chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: BOOSTER; He could not see out of his eye; Has floaters but they have expanded and he could not see out of his left eye; Headache/head is killing him; All of a sudden he got a hot flash go up his head/there was a lot of pressure in his head; This is a spontaneous report received from a contactable consumer. This consumer reported for 56-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 56 years old.  The patient medical history was not reported. Concomitant medications included an unknown anxiety medication. The patient previously received first and second dose of bnt162b2 on unspecified dates for COVID-19 immunisation. In Nov2021, the patient got a Headache and has floaters but they have expanded and he could not see out of his left eye and that went away but he still has a headache. It was reported that when he got the shot, he was sitting in #, states it was really weird, all of a sudden he got a hot flash go up his head, states he got the shot in left arm, his left eye got floaters and there was a lot of pressure in his head and after a couple of seconds it went away. States today he reported that he was at work and someone was talking to him and all of a sudden he got a dull headache, saw floaters again in his left eye, more profound, states he could not see out of his eye, head is killing him, same kind of headache that he had last week. Slight headache. The patient is not one to usually get headaches, or have any issue with his eyes. The outcome of hot flash go up his head/there was a lot of pressure in his head was recovered in Nov2021, outcome of booster, could not see out of his eye was unknown, outcome of other events was not recovered.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Gait disturbance, Head discomfort, Impaired driving ability, Limb discomfort
Clinical narrative: BOOSTER; He could not see out of his eye; Has floaters but they have expanded and he could not see out of his left eye; Headache/head is killing him; All of a sudden he got a hot flash go up his head/there was a lot of pressure in his head; This is a spontaneous report received from a contactable consumer. This consumer reported for 56-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 56 years old.  The patient medical history was not reported. Concomitant medications included an unknown anxiety medication. The patient previously received first and second dose of bnt162b2 on unspecified dates for COVID-19 immunisation. In Nov2021, the patient got a Headache and has floaters but they have expanded and he could not see out of his left eye and that went away but he still has a headache. It was reported that when he got the shot, he was sitting in #, states it was really weird, all of a sudden he got a hot flash go up his head, states he got the shot in left arm, his left eye got floaters and there was a lot of pressure in his head and after a couple of seconds it went away. States today he reported that he was at work and someone was talking to him and all of a sudden he got a dull headache, saw floaters again in his left eye, more profound, states he could not see out of his eye, head is killing him, same kind of headache that he had last week. Slight headache. The patient is not one to usually get headaches, or have any issue with his eyes. The outcome of hot flash go up his head/there was a lot of pressure in his head was recovered in Nov2021, outcome of booster, could not see out of his eye was unknown, outcome of other events was not recovered.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Panic reaction, Sensory disturbance, Visual field defect, Visual impairment
Clinical narrative: BOOSTER; He could not see out of his eye; Has floaters but they have expanded and he could not see out of his left eye; Headache/head is killing him; All of a sudden he got a hot flash go up his head/there was a lot of pressure in his head; This is a spontaneous report received from a contactable consumer. This consumer reported for 56-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 56 years old.  The patient medical history was not reported. Concomitant medications included an unknown anxiety medication. The patient previously received first and second dose of bnt162b2 on unspecified dates for COVID-19 immunisation. In Nov2021, the patient got a Headache and has floaters but they have expanded and he could not see out of his left eye and that went away but he still has a headache. It was reported that when he got the shot, he was sitting in #, states it was really weird, all of a sudden he got a hot flash go up his head, states he got the shot in left arm, his left eye got floaters and there was a lot of pressure in his head and after a couple of seconds it went away. States today he reported that he was at work and someone was talking to him and all of a sudden he got a dull headache, saw floaters again in his left eye, more profound, states he could not see out of his eye, head is killing him, same kind of headache that he had last week. Slight headache. The patient is not one to usually get headaches, or have any issue with his eyes. The outcome of hot flash go up his head/there was a lot of pressure in his head was recovered in Nov2021, outcome of booster, could not see out of his eye was unknown, outcome of other events was not recovered.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: BOOSTER; He could not see out of his eye; Has floaters but they have expanded and he could not see out of his left eye; Headache/head is killing him; All of a sudden he got a hot flash go up his head/there was a lot of pressure in his head; This is a spontaneous report received from a contactable consumer. This consumer reported for 56-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 56 years old.  The patient medical history was not reported. Concomitant medications included an unknown anxiety medication. The patient previously received first and second dose of bnt162b2 on unspecified dates for COVID-19 immunisation. In Nov2021, the patient got a Headache and has floaters but they have expanded and he could not see out of his left eye and that went away but he still has a headache. It was reported that when he got the shot, he was sitting in #, states it was really weird, all of a sudden he got a hot flash go up his head, states he got the shot in left arm, his left eye got floaters and there was a lot of pressure in his head and after a couple of seconds it went away. States today he reported that he was at work and someone was talking to him and all of a sudden he got a dull headache, saw floaters again in his left eye, more profound, states he could not see out of his eye, head is killing him, same kind of headache that he had last week. Slight headache. The patient is not one to usually get headaches, or have any issue with his eyes. The outcome of hot flash go up his head/there was a lot of pressure in his head was recovered in Nov2021, outcome of booster, could not see out of his eye was unknown, outcome of other events was not recovered.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Head discomfort, Headache, Immunisation, Vitreous floaters
Clinical narrative: BOOSTER; He could not see out of his eye; Has floaters but they have expanded and he could not see out of his left eye; Headache/head is killing him; All of a sudden he got a hot flash go up his head/there was a lot of pressure in his head; This is a spontaneous report received from a contactable consumer. This consumer reported for 56-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in Arm Left on 03Nov2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation at the age of 56 years old.  The patient medical history was not reported. Concomitant medications included an unknown anxiety medication. The patient previously received first and second dose of bnt162b2 on unspecified dates for COVID-19 immunisation. In Nov2021, the patient got a Headache and has floaters but they have expanded and he could not see out of his left eye and that went away but he still has a headache. It was reported that when he got the shot, he was sitting in #, states it was really weird, all of a sudden he got a hot flash go up his head, states he got the shot in left arm, his left eye got floaters and there was a lot of pressure in his head and after a couple of seconds it went away. States today he reported that he was at work and someone was talking to him and all of a sudden he got a dull headache, saw floaters again in his left eye, more profound, states he could not see out of his eye, head is killing him, same kind of headache that he had last week. Slight headache. The patient is not one to usually get headaches, or have any issue with his eyes. The outcome of hot flash go up his head/there was a lot of pressure in his head was recovered in Nov2021, outcome of booster, could not see out of his eye was unknown, outcome of other events was not recovered.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: Nausea; Headache; Dizziness; Hot and Cold (fever); Fatigue; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 03Nov2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, thyroid (half thyroid was removed) and unexplained chest pain and allergy to sulfa and iodine used in Intravenous pyelogram (IVP). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and isosorbide mononitrate (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN600) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 19Mar2021 at 10:00 both as a single dose for COVID-19 immunisation. On 04Nov2021 at 02:30, the patient experienced nausea, headache, dizziness, hot and cold (fever) and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, dizziness, hot and cold (fever) and fatigue was resolving at the time of this report.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea; Headache; Dizziness; Hot and Cold (fever); Fatigue; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 03Nov2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, thyroid (half thyroid was removed) and unexplained chest pain and allergy to sulfa and iodine used in Intravenous pyelogram (IVP). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and isosorbide mononitrate (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN600) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 19Mar2021 at 10:00 both as a single dose for COVID-19 immunisation. On 04Nov2021 at 02:30, the patient experienced nausea, headache, dizziness, hot and cold (fever) and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, dizziness, hot and cold (fever) and fatigue was resolving at the time of this report.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Immunisation, Nausea
Clinical narrative: Nausea; Headache; Dizziness; Hot and Cold (fever); Fatigue; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 03Nov2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, thyroid (half thyroid was removed) and unexplained chest pain and allergy to sulfa and iodine used in Intravenous pyelogram (IVP). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and isosorbide mononitrate (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN600) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 19Mar2021 at 10:00 both as a single dose for COVID-19 immunisation. On 04Nov2021 at 02:30, the patient experienced nausea, headache, dizziness, hot and cold (fever) and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, dizziness, hot and cold (fever) and fatigue was resolving at the time of this report.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; Headache; Dizziness; Hot and Cold (fever); Fatigue; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 03Nov2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, thyroid (half thyroid was removed) and unexplained chest pain and allergy to sulfa and iodine used in Intravenous pyelogram (IVP). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and isosorbide mononitrate (MANUFACTURER UNKNOWN), all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received lisinopril (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN600) via an unspecified route of administration in the right arm on 26Feb2021 at 10:00 and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 19Mar2021 at 10:00 both as a single dose for COVID-19 immunisation. On 04Nov2021 at 02:30, the patient experienced nausea, headache, dizziness, hot and cold (fever) and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, headache, dizziness, hot and cold (fever) and fatigue was resolving at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for COVID 19; I tested positive for COVID 19; Injection site soreness; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [15Nov2021], this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from a contactable consumer (patient).  A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 22Mar2021 at 14:00 (Batch/Lot Number: EL3248, age at vaccination 50-year-old) as dose 2, single and dose 1 via an unspecified route of administration in arm left on 01Mar2021 at 14:00 (Batch/Lot Number: EL3248, age at vaccination 50-year-old) as dose 1, single for covid-19 immunisation at other. The patient had none known allergies. Medical history included low thyroid and drug allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications include levothyroxine sodium (Synthroid) (within 2 weeks of vaccination) for an unknown indication and start and stop dates were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient had injection site soreness on 22Mar2021 at 22:00, tested positive for covid 19 on 13Nov2021 and exhibited vaccination failure. The patient underwent lab tests and procedures which included PCR: positive (Nasal Swab) on 13Nov2021. Hospitalization Prolonged was reported as No. The patient did not received treatment for tested positive for covid 19 and received Tylenol as treatment for injection site soreness. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure, Vaccination site pain
Clinical narrative: I tested positive for COVID 19; I tested positive for COVID 19; Injection site soreness; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [15Nov2021], this case now contains serious adverse reaction(s). Information processed together.  This is a spontaneous report received from a contactable consumer (patient).  A 50-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 22Mar2021 at 14:00 (Batch/Lot Number: EL3248, age at vaccination 50-year-old) as dose 2, single and dose 1 via an unspecified route of administration in arm left on 01Mar2021 at 14:00 (Batch/Lot Number: EL3248, age at vaccination 50-year-old) as dose 1, single for covid-19 immunisation at other. The patient had none known allergies. Medical history included low thyroid and drug allergy from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications include levothyroxine sodium (Synthroid) (within 2 weeks of vaccination) for an unknown indication and start and stop dates were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient had injection site soreness on 22Mar2021 at 22:00, tested positive for covid 19 on 13Nov2021 and exhibited vaccination failure. The patient underwent lab tests and procedures which included PCR: positive (Nasal Swab) on 13Nov2021. Hospitalization Prolonged was reported as No. The patient did not received treatment for tested positive for covid 19 and received Tylenol as treatment for injection site soreness. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Condition aggravated, Deafness unilateral, Sleep disorder, Tinnitus
Clinical narrative: 1st adverse report submitted by Health Care Provider and patient after 2nd Pfizer dose and developed tinnitus.  After the booster dose, the first day besides arm pain, developed fever & achiness which went away within 24 hours.  Within a few days of the booster, the tinnitus became higher pitched, louder and constant and remains this way.  Audiology also submitted a report - Report #723214.  Due to  the definite change after the booster, and the progression from vaccination shot #1 to shot #2 to now the booster, my providers and I believe the mRNA vaccine is the cause of the tinnitus.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Pain, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: 1st adverse report submitted by Health Care Provider and patient after 2nd Pfizer dose and developed tinnitus.  After the booster dose, the first day besides arm pain, developed fever & achiness which went away within 24 hours.  Within a few days of the booster, the tinnitus became higher pitched, louder and constant and remains this way.  Audiology also submitted a report - Report #723214.  Due to  the definite change after the booster, and the progression from vaccination shot #1 to shot #2 to now the booster, my providers and I believe the mRNA vaccine is the cause of the tinnitus.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Ear pruritus, Ear swelling, Erythema, Myalgia
Clinical narrative: Red raised rash; Red raised rash; Red raised rash with small pustules appeared on my throat, face, ears, abdomen and armpits.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 10Nov2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity and allergy to plant: evergreen and juniper. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included colecalciferol (NATURE MADE VITAMIN D3) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 14Oct2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 12Nov2021, red raised rash with small pustules appeared on the patient's throat, face, ears, abdomen and armpits. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had been tested for COVID-19. On 11Nov2021, the patient underwent test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events red raised rash with small pustules appeared on throat, face, ears, abdomen and armpits was not resolved at the time of this report.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Rash, Swelling face, Urticaria
Clinical narrative: Red raised rash; Red raised rash; Red raised rash with small pustules appeared on my throat, face, ears, abdomen and armpits.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 10Nov2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity and allergy to plant: evergreen and juniper. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included colecalciferol (NATURE MADE VITAMIN D3) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 14Oct2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 12Nov2021, red raised rash with small pustules appeared on the patient's throat, face, ears, abdomen and armpits. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had been tested for COVID-19. On 11Nov2021, the patient underwent test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events red raised rash with small pustules appeared on throat, face, ears, abdomen and armpits was not resolved at the time of this report.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pustule, Rash erythematous, Rash papular, SARS-CoV-2 test
Clinical narrative: Red raised rash; Red raised rash; Red raised rash with small pustules appeared on my throat, face, ears, abdomen and armpits.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 10Nov2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included gluten sensitivity and allergy to plant: evergreen and juniper. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications taken within two weeks of vaccination included colecalciferol (NATURE MADE VITAMIN D3) for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8020) via an unspecified route of administration in the left arm on 14Oct2021 at 11:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 12Nov2021, red raised rash with small pustules appeared on the patient's throat, face, ears, abdomen and armpits. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had been tested for COVID-19. On 11Nov2021, the patient underwent test for COVID-19 via nasal swab and the result was negative. The clinical outcome of the events red raised rash with small pustules appeared on throat, face, ears, abdomen and armpits was not resolved at the time of this report.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a Moderna COVID-19 vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a Moderna COVID-19 vaccine to a 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a Moderna COVID-19 vaccine to a 17 year old). On 18-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave a Moderna COVID-19 vaccine to a 17 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Eye pain, Fatigue, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Ectremely anxious; rubber band sensation extended to neck; rubber band sensation extended to throat.; exhausted; pain behind the eyes, like there were pins and needles; rubber bands tightly bound on her toes.rubber band sensation extended to her; pain in the throat, described as constricting and odd; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), ANXIETY (Ectremely anxious), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and FATIGUE (exhausted). On 16-Nov-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) and OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.). On an unknown date, the patient experienced ANXIETY (Ectremely anxious). On 13-Nov-2021, OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd) and EYE PAIN (pain behind the eyes, like there were pins and needles) had resolved. At the time of the report, ANXIETY (Ectremely anxious), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her), MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck), OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.) and FATIGUE (exhausted) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant Follow Up Appended; Reporters E-mail Address obtained.; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: Ectremely anxious; rubber band sensation extended to neck; rubber band sensation extended to throat.; exhausted; pain behind the eyes, like there were pins and needles; rubber bands tightly bound on her toes.rubber band sensation extended to her; pain in the throat, described as constricting and odd; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), ANXIETY (Ectremely anxious), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd), EYE PAIN (pain behind the eyes, like there were pins and needles), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her) and FATIGUE (exhausted). On 16-Nov-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck) and OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.). On an unknown date, the patient experienced ANXIETY (Ectremely anxious). On 13-Nov-2021, OROPHARYNGEAL PAIN (pain in the throat, described as constricting and odd) and EYE PAIN (pain behind the eyes, like there were pins and needles) had resolved. At the time of the report, ANXIETY (Ectremely anxious), LIMB DISCOMFORT (rubber bands tightly bound on her toes.rubber band sensation extended to her), MUSCULOSKELETAL DISCOMFORT (rubber band sensation extended to neck), OROPHARYNGEAL DISCOMFORT (rubber band sensation extended to throat.) and FATIGUE (exhausted) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Non Significant Follow Up Appended; Reporters E-mail Address obtained.; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered between 12-24 hours post puncture; many people received a dose from a vial that was left at room temperature,; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered between 12-24 hours post puncture) and PRODUCT STORAGE ERROR (many people received a dose from a vial that was left at room temperature,) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered between 12-24 hours post puncture) and PRODUCT STORAGE ERROR (many people received a dose from a vial that was left at room temperature,). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered between 12-24 hours post puncture) and PRODUCT STORAGE ERROR (many people received a dose from a vial that was left at room temperature,) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided No treatment medications provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Non-Significant Follow up received on 23-nov-2021 and reporters email id and fax number updated
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dry skin, Feeling abnormal, Hyperhidrosis
Clinical narrative: tested positive to covid; tested positive to covid; my hands are not getting dry at all; that it's very weird/I'm shocked; hands always get super dry after one wash; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient got vaccine with Pfizer, and now he/she tested positive to covid. He/she had mild symptoms, and thanks God he/she vaccinated. He/she just want to share something that noticed on himself/herself now during being covid positive that it's very weird. He/she had been washing hands so much with dish soap, using hand sanitizer, cleaning products all day long and his/her hands were not getting dry at all. He/she was shocked. His/her hands always get super dry after one wash. He/she was shocked how his/her hands feel without lotion. Lab data included SARS-CoV-2 test: positive on unspecified date. Outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive to covid; tested positive to covid; my hands are not getting dry at all; that it's very weird/I'm shocked; hands always get super dry after one wash; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient got vaccine with Pfizer, and now he/she tested positive to covid. He/she had mild symptoms, and thanks God he/she vaccinated. He/she just want to share something that noticed on himself/herself now during being covid positive that it's very weird. He/she had been washing hands so much with dish soap, using hand sanitizer, cleaning products all day long and his/her hands were not getting dry at all. He/she was shocked. His/her hands always get super dry after one wash. He/she was shocked how his/her hands feel without lotion. Lab data included SARS-CoV-2 test: positive on unspecified date. Outcome of events was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Fall, Presyncope, Syncope
Clinical narrative: 15 minutes after vaccine, patient stood up to walk to bathroom, fainted and fell to floor.  He did not lose consciousness but he was lightheaded and could not stand. Nurses said it was Vasovagal syncope. He laid down and rested and was fine.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Heart rate increased, Nausea
Clinical narrative: Short of breath, chest pain. heart beats fast with little movement. Dizziness with Nausea. Fever on face and head
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Short of breath, chest pain. heart beats fast with little movement. Dizziness with Nausea. Fever on face and head
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nasal hemorrhage beginning with blowing the nose.  Blood on the tissue indicated the problem, after which it was difficult to stop with pressure.  Make shift plugs worked for perhaps 15 minutes at a time, after which they failed to singularly work.  Applying an external ice pack to the upper nose in combination with a make shift internal plug stabilized the bleed, as long as the plug was in place.  Slept the first night with the plug in place.  Leakage continued through the following day, 11/22.  Leakage continued the night of 11/22 behind a make shift plug, with a large clot forming in the upper nasal cavity that was extracted over 15 minutes with saline solution and sucking, eventually spitting it out.  Leakage continued on and off  to a lesser extent through 11/24, at which point it has ceased thus far.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Fatigue, Headache, Nausea
Clinical narrative: Headache, upper arms and shoulders achy. Next day ringing in my ears, continued, but worse headache, elevated blood pressure, 210/86, nausea, later fever of 99.6. Symptoms of tinnitus and headache have continued through today, 11/26/2021, subsiding and then returning. Also, more joint pain and fatigue.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: Headache, upper arms and shoulders achy. Next day ringing in my ears, continued, but worse headache, elevated blood pressure, 210/86, nausea, later fever of 99.6. Symptoms of tinnitus and headache have continued through today, 11/26/2021, subsiding and then returning. Also, more joint pain and fatigue.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Chills, muscle aches
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Rash
Clinical narrative: Developed a rash on face and neck. Redness and inflammation of skin on the face.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Patient had brief fainting spell after the flu vaccine was administered. She awoke and had patient laying down fully, Patient reported she hadn't eaten that evening so she was given  a cookie and water. Patient stayed for at least 15-20 minutes and reported doing ok and sweating had stopped, then she left. Patient declined an ambulance and was advised to see a doctor.
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Bruising at injection site for influenza vaccine, redness and swelling on left arm near injection below injection site, arm soreness
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Continued tenderness around injection site after second round of Hep B vaccine that was administered by a nurse from the  Health Department at School. Soreness when tapped/touched/laid on.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Atrial fibrillation, Chills, Diarrhoea, Fatigue
Clinical narrative: Side effects included fever of 100.4. , body aches,  vomiting, extreme chills, headache, diarrhea, lethargy, weakness, one bout of Atrill Fib. Side effects lasted about 3 days...leaving me tired and shaky but feeling stronger.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Pyrexia, Tremor
Clinical narrative: Side effects included fever of 100.4. , body aches,  vomiting, extreme chills, headache, diarrhea, lethargy, weakness, one bout of Atrill Fib. Side effects lasted about 3 days...leaving me tired and shaky but feeling stronger.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Side effects included fever of 100.4. , body aches,  vomiting, extreme chills, headache, diarrhea, lethargy, weakness, one bout of Atrill Fib. Side effects lasted about 3 days...leaving me tired and shaky but feeling stronger.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: My hair is falling out in mass amounts especially worse after my second shot on 09/13/21. The fax number I put is incorrect bc of the time I?m making this report the pharmacy was unopened to give me the number.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 2pm Headache 7:30pm Fever and chills
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypersomnia, Movement disorder
Clinical narrative: 4am nausea, sweating, headache, arm pain, continuing until 8pm  Could not physically get out of bed until 12pm. So exhausted after regular shower, slept additional hour. Could not eat for nausea. Spent nearly entire day in bed with maybe 2 active hours.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: 4am nausea, sweating, headache, arm pain, continuing until 8pm  Could not physically get out of bed until 12pm. So exhausted after regular shower, slept additional hour. Could not eat for nausea. Spent nearly entire day in bed with maybe 2 active hours.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Muscle spasms, Peripheral swelling, Skin warm
Clinical narrative: red swollen arm with fever to it for 3/4 days after it cleared up leg cramps occured frequently.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Administered a booster dose of Moderna Vaccine, however resident had already had a booster approx a month earlier
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Random itchy hives/red patches that would appear in certain areas of my body, last 30-40 minutes and then disappear. They would reappear in different places often. This lasted about ten days.