chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Depression, Diarrhoea, Disability, Ear, nose and throat examination, Electrocardiogram normal
Clinical narrative: Severe Vertigo three days after 2nd vaccination requiring hospitalization.  High blood pressure (180/110)and headaches two weeks after.  Massive headaches requiring hospitalization May 30, 2021.  Visits to ENT, Neurologist, Allergist, and Primary care Physician for several weeks following.  Additional symptoms, increasing blood pressure, headaches, insomnia, sleep apnea, diareah for 2 months, tinnitus, hearing loss, extreme neck pain, extreme anxiety, and depression.  Treatments over the following three months included CPAP therapy, blood pressure medication, hearing tests, depression medication, anxiety medication, Migraine medication, Botox shots for neck pain which also helped with headaches, facett block.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram normal, Facet joint block, Fear, Feeling abnormal, Gene mutation identification test negative
Clinical narrative: Severe Vertigo three days after 2nd vaccination requiring hospitalization.  High blood pressure (180/110)and headaches two weeks after.  Massive headaches requiring hospitalization May 30, 2021.  Visits to ENT, Neurologist, Allergist, and Primary care Physician for several weeks following.  Additional symptoms, increasing blood pressure, headaches, insomnia, sleep apnea, diareah for 2 months, tinnitus, hearing loss, extreme neck pain, extreme anxiety, and depression.  Treatments over the following three months included CPAP therapy, blood pressure medication, hearing tests, depression medication, anxiety medication, Migraine medication, Botox shots for neck pain which also helped with headaches, facett block.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypertension, Impaired quality of life, Impaired work ability, Insomnia
Clinical narrative: Severe Vertigo three days after 2nd vaccination requiring hospitalization.  High blood pressure (180/110)and headaches two weeks after.  Massive headaches requiring hospitalization May 30, 2021.  Visits to ENT, Neurologist, Allergist, and Primary care Physician for several weeks following.  Additional symptoms, increasing blood pressure, headaches, insomnia, sleep apnea, diareah for 2 months, tinnitus, hearing loss, extreme neck pain, extreme anxiety, and depression.  Treatments over the following three months included CPAP therapy, blood pressure medication, hearing tests, depression medication, anxiety medication, Migraine medication, Botox shots for neck pain which also helped with headaches, facett block.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Medical diet, Neck pain, Polyuria, Positive airway pressure therapy, SARS-CoV-2 antibody test negative
Clinical narrative: Severe Vertigo three days after 2nd vaccination requiring hospitalization.  High blood pressure (180/110)and headaches two weeks after.  Massive headaches requiring hospitalization May 30, 2021.  Visits to ENT, Neurologist, Allergist, and Primary care Physician for several weeks following.  Additional symptoms, increasing blood pressure, headaches, insomnia, sleep apnea, diareah for 2 months, tinnitus, hearing loss, extreme neck pain, extreme anxiety, and depression.  Treatments over the following three months included CPAP therapy, blood pressure medication, hearing tests, depression medication, anxiety medication, Migraine medication, Botox shots for neck pain which also helped with headaches, facett block.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinoscopy, Sleep apnoea syndrome, Sleep study normal, Social avoidant behaviour, Suicidal ideation
Clinical narrative: Severe Vertigo three days after 2nd vaccination requiring hospitalization.  High blood pressure (180/110)and headaches two weeks after.  Massive headaches requiring hospitalization May 30, 2021.  Visits to ENT, Neurologist, Allergist, and Primary care Physician for several weeks following.  Additional symptoms, increasing blood pressure, headaches, insomnia, sleep apnea, diareah for 2 months, tinnitus, hearing loss, extreme neck pain, extreme anxiety, and depression.  Treatments over the following three months included CPAP therapy, blood pressure medication, hearing tests, depression medication, anxiety medication, Migraine medication, Botox shots for neck pain which also helped with headaches, facett block.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Ultrasound scan normal, Urine analysis normal, Vertigo
Clinical narrative: Severe Vertigo three days after 2nd vaccination requiring hospitalization.  High blood pressure (180/110)and headaches two weeks after.  Massive headaches requiring hospitalization May 30, 2021.  Visits to ENT, Neurologist, Allergist, and Primary care Physician for several weeks following.  Additional symptoms, increasing blood pressure, headaches, insomnia, sleep apnea, diareah for 2 months, tinnitus, hearing loss, extreme neck pain, extreme anxiety, and depression.  Treatments over the following three months included CPAP therapy, blood pressure medication, hearing tests, depression medication, anxiety medication, Migraine medication, Botox shots for neck pain which also helped with headaches, facett block.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Illness, Malaise, Pain
Clinical narrative: severely sick for 5 days; generalized aches and pains; had no appetite; Severely fatigue; malaise; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team for a Pfizer sponsored program (159558). The reporter is the parent.  A 45 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Jan2021 13:00 (Lot number: EL9262) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (ongoing), notes: Has category 3, Has had since a child. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Time: 12:00, Anatomical Site of injection: Left Shoulder, Route of administration: Intramuscular, Batch/Lot number: EK9231), administration date: 07Jan2021, when the patient was 44 years old, for COVID-19 immunization, reaction(s): "no adverse events". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "severely sick for 5 days"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "generalized aches and pains"; DECREASED APPETITE (non-serious) with onset 2021, outcome "recovered" (2021), described as "had no appetite"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Severely fatigue"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "malaise".  Additional information: Additional vaccines administered on same date of the pfizer suspect were none. Prior vaccinations (within 4 weeks) were none. Ae(s) following prior vaccinations were none. After the second dose patient was severely sick from approximately day 2 to day 7. Events did not require emergency room or physician office visit. Relatedness of drug to reaction(s)/event(s) No appetite, generalized aches and pains and Malaise was related (Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection).  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Dizziness, Heart rate
Clinical narrative: Increase in body temperature; Heart rate increase; Dizziness; Chilling; Nausea / felt like throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2021 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Increase in body temperature"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Heart rate increase"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; CHILLS (non-serious), outcome "unknown", described as "Chilling"; NAUSEA (non-serious), outcome "unknown", described as "Nausea / felt like throwing up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the second dose of BNT162B2 on 17Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea
Clinical narrative: Increase in body temperature; Heart rate increase; Dizziness; Chilling; Nausea / felt like throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 29 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jan2021 (Batch/Lot number: unknown) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Increase in body temperature"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Heart rate increase"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; CHILLS (non-serious), outcome "unknown", described as "Chilling"; NAUSEA (non-serious), outcome "unknown", described as "Nausea / felt like throwing up". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the second dose of BNT162B2 on 17Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test result: Positive / covid test date: 10Jan2022; covid test result: Positive / covid test date: 10Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 16:45 (Lot number: EP7533) at the age of 64 years as dose 2, single and administration date 03Mar2021 16:45 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D NOS; POTASSIUM CITRATE; TRAMADOL; AMBIEN. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Previous dose details: , Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EN6204, Prev dose lot unknown=False, Prev dose administration date=03Mar2021, Prev dose administration time=04:45PM, Prev dose number=1), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test result: Positive / covid test date: 10Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Headache, Magnetic resonance imaging
Clinical narrative: covid test result: Positive / covid test date: 10Jan2022; covid test result: Positive / covid test date: 10Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 16:45 (Lot number: EP7533) at the age of 64 years as dose 2, single and administration date 03Mar2021 16:45 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN D NOS; POTASSIUM CITRATE; TRAMADOL; AMBIEN. Vaccination history included: Covid-19 vaccine (Dose Number: 1, Previous dose details: , Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EN6204, Prev dose lot unknown=False, Prev dose administration date=03Mar2021, Prev dose administration time=04:45PM, Prev dose number=1), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Jan2022, outcome "unknown" and all described as "covid test result: Positive / covid test date: 10Jan2022". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal Swab.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested Positive for COVID. Symptoms include sore throat, cough, and stuffy nose.; Tested Positive for COVID. Symptoms include sore throat, cough, and stuffy nose.; dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12Oct2021 (Lot number: EW0217) at the age of 34 years as dose 3 (booster), single, administration date 23Feb2021 (Lot number: EL3247) as dose 2, single and administration date 01Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No other vaccine in four weeks. No covid prior vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 12Oct2021, outcome "unknown", described as "dose number 3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jan2022, outcome "recovering" and all described as "Tested Positive for COVID. Symptoms include sore throat, cough, and stuffy nose.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, SARS-CoV-2 test
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 83 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26Jan2021 (Lot number: EN5318) as dose 1, single and intramuscular, administered in arm left, administration date 17Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELOXICAM taken for intervertebral disc degeneration, arthritis (ongoing); GABAPENTIN taken for neuropathy peripheral (ongoing); LORATADINE taken for hypersensitivity (ongoing). The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the vaccination. Chills only after 1st and 2nd.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: long menstruation 60 days of spotting/bleeding; long menstruation 60 days of spotting/bleeding; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 35 year old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 13Sep2021 14:30 (Lot number: fc3183) at the age of 35 years as dose 1, single dose for COVID-19 immunisation. Relevant medical history included: "hypothyroid" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant), INTERMENSTRUAL BLEEDING (medically significant) all with onset 19Sep2021, outcome "not recovered" and all described as "long menstruation 60 days of spotting/bleeding". The event "long menstruation 60 days of spotting/bleeding" and "long menstruation 60 days of spotting/bleeding" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of heavy menstrual bleeding, intermenstrual bleeding. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number 30135ba/expiration date: not provided), via an unspecified route of administration, on 04Oct2021at 02:30 PM (at the age of 35 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased, Thrombocytopenia, Vaginal haemorrhage
Clinical narrative: thrombocytopenia; platelet count of 8000; vaginal bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOCYTOPENIA (hospitalization, Medically Significant ), outcome "unknown", described as "thrombocytopenia"; PLATELET COUNT DECREASED (hospitalization), outcome "unknown", described as "platelet count of 8000"; VAGINAL HAEMORRHAGE (hospitalization), outcome "recovered", described as "vaginal bleeding". The patient underwent the following laboratory tests and procedures: platelet count: 8000, notes: Low platelets diagnosed with Thrombocytopenia. Therapeutic measures were taken as a result of thrombocytopenia, platelet count decreased. Clinical course: The patient began having vaginal bleeding after getting the Pfizer Covid Vaccine. The patient eventually diagnosed with  thrombocytopenia and hospitalized with a platelet count of 8000.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and 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: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Abulia, Aggression, Anti-thyroid antibody, Antibody test negative
Clinical narrative: Around November 28, 2021 parents started noticing a shift in her behaviors.  She began being more indecisive and was often responding "I don't know to questions".  She seemed less confident, asking questions over and over, play was more hyperactive and more aggressive. She began doing some counting rituals, like flickering lights on and off and counting when doing things. Family members and family friends noticed a difference in her. School did not notice a significant difference although mom notes if kids aren't disruptive they don't get much attention at her school. Parents report she was doing fine keeping up with her schoolwork and had improved scores on her end of the semester testing. Mom reports she started struggling more in gymnastics class and when they were doing a counting activity she got very frustrated and went to the corner and was crying.   The second dose of COVID 19 vaccine was given on 12/15 and around 12/18 things significantly worsened. Parents feel she has been confused, difficulty answering even simple questions, not focused, doing very frequent counting rituals. All symptoms she was having seems magnified. She was not functioning well. Parents have been noticing her doing odd repetitive movements, like shoulder shrugs and counting on her fingers. Mom feels her personality has changed too, laughing at things inappropriately, more emotional. Mom describes her as "acting like a toddler". Notes that she is sometimes eating her food with her hands rather than utensils, having meltdowns, having times where she is not using words and pointing/grunting to show what she wants. Asking the same question multiple times over and over. Despite seeming confused parents do report she has been able to play games, build Legos via directions and other cognitive tasks ok. Since that time, her mother feels patients behavior and personality have shifted towards her previous baseline, but she remains far different than she was previously.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, Aphasia, Blood copper normal, Blood immunoglobulin A normal, Blood immunoglobulin E increased
Clinical narrative: Around November 28, 2021 parents started noticing a shift in her behaviors.  She began being more indecisive and was often responding "I don't know to questions".  She seemed less confident, asking questions over and over, play was more hyperactive and more aggressive. She began doing some counting rituals, like flickering lights on and off and counting when doing things. Family members and family friends noticed a difference in her. School did not notice a significant difference although mom notes if kids aren't disruptive they don't get much attention at her school. Parents report she was doing fine keeping up with her schoolwork and had improved scores on her end of the semester testing. Mom reports she started struggling more in gymnastics class and when they were doing a counting activity she got very frustrated and went to the corner and was crying.   The second dose of COVID 19 vaccine was given on 12/15 and around 12/18 things significantly worsened. Parents feel she has been confused, difficulty answering even simple questions, not focused, doing very frequent counting rituals. All symptoms she was having seems magnified. She was not functioning well. Parents have been noticing her doing odd repetitive movements, like shoulder shrugs and counting on her fingers. Mom feels her personality has changed too, laughing at things inappropriately, more emotional. Mom describes her as "acting like a toddler". Notes that she is sometimes eating her food with her hands rather than utensils, having meltdowns, having times where she is not using words and pointing/grunting to show what she wants. Asking the same question multiple times over and over. Despite seeming confused parents do report she has been able to play games, build Legos via directions and other cognitive tasks ok. Since that time, her mother feels patients behavior and personality have shifted towards her previous baseline, but she remains far different than she was previously.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M normal, Borrelia test negative, C-reactive protein normal, Ceruloplasmin normal
Clinical narrative: Around November 28, 2021 parents started noticing a shift in her behaviors.  She began being more indecisive and was often responding "I don't know to questions".  She seemed less confident, asking questions over and over, play was more hyperactive and more aggressive. She began doing some counting rituals, like flickering lights on and off and counting when doing things. Family members and family friends noticed a difference in her. School did not notice a significant difference although mom notes if kids aren't disruptive they don't get much attention at her school. Parents report she was doing fine keeping up with her schoolwork and had improved scores on her end of the semester testing. Mom reports she started struggling more in gymnastics class and when they were doing a counting activity she got very frustrated and went to the corner and was crying.   The second dose of COVID 19 vaccine was given on 12/15 and around 12/18 things significantly worsened. Parents feel she has been confused, difficulty answering even simple questions, not focused, doing very frequent counting rituals. All symptoms she was having seems magnified. She was not functioning well. Parents have been noticing her doing odd repetitive movements, like shoulder shrugs and counting on her fingers. Mom feels her personality has changed too, laughing at things inappropriately, more emotional. Mom describes her as "acting like a toddler". Notes that she is sometimes eating her food with her hands rather than utensils, having meltdowns, having times where she is not using words and pointing/grunting to show what she wants. Asking the same question multiple times over and over. Despite seeming confused parents do report she has been able to play games, build Legos via directions and other cognitive tasks ok. Since that time, her mother feels patients behavior and personality have shifted towards her previous baseline, but she remains far different than she was previously.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Crying, Disturbance in attention, Dyskinesia, Emotional disorder
Clinical narrative: Around November 28, 2021 parents started noticing a shift in her behaviors.  She began being more indecisive and was often responding "I don't know to questions".  She seemed less confident, asking questions over and over, play was more hyperactive and more aggressive. She began doing some counting rituals, like flickering lights on and off and counting when doing things. Family members and family friends noticed a difference in her. School did not notice a significant difference although mom notes if kids aren't disruptive they don't get much attention at her school. Parents report she was doing fine keeping up with her schoolwork and had improved scores on her end of the semester testing. Mom reports she started struggling more in gymnastics class and when they were doing a counting activity she got very frustrated and went to the corner and was crying.   The second dose of COVID 19 vaccine was given on 12/15 and around 12/18 things significantly worsened. Parents feel she has been confused, difficulty answering even simple questions, not focused, doing very frequent counting rituals. All symptoms she was having seems magnified. She was not functioning well. Parents have been noticing her doing odd repetitive movements, like shoulder shrugs and counting on her fingers. Mom feels her personality has changed too, laughing at things inappropriately, more emotional. Mom describes her as "acting like a toddler". Notes that she is sometimes eating her food with her hands rather than utensils, having meltdowns, having times where she is not using words and pointing/grunting to show what she wants. Asking the same question multiple times over and over. Despite seeming confused parents do report she has been able to play games, build Legos via directions and other cognitive tasks ok. Since that time, her mother feels patients behavior and personality have shifted towards her previous baseline, but she remains far different than she was previously.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Frustration tolerance decreased, Full blood count normal, Grunting, Inappropriate affect, Laboratory test
Clinical narrative: Around November 28, 2021 parents started noticing a shift in her behaviors.  She began being more indecisive and was often responding "I don't know to questions".  She seemed less confident, asking questions over and over, play was more hyperactive and more aggressive. She began doing some counting rituals, like flickering lights on and off and counting when doing things. Family members and family friends noticed a difference in her. School did not notice a significant difference although mom notes if kids aren't disruptive they don't get much attention at her school. Parents report she was doing fine keeping up with her schoolwork and had improved scores on her end of the semester testing. Mom reports she started struggling more in gymnastics class and when they were doing a counting activity she got very frustrated and went to the corner and was crying.   The second dose of COVID 19 vaccine was given on 12/15 and around 12/18 things significantly worsened. Parents feel she has been confused, difficulty answering even simple questions, not focused, doing very frequent counting rituals. All symptoms she was having seems magnified. She was not functioning well. Parents have been noticing her doing odd repetitive movements, like shoulder shrugs and counting on her fingers. Mom feels her personality has changed too, laughing at things inappropriately, more emotional. Mom describes her as "acting like a toddler". Notes that she is sometimes eating her food with her hands rather than utensils, having meltdowns, having times where she is not using words and pointing/grunting to show what she wants. Asking the same question multiple times over and over. Despite seeming confused parents do report she has been able to play games, build Legos via directions and other cognitive tasks ok. Since that time, her mother feels patients behavior and personality have shifted towards her previous baseline, but she remains far different than she was previously.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mycoplasma test positive, Personality change, Psychiatric symptom, Psychomotor hyperactivity
Clinical narrative: Around November 28, 2021 parents started noticing a shift in her behaviors.  She began being more indecisive and was often responding "I don't know to questions".  She seemed less confident, asking questions over and over, play was more hyperactive and more aggressive. She began doing some counting rituals, like flickering lights on and off and counting when doing things. Family members and family friends noticed a difference in her. School did not notice a significant difference although mom notes if kids aren't disruptive they don't get much attention at her school. Parents report she was doing fine keeping up with her schoolwork and had improved scores on her end of the semester testing. Mom reports she started struggling more in gymnastics class and when they were doing a counting activity she got very frustrated and went to the corner and was crying.   The second dose of COVID 19 vaccine was given on 12/15 and around 12/18 things significantly worsened. Parents feel she has been confused, difficulty answering even simple questions, not focused, doing very frequent counting rituals. All symptoms she was having seems magnified. She was not functioning well. Parents have been noticing her doing odd repetitive movements, like shoulder shrugs and counting on her fingers. Mom feels her personality has changed too, laughing at things inappropriately, more emotional. Mom describes her as "acting like a toddler". Notes that she is sometimes eating her food with her hands rather than utensils, having meltdowns, having times where she is not using words and pointing/grunting to show what she wants. Asking the same question multiple times over and over. Despite seeming confused parents do report she has been able to play games, build Legos via directions and other cognitive tasks ok. Since that time, her mother feels patients behavior and personality have shifted towards her previous baseline, but she remains far different than she was previously.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Repetitive speech, SARS-CoV-2 antibody test positive, Streptococcus test positive
Clinical narrative: Around November 28, 2021 parents started noticing a shift in her behaviors.  She began being more indecisive and was often responding "I don't know to questions".  She seemed less confident, asking questions over and over, play was more hyperactive and more aggressive. She began doing some counting rituals, like flickering lights on and off and counting when doing things. Family members and family friends noticed a difference in her. School did not notice a significant difference although mom notes if kids aren't disruptive they don't get much attention at her school. Parents report she was doing fine keeping up with her schoolwork and had improved scores on her end of the semester testing. Mom reports she started struggling more in gymnastics class and when they were doing a counting activity she got very frustrated and went to the corner and was crying.   The second dose of COVID 19 vaccine was given on 12/15 and around 12/18 things significantly worsened. Parents feel she has been confused, difficulty answering even simple questions, not focused, doing very frequent counting rituals. All symptoms she was having seems magnified. She was not functioning well. Parents have been noticing her doing odd repetitive movements, like shoulder shrugs and counting on her fingers. Mom feels her personality has changed too, laughing at things inappropriately, more emotional. Mom describes her as "acting like a toddler". Notes that she is sometimes eating her food with her hands rather than utensils, having meltdowns, having times where she is not using words and pointing/grunting to show what she wants. Asking the same question multiple times over and over. Despite seeming confused parents do report she has been able to play games, build Legos via directions and other cognitive tasks ok. Since that time, her mother feels patients behavior and personality have shifted towards her previous baseline, but she remains far different than she was previously.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold, Headache, Musculoskeletal stiffness, Osteitis
Clinical narrative: got sick with COVID; got sick with COVID; sick; they were running fevers and had aches; they were running fevers and had aches; had brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EL6004) at the age of 69 years as dose 2, single and administration date 06Feb2021 (Lot number: EL9263) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: VALSARTAN taken for hypertension. Past drug history included: Losartan, stop date: 2018, reaction(s): "tumors", notes: She says she thinks she stopped taking Losartan in 2018.; Losartan, stop date: 2018, reaction(s): "cysts in her breasts and leg", notes: She says she thinks she stopped taking Losartan in 2018., Caller says there were cysts, it was Dec2019.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021) and all described as "got sick with COVID"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "they were running fevers and had aches"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "had brain fog". By Tuesday she got sick with COVID, they had COVID during Jul and Aug. She clarifies she had COVID last summer in Jul, at the end of Jul into the beginning of Aug and she was sick three weeks and had brain fog for two months. She says because she tested negative and didn't feel like going back to be tested again the next day, she didn't get offered any treatment. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative, notes: COVID test done in the nose. Therapeutic measures were not taken as a result of vaccination failure, covid-19, illness, pyrexia, pain, feeling abnormal.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Tinnitus
Clinical narrative: got sick with COVID; got sick with COVID; sick; they were running fevers and had aches; they were running fevers and had aches; had brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EL6004) at the age of 69 years as dose 2, single and administration date 06Feb2021 (Lot number: EL9263) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: VALSARTAN taken for hypertension. Past drug history included: Losartan, stop date: 2018, reaction(s): "tumors", notes: She says she thinks she stopped taking Losartan in 2018.; Losartan, stop date: 2018, reaction(s): "cysts in her breasts and leg", notes: She says she thinks she stopped taking Losartan in 2018., Caller says there were cysts, it was Dec2019.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021) and all described as "got sick with COVID"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "they were running fevers and had aches"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "had brain fog". By Tuesday she got sick with COVID, they had COVID during Jul and Aug. She clarifies she had COVID last summer in Jul, at the end of Jul into the beginning of Aug and she was sick three weeks and had brain fog for two months. She says because she tested negative and didn't feel like going back to be tested again the next day, she didn't get offered any treatment. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative, notes: COVID test done in the nose. Therapeutic measures were not taken as a result of vaccination failure, covid-19, illness, pyrexia, pain, feeling abnormal.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, Illness, Pain, Pyrexia
Clinical narrative: got sick with COVID; got sick with COVID; sick; they were running fevers and had aches; they were running fevers and had aches; had brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EL6004) at the age of 69 years as dose 2, single and administration date 06Feb2021 (Lot number: EL9263) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: VALSARTAN taken for hypertension. Past drug history included: Losartan, stop date: 2018, reaction(s): "tumors", notes: She says she thinks she stopped taking Losartan in 2018.; Losartan, stop date: 2018, reaction(s): "cysts in her breasts and leg", notes: She says she thinks she stopped taking Losartan in 2018., Caller says there were cysts, it was Dec2019.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021) and all described as "got sick with COVID"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "they were running fevers and had aches"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "had brain fog". By Tuesday she got sick with COVID, they had COVID during Jul and Aug. She clarifies she had COVID last summer in Jul, at the end of Jul into the beginning of Aug and she was sick three weeks and had brain fog for two months. She says because she tested negative and didn't feel like going back to be tested again the next day, she didn't get offered any treatment. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative, notes: COVID test done in the nose. Therapeutic measures were not taken as a result of vaccination failure, covid-19, illness, pyrexia, pain, feeling abnormal.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination failure
Clinical narrative: got sick with COVID; got sick with COVID; sick; they were running fevers and had aches; they were running fevers and had aches; had brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Lot number: EL6004) at the age of 69 years as dose 2, single and administration date 06Feb2021 (Lot number: EL9263) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: VALSARTAN taken for hypertension. Past drug history included: Losartan, stop date: 2018, reaction(s): "tumors", notes: She says she thinks she stopped taking Losartan in 2018.; Losartan, stop date: 2018, reaction(s): "cysts in her breasts and leg", notes: She says she thinks she stopped taking Losartan in 2018., Caller says there were cysts, it was Dec2019.  The following information was reported: VACCINATION FAILURE (medically significant) with onset 2021, outcome "unknown", COVID-19 (medically significant) with onset 2021, outcome "recovered" (2021) and all described as "got sick with COVID"; ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sick"; PYREXIA (non-serious), PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "they were running fevers and had aches"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered" (2021), described as "had brain fog". By Tuesday she got sick with COVID, they had COVID during Jul and Aug. She clarifies she had COVID last summer in Jul, at the end of Jul into the beginning of Aug and she was sick three weeks and had brain fog for two months. She says because she tested negative and didn't feel like going back to be tested again the next day, she didn't get offered any treatment. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative, notes: COVID test done in the nose. Therapeutic measures were not taken as a result of vaccination failure, covid-19, illness, pyrexia, pain, feeling abnormal.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Apraxia, Behaviour disorder, Dysgraphia, Electroencephalogram
Clinical narrative: Adverse neurological symptoms; Daily headaches; Nausea; Numbness on left side of body; Cognitive impairment; Memory loss; Ringing in ears; Dissociative feeling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 15 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 (Lot number: FIA7485) at the age of 15 years as dose 1, single for covid-19 immunisation at Pharmacy or Drug Store. The patient had no relevant medical history. There were no concomitant medications. Other vaccine in four weeks: No. Other medications in two weeks: No. Covid prior vaccination: No. The following information was reported: NEUROLOGICAL SYMPTOM (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Adverse neurological symptoms"; HEADACHE (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Daily headaches"; NAUSEA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Nausea"; HYPOAESTHESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Numbness on left side of body"; COGNITIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Cognitive impairment"; AMNESIA (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Memory loss"; TINNITUS (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Ringing in ears"; DISSOCIATIVE DISORDER (hospitalization) with onset 23Aug2021, outcome "not recovered", described as "Dissociative feeling". The patient was hospitalized for neurological symptom, headache, nausea, hypoaesthesia, cognitive disorder, amnesia, tinnitus, dissociative disorder (hospitalization duration: 2 day(s)). The events "adverse neurological symptoms", "daily headaches", "nausea", "numbness on left side of body", "cognitive impairment", "memory loss", "ringing in ears" and "dissociative feeling" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive, notes: Blood test, post vaccination. Therapeutic measures were taken as a result of headache. Treatment with Pain reliever for headache symptoms only.