chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Antiphospholipid syndrome, Cardiac dysfunction, Chest pain, Dyspnoea
Clinical narrative: blood clots in patient's lungs; antiphospholipid syndrome; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation at the age of 19-year-old. The patient previously received the dose 1 in Arm Left on 02Jan2021 (Batch/Lot Number: EL0140) as single dose for covid-19 immunisation at the age of 19-year-old. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and Birth Control. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination and hasn't the patient been tested for COVID-19 since the vaccination. On 04Feb2021 the Patient had shortness of breath and chest pain resulting in visit to ER where doctors found blood clots in patient's lungs. Patient was hospitalized for 3 days and received INARI procedure to remove the blood clots. Patient is now on blood thinner and has since been diagnosed with antiphospholipid syndrome. Outcome of the events was recovered with sequelae. Treatment received for the events included INARI procedure, Heparin, Eliquis, Warfarin. The events resulted in visit of doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were reported as serious with seriousness criteria of Hospitalization and Life threatening.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, Stress cardiomyopathy, Thrombectomy
Clinical narrative: blood clots in patient's lungs; antiphospholipid syndrome; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation at the age of 19-year-old. The patient previously received the dose 1 in Arm Left on 02Jan2021 (Batch/Lot Number: EL0140) as single dose for covid-19 immunisation at the age of 19-year-old. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and Birth Control. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination and hasn't the patient been tested for COVID-19 since the vaccination. On 04Feb2021 the Patient had shortness of breath and chest pain resulting in visit to ER where doctors found blood clots in patient's lungs. Patient was hospitalized for 3 days and received INARI procedure to remove the blood clots. Patient is now on blood thinner and has since been diagnosed with antiphospholipid syndrome. Outcome of the events was recovered with sequelae. Treatment received for the events included INARI procedure, Heparin, Eliquis, Warfarin. The events resulted in visit of doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were reported as serious with seriousness criteria of Hospitalization and Life threatening.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antiphospholipid syndrome, Blood test, Chest pain, Dyspnoea, Pulmonary thrombosis
Clinical narrative: blood clots in patient's lungs; antiphospholipid syndrome; shortness of breath; chest pain; This is a spontaneous report from a contactable consumer (patient). A 19-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jan2021 (Batch/Lot Number: EL3248) as single dose for covid-19 immunisation at the age of 19-year-old. The patient previously received the dose 1 in Arm Left on 02Jan2021 (Batch/Lot Number: EL0140) as single dose for covid-19 immunisation at the age of 19-year-old. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and Birth Control. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination and hasn't the patient been tested for COVID-19 since the vaccination. On 04Feb2021 the Patient had shortness of breath and chest pain resulting in visit to ER where doctors found blood clots in patient's lungs. Patient was hospitalized for 3 days and received INARI procedure to remove the blood clots. Patient is now on blood thinner and has since been diagnosed with antiphospholipid syndrome. Outcome of the events was recovered with sequelae. Treatment received for the events included INARI procedure, Heparin, Eliquis, Warfarin. The events resulted in visit of doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were reported as serious with seriousness criteria of Hospitalization and Life threatening.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Periorbital swelling
Clinical narrative: lots of swelling and redness around left eye; lots of swelling and redness around left eye; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EWVISO and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 30May2021 at 14:00 hours, as dose 1, single (at the age of 12-years-old) for covid-19 immunisation. The patient medical history was not reported. Patient previously took amoxicillin; clavulanic acid (Augmentin) and experienced allergies to Augmentin. The concomitant medication was not reported.Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had received other unspecified medications within 2 weeks of vaccination. On 30May2021, at 16:00 hours (noticed 2 hours after shot but could have happened sooner), patient had lots of swelling and redness around left eye. Patient had emergency room/department or urgent care visit. Patient had not been tested for COVID-19, post vaccination. Patient received Benadryl, as treatment. The events were reported as non-serious by the reporter. The outcome of both the events was recovering.  Follow-up attempts have been completed and no further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Periorbital swelling
Clinical narrative: lots of swelling and redness around left eye; lots of swelling and redness around left eye; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EWVISO and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 30May2021 at 14:00 hours, as dose 1, single (at the age of 12-years-old) for covid-19 immunisation. The patient medical history was not reported. Patient previously took amoxicillin; clavulanic acid (Augmentin) and experienced allergies to Augmentin. The concomitant medication was not reported.Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Patient had received other unspecified medications within 2 weeks of vaccination. On 30May2021, at 16:00 hours (noticed 2 hours after shot but could have happened sooner), patient had lots of swelling and redness around left eye. Patient had emergency room/department or urgent care visit. Patient had not been tested for COVID-19, post vaccination. Patient received Benadryl, as treatment. The events were reported as non-serious by the reporter. The outcome of both the events was recovering.  Follow-up attempts have been completed and no further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, HEPA, MENB
Symptoms: Feeling abnormal, Hypoaesthesia
Clinical narrative: Pt is a 17 yr/o female who presents with numbness to right side of her face that started on Thursday. She reports Wednesday it felt funny but no numbness or paralysis. Patient reports Thursday she went to PMD for vaccinations face still felt funny but not numb or inability to smile or raise eyebrow.  Patient reports Friday and today she is unable to lift eyebrow or smile on the right side. She has not had any blurry vision, no speech abnormality, no headaches, no extremity weakness. Patient with no difficulty ambulating. She has not had any recent illness, no hx of HSV or herpes, no hx of tick bites or removal of ticks from body and no recent fevers or rash. Mom did mention that she did have the covid vaccine pfizer on 6/15. She did not have any symptoms after the vaccines and did well until Thursday. She did receive vaccinations on 7/1, hep a and menigococcal B and conjugate vaccine. She has never had any previous reactions to vaccines. She is otherwise interactive gcs 15.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, HEPA, MENB
Symptoms: Facial paralysis, Feeling abnormal, Hypoaesthesia
Clinical narrative: Pt is a 17 yr/o female who presents with numbness to right side of her face that started on Thursday. She reports Wednesday it felt funny but no numbness or paralysis. Patient reports Thursday she went to PMD for vaccinations face still felt funny but not numb or inability to smile or raise eyebrow.  Patient reports Friday and today she is unable to lift eyebrow or smile on the right side. She has not had any blurry vision, no speech abnormality, no headaches, no extremity weakness. Patient with no difficulty ambulating. She has not had any recent illness, no hx of HSV or herpes, no hx of tick bites or removal of ticks from body and no recent fevers or rash. Mom did mention that she did have the covid vaccine pfizer on 6/15. She did not have any symptoms after the vaccines and did well until Thursday. She did receive vaccinations on 7/1, hep a and menigococcal B and conjugate vaccine. She has never had any previous reactions to vaccines. She is otherwise interactive gcs 15.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abscess drainage, Appendicitis, Blood test, Computerised tomogram abdomen abnormal, Myalgia
Clinical narrative: Systemic: Patient was hospitalized and eventually had to have his appendix removed-Severe, Additional Details: Per the pharmacist who took the initial report on 7/8/21, the patient was "hospitalized 2 days after vaccine". A note was left for me to follow-up with her mom, which I did today, 7/12/21.  I spoke with her and she was not very explanatory, but only mentioned that he was in the hospital and eventually had his appendix removed and is still trying to recover.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Therapeutic aspiration, Ultrasound scan, Vomiting
Clinical narrative: Systemic: Patient was hospitalized and eventually had to have his appendix removed-Severe, Additional Details: Per the pharmacist who took the initial report on 7/8/21, the patient was "hospitalized 2 days after vaccine". A note was left for me to follow-up with her mom, which I did today, 7/12/21.  I spoke with her and she was not very explanatory, but only mentioned that he was in the hospital and eventually had his appendix removed and is still trying to recover.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Appendicectomy
Clinical narrative: Systemic: Patient was hospitalized and eventually had to have his appendix removed-Severe, Additional Details: Per the pharmacist who took the initial report on 7/8/21, the patient was "hospitalized 2 days after vaccine". A note was left for me to follow-up with her mom, which I did today, 7/12/21.  I spoke with her and she was not very explanatory, but only mentioned that he was in the hospital and eventually had his appendix removed and is still trying to recover.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Neurological examination abnormal, Paraesthesia, Peripheral sensory neuropathy
Clinical narrative: Diagnosis sensory ganglionopathy following a "GBS like" episode.; Onset of tingling/numbness the day following 2nd covid vaccine; Onset of tingling/numbness the day following 2nd covid vaccine; Diagnosis sensory ganglionopathy following a "GBS like" episode.; This is a spontaneous report received from a contactable consumer (patient). This 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 20Apr2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. Medical history included seasonal allergy gadolinium contrast MRI and allergic to metal (Nickel). Concomitant medications included vitamin b complex taken for an unspecified indication and ergocalciferol (Vit D) taken for an unspecified indication. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8734) via an unspecified route of administration on 30Mar2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. On 21Apr2021 at 01:00 pm the patient experienced diagnosis sensory ganglionopathy following a "gbs like" episode, onset of tingling/numbness the day following 2nd covid vaccine. The patient underwent lab tests and procedures which included gadolinium contrast MRI which showed Known allergies: Gadolinium contrast MRI. On 23 Apr2021 the patient had primary care appointment. On 26Apr2021 she had neurology appointment. On 25Jun2021 she had neurological testing. The patient continued care and was referred to rheumatology. The patient had not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia, Peripheral sensory neuropathy
Clinical narrative: Diagnosis sensory ganglionopathy following a "GBS like" episode.; Onset of tingling/numbness the day following 2nd covid vaccine; Onset of tingling/numbness the day following 2nd covid vaccine; Diagnosis sensory ganglionopathy following a "GBS like" episode.; This is a spontaneous report received from a contactable consumer (patient). This 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 20Apr2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. Medical history included seasonal allergy gadolinium contrast MRI and allergic to metal (Nickel). Concomitant medications included vitamin b complex taken for an unspecified indication and ergocalciferol (Vit D) taken for an unspecified indication. It was mentioned that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 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 received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8734) via an unspecified route of administration on 30Mar2021 at 09:45 (at 52-year-old), at single dose for COVID-19 immunization. On 21Apr2021 at 01:00 pm the patient experienced diagnosis sensory ganglionopathy following a "gbs like" episode, onset of tingling/numbness the day following 2nd covid vaccine. The patient underwent lab tests and procedures which included gadolinium contrast MRI which showed Known allergies: Gadolinium contrast MRI. On 23 Apr2021 the patient had primary care appointment. On 26Apr2021 she had neurology appointment. On 25Jun2021 she had neurological testing. The patient continued care and was referred to rheumatology. The patient had not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal mass, Abdominal pain, Computerised tomogram, Headache
Clinical narrative: rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine; she had a headache on the side of her head; This is a spontaneous report from a contactable consumer(patient).  This 59-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8731) via an unspecified route of administration on 19Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.  The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunization.On 19Apr2021, the patient experienced that her left lower abdomen started hurting pretty bad, rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine and on the same day at 09:00, within an hour after the shot, she had a headache on the side of her head where she does not usually get a headache, laid down and then it went away.On an unspecified date in 19Apr2021, something happened with the ovaries and was hospitalized on 20Apr2021. A few hours later, she mentioned that her left lower abdomen started hurting pretty bad and she was hospitalized the next day. She still had pain and so she had to get a CAT scan with dye on 15Jun2021 and they found that something was not right. She had a rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine, she got the clearance that everything was okay and that they were still running test for the ovaries. She mentioned that something was not right with the vaccine and that she saw something online about the COVID-19 vaccine for Pfizer causing increase protein in the serum which was compatible with ovarian follicle protein and maybe there was a spike or something. She had the vaccine and after the second shot she had a bad reaction and asked if there was a correlation between the vaccine and effecting the ovaries. She already had the Cat-Scan with the dye and she was still having problems and she was meeting with the doctor next week to go over it. she will go over the results with doctor next Friday or next week. It started after the vaccine. She ended up in hospital the next day after the vaccine.Outcome was resolved for event headache was on 19Apr2021 and for event rupture of ovarian cyst resolved in Apr2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Ultrasound scan vagina
Clinical narrative: rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine; she had a headache on the side of her head; This is a spontaneous report from a contactable consumer(patient).  This 59-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8731) via an unspecified route of administration on 19Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.  The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunization.On 19Apr2021, the patient experienced that her left lower abdomen started hurting pretty bad, rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine and on the same day at 09:00, within an hour after the shot, she had a headache on the side of her head where she does not usually get a headache, laid down and then it went away.On an unspecified date in 19Apr2021, something happened with the ovaries and was hospitalized on 20Apr2021. A few hours later, she mentioned that her left lower abdomen started hurting pretty bad and she was hospitalized the next day. She still had pain and so she had to get a CAT scan with dye on 15Jun2021 and they found that something was not right. She had a rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine, she got the clearance that everything was okay and that they were still running test for the ovaries. She mentioned that something was not right with the vaccine and that she saw something online about the COVID-19 vaccine for Pfizer causing increase protein in the serum which was compatible with ovarian follicle protein and maybe there was a spike or something. She had the vaccine and after the second shot she had a bad reaction and asked if there was a correlation between the vaccine and effecting the ovaries. She already had the Cat-Scan with the dye and she was still having problems and she was meeting with the doctor next week to go over it. she will go over the results with doctor next Friday or next week. It started after the vaccine. She ended up in hospital the next day after the vaccine.Outcome was resolved for event headache was on 19Apr2021 and for event rupture of ovarian cyst resolved in Apr2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine; she had a headache on the side of her head; This is a spontaneous report from a contactable consumer(patient).  This 59-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8731) via an unspecified route of administration on 19Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.  The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunization.On 19Apr2021, the patient experienced that her left lower abdomen started hurting pretty bad, rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine and on the same day at 09:00, within an hour after the shot, she had a headache on the side of her head where she does not usually get a headache, laid down and then it went away.On an unspecified date in 19Apr2021, something happened with the ovaries and was hospitalized on 20Apr2021. A few hours later, she mentioned that her left lower abdomen started hurting pretty bad and she was hospitalized the next day. She still had pain and so she had to get a CAT scan with dye on 15Jun2021 and they found that something was not right. She had a rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine, she got the clearance that everything was okay and that they were still running test for the ovaries. She mentioned that something was not right with the vaccine and that she saw something online about the COVID-19 vaccine for Pfizer causing increase protein in the serum which was compatible with ovarian follicle protein and maybe there was a spike or something. She had the vaccine and after the second shot she had a bad reaction and asked if there was a correlation between the vaccine and effecting the ovaries. She already had the Cat-Scan with the dye and she was still having problems and she was meeting with the doctor next week to go over it. she will go over the results with doctor next Friday or next week. It started after the vaccine. She ended up in hospital the next day after the vaccine.Outcome was resolved for event headache was on 19Apr2021 and for event rupture of ovarian cyst resolved in Apr2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Headache, Ovarian cyst ruptured
Clinical narrative: rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine; she had a headache on the side of her head; This is a spontaneous report from a contactable consumer(patient).  This 59-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8731) via an unspecified route of administration on 19Apr2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.  The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunization.On 19Apr2021, the patient experienced that her left lower abdomen started hurting pretty bad, rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine and on the same day at 09:00, within an hour after the shot, she had a headache on the side of her head where she does not usually get a headache, laid down and then it went away.On an unspecified date in 19Apr2021, something happened with the ovaries and was hospitalized on 20Apr2021. A few hours later, she mentioned that her left lower abdomen started hurting pretty bad and she was hospitalized the next day. She still had pain and so she had to get a CAT scan with dye on 15Jun2021 and they found that something was not right. She had a rupture of ovarian cyst within 12 hours of getting the second dose of the vaccine, she got the clearance that everything was okay and that they were still running test for the ovaries. She mentioned that something was not right with the vaccine and that she saw something online about the COVID-19 vaccine for Pfizer causing increase protein in the serum which was compatible with ovarian follicle protein and maybe there was a spike or something. She had the vaccine and after the second shot she had a bad reaction and asked if there was a correlation between the vaccine and effecting the ovaries. She already had the Cat-Scan with the dye and she was still having problems and she was meeting with the doctor next week to go over it. she will go over the results with doctor next Friday or next week. It started after the vaccine. She ended up in hospital the next day after the vaccine.Outcome was resolved for event headache was on 19Apr2021 and for event rupture of ovarian cyst resolved in Apr2021.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Contusion, Diarrhoea, Dizziness, Fatigue
Clinical narrative: GI symptoms; ITP recurrence; ITP recurrence; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 15May2021 (Batch/Lot number unknown), as dose 2, single, at age 63 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had a remote history of Idiopathic Thrombocytopenic Purpura (ITP) from an unknown date, not reported if ongoing or not. The patent was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on an unspecified date (Batch/Lot number unknown), as dose 1, single, for COVID-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22May2021, 7 days after the second vaccination, the patient experienced nonspecific constitutional symptoms and some GI symptoms. The patient was found to have ITP recurrence. The events resulted to hospitalization on 23Jun2021. Treatment for the events included IVIG and steroids. The patient was recovering from the events. It was unknown if the events were associated with the vaccine dose.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Immunoglobulin therapy, Myalgia, Pain in extremity, Platelet count decreased
Clinical narrative: GI symptoms; ITP recurrence; ITP recurrence; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 15May2021 (Batch/Lot number unknown), as dose 2, single, at age 63 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had a remote history of Idiopathic Thrombocytopenic Purpura (ITP) from an unknown date, not reported if ongoing or not. The patent was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on an unspecified date (Batch/Lot number unknown), as dose 1, single, for COVID-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22May2021, 7 days after the second vaccination, the patient experienced nonspecific constitutional symptoms and some GI symptoms. The patient was found to have ITP recurrence. The events resulted to hospitalization on 23Jun2021. Treatment for the events included IVIG and steroids. The patient was recovering from the events. It was unknown if the events were associated with the vaccine dose.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: GI symptoms; ITP recurrence; ITP recurrence; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 15May2021 (Batch/Lot number unknown), as dose 2, single, at age 63 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had a remote history of Idiopathic Thrombocytopenic Purpura (ITP) from an unknown date, not reported if ongoing or not. The patent was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on an unspecified date (Batch/Lot number unknown), as dose 1, single, for COVID-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22May2021, 7 days after the second vaccination, the patient experienced nonspecific constitutional symptoms and some GI symptoms. The patient was found to have ITP recurrence. The events resulted to hospitalization on 23Jun2021. Treatment for the events included IVIG and steroids. The patient was recovering from the events. It was unknown if the events were associated with the vaccine dose.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disease recurrence, Gastrointestinal disorder, Immune thrombocytopenia
Clinical narrative: GI symptoms; ITP recurrence; ITP recurrence; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 15May2021 (Batch/Lot number unknown), as dose 2, single, at age 63 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had a remote history of Idiopathic Thrombocytopenic Purpura (ITP) from an unknown date, not reported if ongoing or not. The patent was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on an unspecified date (Batch/Lot number unknown), as dose 1, single, for COVID-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22May2021, 7 days after the second vaccination, the patient experienced nonspecific constitutional symptoms and some GI symptoms. The patient was found to have ITP recurrence. The events resulted to hospitalization on 23Jun2021. Treatment for the events included IVIG and steroids. The patient was recovering from the events. It was unknown if the events were associated with the vaccine dose.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events  . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: she cannot pee; she missed her menstrual cycle for the entire month of June; autoimmune deficiency; her hands have been freezing up; Muscle pain; lymph nodes are swollen; she shakes really bad; she cannot swallow/ can barely eat; she gets weaker; She is scared every night; she can barely have a bowel movement; Her muscles are tight; felt like it was shutting her body down; she was so sad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) at the age of 30 years as single dose for covid-19 immunisation. There were no medical history or concomitant medications. Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Patient stated she was having bad side effects and didn't know what to do. She felt like it was shutting her body down. Since the second dose she missed her menstrual cycle for the entire month of June. She had been to the hospital 15-20 times. Said her hands had been freezing up, she had muscle pain, lymph nodes are swollen, she shaked really bad, she cannot swallow, she cannot pee. She kept going to the hospital; stated she was scared for her life and kept going to the emergency room but cannot get an answer. Patient said she was healthy before the vaccine. They told her she had an autoimmune deficiency after the shot. Stated she had never had anything autoimmune before. They tested her for was though and all the tests were negative. Said they did a CT scan of her stomach and tested her for everything. Stated she got weaker everyday. It just kept getting worse and she didn't know what to do. It had worsened gradually over time. Stated she felt there was no guarantee that she would live. She was scared every night. Her muscles were tight, she was in and out of the emergency room. Said the emergency room kept sending her away. Stated she can barely have a bowel movement or eat. Stated this all happened after the vaccine. She was a perfectly healthy 30 year old woman before the vaccine. The vaccine was ruining her life. She had gradually gotten worse over time. Everyday she felt worse and she was so sad. Patient had mentioned testing for autoimmune deficiency that was negative earlier in the call. She had also mentioned a CT Scan of her stomach and being tested for everything. No results provided by the caller. Outcome of events were unknown.   Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin, Tremor
Clinical narrative: she cannot pee; she missed her menstrual cycle for the entire month of June; autoimmune deficiency; her hands have been freezing up; Muscle pain; lymph nodes are swollen; she shakes really bad; she cannot swallow/ can barely eat; she gets weaker; She is scared every night; she can barely have a bowel movement; Her muscles are tight; felt like it was shutting her body down; she was so sad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) at the age of 30 years as single dose for covid-19 immunisation. There were no medical history or concomitant medications. Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Patient stated she was having bad side effects and didn't know what to do. She felt like it was shutting her body down. Since the second dose she missed her menstrual cycle for the entire month of June. She had been to the hospital 15-20 times. Said her hands had been freezing up, she had muscle pain, lymph nodes are swollen, she shaked really bad, she cannot swallow, she cannot pee. She kept going to the hospital; stated she was scared for her life and kept going to the emergency room but cannot get an answer. Patient said she was healthy before the vaccine. They told her she had an autoimmune deficiency after the shot. Stated she had never had anything autoimmune before. They tested her for was though and all the tests were negative. Said they did a CT scan of her stomach and tested her for everything. Stated she got weaker everyday. It just kept getting worse and she didn't know what to do. It had worsened gradually over time. Stated she felt there was no guarantee that she would live. She was scared every night. Her muscles were tight, she was in and out of the emergency room. Said the emergency room kept sending her away. Stated she can barely have a bowel movement or eat. Stated this all happened after the vaccine. She was a perfectly healthy 30 year old woman before the vaccine. The vaccine was ruining her life. She had gradually gotten worse over time. Everyday she felt worse and she was so sad. Patient had mentioned testing for autoimmune deficiency that was negative earlier in the call. She had also mentioned a CT Scan of her stomach and being tested for everything. No results provided by the caller. Outcome of events were unknown.   Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autoimmune disorder, Computerised tomogram, Constipation, Depressed mood
Clinical narrative: she cannot pee; she missed her menstrual cycle for the entire month of June; autoimmune deficiency; her hands have been freezing up; Muscle pain; lymph nodes are swollen; she shakes really bad; she cannot swallow/ can barely eat; she gets weaker; She is scared every night; she can barely have a bowel movement; Her muscles are tight; felt like it was shutting her body down; she was so sad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) at the age of 30 years as single dose for covid-19 immunisation. There were no medical history or concomitant medications. Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Patient stated she was having bad side effects and didn't know what to do. She felt like it was shutting her body down. Since the second dose she missed her menstrual cycle for the entire month of June. She had been to the hospital 15-20 times. Said her hands had been freezing up, she had muscle pain, lymph nodes are swollen, she shaked really bad, she cannot swallow, she cannot pee. She kept going to the hospital; stated she was scared for her life and kept going to the emergency room but cannot get an answer. Patient said she was healthy before the vaccine. They told her she had an autoimmune deficiency after the shot. Stated she had never had anything autoimmune before. They tested her for was though and all the tests were negative. Said they did a CT scan of her stomach and tested her for everything. Stated she got weaker everyday. It just kept getting worse and she didn't know what to do. It had worsened gradually over time. Stated she felt there was no guarantee that she would live. She was scared every night. Her muscles were tight, she was in and out of the emergency room. Said the emergency room kept sending her away. Stated she can barely have a bowel movement or eat. Stated this all happened after the vaccine. She was a perfectly healthy 30 year old woman before the vaccine. The vaccine was ruining her life. She had gradually gotten worse over time. Everyday she felt worse and she was so sad. Patient had mentioned testing for autoimmune deficiency that was negative earlier in the call. She had also mentioned a CT Scan of her stomach and being tested for everything. No results provided by the caller. Outcome of events were unknown.   Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Fear, Feeling abnormal, Laboratory test, Lymphadenopathy
Clinical narrative: she cannot pee; she missed her menstrual cycle for the entire month of June; autoimmune deficiency; her hands have been freezing up; Muscle pain; lymph nodes are swollen; she shakes really bad; she cannot swallow/ can barely eat; she gets weaker; She is scared every night; she can barely have a bowel movement; Her muscles are tight; felt like it was shutting her body down; she was so sad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) at the age of 30 years as single dose for covid-19 immunisation. There were no medical history or concomitant medications. Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Patient stated she was having bad side effects and didn't know what to do. She felt like it was shutting her body down. Since the second dose she missed her menstrual cycle for the entire month of June. She had been to the hospital 15-20 times. Said her hands had been freezing up, she had muscle pain, lymph nodes are swollen, she shaked really bad, she cannot swallow, she cannot pee. She kept going to the hospital; stated she was scared for her life and kept going to the emergency room but cannot get an answer. Patient said she was healthy before the vaccine. They told her she had an autoimmune deficiency after the shot. Stated she had never had anything autoimmune before. They tested her for was though and all the tests were negative. Said they did a CT scan of her stomach and tested her for everything. Stated she got weaker everyday. It just kept getting worse and she didn't know what to do. It had worsened gradually over time. Stated she felt there was no guarantee that she would live. She was scared every night. Her muscles were tight, she was in and out of the emergency room. Said the emergency room kept sending her away. Stated she can barely have a bowel movement or eat. Stated this all happened after the vaccine. She was a perfectly healthy 30 year old woman before the vaccine. The vaccine was ruining her life. She had gradually gotten worse over time. Everyday she felt worse and she was so sad. Patient had mentioned testing for autoimmune deficiency that was negative earlier in the call. She had also mentioned a CT Scan of her stomach and being tested for everything. No results provided by the caller. Outcome of events were unknown.   Information about lot/batch number has been requested.