chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Headache; Fever; Stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 06May2021 at 15:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight, anxiety, esophageal reflux and depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included daily vitamin (MANUFACTURER UNKNOWN) and sertraline (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 06May2021 at 22:30, the patient experienced sore arm, headache, fever and stomach ache. 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 sore arm, headache, fever and stomach ache were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intermenstrual bleeding, Lymphadenopathy, Thrombosis
Clinical narrative: Swelling of lymph nodes in armpit; This is a spontaneous report from a contactable health care professional, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); buspirone (MANUFACTURER UNKNOWN) and alprazolam (XANAX); all for unknown indication started on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administration in the right arm on 14Apr2021 at 18:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 07:30, 48 hours after vaccination, the patient experienced swelling of lymph nodes in armpit. Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lymph nodes in armpit was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph nodes in armpit; This is a spontaneous report from a contactable health care professional, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 05May2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); buspirone (MANUFACTURER UNKNOWN) and alprazolam (XANAX); all for unknown indication started on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8732) via an unspecified route of administration in the right arm on 14Apr2021 at 18:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 07:30, 48 hours after vaccination, the patient experienced swelling of lymph nodes in armpit. Therapeutic measures were not taken as a result of the event. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lymph nodes in armpit was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Caffeine allergy, Nausea, Palpitations, Tremor
Clinical narrative: Extreme sensitivity to caffeine.; Shakes; Heart palpitations; Mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 02May2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 08:45, after the second shot of vaccine, the patient experienced an extreme sensitivity to caffeine, prior to the second dose of Pfizer, the patient had a large tolerance to coffee or caffeine where she was never affected by any caffeine ingestion, within a day of her second Pfizer dose, she was extremely sensitive to caffeine, where she got shakes, heart palpitations and mild nausea after drinking less than a few sips of plain black coffee. 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 extremely sensitive to caffeine, shakes, heart palpitations and mild nausea were not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Nausea, Palpitations, Tremor
Clinical narrative: Extreme sensitivity to caffeine.; Shakes; Heart palpitations; Mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 02May2021 at 16:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. 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 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 08:45, after the second shot of vaccine, the patient experienced an extreme sensitivity to caffeine, prior to the second dose of Pfizer, the patient had a large tolerance to coffee or caffeine where she was never affected by any caffeine ingestion, within a day of her second Pfizer dose, she was extremely sensitive to caffeine, where she got shakes, heart palpitations and mild nausea after drinking less than a few sips of plain black coffee. 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 extremely sensitive to caffeine, shakes, heart palpitations and mild nausea were not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: I started getting a specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter and to a lesser degree, almond butter.; I started getting a specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter and to a lesser degree, almond butter.; I also notice the same smell in my body odor and feces; I also notice the same smell in my body odor and feces (which may be related to eating the above objects). These may be related in the sense that they are all dry roasted; This is a spontaneous report from a contactable physician, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 17:30 at the age of 47-years-old as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 27Apr2021, the patient started getting a specific very unpleasant metallic smell to pistachios, peanut butter, and to a lesser degree, almond butter. The patient also noticed the same smell in his body odor and feces. These might be related in the sense that they were all dry roasted. He had looked at vaccine smell changes, and the best he could found was that changes in smell resolved after a few days. But mined had not diminished at all. 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. The clinical outcome of the events specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter, and to a lesser degree, almond butter, and also noticed the same smell in his body odor and feces was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal faeces, Hypogeusia, Parosmia, Skin odour abnormal
Clinical narrative: I started getting a specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter and to a lesser degree, almond butter.; I started getting a specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter and to a lesser degree, almond butter.; I also notice the same smell in my body odor and feces; I also notice the same smell in my body odor and feces (which may be related to eating the above objects). These may be related in the sense that they are all dry roasted; This is a spontaneous report from a contactable physician, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 17:30 at the age of 47-years-old as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 27Apr2021, the patient started getting a specific very unpleasant metallic smell to pistachios, peanut butter, and to a lesser degree, almond butter. The patient also noticed the same smell in his body odor and feces. These might be related in the sense that they were all dry roasted. He had looked at vaccine smell changes, and the best he could found was that changes in smell resolved after a few days. But mined had not diminished at all. 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. The clinical outcome of the events specific very unpleasant metallic smell (and to a lesser degree taste) to pistachios, peanut butter, and to a lesser degree, almond butter, and also noticed the same smell in his body odor and feces was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash all over patients body; This is a spontaneous report from a contactable consumer, the patient. A 16-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 07May2021 at 11:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included "5P minus" and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included cannabidiol (EPIDIOLEX) for an unknown indication from an unknown date and unknown if ongoing. On 08May2021 at 22:00, the patient experienced rash all over the patient's body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with over the counter cortizone itch cream (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash all over the patient's body was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Rash erythematous
Clinical narrative: Red, swollen toes in both feet with red spots; Red, swollen toes in both feet with red spots; Red, swollen toes in both feet with red spots; 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: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 at 11:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified vitamin supplements and calcium (MANUFACTURER UNKNOWN) (reported as calcium supplements); both from unknown dates and 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 in the left arm on 17Apr2021 at 00:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 13:00, the patient experienced red, swollen toes in both feet with red spots. 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 red, swollen toes in both feet with red spots was resolving 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: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Rash macular
Clinical narrative: Red, swollen toes in both feet with red spots; Red, swollen toes in both feet with red spots; Red, swollen toes in both feet with red spots; 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: UNKNOWN) via an unspecified route of administration in the left arm on 09May2021 at 11:15 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified vitamin supplements and calcium (MANUFACTURER UNKNOWN) (reported as calcium supplements); both from unknown dates and 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 in the left arm on 17Apr2021 at 00:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 13:00, the patient experienced red, swollen toes in both feet with red spots. 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 red, swollen toes in both feet with red spots was resolving 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: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in armpit; This is a spontaneous report from a contactable nurse, the patient. 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 on 08May2021 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On 10May2021, the patient experienced swollen lymph node in armpit. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node in armpit was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; 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: ER0168) via an unspecified route of administration in the left arm on 05May2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had known allergies to dairy. 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 insulin human (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all taken for unknown indications 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: ER8734) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 18:30, the patient experienced loss of taste. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event loss of taste was resolved on 10May2021.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Skin irritation, Urticaria
Clinical narrative: Severe rashes all over the body with hives, itching and irritation; Severe rashes all over the body with hives, itching and irritation; Severe rashes all over the body with hives, itching and irritation; This is a spontaneous report from a contactable consumer, the patient. A 32-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 30Apr2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Prior to 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8955) via an unspecified route of administration in the left arm on 26Mar2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and received sulfur (SULPHUR) for an unknown indication on unknown date and experienced drug allergy. On 05May2021 at 18:00, the patient experienced severe rashes all over the body with hives, itching and irritation. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatments with steroids and antihistamines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe rashes all over the body with hives, itching and irritation was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Severe rashes all over the body with hives, itching and irritation; Severe rashes all over the body with hives, itching and irritation; Severe rashes all over the body with hives, itching and irritation; This is a spontaneous report from a contactable consumer, the patient. A 32-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 30Apr2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Prior to 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 COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP8955) via an unspecified route of administration in the left arm on 26Mar2021 at 17:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and received sulfur (SULPHUR) for an unknown indication on unknown date and experienced drug allergy. On 05May2021 at 18:00, the patient experienced severe rashes all over the body with hives, itching and irritation. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatments with steroids and antihistamines. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe rashes all over the body with hives, itching and irritation was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine
Clinical narrative: Extremely intense migraine attack that hasn't decreased since after the first dose. (12 days so far); This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 12:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder (OCD) and menstrual migraines. Concomitant medications included memantine (MANUFACTURER UNKNOWN) and piroxicam (PAXIL). 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 02May2021 at 07:00 the patient experienced extremely intense migraine attack that has not decreased since after the first dose (12 days so far).The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of migraine attack and included treatment with tramadol for pain. The clinical outcome of the event migraine attack was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Balance disorder, Dizziness, Feeling abnormal, Hyperacusis
Clinical narrative: Severe vertigo; Dizziness/Lightheadedness; Motion sickness; Blurred vision; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient 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 17Mar2021 at 14:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history includes history of inflammatory breast cancer, seasonal allergies and sensitivity to chemicals and fragrances. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (EUTHYROX) 75mcg and colecalciferol 5000 IU (VITAMIN D3); both for an unknown indication from an unknown date and unknown if ongoing. On 27Mar2021 at 07:00, 10 days after vaccination, the patient experienced severe vertigo which had not resolved since then. Vertigo was not as severe every day as it was at onset. It alternated with periods of dizziness and light-headedness and motion sickness along with blurred vision and tinnitus. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the vertigo, dizziness, light-headedness, motion sickness, blurred vision and tinnitus which included treatment with physical therapy - Epley maneuver. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vertigo, periods of dizziness and lightheadedness and motion sickness along with blurred vision and tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Motion sickness, Nausea, Pain, Photophobia, Pyrexia
Clinical narrative: Severe vertigo; Dizziness/Lightheadedness; Motion sickness; Blurred vision; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient 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 17Mar2021 at 14:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history includes history of inflammatory breast cancer, seasonal allergies and sensitivity to chemicals and fragrances. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (EUTHYROX) 75mcg and colecalciferol 5000 IU (VITAMIN D3); both for an unknown indication from an unknown date and unknown if ongoing. On 27Mar2021 at 07:00, 10 days after vaccination, the patient experienced severe vertigo which had not resolved since then. Vertigo was not as severe every day as it was at onset. It alternated with periods of dizziness and light-headedness and motion sickness along with blurred vision and tinnitus. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the vertigo, dizziness, light-headedness, motion sickness, blurred vision and tinnitus which included treatment with physical therapy - Epley maneuver. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vertigo, periods of dizziness and lightheadedness and motion sickness along with blurred vision and tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vertigo, Vestibular function test normal, Vision blurred, Vitreous floaters
Clinical narrative: Severe vertigo; Dizziness/Lightheadedness; Motion sickness; Blurred vision; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient 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 17Mar2021 at 14:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history includes history of inflammatory breast cancer, seasonal allergies and sensitivity to chemicals and fragrances. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (EUTHYROX) 75mcg and colecalciferol 5000 IU (VITAMIN D3); both for an unknown indication from an unknown date and unknown if ongoing. On 27Mar2021 at 07:00, 10 days after vaccination, the patient experienced severe vertigo which had not resolved since then. Vertigo was not as severe every day as it was at onset. It alternated with periods of dizziness and light-headedness and motion sickness along with blurred vision and tinnitus. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the vertigo, dizziness, light-headedness, motion sickness, blurred vision and tinnitus which included treatment with physical therapy - Epley maneuver. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vertigo, periods of dizziness and lightheadedness and motion sickness along with blurred vision and tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Motion sickness, Tinnitus, Vertigo, Vision blurred
Clinical narrative: Severe vertigo; Dizziness/Lightheadedness; Motion sickness; Blurred vision; Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient 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 17Mar2021 at 14:00 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history includes history of inflammatory breast cancer, seasonal allergies and sensitivity to chemicals and fragrances. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine sodium (EUTHYROX) 75mcg and colecalciferol 5000 IU (VITAMIN D3); both for an unknown indication from an unknown date and unknown if ongoing. On 27Mar2021 at 07:00, 10 days after vaccination, the patient experienced severe vertigo which had not resolved since then. Vertigo was not as severe every day as it was at onset. It alternated with periods of dizziness and light-headedness and motion sickness along with blurred vision and tinnitus. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the vertigo, dizziness, light-headedness, motion sickness, blurred vision and tinnitus which included treatment with physical therapy - Epley maneuver. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vertigo, periods of dizziness and lightheadedness and motion sickness along with blurred vision and tinnitus was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis
Clinical narrative: About 3 days after the vaccine, I started having random bloody noses; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0170) via an unspecified route of administration in the right arm on 21Apr2021 at 16:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, bloody noses and known allergies to latex, various foods, molds, pollens, etc. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC), montelukast sodium (SINGULAIR), citalopram (MANUFACTURER UNKNOWN), fluticasone propionate/salmeterol xinafoate (ADVAIR) and vitamin d nos (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Apr2021, about 3 days after the vaccine, the patient experienced random bloody noses for about a week. For about a week, the patient had around 2 per day and now she had one every few days. The patient reported that prior to the vaccine, bloody noses were very very rare. 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 random bloody noses for about a week, she had around 2 per day and now had one every few days was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: I had Bell's Palsy. It was like a stroke. I had known muscle control of the left side of my face. I went to the ER Hospital. They did a CT scan and physical checks. I had an EKG also. The doctor said it was Bell's Palsy and not a stoke. It took about 3 months for all the symptoms to go completely away.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Electrocardiogram, Facial paresis
Clinical narrative: I had Bell's Palsy. It was like a stroke. I had known muscle control of the left side of my face. I went to the ER Hospital. They did a CT scan and physical checks. I had an EKG also. The doctor said it was Bell's Palsy and not a stoke. It took about 3 months for all the symptoms to go completely away.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom
Clinical narrative: I had Bell's Palsy. It was like a stroke. I had known muscle control of the left side of my face. I went to the ER Hospital. They did a CT scan and physical checks. I had an EKG also. The doctor said it was Bell's Palsy and not a stoke. It took about 3 months for all the symptoms to go completely away.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Burning sensation, Pain, Pruritus
Clinical narrative: Develop blisters on her body/after 24 hours, the blisters went to her back, abdominal area, and chest; Her blisters were itching and itching; She is upset; This is a spontaneous report from a contactable consumer or other non HCP (Patient) reporting for herself.  A 62-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EP6955) as DOSE 1, SINGLE (at the age of 62-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced develop blisters on her body/after 24 hours, the blisters went to her back, abdominal area, and chest, her blisters were itching and itching on 22Mar2021. The patient was upset on unknown date in Mar2021. It was reported that within 2 hours of vaccination the patient started to develop blisters on her body (unclear where) and stated after 24 hours the blisters went to her back, abdominal area and chest. The patent saw her to her physician and was prescribed unspecified ointment however it didn't work. The patient then went to a skin physician and was given unspecified medication and ointment. She took the medications for 2.5 months however it was not working. States the blisters go away and then they come back. Other products and investigations were not provided. It was reported that initially did not have questions, she wanted treatment recommendations and was referred back to her physician. The patient was upset, the whole night, at midnight, her blisters were itching and itching and she does not know what to do. The patient received second dose of bnt162b2 on 12Apr2021 (BNT162B2 Formulation: Solution for injection) (Lot: EW0151, NDC, expiry unknown) for covid-19 immunisation. It was reported that the patient visited the ER, for treatment, and they took Biofreeze to her blisters and they still on her body. Therapeutic measures were taken as a result of blisters and blisters itching. The outcome of events blisters and blisters itching was not recovered and outcome of event she was upset was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Depressed mood, Pruritus
Clinical narrative: Develop blisters on her body/after 24 hours, the blisters went to her back, abdominal area, and chest; Her blisters were itching and itching; She is upset; This is a spontaneous report from a contactable consumer or other non HCP (Patient) reporting for herself.  A 62-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22Mar2021 (Batch/Lot Number: EP6955) as DOSE 1, SINGLE (at the age of 62-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced develop blisters on her body/after 24 hours, the blisters went to her back, abdominal area, and chest, her blisters were itching and itching on 22Mar2021. The patient was upset on unknown date in Mar2021. It was reported that within 2 hours of vaccination the patient started to develop blisters on her body (unclear where) and stated after 24 hours the blisters went to her back, abdominal area and chest. The patent saw her to her physician and was prescribed unspecified ointment however it didn't work. The patient then went to a skin physician and was given unspecified medication and ointment. She took the medications for 2.5 months however it was not working. States the blisters go away and then they come back. Other products and investigations were not provided. It was reported that initially did not have questions, she wanted treatment recommendations and was referred back to her physician. The patient was upset, the whole night, at midnight, her blisters were itching and itching and she does not know what to do. The patient received second dose of bnt162b2 on 12Apr2021 (BNT162B2 Formulation: Solution for injection) (Lot: EW0151, NDC, expiry unknown) for covid-19 immunisation. It was reported that the patient visited the ER, for treatment, and they took Biofreeze to her blisters and they still on her body. Therapeutic measures were taken as a result of blisters and blisters itching. The outcome of events blisters and blisters itching was not recovered and outcome of event she was upset was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: After 2 days started to have Knee Joint pain and it does not go away after 4 days now; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FW0181, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 11Jun2021 at 15:15 (age at vaccination: 53years-old) as dose 1, single for COVID-19 immunization. Medical history was reported as None and Concomitant medication included vitamin c [ascorbic acid]; cetirizine hydrochloride (ZYNCET) and Quercetin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior and did not received other medications 2 weeks prior to the COVID vaccine. Patient had no known allergies. The patient was not tested positive for covid 19 prior to vaccination and had not been tested COVID post vaccination. On 13Jun2021, the patient reported that After 2 days of vaccination she started to have Knee Joint pain and it does not go away after 4 days at the time of reporting. No treatment received for the event. The outcome of the event was not yet recovered.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dermatitis contact, Glossodynia, Pyrexia, Tongue disorder
Clinical narrative: tongue and lips are swollen,  lips are cracked with some bleeding.; tongue and lips are swollen,  lips are cracked with some bleeding.; tongue and lips are swollen,  lips are cracked with some bleeding.; lips are cracked with some bleeding; very deep purple color, about the size of a dime, around the injection site.",; Tongue is very painful - feels like it got severely burnt; Tongue is very painful - feels like it got severely burnt; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in arm right on 20Apr2021 08:45 (at the age of 56-year-old) at dose 1, single for covid-19 immunisation. Medical history included high blood pressure and cholesterol, Bicuspid aortic valve. Patient had Known allergies with erythromycin. Concomitant medications included amlodipine (AMLODI-PINE) 2.5 mg; rosuvastatin (ROSUVASTATIN) 20mg; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYL-SALICYLIC ACID]) 81mg, all taken for an unspecified indication, start and stop date were not reported, patient received these medications in two weeks. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested for covid post vaccination. On 20Apr2021 18:00 the patient experienced adverse event: tongue and lips are swollen, lips are cracked with some bleeding. Tongue is very painful - feels like it got severely burnt. Nothing soothes nor dulls the pain. This presented the evening of 20Apr2021. It hasn't improved over these past three days. If no improvement by 26Apr, I will seek medical intervention. Also very deep purple color, about the size of a dime, around the injection site. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.  Follow-up (22Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chapped lips, Glossodynia, Lip haemorrhage, Lip swelling, Swollen tongue
Clinical narrative: tongue and lips are swollen,  lips are cracked with some bleeding.; tongue and lips are swollen,  lips are cracked with some bleeding.; tongue and lips are swollen,  lips are cracked with some bleeding.; lips are cracked with some bleeding; very deep purple color, about the size of a dime, around the injection site.",; Tongue is very painful - feels like it got severely burnt; Tongue is very painful - feels like it got severely burnt; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in arm right on 20Apr2021 08:45 (at the age of 56-year-old) at dose 1, single for covid-19 immunisation. Medical history included high blood pressure and cholesterol, Bicuspid aortic valve. Patient had Known allergies with erythromycin. Concomitant medications included amlodipine (AMLODI-PINE) 2.5 mg; rosuvastatin (ROSUVASTATIN) 20mg; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYL-SALICYLIC ACID]) 81mg, all taken for an unspecified indication, start and stop date were not reported, patient received these medications in two weeks. Patient did not have other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested for covid post vaccination. On 20Apr2021 18:00 the patient experienced adverse event: tongue and lips are swollen, lips are cracked with some bleeding. Tongue is very painful - feels like it got severely burnt. Nothing soothes nor dulls the pain. This presented the evening of 20Apr2021. It hasn't improved over these past three days. If no improvement by 26Apr, I will seek medical intervention. Also very deep purple color, about the size of a dime, around the injection site. Patient did not receive treatment for the adverse events. Outcome of the events was not resolved.  Follow-up (22Oct2021): Follow-up attempts are completed. No further information is expected.