chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Apnoea, Asthenia, Full blood count abnormal, Influenza virus test negative, Laboratory test abnormal
Clinical narrative: pancytopenia; viral sepsis; fever/ running high fever; stomach upset; arm pain; headache; more tired; never felt quite right/ feeling generally unwell; elevated inflammatory markers like Ddimer; This is a spontaneous report from a contactable nurse(patient). This 39-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) at single dose on 31Dec2021 10:00 via an unknown route in right arm for Covid-19 immunization. Medical history included SLE and seizures. Prior to vaccination, the patient was diagnosed with COVID-19. Past drug history included tramadol hydrochloride (ULTRAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included levetiracetam (KEPPRA), aciclovir (ACYCLOVIR), azathioprine  (IMURAN ), cefixime (FLEXERIL ), methenamine mandelate, methionine (G ), hydroxychloroquine sulfate (PLAQUENIL). After immunization on 21Apr2021 16:00, patient had the stated reactions of fever, stomach upset, arm pain, and headache for 2-3days. But then she seemed to stay more tired and never felt quite right. 2 days before her second dose she started running high fever and feeling generally unwell. Covid and flu test were negative. Urgent care ran a CBC and it showed pancytopenia. She was sent to the hospital and admitted for 9 days with what appeared to be viral sepsis, elevated inflammatory markers like Ddimer, and pancytopenia of unknown origin. It took almost 7 weeks to get back to some kind of normal functioning. Patient ran fevers for 18 days. The doctors did not feel like the viruses, lupus, or medications alone could explain the illness that she had and worried that the vaccine was a catalyst to all the rest of the events. She showed positive IGG immunity but now she did not. IGM/IGG on an unknown date was negative. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was resolving. The report was assessed as serious with seriousness criteria of historization and lie-threatening.      Follow-up attempts are needed. Further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Sepsis
Clinical narrative: pancytopenia; viral sepsis; fever/ running high fever; stomach upset; arm pain; headache; more tired; never felt quite right/ feeling generally unwell; elevated inflammatory markers like Ddimer; This is a spontaneous report from a contactable nurse(patient). This 39-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) at single dose on 31Dec2021 10:00 via an unknown route in right arm for Covid-19 immunization. Medical history included SLE and seizures. Prior to vaccination, the patient was diagnosed with COVID-19. Past drug history included tramadol hydrochloride (ULTRAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included levetiracetam (KEPPRA), aciclovir (ACYCLOVIR), azathioprine  (IMURAN ), cefixime (FLEXERIL ), methenamine mandelate, methionine (G ), hydroxychloroquine sulfate (PLAQUENIL). After immunization on 21Apr2021 16:00, patient had the stated reactions of fever, stomach upset, arm pain, and headache for 2-3days. But then she seemed to stay more tired and never felt quite right. 2 days before her second dose she started running high fever and feeling generally unwell. Covid and flu test were negative. Urgent care ran a CBC and it showed pancytopenia. She was sent to the hospital and admitted for 9 days with what appeared to be viral sepsis, elevated inflammatory markers like Ddimer, and pancytopenia of unknown origin. It took almost 7 weeks to get back to some kind of normal functioning. Patient ran fevers for 18 days. The doctors did not feel like the viruses, lupus, or medications alone could explain the illness that she had and worried that the vaccine was a catalyst to all the rest of the events. She showed positive IGG immunity but now she did not. IGM/IGG on an unknown date was negative. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was resolving. The report was assessed as serious with seriousness criteria of historization and lie-threatening.      Follow-up attempts are needed. Further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Blood immunoglobulin G, Fatigue, Fibrin D dimer, Full blood count
Clinical narrative: pancytopenia; viral sepsis; fever/ running high fever; stomach upset; arm pain; headache; more tired; never felt quite right/ feeling generally unwell; elevated inflammatory markers like Ddimer; This is a spontaneous report from a contactable nurse(patient). This 39-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) at single dose on 31Dec2021 10:00 via an unknown route in right arm for Covid-19 immunization. Medical history included SLE and seizures. Prior to vaccination, the patient was diagnosed with COVID-19. Past drug history included tramadol hydrochloride (ULTRAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included levetiracetam (KEPPRA), aciclovir (ACYCLOVIR), azathioprine  (IMURAN ), cefixime (FLEXERIL ), methenamine mandelate, methionine (G ), hydroxychloroquine sulfate (PLAQUENIL). After immunization on 21Apr2021 16:00, patient had the stated reactions of fever, stomach upset, arm pain, and headache for 2-3days. But then she seemed to stay more tired and never felt quite right. 2 days before her second dose she started running high fever and feeling generally unwell. Covid and flu test were negative. Urgent care ran a CBC and it showed pancytopenia. She was sent to the hospital and admitted for 9 days with what appeared to be viral sepsis, elevated inflammatory markers like Ddimer, and pancytopenia of unknown origin. It took almost 7 weeks to get back to some kind of normal functioning. Patient ran fevers for 18 days. The doctors did not feel like the viruses, lupus, or medications alone could explain the illness that she had and worried that the vaccine was a catalyst to all the rest of the events. She showed positive IGG immunity but now she did not. IGM/IGG on an unknown date was negative. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was resolving. The report was assessed as serious with seriousness criteria of historization and lie-threatening.      Follow-up attempts are needed. Further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Inflammatory marker increased, Malaise, Pain in extremity, Pancytopenia
Clinical narrative: pancytopenia; viral sepsis; fever/ running high fever; stomach upset; arm pain; headache; more tired; never felt quite right/ feeling generally unwell; elevated inflammatory markers like Ddimer; This is a spontaneous report from a contactable nurse(patient). This 39-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) at single dose on 31Dec2021 10:00 via an unknown route in right arm for Covid-19 immunization. Medical history included SLE and seizures. Prior to vaccination, the patient was diagnosed with COVID-19. Past drug history included tramadol hydrochloride (ULTRAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included levetiracetam (KEPPRA), aciclovir (ACYCLOVIR), azathioprine  (IMURAN ), cefixime (FLEXERIL ), methenamine mandelate, methionine (G ), hydroxychloroquine sulfate (PLAQUENIL). After immunization on 21Apr2021 16:00, patient had the stated reactions of fever, stomach upset, arm pain, and headache for 2-3days. But then she seemed to stay more tired and never felt quite right. 2 days before her second dose she started running high fever and feeling generally unwell. Covid and flu test were negative. Urgent care ran a CBC and it showed pancytopenia. She was sent to the hospital and admitted for 9 days with what appeared to be viral sepsis, elevated inflammatory markers like Ddimer, and pancytopenia of unknown origin. It took almost 7 weeks to get back to some kind of normal functioning. Patient ran fevers for 18 days. The doctors did not feel like the viruses, lupus, or medications alone could explain the illness that she had and worried that the vaccine was a catalyst to all the rest of the events. She showed positive IGG immunity but now she did not. IGM/IGG on an unknown date was negative. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was resolving. The report was assessed as serious with seriousness criteria of historization and lie-threatening.      Follow-up attempts are needed. Further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Viral sepsis
Clinical narrative: pancytopenia; viral sepsis; fever/ running high fever; stomach upset; arm pain; headache; more tired; never felt quite right/ feeling generally unwell; elevated inflammatory markers like Ddimer; This is a spontaneous report from a contactable nurse(patient). This 39-year-old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) at single dose on 31Dec2021 10:00 via an unknown route in right arm for Covid-19 immunization. Medical history included SLE and seizures. Prior to vaccination, the patient was diagnosed with COVID-19. Past drug history included tramadol hydrochloride (ULTRAM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included levetiracetam (KEPPRA), aciclovir (ACYCLOVIR), azathioprine  (IMURAN ), cefixime (FLEXERIL ), methenamine mandelate, methionine (G ), hydroxychloroquine sulfate (PLAQUENIL). After immunization on 21Apr2021 16:00, patient had the stated reactions of fever, stomach upset, arm pain, and headache for 2-3days. But then she seemed to stay more tired and never felt quite right. 2 days before her second dose she started running high fever and feeling generally unwell. Covid and flu test were negative. Urgent care ran a CBC and it showed pancytopenia. She was sent to the hospital and admitted for 9 days with what appeared to be viral sepsis, elevated inflammatory markers like Ddimer, and pancytopenia of unknown origin. It took almost 7 weeks to get back to some kind of normal functioning. Patient ran fevers for 18 days. The doctors did not feel like the viruses, lupus, or medications alone could explain the illness that she had and worried that the vaccine was a catalyst to all the rest of the events. She showed positive IGG immunity but now she did not. IGM/IGG on an unknown date was negative. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was resolving. The report was assessed as serious with seriousness criteria of historization and lie-threatening.      Follow-up attempts are needed. Further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Hyperhidrosis, Paraesthesia oral
Clinical narrative: 2/26/21 within approximately 5 minutes began to have severe shortness of breath due to severe coughing that is difficult to stop.  She says her throat and back are starting to hurt because she is coughing..  She is speaking in shortened sentences due to severity of her coughing.  Coughing so severely at time of arrival that she essentially could not breathe; however, no wheezing was appreciated and pulse ox at that time was 100% on RA; they did place patient on NRB for prophylaxis.  Patient given prednisone, duoneb with good response. 3/24/21 received her second COVID vaccine this morning and 15 minutes after, developed shortness of breath and cough. Medical emergency was called and patient was brought to the ED on non-rebreather, oxygen sats 97-100% en route. No other interventions in the clinic. Here in the ED, she is unable to speak in full sentences.    Patient given prednisone, duoneb with good response.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngeal paraesthesia, Tremor
Clinical narrative: 2/26/21 within approximately 5 minutes began to have severe shortness of breath due to severe coughing that is difficult to stop.  She says her throat and back are starting to hurt because she is coughing..  She is speaking in shortened sentences due to severity of her coughing.  Coughing so severely at time of arrival that she essentially could not breathe; however, no wheezing was appreciated and pulse ox at that time was 100% on RA; they did place patient on NRB for prophylaxis.  Patient given prednisone, duoneb with good response. 3/24/21 received her second COVID vaccine this morning and 15 minutes after, developed shortness of breath and cough. Medical emergency was called and patient was brought to the ED on non-rebreather, oxygen sats 97-100% en route. No other interventions in the clinic. Here in the ED, she is unable to speak in full sentences.    Patient given prednisone, duoneb with good response.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Cough, Dyspnoea, Oropharyngeal pain
Clinical narrative: 2/26/21 within approximately 5 minutes began to have severe shortness of breath due to severe coughing that is difficult to stop.  She says her throat and back are starting to hurt because she is coughing..  She is speaking in shortened sentences due to severity of her coughing.  Coughing so severely at time of arrival that she essentially could not breathe; however, no wheezing was appreciated and pulse ox at that time was 100% on RA; they did place patient on NRB for prophylaxis.  Patient given prednisone, duoneb with good response. 3/24/21 received her second COVID vaccine this morning and 15 minutes after, developed shortness of breath and cough. Medical emergency was called and patient was brought to the ED on non-rebreather, oxygen sats 97-100% en route. No other interventions in the clinic. Here in the ED, she is unable to speak in full sentences.    Patient given prednisone, duoneb with good response.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Over the next two months, 4 instances of piercing headache accompanied by blurred vision lasting for more than 2 hours and resistent to regular strength acetimeniphan.  Over the same two months, continuous low level headaches, chills, disrupted sleep.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Headache, Sleep disorder, Vision blurred
Clinical narrative: Over the next two months, 4 instances of piercing headache accompanied by blurred vision lasting for more than 2 hours and resistent to regular strength acetimeniphan.  Over the same two months, continuous low level headaches, chills, disrupted sleep.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness, Conjunctival oedema, Eye pain, Ophthalmological examination abnormal, Vision blurred
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Blood test normal, Computerised tomogram normal, Conjunctival oedema, Laboratory test normal
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging normal, Ocular hyperaemia, Optic neuritis, Vision blurred
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blindness, Blindness unilateral, Blood culture negative
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF test normal, Conjunctival oedema, Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Epstein-Barr virus test negative
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye pain, Herpes simplex test negative, Magnetic resonance imaging head abnormal, Magnetic resonance imaging head normal, Optic atrophy
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Optic neuritis, Optic neuropathy, Pain, Papilloedema, Periorbital swelling
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rheumatoid factor negative, SARS-CoV-2 test negative, Sudden visual loss, Varicella virus test negative
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presented to emergency department with one day of rapidly progressive vision loss in left eye to no light perception and pain with extra-ocular movements, chemosis, and swelling around the eye. Optic disc swelling noted. Patient initiated on steroids, antimicrobials, and antivirals: the later two discontinued when infectious workup negative. Patient discharged on steroids. On follow-up with neuro-ophthamology, patient's left eye remains without light perception. Left optic nerve is pale and right optic nerve is normal. There is no improvement in the right eye and no recovery in the left eye. Patient diagnosed with severe left optic neuropathy consistent with optic neuritis. Steroids discontinued.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: hives, itching, nausea, tired
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Pruritus, Urticaria
Clinical narrative: hives, itching, nausea, tired
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Numbness/weakness in arms - burning at times Extreme itching in arms and legs at times Leg cramps Heart beating hard suddenly just from being still or laying down Pin point pain spots on my spine which started within hours of receiving the vaccine Red dots on legs and arms skin (Petechiae) Shortness of breath climbing stairs, sometimes just walking or sitting Sensation is arm, is like it?s falling asleep, has lasted for hours or days especially right side Throbbing in right ear at times Muscle jumping at times Have experienced extreme itchiness where I have had numbness/muscle weakness Facial numbness around mouth and some involuntary twitching on right side Neck ache - cramps A ton of Floaters in eye site Back pain repeatedly Actual worsening cramps Specific pin point cramps mostly in legs which last for a long time or come and go for several days Pin point pain in chest of left side INSANE HEADACHE Now getting small head aches each day Small spider veins on legs I was a person who worked out basically every day over the last 10 years before the vaccine. I have not worked out one day since, I wouldn?t even try because I?m out of breath just from walking up stairs, leg cramps from doing nothing.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Burning sensation, Dyspnoea, Ear discomfort
Clinical narrative: Numbness/weakness in arms - burning at times Extreme itching in arms and legs at times Leg cramps Heart beating hard suddenly just from being still or laying down Pin point pain spots on my spine which started within hours of receiving the vaccine Red dots on legs and arms skin (Petechiae) Shortness of breath climbing stairs, sometimes just walking or sitting Sensation is arm, is like it?s falling asleep, has lasted for hours or days especially right side Throbbing in right ear at times Muscle jumping at times Have experienced extreme itchiness where I have had numbness/muscle weakness Facial numbness around mouth and some involuntary twitching on right side Neck ache - cramps A ton of Floaters in eye site Back pain repeatedly Actual worsening cramps Specific pin point cramps mostly in legs which last for a long time or come and go for several days Pin point pain in chest of left side INSANE HEADACHE Now getting small head aches each day Small spider veins on legs I was a person who worked out basically every day over the last 10 years before the vaccine. I have not worked out one day since, I wouldn?t even try because I?m out of breath just from walking up stairs, leg cramps from doing nothing.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hypoaesthesia, Muscle spasms, Muscle twitching
Clinical narrative: Numbness/weakness in arms - burning at times Extreme itching in arms and legs at times Leg cramps Heart beating hard suddenly just from being still or laying down Pin point pain spots on my spine which started within hours of receiving the vaccine Red dots on legs and arms skin (Petechiae) Shortness of breath climbing stairs, sometimes just walking or sitting Sensation is arm, is like it?s falling asleep, has lasted for hours or days especially right side Throbbing in right ear at times Muscle jumping at times Have experienced extreme itchiness where I have had numbness/muscle weakness Facial numbness around mouth and some involuntary twitching on right side Neck ache - cramps A ton of Floaters in eye site Back pain repeatedly Actual worsening cramps Specific pin point cramps mostly in legs which last for a long time or come and go for several days Pin point pain in chest of left side INSANE HEADACHE Now getting small head aches each day Small spider veins on legs I was a person who worked out basically every day over the last 10 years before the vaccine. I have not worked out one day since, I wouldn?t even try because I?m out of breath just from walking up stairs, leg cramps from doing nothing.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Petechiae, Pruritus, Spider vein, Spinal pain
Clinical narrative: Numbness/weakness in arms - burning at times Extreme itching in arms and legs at times Leg cramps Heart beating hard suddenly just from being still or laying down Pin point pain spots on my spine which started within hours of receiving the vaccine Red dots on legs and arms skin (Petechiae) Shortness of breath climbing stairs, sometimes just walking or sitting Sensation is arm, is like it?s falling asleep, has lasted for hours or days especially right side Throbbing in right ear at times Muscle jumping at times Have experienced extreme itchiness where I have had numbness/muscle weakness Facial numbness around mouth and some involuntary twitching on right side Neck ache - cramps A ton of Floaters in eye site Back pain repeatedly Actual worsening cramps Specific pin point cramps mostly in legs which last for a long time or come and go for several days Pin point pain in chest of left side INSANE HEADACHE Now getting small head aches each day Small spider veins on legs I was a person who worked out basically every day over the last 10 years before the vaccine. I have not worked out one day since, I wouldn?t even try because I?m out of breath just from walking up stairs, leg cramps from doing nothing.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vitreous floaters
Clinical narrative: Numbness/weakness in arms - burning at times Extreme itching in arms and legs at times Leg cramps Heart beating hard suddenly just from being still or laying down Pin point pain spots on my spine which started within hours of receiving the vaccine Red dots on legs and arms skin (Petechiae) Shortness of breath climbing stairs, sometimes just walking or sitting Sensation is arm, is like it?s falling asleep, has lasted for hours or days especially right side Throbbing in right ear at times Muscle jumping at times Have experienced extreme itchiness where I have had numbness/muscle weakness Facial numbness around mouth and some involuntary twitching on right side Neck ache - cramps A ton of Floaters in eye site Back pain repeatedly Actual worsening cramps Specific pin point cramps mostly in legs which last for a long time or come and go for several days Pin point pain in chest of left side INSANE HEADACHE Now getting small head aches each day Small spider veins on legs I was a person who worked out basically every day over the last 10 years before the vaccine. I have not worked out one day since, I wouldn?t even try because I?m out of breath just from walking up stairs, leg cramps from doing nothing.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: feet were numb, they felt like they were asleep, which progressed from his feet up his legs to his stomach and chest area, then to arms and hands/ diagnosed with Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8735), via an unspecified route of administration, administered in the left arm on 15Apr2021 at 15:30 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had not received other vaccinations on the same dates as when he got the Pfizer COVID-19 vaccine injections, or in the four weeks prior. The patient also stated that he has not started new medications. The patient previously received the first dose of BNT162B2 on 24Mar2021 (lot number: EP6955) at 15:30 in his left arm for COVID-19 immunization. On 18Apr2021, 3 days after the patient got his second dose his feet were numb, they felt like they were asleep, which progressed from his feet up his legs to his stomach and chest area, then to arms and hands. It has stayed the same since it got to his arms. He says he is probably on day 22 at the time of the report. He says he got to see a neurologist and he was diagnosed with Guillain-Barre syndrome. The patient reported that there has been no treatment and was told that it has to run its course. The patient was not hospitalized for the event. He says he just wanted to report that and that he was also curious if others have been reporting that. He says he has never experienced this before, he was very healthy and never had any symptoms with vaccines before, this is all brand new to him. The outcome of the event was not recovered.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: feet were numb, they felt like they were asleep, which progressed from his feet up his legs to his stomach and chest area, then to arms and hands/ diagnosed with Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8735), via an unspecified route of administration, administered in the left arm on 15Apr2021 at 15:30 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had not received other vaccinations on the same dates as when he got the Pfizer COVID-19 vaccine injections, or in the four weeks prior. The patient also stated that he has not started new medications. The patient previously received the first dose of BNT162B2 on 24Mar2021 (lot number: EP6955) at 15:30 in his left arm for COVID-19 immunization. On 18Apr2021, 3 days after the patient got his second dose his feet were numb, they felt like they were asleep, which progressed from his feet up his legs to his stomach and chest area, then to arms and hands. It has stayed the same since it got to his arms. He says he is probably on day 22 at the time of the report. He says he got to see a neurologist and he was diagnosed with Guillain-Barre syndrome. The patient reported that there has been no treatment and was told that it has to run its course. The patient was not hospitalized for the event. He says he just wanted to report that and that he was also curious if others have been reporting that. He says he has never experienced this before, he was very healthy and never had any symptoms with vaccines before, this is all brand new to him. The outcome of the event was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Arthralgia, Cerebral haemorrhage, Computerised tomogram abnormal, Fatigue
Clinical narrative: intracranial hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Apr2021 18:30 (lot number: EW0161) at 1st dose, single for COVID-19 immunization. Medical history included known allergies with penicillin; and also reported other medical history: none. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. The patient experienced intracranial hemorrhage on 24Apr2021 20:00. Clinical course reported as follows: ended up being rushed to the emergency and spent in the hospital and ICU 12 days with an intracranial hemorrhage. This event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event). Number of days in hospitalization was 12. The patient received treatment with hospitalization and 21 days of neopidine. The patient had no COVID prior vaccination and had COVID tested post vaccination with COVID test in Apr2021 and result was negative. The outcome of the event intracranial hemorrhage was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Hypoaesthesia oral, Injection site warmth, Intensive care
Clinical narrative: intracranial hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Apr2021 18:30 (lot number: EW0161) at 1st dose, single for COVID-19 immunization. Medical history included known allergies with penicillin; and also reported other medical history: none. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. The patient experienced intracranial hemorrhage on 24Apr2021 20:00. Clinical course reported as follows: ended up being rushed to the emergency and spent in the hospital and ICU 12 days with an intracranial hemorrhage. This event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event). Number of days in hospitalization was 12. The patient received treatment with hospitalization and 21 days of neopidine. The patient had no COVID prior vaccination and had COVID tested post vaccination with COVID test in Apr2021 and result was negative. The outcome of the event intracranial hemorrhage was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity, Peripheral swelling, Sensory disturbance
Clinical narrative: intracranial hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Apr2021 18:30 (lot number: EW0161) at 1st dose, single for COVID-19 immunization. Medical history included known allergies with penicillin; and also reported other medical history: none. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. The patient experienced intracranial hemorrhage on 24Apr2021 20:00. Clinical course reported as follows: ended up being rushed to the emergency and spent in the hospital and ICU 12 days with an intracranial hemorrhage. This event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event). Number of days in hospitalization was 12. The patient received treatment with hospitalization and 21 days of neopidine. The patient had no COVID prior vaccination and had COVID tested post vaccination with COVID test in Apr2021 and result was negative. The outcome of the event intracranial hemorrhage was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage intracranial, SARS-CoV-2 test
Clinical narrative: intracranial hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 17Apr2021 18:30 (lot number: EW0161) at 1st dose, single for COVID-19 immunization. Medical history included known allergies with penicillin; and also reported other medical history: none. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. The patient experienced intracranial hemorrhage on 24Apr2021 20:00. Clinical course reported as follows: ended up being rushed to the emergency and spent in the hospital and ICU 12 days with an intracranial hemorrhage. This event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and life threatening illness (immediate risk of death from the event). Number of days in hospitalization was 12. The patient received treatment with hospitalization and 21 days of neopidine. The patient had no COVID prior vaccination and had COVID tested post vaccination with COVID test in Apr2021 and result was negative. The outcome of the event intracranial hemorrhage was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pericarditis
Clinical narrative: Acute pericarditis.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary normal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Pericarditis
Clinical narrative: Acute pericarditis.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleuritic pain, Troponin normal
Clinical narrative: Acute pericarditis.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Deep vein thrombosis, Hypercoagulation, Monoclonal gammopathy, Pulmonary embolism
Clinical narrative: Blood clot in leg and one in each lung. Admitted to hospital on 02May2021; Blood clot in leg and one in each lung. Admitted to hospital on 02May2021; This is a spontaneous report received from a contactable consumer. A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 29Apr2021 08:30 (at 55 years old, not pregnant) (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. No concomitant medications. On 02May2021 08:30 patient experienced Blood clot in leg and one in each lung. Admitted to hospital on 02May2021.No other vaccine in four weeks. No other medications in two weeks. Treatment for event was Blood thinners. No covid prior vaccination. Not covid tested post vaccination. The outcome of the events was not recovered. Events resulted in visit to emergency room and physician office. Device Date: 12May2021.  Information on the Lot/Batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: Blood clot in leg and one in each lung. Admitted to hospital on 02May2021; Blood clot in leg and one in each lung. Admitted to hospital on 02May2021; This is a spontaneous report received from a contactable consumer. A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 29Apr2021 08:30 (at 55 years old, not pregnant) (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. No concomitant medications. On 02May2021 08:30 patient experienced Blood clot in leg and one in each lung. Admitted to hospital on 02May2021.No other vaccine in four weeks. No other medications in two weeks. Treatment for event was Blood thinners. No covid prior vaccination. Not covid tested post vaccination. The outcome of the events was not recovered. Events resulted in visit to emergency room and physician office. Device Date: 12May2021.  Information on the Lot/Batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture negative, Borrelia test, CSF culture negative, CSF white blood cell count increased, Cerebellar infarction
Clinical narrative: Small stroke; Meningitis; Acute encephalitis; I lost my balance and endurance; could not walk on my own; This is a spontaneous report received from a contactable consumer reporting for himself. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 62 years old on 20Apr2021 (Lot number EW0161) on Right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included high cholesterol, depression, anxiety. Concomitant medications included colecalciferol (VITAMIN D), venlafaxine, acetylsalicylic acid (ASPRIN), atorvastatin. Historical Vaccine included first dose of BNT162B2 (Lot number ER8734) at the age of 62 years old on 30Mar2021 on Right arm for COVID-19 immunization. The patient stated "I could not walk on my own. I lost my balance and endurance. I spent two weeks in the hospital with a diagnosis of meningitis and acute encephalitis. I also had a small stroke. I am learning how to do everything again. I have outpatient physical therapy and occupational therapy along with several follow up appointments." The events start date were on 24Apr2021. All events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Number days hospitalization was 15 days. Lab data also included Nasal Swab on 29Apr2021 with Negative result. Treatment received for the events included IVIg therapy, antibiotics, PT, OT, SLP. The outcome of the events were not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cognitive disorder, Diplopia, Dizziness, Encephalitis, Enterovirus test
Clinical narrative: Small stroke; Meningitis; Acute encephalitis; I lost my balance and endurance; could not walk on my own; This is a spontaneous report received from a contactable consumer reporting for himself. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 62 years old on 20Apr2021 (Lot number EW0161) on Right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included high cholesterol, depression, anxiety. Concomitant medications included colecalciferol (VITAMIN D), venlafaxine, acetylsalicylic acid (ASPRIN), atorvastatin. Historical Vaccine included first dose of BNT162B2 (Lot number ER8734) at the age of 62 years old on 30Mar2021 on Right arm for COVID-19 immunization. The patient stated "I could not walk on my own. I lost my balance and endurance. I spent two weeks in the hospital with a diagnosis of meningitis and acute encephalitis. I also had a small stroke. I am learning how to do everything again. I have outpatient physical therapy and occupational therapy along with several follow up appointments." The events start date were on 24Apr2021. All events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Number days hospitalization was 15 days. Lab data also included Nasal Swab on 29Apr2021 with Negative result. Treatment received for the events included IVIg therapy, antibiotics, PT, OT, SLP. The outcome of the events were not resolved.  Information on Lot/Batch number was available. Additional information has been requested.