chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Headache, Heart rate increased, Injection site pruritus, Injection site warmth
Clinical narrative: an elevated heart rate; problems with breathing; This is a spontaneous report from a contactable consumer (patient), received from a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 15Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history included lot of allergies. Concomitant medications were not reported. The patient's past drugs included Benadryl and Epipen, and experienced allergy with both drugs. On 15Mar2021, within a few minutes after the first dose of vaccine, the patient experienced an elevated heart rate and problems with breathing. Patient received a note from her doctor stating that she cannot get the second dose as well. Patient underwent lab test and procedures which included heart rate: an elevated heart rate, on an unspecified date. The clinical outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Rash, Somnolence, Swelling, Swollen tongue
Clinical narrative: an elevated heart rate; problems with breathing; This is a spontaneous report from a contactable consumer (patient), received from a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 15Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history included lot of allergies. Concomitant medications were not reported. The patient's past drugs included Benadryl and Epipen, and experienced allergy with both drugs. On 15Mar2021, within a few minutes after the first dose of vaccine, the patient experienced an elevated heart rate and problems with breathing. Patient received a note from her doctor stating that she cannot get the second dose as well. Patient underwent lab test and procedures which included heart rate: an elevated heart rate, on an unspecified date. The clinical outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: an elevated heart rate; problems with breathing; This is a spontaneous report from a contactable consumer (patient), received from a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 15Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history included lot of allergies. Concomitant medications were not reported. The patient's past drugs included Benadryl and Epipen, and experienced allergy with both drugs. On 15Mar2021, within a few minutes after the first dose of vaccine, the patient experienced an elevated heart rate and problems with breathing. Patient received a note from her doctor stating that she cannot get the second dose as well. Patient underwent lab test and procedures which included heart rate: an elevated heart rate, on an unspecified date. The clinical outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: an elevated heart rate; problems with breathing; This is a spontaneous report from a contactable consumer (patient), received from a Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 15Mar2021, as dose 1, single for COVID-19 immunization. The patient's medical history included lot of allergies. Concomitant medications were not reported. The patient's past drugs included Benadryl and Epipen, and experienced allergy with both drugs. On 15Mar2021, within a few minutes after the first dose of vaccine, the patient experienced an elevated heart rate and problems with breathing. Patient received a note from her doctor stating that she cannot get the second dose as well. Patient underwent lab test and procedures which included heart rate: an elevated heart rate, on an unspecified date. The clinical outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal inflammation, Lymph node pain, Pain
Clinical narrative: Lymph node swelling; Pulsing; Chills; Inflammation of GI tract from top to bottom - lasted 5-6 days; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old non-pregnant female patient received bnt162b2 (Pfizer; solution for injection; Lot Number: ENG208), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 at 09:15 AM (at the age of 62 years, non-pregnant) as dose 1, single for covid-19 immunisation. Relevant medical history included Graves disease and it was treated with radioactive Iodine, other autoimmune problems.Patient previously took Cephalexin, and experienced Graves disease and autoimmune IBS (Irritable bowel syndrome), possible Sjogrens. Concomitant medications included thyroid (ARMOUR THYROID); calcium; pregnenolone and Osteoben taken for an unspecified indication. The patient had known allergy of epinephrine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021, 13 days after vaccination patient experienced lymph node swelling and pulsing, chills, inflammation of GI tract from top to bottom which lasted for 5-6 days. Patient did not receive any treatment for the events. since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Gastrointestinal inflammation, Heart rate increased, Lymphadenopathy
Clinical narrative: Lymph node swelling; Pulsing; Chills; Inflammation of GI tract from top to bottom - lasted 5-6 days; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old non-pregnant female patient received bnt162b2 (Pfizer; solution for injection; Lot Number: ENG208), dose 1 via an unspecified route of administration, administered in left arm on 11Mar2021 at 09:15 AM (at the age of 62 years, non-pregnant) as dose 1, single for covid-19 immunisation. Relevant medical history included Graves disease and it was treated with radioactive Iodine, other autoimmune problems.Patient previously took Cephalexin, and experienced Graves disease and autoimmune IBS (Irritable bowel syndrome), possible Sjogrens. Concomitant medications included thyroid (ARMOUR THYROID); calcium; pregnenolone and Osteoben taken for an unspecified indication. The patient had known allergy of epinephrine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021, 13 days after vaccination patient experienced lymph node swelling and pulsing, chills, inflammation of GI tract from top to bottom which lasted for 5-6 days. Patient did not receive any treatment for the events. since the vaccination, patient has not been tested for COVID-19. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blister, Chills, Headache, Herpes zoster
Clinical narrative: Back pain started then vesicles the next day with rash on right torso; Nerve pain accompanied the itching; Nerve pain accompanied the itching; Shingles outbreak 5 days post vaccine; Back pain started; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension (HTN), adrenal insufficiency and hypothyroidism. The patient was allergic to fish. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), hydrocortisone (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and vitamin D (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously took morphine 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 16Mar2021, 5 days post vaccine, the patient experienced shingles outbreak which started with back pain. On 17Mar2021, the next day, vesicles appeared with rash on right torso and nerve pain accompanied with itching. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Valtrex from 19Mar2021 for a duration of 7 days. The vesicles had dried up by 30Mar2021 and the pain had subsided, but the patient still had some residual nerve pain on torso when touched. The clinical outcome of the events shingles, back pain, vesicles with rash on right torso and nerve pain accompanied with itching were resolved with lasting effects on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Lymph node pain, Lymphadenopathy, Malaise, Neuralgia
Clinical narrative: Back pain started then vesicles the next day with rash on right torso; Nerve pain accompanied the itching; Nerve pain accompanied the itching; Shingles outbreak 5 days post vaccine; Back pain started; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension (HTN), adrenal insufficiency and hypothyroidism. The patient was allergic to fish. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), hydrocortisone (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and vitamin D (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously took morphine 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 16Mar2021, 5 days post vaccine, the patient experienced shingles outbreak which started with back pain. On 17Mar2021, the next day, vesicles appeared with rash on right torso and nerve pain accompanied with itching. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Valtrex from 19Mar2021 for a duration of 7 days. The vesicles had dried up by 30Mar2021 and the pain had subsided, but the patient still had some residual nerve pain on torso when touched. The clinical outcome of the events shingles, back pain, vesicles with rash on right torso and nerve pain accompanied with itching were resolved with lasting effects on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Back pain started then vesicles the next day with rash on right torso; Nerve pain accompanied the itching; Nerve pain accompanied the itching; Shingles outbreak 5 days post vaccine; Back pain started; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension (HTN), adrenal insufficiency and hypothyroidism. The patient was allergic to fish. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), hydrocortisone (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and vitamin D (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously took morphine 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 16Mar2021, 5 days post vaccine, the patient experienced shingles outbreak which started with back pain. On 17Mar2021, the next day, vesicles appeared with rash on right torso and nerve pain accompanied with itching. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Valtrex from 19Mar2021 for a duration of 7 days. The vesicles had dried up by 30Mar2021 and the pain had subsided, but the patient still had some residual nerve pain on torso when touched. The clinical outcome of the events shingles, back pain, vesicles with rash on right torso and nerve pain accompanied with itching were resolved with lasting effects on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tenderness
Clinical narrative: Back pain started then vesicles the next day with rash on right torso; Nerve pain accompanied the itching; Nerve pain accompanied the itching; Shingles outbreak 5 days post vaccine; Back pain started; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension (HTN), adrenal insufficiency and hypothyroidism. The patient was allergic to fish. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), hydrocortisone (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and vitamin D (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously took morphine 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 16Mar2021, 5 days post vaccine, the patient experienced shingles outbreak which started with back pain. On 17Mar2021, the next day, vesicles appeared with rash on right torso and nerve pain accompanied with itching. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Valtrex from 19Mar2021 for a duration of 7 days. The vesicles had dried up by 30Mar2021 and the pain had subsided, but the patient still had some residual nerve pain on torso when touched. The clinical outcome of the events shingles, back pain, vesicles with rash on right torso and nerve pain accompanied with itching were resolved with lasting effects on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster, Neuralgia, Pruritus, Rash vesicular
Clinical narrative: Back pain started then vesicles the next day with rash on right torso; Nerve pain accompanied the itching; Nerve pain accompanied the itching; Shingles outbreak 5 days post vaccine; Back pain started; This is a spontaneous report from a contactable nurse, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 11Mar2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included Hypertension (HTN), adrenal insufficiency and hypothyroidism. The patient was allergic to fish. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID), hydrocortisone (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and vitamin D (MANUFACTURER UNKNOWN), all taken for unspecified indications from unknown dates. The patient previously took morphine 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 16Mar2021, 5 days post vaccine, the patient experienced shingles outbreak which started with back pain. On 17Mar2021, the next day, vesicles appeared with rash on right torso and nerve pain accompanied with itching. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Valtrex from 19Mar2021 for a duration of 7 days. The vesicles had dried up by 30Mar2021 and the pain had subsided, but the patient still had some residual nerve pain on torso when touched. The clinical outcome of the events shingles, back pain, vesicles with rash on right torso and nerve pain accompanied with itching were resolved with lasting effects on 30Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Paresthesia; Numb skin; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 10:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma and chemotherapy in 2015. Patient had no allergies to medications, food, or other product. Concomitant medications include amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS), biotin (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. 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 01Apr2021 at 10:30, the patient experienced paresthesia and numb skin. 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 events. The clinical outcome of the events of paresthesia and numbness was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Paresthesia; Numb skin; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Apr2021 at 10:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma and chemotherapy in 2015. Patient had no allergies to medications, food, or other product. Concomitant medications include amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (JUICE PLUS), biotin (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and zinc (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication and unknown if ongoing. 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 01Apr2021 at 10:30, the patient experienced paresthesia and numb skin. 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 events. The clinical outcome of the events of paresthesia and numbness was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Facial swelling - lip cheek area; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo150) via an unspecified route of administration in the left arm on 06Apr2021 at 13:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease and gluten intolerance (gluten allergy). Concomitant medications 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 4 weeks prior to the COVID vaccine. On 07Apr2021 at 04:00, the patient experienced facial swelling - lip cheek area. The patient woke up at 4am (14 hours after injection) with swelling. She took 2 oral Benadryl tablets and swelling appeared to stabilize. At around 10am swelling stated to decline and by 5pm had almost fully subsided. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of facial swelling and included treatment with 2 oral BENADRYL tablets. The clinical outcome of the event facial swelling-lip cheek area was recovered on 07April2021 by 17:00.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling - lip cheek area; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ewo150) via an unspecified route of administration in the left arm on 06Apr2021 at 13:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease and gluten intolerance (gluten allergy). Concomitant medications 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 4 weeks prior to the COVID vaccine. On 07Apr2021 at 04:00, the patient experienced facial swelling - lip cheek area. The patient woke up at 4am (14 hours after injection) with swelling. She took 2 oral Benadryl tablets and swelling appeared to stabilize. At around 10am swelling stated to decline and by 5pm had almost fully subsided. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of facial swelling and included treatment with 2 oral BENADRYL tablets. The clinical outcome of the event facial swelling-lip cheek area was recovered on 07April2021 by 17:00.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer, the patient. A 50-years-old non-pregnant female patient 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 01Apr2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and arthritis. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), naproxen sodium (ALEVE), vitamin c (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) all were from an unknown date for an unknown indication. The patient previously received sulfa medicines and penicillin and experienced allergy. Prior to 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 04Apr2021 at 08:00, 3 days after vaccination, the patient experienced shingles. The event resulted in a doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event shingles included treatment with valacyclovir and gabapentin. The clinical outcome of the events shingles was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus which appeared 12-h after vaccine. Severity has since increased.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received 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 16:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208) via an unspecified route of administration in the left arm on 12Mar2021 at 07:15 (at the age of 29-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 vaccine within four weeks prior to the COVID vaccine. On 07Apr2021 at 03:00, the patient experienced tinnitus which appeared 12 hours after second vaccine. Severity had since increased. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as result of adverse event. The clinical outcome of tinnitus which appeared 12 hours after second vaccine was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pruritus, Headache, Oral pruritus, Paraesthesia oral, Pruritus
Clinical narrative: tongue felt funny; Rash; hives; itching all over body; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:15 (Lot Number: ER8731) as single dose (at the age of 60-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. There were no concomitant medications. The patient previously took Bactrim DS and experienced allergies. The patient experienced Rash, hives, itching all over body including scalp, and tongue felt funny on 07Apr2021 12:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included Prednisone and Epi-pen. The outcome of the events was recovering. The events were considered as serious (medically significant). The patient was not COVID tested post vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin disorder, Urticaria
Clinical narrative: tongue felt funny; Rash; hives; itching all over body; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:15 (Lot Number: ER8731) as single dose (at the age of 60-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. There were no concomitant medications. The patient previously took Bactrim DS and experienced allergies. The patient experienced Rash, hives, itching all over body including scalp, and tongue felt funny on 07Apr2021 12:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included Prednisone and Epi-pen. The outcome of the events was recovering. The events were considered as serious (medically significant). The patient was not COVID tested post vaccination.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Tongue disorder, Urticaria
Clinical narrative: tongue felt funny; Rash; hives; itching all over body; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 09:15 (Lot Number: ER8731) as single dose (at the age of 60-years-old) for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. There were no concomitant medications. The patient previously took Bactrim DS and experienced allergies. The patient experienced Rash, hives, itching all over body including scalp, and tongue felt funny on 07Apr2021 12:00. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included Prednisone and Epi-pen. The outcome of the events was recovering. The events were considered as serious (medically significant). The patient was not COVID tested post vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Ear pain, Head discomfort, Hyperacusis, Hypoacusis
Clinical narrative: Ear noises/vibrations; hearing muffled; Pain; Sensitivity to sound; Acute serous otitis media, left ear; Pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EB8734), via an unspecified route of administration in the left arm on 02Apr2021 at 18:15 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took amoxicillin and experienced 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 02Apr2021, the patient experienced pain in arm. On 09Apr2021 at 03:00, after 7 days of vaccine patient woke up and experienced ear noises/vibrations and hearing muffled. Also have pain and sensitivity to sound. The patient went to doctor after work and was diagnosed with acute serous otitis media in left ear. Physician advised patient that it was immune response from vaccine and prescribed medicine and recommended allegra D or claritin D as a treatment. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with allegra D or claritin D, methylprednisolone/medrol from an unknown date. The clinical outcome of the event pain in arm was recovered on 02Apr2021. The clinical outcome of the events ear noises/vibrations, hearing muffled, pain, sensitivity to sound and acute serous otitis media were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Middle ear effusion, Pain in extremity
Clinical narrative: Ear noises/vibrations; hearing muffled; Pain; Sensitivity to sound; Acute serous otitis media, left ear; Pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EB8734), via an unspecified route of administration in the left arm on 02Apr2021 at 18:15 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took amoxicillin and experienced 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 02Apr2021, the patient experienced pain in arm. On 09Apr2021 at 03:00, after 7 days of vaccine patient woke up and experienced ear noises/vibrations and hearing muffled. Also have pain and sensitivity to sound. The patient went to doctor after work and was diagnosed with acute serous otitis media in left ear. Physician advised patient that it was immune response from vaccine and prescribed medicine and recommended allegra D or claritin D as a treatment. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with allegra D or claritin D, methylprednisolone/medrol from an unknown date. The clinical outcome of the event pain in arm was recovered on 02Apr2021. The clinical outcome of the events ear noises/vibrations, hearing muffled, pain, sensitivity to sound and acute serous otitis media were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Hypoacusis, Otitis media acute, Pain, Pain in extremity
Clinical narrative: Ear noises/vibrations; hearing muffled; Pain; Sensitivity to sound; Acute serous otitis media, left ear; Pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EB8734), via an unspecified route of administration in the left arm on 02Apr2021 at 18:15 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took amoxicillin and experienced 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 02Apr2021, the patient experienced pain in arm. On 09Apr2021 at 03:00, after 7 days of vaccine patient woke up and experienced ear noises/vibrations and hearing muffled. Also have pain and sensitivity to sound. The patient went to doctor after work and was diagnosed with acute serous otitis media in left ear. Physician advised patient that it was immune response from vaccine and prescribed medicine and recommended allegra D or claritin D as a treatment. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with allegra D or claritin D, methylprednisolone/medrol from an unknown date. The clinical outcome of the event pain in arm was recovered on 02Apr2021. The clinical outcome of the events ear noises/vibrations, hearing muffled, pain, sensitivity to sound and acute serous otitis media were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ear noises/vibrations; hearing muffled; Pain; Sensitivity to sound; Acute serous otitis media, left ear; Pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EB8734), via an unspecified route of administration in the left arm on 02Apr2021 at 18:15 (at the age of 29-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously took amoxicillin and experienced 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 02Apr2021, the patient experienced pain in arm. On 09Apr2021 at 03:00, after 7 days of vaccine patient woke up and experienced ear noises/vibrations and hearing muffled. Also have pain and sensitivity to sound. The patient went to doctor after work and was diagnosed with acute serous otitis media in left ear. Physician advised patient that it was immune response from vaccine and prescribed medicine and recommended allegra D or claritin D as a treatment. The events resulted in emergency room/department visit or urgent care. Therapeutic measures were taken as a result of the events which included treatment with allegra D or claritin D, methylprednisolone/medrol from an unknown date. The clinical outcome of the event pain in arm was recovered on 02Apr2021. The clinical outcome of the events ear noises/vibrations, hearing muffled, pain, sensitivity to sound and acute serous otitis media were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: was in menopause (last period Jan2019), period started again on 06Apr2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EN6205) via an unspecified route of administration administered in arm left on 18Mar2021 14:45 as dose 1, single for covid-19 immunization at the age of 51-years-old. Medical history included asthma, neurofibromatosis type 1 (NF1), allergies: MRI contrast dye and, menopause (last period Jan2019). Concomitant medications included colecalciferol (VITAMIN D); fish oil; cetirizine hydrochloride (ZYRTEC) and; multivitamins - all taken for unspecified indications, start and stop dates were not reported. The patient was not pregnant at the time of event and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. The patient was in menopause (last period Jan2019), period started again on 06Apr2021 10:00 AM. Treatment was not received for the event. The outcome of the event was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: was in menopause (last period Jan2019), period started again on 06Apr2021; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EN6205) via an unspecified route of administration administered in arm left on 18Mar2021 14:45 as dose 1, single for covid-19 immunization at the age of 51-years-old. Medical history included asthma, neurofibromatosis type 1 (NF1), allergies: MRI contrast dye and, menopause (last period Jan2019). Concomitant medications included colecalciferol (VITAMIN D); fish oil; cetirizine hydrochloride (ZYRTEC) and; multivitamins - all taken for unspecified indications, start and stop dates were not reported. The patient was not pregnant at the time of event and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. The patient was in menopause (last period Jan2019), period started again on 06Apr2021 10:00 AM. Treatment was not received for the event. The outcome of the event was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eructation, Feeling abnormal, Vomiting
Clinical narrative: Vomiting; nausea; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 06Apr2021 at 14:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetic. Concomitant medications included metformin (MANUFACTURER UNKNOWN) 500mg four times a day, losartan potassium (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) 20mg, ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, colecalciferol, retinol, pantothenic acid, riboflavin, phytomenadione, nicotinamide, betacarotene, iron, magnesium, manganese, potassium, chromium, copper, zinc, calcium, iodine, phosphorus, selenium, vitamin b12 nos, xantofyl, lycopene, vitamin b1 nos, vitamin e nos (CENTRUM SILVER) once a day, brinzolamide (AZOPT), timolol maleate (MANUFACTURER UNKNOWN), latanoprostene bunod (VYZULTA) and glimepiride (MANUFACTURER UNKNOWN) 4mg; all for unspecified indication from unknown date . The patient previously took ibuprofen (ADVIL) for unspecified indication on unknown date 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 07Apr2021 at 14:15, the patient experienced nausea and at 15:15 patient experienced vomiting after which patient came home and at 16:00 had another vomit, no temperature. On 07Apr2021 same feeling no vomit, on 08Apr2021, had same feeling like vomit, but none. On 09Apr2021, all day was okay then at night around 23:00, patient felt that he was going to vomit and went to bed and got up on 10Apr2021 with same feeling that he was going to vomit, post which patient had a good breakfast and after 4 hours had same feeling. 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 reported event. The clinical outcome of the events vomiting and feeling like vomit was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Vomiting; nausea; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 06Apr2021 at 14:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history included type 2 diabetic. Concomitant medications included metformin (MANUFACTURER UNKNOWN) 500mg four times a day, losartan potassium (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) 20mg, ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, colecalciferol, retinol, pantothenic acid, riboflavin, phytomenadione, nicotinamide, betacarotene, iron, magnesium, manganese, potassium, chromium, copper, zinc, calcium, iodine, phosphorus, selenium, vitamin b12 nos, xantofyl, lycopene, vitamin b1 nos, vitamin e nos (CENTRUM SILVER) once a day, brinzolamide (AZOPT), timolol maleate (MANUFACTURER UNKNOWN), latanoprostene bunod (VYZULTA) and glimepiride (MANUFACTURER UNKNOWN) 4mg; all for unspecified indication from unknown date . The patient previously took ibuprofen (ADVIL) for unspecified indication on unknown date 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 07Apr2021 at 14:15, the patient experienced nausea and at 15:15 patient experienced vomiting after which patient came home and at 16:00 had another vomit, no temperature. On 07Apr2021 same feeling no vomit, on 08Apr2021, had same feeling like vomit, but none. On 09Apr2021, all day was okay then at night around 23:00, patient felt that he was going to vomit and went to bed and got up on 10Apr2021 with same feeling that he was going to vomit, post which patient had a good breakfast and after 4 hours had same feeling. 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 reported event. The clinical outcome of the events vomiting and feeling like vomit was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.