2021 at 13:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. 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 04Mar2021 the patient experienced rash which progressively spread all over and gotten worse over time. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with testing and steroid therapy from an unknown date. The clinical outcome of the event rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypoacusis, Tinnitus, Visual snow syndrome
Clinical narrative: Very fatigued; for the first 2-3 hours after waking up I would be lightheaded when I stood up.; Ears would start ringing; Vision was like static; Sounds became really quiet; This is a spontaneous report from a contactable consumer, the patient. An 18-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 left arm on 09Apr2021 at 18:45 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medication included desogestrel, ethinylestradiol (KARIVA) for birth control from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: ER8727), via an unspecified route of administration in the left arm on 19Mar2021 at 16:30 (at the age of 17-years-old), as a single dose for COVID-19 immunisation. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 10:30, the patient experienced very fatigued (which the patient was expecting) but for the first 2-3 hours after waking up the patient would be light headed when stood up. If the patient stood up for longer than a few seconds, vision was like static and ears would start ringing. Once lay back down, the vision came back within a minute and the hearing was back to normal in 5-7 minutes. However, it happened every time the patient stood up and walked for the first 2-3 hours. The patient found that it was better after ate some food. 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. The clinical outcome of the events very fatigued, light headed, vision was like static, sounds became really quiet and ears would start ringing were resolved on 10Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache within 2 hours of the vaccination; This is a spontaneous report from a contactable consumer, the patient. A 43-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 11Apr2021 at 12:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination.  The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 14:00, the patient experienced headache within 2 hours of the vaccination. 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, and emergency room/department or urgent care. The clinical outcome of the event headache within 2 hours of the vaccination was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Food intolerance, Headache, Migraine, Misophonia
Clinical narrative: severe headache; nausea; on top of a migraine; room was spinning-never happened to me before.; Bowels emptied; could not tolerate food or water; could not tolerate to light; Could not tolerate noise; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included lower back pain. The patient did not have any allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), plantago ovata seed husk (PSYLLIUM SEED HUSK CAPSULES) and multivitamin (MANUFACTURER UNKNOWN) for unknown indication and unknown date within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ENI0206) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 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 09Apr2021  at 03:00 two nights after the vaccination, the patient experienced that the room was spinning, which never happened to her before. On 09Apr2021 at 20:00 after seventeen hours, experienced with severe headache and nausea, which was like a sinus headache on top of a migraine. On an unknown date in Apr 2021, the patient experienced emptied bowels, could not tolerate to food or water or light or to noise. No therapeutic measures were taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events spinning sensation, headache, nausea, migraine, emptied bowels, could not tolerate to food or water or light or to noise were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Photophobia, Vertigo
Clinical narrative: severe headache; nausea; on top of a migraine; room was spinning-never happened to me before.; Bowels emptied; could not tolerate food or water; could not tolerate to light; Could not tolerate noise; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included lower back pain. The patient did not have any allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), plantago ovata seed husk (PSYLLIUM SEED HUSK CAPSULES) and multivitamin (MANUFACTURER UNKNOWN) for unknown indication and unknown date within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ENI0206) via an unspecified route of administration in the left arm on 10Mar2021 at 13:00 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 09Apr2021  at 03:00 two nights after the vaccination, the patient experienced that the room was spinning, which never happened to her before. On 09Apr2021 at 20:00 after seventeen hours, experienced with severe headache and nausea, which was like a sinus headache on top of a migraine. On an unknown date in Apr 2021, the patient experienced emptied bowels, could not tolerate to food or water or light or to noise. No therapeutic measures were taken as a result of the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events spinning sensation, headache, nausea, migraine, emptied bowels, could not tolerate to food or water or light or to noise were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: Rash on the feet and lower legs; Small dark red spots, not itchy. Appeared this morning, day 3; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 08Apr2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11Apr2021 at 11:00, the patient experienced rash on the feet and lower legs and small dark red spots, not itchy. The patient reported that this rash on feet and lower legs and small red spots appeared in morning of day 3. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event rash on the feet and lower legs, small dark red spots, not itchy was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Ocular discomfort
Clinical narrative: Flushed hot cheeks; dizziness; eye discomfort; This is a spontaneous report from a contactable consumer, the patient. A 38-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 right arm on 10Apr2021 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included bcp (MANUFACTURER UNKNOWN) from unknown date for an unknown indication. 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 10Apr2021 the patient experienced flushed hot cheeks, dizziness, and eye discomfort. 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 flushed hot cheeks, dizziness, and eye discomfort were recovered on unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: left shoulder joint pain; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 20Feb2021 at 11:45 as a single dose for COVID-19 immunisation. Medical history included stage 1 hypertension and ankle pain from injury. Concomitant medications included telmisartan (MANUFACTURER UNKNOWN) 20 mg, started on an unknown date for unspecified indication and was taking once per day and isradipine (MANUFACTURER UNKNOWN) 2.5 mg, started on an unknown date for unspecified indication and was taking twice per day. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration on 30Jan2021 at 12:15 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not tested positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021, the patient experienced right hip and left shoulder joint pain, mild to severe in hip, mild in shoulder and prior ankle pain from long ago injury was now noticeably worse. Therapeutic measures were taken as a result of right hip and left shoulder joint pain, mild to severe in hip, mild in shoulder and ankle pain which included treatment with meloxicam once per day for 14 days. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events right hip and left shoulder joint pain, mild to severe in hip, mild in shoulder and ankle pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Computerised tomogram, Ultrasound scan
Clinical narrative: Severe lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 21Feb2021 at 11:15 (at the age of 16-years-old) and 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 20Mar2021 (at the age of 16-years-old), both as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to vaccination. Medical history was reported as none. 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 take any concomitant medications. The patient did not have any allergies to food, medications, or other products. On 18Mar2021, the patient experienced severe lower back pain. The event resulted 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 severe lower back pain and included treatment with unspecified pain medications. The patient underwent lab tests and procedures which included computed tomography (CT) scan, ultrasound and blood tests on an unknown date and the results were unknown. The clinical outcome of the event severe lower back pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Confusional state, Fatigue, Gait disturbance, Headache
Clinical narrative: Third day - Worse joint pain; ankle pain; knees trouble walking; second day - Joint pain; headache,; tired; First day  - Confused feeling; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension It was unknown whether the patient had allergies to medications, food, or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN)   25 mg for unknown indication, from unknown time. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, first day the patient experienced confused feeling. On 09Apr2021, second day the patient experienced joint pain, headache, tired. On 10Apr2021, third day the patient experienced worse joint pain, ankle pain and knees trouble walking. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events confused feeling, joint pain, headache, tired, worse joint pain, ankle pain and knees trouble walking were not recovered, at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Third day - Worse joint pain; ankle pain; knees trouble walking; second day - Joint pain; headache,; tired; First day  - Confused feeling; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension It was unknown whether the patient had allergies to medications, food, or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN)   25 mg for unknown indication, from unknown time. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Apr2021, first day the patient experienced confused feeling. On 09Apr2021, second day the patient experienced joint pain, headache, tired. On 10Apr2021, third day the patient experienced worse joint pain, ankle pain and knees trouble walking. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events confused feeling, joint pain, headache, tired, worse joint pain, ankle pain and knees trouble walking were not recovered, at this time of report.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urine odour abnormal
Clinical narrative: Strong smelling urine; "administration_date 10Apr2021, dose_number=2/ administration_date 27Mar2021, dose_number=1"; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  On 10Apr2021, the patient experienced "administration date 10Apr2021, dose number=2/ administration date 27Mar2021, dose number=1". On 11Apr2021 at 08:00, the patient had strong smelling urine. The patient did not receive any treatment for the event. The clinical outcome of the event strong smelling urine was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Lymph node pain
Clinical narrative: Brain fog; Severe body aches; Painful lymph nodes under left armpit; Low grade fever; Chills; Headaches; Extreme fatigue; Left arm pain at injection site; Swelling of lymph nodes under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, high cholesterol and sulphonamide allergy. Concomitant medications included zafirlukast (MANUFACTURER UNKNOWN), ezetimibe (ZETIA), colecalciferol (VITAMIN D3), ascorbic acid; herbal nos; levoglutamide; lysine; magnesium; manganese; retinol; riboflavin; selenium; tocopherol; zinc (AIRBORNE) and ibuprofen (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient previously took codeine, quinolones and Zantac and experienced allergy to these medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 18Mar2021 at 11:30 (at the age of 63-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 08Apr2021 at 22:00, the patient experienced low grade fever and chills, severe body aches, headaches, extreme fatigue, left arm pain at injection site, painful swelling of lymph nodes under left armpit and brain fog. The patient did not receive any treatment for the events. The symptoms were the worst between 10 and 48 hours post vaccine but were still present to a lesser extent as of 76 hours post vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events low grade fever and chills, severe body aches, headaches, extreme fatigue, left arm pain at injection site, painful swelling of lymph nodes under left armpit and brain fog was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Brain fog; Severe body aches; Painful lymph nodes under left armpit; Low grade fever; Chills; Headaches; Extreme fatigue; Left arm pain at injection site; Swelling of lymph nodes under left armpit; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Apr2021 at 11:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, high cholesterol and sulphonamide allergy. Concomitant medications included zafirlukast (MANUFACTURER UNKNOWN), ezetimibe (ZETIA), colecalciferol (VITAMIN D3), ascorbic acid; herbal nos; levoglutamide; lysine; magnesium; manganese; retinol; riboflavin; selenium; tocopherol; zinc (AIRBORNE) and ibuprofen (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient previously took codeine, quinolones and Zantac and experienced allergy to these medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 18Mar2021 at 11:30 (at the age of 63-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 08Apr2021 at 22:00, the patient experienced low grade fever and chills, severe body aches, headaches, extreme fatigue, left arm pain at injection site, painful swelling of lymph nodes under left armpit and brain fog. The patient did not receive any treatment for the events. The symptoms were the worst between 10 and 48 hours post vaccine but were still present to a lesser extent as of 76 hours post vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events low grade fever and chills, severe body aches, headaches, extreme fatigue, left arm pain at injection site, painful swelling of lymph nodes under left armpit and brain fog was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rash; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL 3302) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient was not allergic 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 medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:30, the patient experienced hives and rash. 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 hives and rash were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: My throat started to feel swollen; Felt dizzy; Nauseous; Head ache; Weakness; Tired; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0158) via an unspecified route of administration in the right arm on 11Apr2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included ascorbic acid (VITAMIN C) 1000 mg and zinc 50 mg (MANUFACTURER UNKNOWN) on unspecified dates, for unknown indication and unknown if ongoing. 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. On 11Apr2021 at 12:30 approximately 30 minutes after receiving the first dose of vaccine, the patient throat started to feel swollen, felt dizzy, nauseous, head ache, weakness and tired. 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 reported events. The clinical outcome of the events throat started to feel swollen, felt dizzy, nauseous, head ache, weakness and tired were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: My throat started to feel swollen; Felt dizzy; Nauseous; Head ache; Weakness; Tired; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0158) via an unspecified route of administration in the right arm on 11Apr2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. Concomitant medications included ascorbic acid (VITAMIN C) 1000 mg and zinc 50 mg (MANUFACTURER UNKNOWN) on unspecified dates, for unknown indication and unknown if ongoing. 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. On 11Apr2021 at 12:30 approximately 30 minutes after receiving the first dose of vaccine, the patient throat started to feel swollen, felt dizzy, nauseous, head ache, weakness and tired. 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 reported events. The clinical outcome of the events throat started to feel swollen, felt dizzy, nauseous, head ache, weakness and tired were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Felt dizzy and nausea 10 to 15 after receiving shot; Felt dizzy and nausea 10 to 15 after receiving shot; This is a spontaneous report from a contactable pharmacist. An adult non-pregnant female patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an intramuscular route of administration in the left arm on 11Apr2021 at 14:30, as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown whether the patient had any known allergies to food, medications or other products. It was unknown whether the patient received any other medications within 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 11Apr2021, the patient felt dizzy and nausea 10 to 15 after receiving shot. The reporter had to call doctor to pick her up. No therapeutic measures were taken as a result of the events. The clinical outcome of the events felt dizzy and nausea 10 to 15 after receiving shot was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: Severe nausea without vomiting; severe diarrhea 2-4 times a day; This is a spontaneous report from a contactable consumer, the patient. A 19-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 the age of 19-years-old) as a, single dose for COVID-19 immunisation. Medical history was and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced severe nausea without vomiting and severe diarrhea 2-4 times a day. The events were impacting on the patient's functioning. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of severe nausea without vomiting and severe diarrhea 2-4 times a day were not recovered.  No follow-up attempts are needed; information about lot number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 26-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 10Apr2021 at 14:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications 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 11Apr2021 at 12:00, the patient experienced headache and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache and chills were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.