chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased interest, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Cloudy vision; Lightheaded; Numbness in left arm and hand; Strange dreams; Constipation; Loss of appetite; Lack of interest in anything; Chills; Fatigue; Abdominal pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease. Concomitant medications were not reported. The patient previously received metronidazole (FLAGYL) and experienced drug allergy. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 14:45, the patient experienced chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest in anything that was going on from 8 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 26Mar2021 which included nasal swab test and the test result was negative. The patient did not receive any treatment for the events chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest. The clinical outcomes of the events chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vision blurred
Clinical narrative: Cloudy vision; Lightheaded; Numbness in left arm and hand; Strange dreams; Constipation; Loss of appetite; Lack of interest in anything; Chills; Fatigue; Abdominal pain; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease. Concomitant medications were not reported. The patient previously received metronidazole (FLAGYL) and experienced drug allergy. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 14:45, the patient experienced chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest in anything that was going on from 8 days. The adverse events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 26Mar2021 which included nasal swab test and the test result was negative. The patient did not receive any treatment for the events chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest. The clinical outcomes of the events chills, fatigue, abdominal pain, lightheaded, headache, cloudy vision, numbness in left arm and hand, strange dreams, loss of appetite, constipation and lack of interest were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Fatigue, Feeling abnormal, Ophthalmological examination normal, Pupil dilation procedure
Clinical narrative: Visual disturbance; Inability to concentrate; Brain fog; Covid test result: Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional.   A 53-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included hashimoto's thyroiditis, food allergy, dairy intolerance (Known allergies: dairy), gluten sensitivity from an unknown date and unknown if ongoing Known allergies: gluten. Concomitant medications included thyroid (ARMOUR THYROID), estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took levothyroxine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient experienced covid test result: positive on 21Mar2021 and about 4-5 days afterward I suffered from brain fog, inability to concentrate, visual disturbance, On 22Mar2021 13:15. This lasted for several days. The events Covid test result: Positive assessed as serious (medically significant) while other event was non-serious. No treatment was received for the events. The outcome of the events Covid test result: Positive was reported as unknown and while for other was resolved with Sequel.   Information on lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Scan, Visual impairment
Clinical narrative: Visual disturbance; Inability to concentrate; Brain fog; Covid test result: Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional.   A 53-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included hashimoto's thyroiditis, food allergy, dairy intolerance (Known allergies: dairy), gluten sensitivity from an unknown date and unknown if ongoing Known allergies: gluten. Concomitant medications included thyroid (ARMOUR THYROID), estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took levothyroxine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient experienced covid test result: positive on 21Mar2021 and about 4-5 days afterward I suffered from brain fog, inability to concentrate, visual disturbance, On 22Mar2021 13:15. This lasted for several days. The events Covid test result: Positive assessed as serious (medically significant) while other event was non-serious. No treatment was received for the events. The outcome of the events Covid test result: Positive was reported as unknown and while for other was resolved with Sequel.   Information on lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Disturbance in attention, Feeling abnormal, SARS-CoV-2 test, Visual impairment
Clinical narrative: Visual disturbance; Inability to concentrate; Brain fog; Covid test result: Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional.   A 53-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included hashimoto's thyroiditis, food allergy, dairy intolerance (Known allergies: dairy), gluten sensitivity from an unknown date and unknown if ongoing Known allergies: gluten. Concomitant medications included thyroid (ARMOUR THYROID), estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took levothyroxine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient experienced covid test result: positive on 21Mar2021 and about 4-5 days afterward I suffered from brain fog, inability to concentrate, visual disturbance, On 22Mar2021 13:15. This lasted for several days. The events Covid test result: Positive assessed as serious (medically significant) while other event was non-serious. No treatment was received for the events. The outcome of the events Covid test result: Positive was reported as unknown and while for other was resolved with Sequel.   Information on lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Eye pain, Headache, Ophthalmological examination, SARS-CoV-2 test
Clinical narrative: Visual disturbance; Inability to concentrate; Brain fog; Covid test result: Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional.   A 53-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included hashimoto's thyroiditis, food allergy, dairy intolerance (Known allergies: dairy), gluten sensitivity from an unknown date and unknown if ongoing Known allergies: gluten. Concomitant medications included thyroid (ARMOUR THYROID), estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took levothyroxine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient experienced covid test result: positive on 21Mar2021 and about 4-5 days afterward I suffered from brain fog, inability to concentrate, visual disturbance, On 22Mar2021 13:15. This lasted for several days. The events Covid test result: Positive assessed as serious (medically significant) while other event was non-serious. No treatment was received for the events. The outcome of the events Covid test result: Positive was reported as unknown and while for other was resolved with Sequel.   Information on lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination failure, Visual impairment
Clinical narrative: Visual disturbance; Inability to concentrate; Brain fog; Covid test result: Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional.   A 53-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 18Mar2021 16:30 (at the age of 53-years-old) as dose 1, single for covid-19 immunisation. Medical history included hashimoto's thyroiditis, food allergy, dairy intolerance (Known allergies: dairy), gluten sensitivity from an unknown date and unknown if ongoing Known allergies: gluten. Concomitant medications included thyroid (ARMOUR THYROID), estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took levothyroxine and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient experienced covid test result: positive on 21Mar2021 and about 4-5 days afterward I suffered from brain fog, inability to concentrate, visual disturbance, On 22Mar2021 13:15. This lasted for several days. The events Covid test result: Positive assessed as serious (medically significant) while other event was non-serious. No treatment was received for the events. The outcome of the events Covid test result: Positive was reported as unknown and while for other was resolved with Sequel.   Information on lot/batch number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: She has 2-3 hives on her face which emerged from nowhere.; Caller reported itchiness around her arms and jaw.; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received first dose of BNT162B2(Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number EW0172), via Intramuscular route of administration on 02Jul2021 at 9:30(at the age of 49-years-old) am into left upper arm as a single dose for COVID-19 immunization at Health department. Medical history included ongoing rheumatoid arthritis diagnosed 20 years ago. Concomitant medication(s) included rituximab (RITUXAN SC) taken for rheumatoid arthritis from an unspecified start date and ongoing. The patient previously took pneumonia vaccine she had swelling and rashes on her arm. She had the first vaccine this morning. On 02Jul2021, the patient had itchiness in arm and the itchiness then started in her jaw. She has 2-3 hives on her face which emerged from nowhere. She wants to know if she can take Benadryl. She is keeping a watch on the hives since they popped up pretty quick, she possibly has 3 hives now. Itchiness started 2 hours ago in the arm. Itchiness in jaw started 30 minutes ago. Hives started 30 minutes ago. No treatment was given for the events. The patient was not visited to Emergency Room and Physician Office. he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: She has 2-3 hives on her face which emerged from nowhere.; Caller reported itchiness around her arms and jaw.; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received first dose of BNT162B2(Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot number EW0172), via Intramuscular route of administration on 02Jul2021 at 9:30(at the age of 49-years-old) am into left upper arm as a single dose for COVID-19 immunization at Health department. Medical history included ongoing rheumatoid arthritis diagnosed 20 years ago. Concomitant medication(s) included rituximab (RITUXAN SC) taken for rheumatoid arthritis from an unspecified start date and ongoing. The patient previously took pneumonia vaccine she had swelling and rashes on her arm. She had the first vaccine this morning. On 02Jul2021, the patient had itchiness in arm and the itchiness then started in her jaw. She has 2-3 hives on her face which emerged from nowhere. She wants to know if she can take Benadryl. She is keeping a watch on the hives since they popped up pretty quick, she possibly has 3 hives now. Itchiness started 2 hours ago in the arm. Itchiness in jaw started 30 minutes ago. Hives started 30 minutes ago. No treatment was given for the events. The patient was not visited to Emergency Room and Physician Office. he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Other Medication in two weeks: Dietary suppliment, ibupropen; Itchy body rash; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201) via an unspecified route of administration, administered in left arm on 12Feb2021 at 13:30 as dose 1, single for COVID-19 immunization and ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history included macular degeneration and high blood pressure. Patient has known allergies with meclomen, phenergan, promethazine and nickel. The patient concomitant medications were not reported. 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 received dietary supplement, ibupropen (contraindicated product administered) within 2 weeks of vaccination. On 13Feb2021 at 13:00, the patient had itchy body rash. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contraindicated product administered, Rash pruritic
Clinical narrative: Other Medication in two weeks: Dietary suppliment, ibupropen; Itchy body rash; This is a spontaneous report from a contactable consumer (Patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6201) via an unspecified route of administration, administered in left arm on 12Feb2021 at 13:30 as dose 1, single for COVID-19 immunization and ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history included macular degeneration and high blood pressure. Patient has known allergies with meclomen, phenergan, promethazine and nickel. The patient concomitant medications were not reported. 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 received dietary supplement, ibupropen (contraindicated product administered) within 2 weeks of vaccination. On 13Feb2021 at 13:00, the patient had itchy body rash. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Balance disorder, Bell's palsy, Dizziness, Dysarthria
Clinical narrative: 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; This is a spontaneous report from a contactable consumer. This 52-years old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in Jun2021 (at 52-year-old) in right arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for covid-19 since the vaccination. The patient previously took psyllium husk powder, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in 23May2021 at 03:30 PM (at 52-year-old) in right arm as dose 1, single for COVID-19 immunization. On 23Jun2021 the patient felt like her equilibrium was off, she had pain in her ear, had severe headaches for 4 days and developed Bells Palsy on 26Jun2021. Therapeutic measures were taken with prednisone and valacyclovir. The patient had required emergency room visit. On 27Jun2021 the headaches recovered. The events of headache, pain in her ear and equilibrium was off had not recovered. The device date was 29Jun2021.  Follow-Up (01Jul2021): Follow-up attempts were completed. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Facial paralysis, Headache, Neurological symptom, Tremor
Clinical narrative: 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; This is a spontaneous report from a contactable consumer. This 52-years old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in Jun2021 (at 52-year-old) in right arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for covid-19 since the vaccination. The patient previously took psyllium husk powder, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in 23May2021 at 03:30 PM (at 52-year-old) in right arm as dose 1, single for COVID-19 immunization. On 23Jun2021 the patient felt like her equilibrium was off, she had pain in her ear, had severe headaches for 4 days and developed Bells Palsy on 26Jun2021. Therapeutic measures were taken with prednisone and valacyclovir. The patient had required emergency room visit. On 27Jun2021 the headaches recovered. The events of headache, pain in her ear and equilibrium was off had not recovered. The device date was 29Jun2021.  Follow-Up (01Jul2021): Follow-up attempts were completed. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; This is a spontaneous report from a contactable consumer. This 52-years old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in Jun2021 (at 52-year-old) in right arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for covid-19 since the vaccination. The patient previously took psyllium husk powder, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in 23May2021 at 03:30 PM (at 52-year-old) in right arm as dose 1, single for COVID-19 immunization. On 23Jun2021 the patient felt like her equilibrium was off, she had pain in her ear, had severe headaches for 4 days and developed Bells Palsy on 26Jun2021. Therapeutic measures were taken with prednisone and valacyclovir. The patient had required emergency room visit. On 27Jun2021 the headaches recovered. The events of headache, pain in her ear and equilibrium was off had not recovered. The device date was 29Jun2021.  Follow-Up (01Jul2021): Follow-up attempts were completed. No further information was expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Bell's palsy, Ear pain, Headache
Clinical narrative: 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; 6/23 I started feeling like my equilibrium was off. Pain in my ear. I had severe headaches for 4 days and developed Bells Palsy on 6/26.; This is a spontaneous report from a contactable consumer. This 52-years old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in Jun2021 (at 52-year-old) in right arm as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications the patient received within 2 weeks of vaccination were reported as none. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for covid-19 since the vaccination. The patient previously took psyllium husk powder, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 0757620) via an unspecified route of administration on an unknown date in 23May2021 at 03:30 PM (at 52-year-old) in right arm as dose 1, single for COVID-19 immunization. On 23Jun2021 the patient felt like her equilibrium was off, she had pain in her ear, had severe headaches for 4 days and developed Bells Palsy on 26Jun2021. Therapeutic measures were taken with prednisone and valacyclovir. The patient had required emergency room visit. On 27Jun2021 the headaches recovered. The events of headache, pain in her ear and equilibrium was off had not recovered. The device date was 29Jun2021.  Follow-Up (01Jul2021): Follow-up attempts were completed. No further information was expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Gait disturbance, Magnetic resonance imaging, Paraesthesia, Scan
Clinical narrative: Guillain Barre syndrome; pins and needles in her feet; loss of the ability to walk; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (pins and needles in her feet) (seriousness criterion hospitalization) and GAIT INABILITY (loss of the ability to walk) (seriousness criterion hospitalization). The patient was hospitalized on 24-May-2021 due to GAIT INABILITY, GUILLAIN-BARRE SYNDROME and PARAESTHESIA. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) on 26-May-2021 at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Computerised tomogram: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Lumbar puncture: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Magnetic resonance imaging: guillain barre syndrome (abnormal) Guillain Barre syndrome.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. She was moved to rehab on Memorial Day Weekend. She is still in physical therapy and has residual pins and needles.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Gait inability, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Guillain Barre syndrome; pins and needles in her feet; loss of the ability to walk; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (pins and needles in her feet) (seriousness criterion hospitalization) and GAIT INABILITY (loss of the ability to walk) (seriousness criterion hospitalization). The patient was hospitalized on 24-May-2021 due to GAIT INABILITY, GUILLAIN-BARRE SYNDROME and PARAESTHESIA. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) on 26-May-2021 at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Computerised tomogram: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Lumbar puncture: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Magnetic resonance imaging: guillain barre syndrome (abnormal) Guillain Barre syndrome.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. She was moved to rehab on Memorial Day Weekend. She is still in physical therapy and has residual pins and needles.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Guillain Barre syndrome; pins and needles in her feet; loss of the ability to walk; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 002B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant), PARAESTHESIA (pins and needles in her feet) (seriousness criterion hospitalization) and GAIT INABILITY (loss of the ability to walk) (seriousness criterion hospitalization). The patient was hospitalized on 24-May-2021 due to GAIT INABILITY, GUILLAIN-BARRE SYNDROME and PARAESTHESIA. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) on 26-May-2021 at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome), PARAESTHESIA (pins and needles in her feet) and GAIT INABILITY (loss of the ability to walk) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Computerised tomogram: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Lumbar puncture: guillain barre syndrome (abnormal) Guillain Barre syndrome. On 24-May-2021, Magnetic resonance imaging: guillain barre syndrome (abnormal) Guillain Barre syndrome.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. She was moved to rehab on Memorial Day Weekend. She is still in physical therapy and has residual pins and needles.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Electric shock sensation, Pain in extremity, Paraesthesia
Clinical narrative: experienced a shocking sensation throughout my entire body, like a jolt of electricity, only happened sporadically when I moved; My vision would gray-out (like static on an untuned TV channel) for a second; Typical soreness in left arm for 3 days; light tingling/prickly sensation in left arm/tingling/prickly sensation spread to upper torso and right arm; disassociated feeling from my left arm; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 06Jun2021 12:15 as dose 1, single for COVID-19 immunization in a Pharmacy or Drug Store. Medical history included arteriosclerosis from an unknown date. No known allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); atorvastatin; sotalol; and ezetimibe all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No prior COVID vaccination. Not diagnosed with COVID-19 prior to vaccination. Not tested for COVID-19 post vaccination. On 24Jun2021 16:00, the patient experienced typical soreness in left arm for 3 days, then continued light tingling/prickly sensation in left arm and spread to upper torso and right arm, disassociated feeling from my left arm, experienced a shocking sensation through-out my entire body, like a jolt of electricity which only happened sporadically when I moved and didn't happen due to repetitive movements, vision would gray out (like static on an untuned TV channel) for a second. 4 days later, the shocks have subsided and so has the tingling/prickly feeling, but they still are present. No treatment was given for the events. The reporter considered the events as non-serious and did not result in death or life threatening condition, caused/prolonged hospitalization, disabling/incapacitating, nor congenital anomaly/birth defect. The outcome of the events was not recovered at the time of report.   Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chromatopsia, Dissociation, Electric shock sensation, Pain in extremity, Paraesthesia
Clinical narrative: experienced a shocking sensation throughout my entire body, like a jolt of electricity, only happened sporadically when I moved; My vision would gray-out (like static on an untuned TV channel) for a second; Typical soreness in left arm for 3 days; light tingling/prickly sensation in left arm/tingling/prickly sensation spread to upper torso and right arm; disassociated feeling from my left arm; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0191), via an unspecified route of administration, administered in Arm Left on 06Jun2021 12:15 as dose 1, single for COVID-19 immunization in a Pharmacy or Drug Store. Medical history included arteriosclerosis from an unknown date. No known allergies. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)); atorvastatin; sotalol; and ezetimibe all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No prior COVID vaccination. Not diagnosed with COVID-19 prior to vaccination. Not tested for COVID-19 post vaccination. On 24Jun2021 16:00, the patient experienced typical soreness in left arm for 3 days, then continued light tingling/prickly sensation in left arm and spread to upper torso and right arm, disassociated feeling from my left arm, experienced a shocking sensation through-out my entire body, like a jolt of electricity which only happened sporadically when I moved and didn't happen due to repetitive movements, vision would gray out (like static on an untuned TV channel) for a second. 4 days later, the shocks have subsided and so has the tingling/prickly feeling, but they still are present. No treatment was given for the events. The reporter considered the events as non-serious and did not result in death or life threatening condition, caused/prolonged hospitalization, disabling/incapacitating, nor congenital anomaly/birth defect. The outcome of the events was not recovered at the time of report.   Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Electrocardiogram abnormal, Fatigue
Clinical narrative: Patient presented with severe fatigue, nausea, lightheadedness, and palpitations. Started 1 day after 2nd dose of vaccine. Called off work day after 2nd vaccine. Went to ER with palpitations and lightheadedness 3 days after her 2nd dose. Was given fluids and nausea medication and sent home. 8 days after her 2nd dose, she was admitted to the hospital with worsening nausea, fatigue, lightheaded, and palpitations. Her heart rate would elevate into the 140's with minimal exertion. She works as a nurse at night, normally does not have any medical problems or fatigue or palpitations. Very fatigued and painful with abdominal pain, nauseated and vomiting. Required IV narcotics and IV benzos for pain control and nausea control. Palpitations uncontrolled with lopressor, fatigue and nausea difficult to control. palpitations did not improve with improvement of oral intake or with fluid resuscitation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Nausea, Presyncope, Tachycardia
Clinical narrative: Patient presented with severe fatigue, nausea, lightheadedness, and palpitations. Started 1 day after 2nd dose of vaccine. Called off work day after 2nd vaccine. Went to ER with palpitations and lightheadedness 3 days after her 2nd dose. Was given fluids and nausea medication and sent home. 8 days after her 2nd dose, she was admitted to the hospital with worsening nausea, fatigue, lightheaded, and palpitations. Her heart rate would elevate into the 140's with minimal exertion. She works as a nurse at night, normally does not have any medical problems or fatigue or palpitations. Very fatigued and painful with abdominal pain, nauseated and vomiting. Required IV narcotics and IV benzos for pain control and nausea control. Palpitations uncontrolled with lopressor, fatigue and nausea difficult to control. palpitations did not improve with improvement of oral intake or with fluid resuscitation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Angiogram pulmonary normal, Blood corticotrophin normal, C-reactive protein normal, Colonoscopy normal
Clinical narrative: Patient presented with severe fatigue, nausea, lightheadedness, and palpitations. Started 1 day after 2nd dose of vaccine. Called off work day after 2nd vaccine. Went to ER with palpitations and lightheadedness 3 days after her 2nd dose. Was given fluids and nausea medication and sent home. 8 days after her 2nd dose, she was admitted to the hospital with worsening nausea, fatigue, lightheaded, and palpitations. Her heart rate would elevate into the 140's with minimal exertion. She works as a nurse at night, normally does not have any medical problems or fatigue or palpitations. Very fatigued and painful with abdominal pain, nauseated and vomiting. Required IV narcotics and IV benzos for pain control and nausea control. Palpitations uncontrolled with lopressor, fatigue and nausea difficult to control. palpitations did not improve with improvement of oral intake or with fluid resuscitation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Cortisol normal, Dizziness, Echocardiogram normal, Fatigue
Clinical narrative: Patient presented with severe fatigue, nausea, lightheadedness, and palpitations. Started 1 day after 2nd dose of vaccine. Called off work day after 2nd vaccine. Went to ER with palpitations and lightheadedness 3 days after her 2nd dose. Was given fluids and nausea medication and sent home. 8 days after her 2nd dose, she was admitted to the hospital with worsening nausea, fatigue, lightheaded, and palpitations. Her heart rate would elevate into the 140's with minimal exertion. She works as a nurse at night, normally does not have any medical problems or fatigue or palpitations. Very fatigued and painful with abdominal pain, nauseated and vomiting. Required IV narcotics and IV benzos for pain control and nausea control. Palpitations uncontrolled with lopressor, fatigue and nausea difficult to control. palpitations did not improve with improvement of oral intake or with fluid resuscitation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Gastrointestinal pathogen panel, Heart rate increased, Hepatic steatosis, Impaired work ability
Clinical narrative: Patient presented with severe fatigue, nausea, lightheadedness, and palpitations. Started 1 day after 2nd dose of vaccine. Called off work day after 2nd vaccine. Went to ER with palpitations and lightheadedness 3 days after her 2nd dose. Was given fluids and nausea medication and sent home. 8 days after her 2nd dose, she was admitted to the hospital with worsening nausea, fatigue, lightheaded, and palpitations. Her heart rate would elevate into the 140's with minimal exertion. She works as a nurse at night, normally does not have any medical problems or fatigue or palpitations. Very fatigued and painful with abdominal pain, nauseated and vomiting. Required IV narcotics and IV benzos for pain control and nausea control. Palpitations uncontrolled with lopressor, fatigue and nausea difficult to control. palpitations did not improve with improvement of oral intake or with fluid resuscitation.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Metabolic function test normal, Nausea, Oesophagogastroduodenoscopy normal, Palpitations
Clinical narrative: Patient presented with severe fatigue, nausea, lightheadedness, and palpitations. Started 1 day after 2nd dose of vaccine. Called off work day after 2nd vaccine. Went to ER with palpitations and lightheadedness 3 days after her 2nd dose. Was given fluids and nausea medication and sent home. 8 days after her 2nd dose, she was admitted to the hospital with worsening nausea, fatigue, lightheaded, and palpitations. Her heart rate would elevate into the 140's with minimal exertion. She works as a nurse at night, normally does not have any medical problems or fatigue or palpitations. Very fatigued and painful with abdominal pain, nauseated and vomiting. Required IV narcotics and IV benzos for pain control and nausea control. Palpitations uncontrolled with lopressor, fatigue and nausea difficult to control. palpitations did not improve with improvement of oral intake or with fluid resuscitation.