chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dysstasia, Gait disturbance, Joint swelling, Mobility decreased
Clinical narrative: Diagnosed with medicine induced Lupus; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient. A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 16:00 (Lot number: FF884) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies sulfa iodine antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LUPUS-LIKE SYNDROME (disability, medically significant) with onset 01Oct2021 12:00, outcome "not recovered", described as "Diagnosed with medicine induced Lupus". The event "diagnosed with medicine induced lupus" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood work: unknown results. Therapeutic measures were taken as a result of lupus-like syndrome included Tylenol ice pack blood work. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Lupus-like syndrome
Clinical narrative: Diagnosed with medicine induced Lupus; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient. A 53-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Sep2021 16:00 (Lot number: FF884) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies sulfa iodine antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LUPUS-LIKE SYNDROME (disability, medically significant) with onset 01Oct2021 12:00, outcome "not recovered", described as "Diagnosed with medicine induced Lupus". The event "diagnosed with medicine induced lupus" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood work: unknown results. Therapeutic measures were taken as a result of lupus-like syndrome included Tylenol ice pack blood work. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, CSF protein, Chills, Computerised tomogram head, Guillain-Barre syndrome
Clinical narrative: within 12 hrs. fever; extreme chills; tingling allover; deep muscle pain to extremities; pain in spine, neck and head; muscle spasms and some shortness of breath. Four hours later I was completely paralyzed-I did not lose feeling, I could not move extremities or sit up. I slowly within about 2-3 hours I regained gross motor movements using a walker. I saw my MD on 9/29/21 and was sent to the ER. They did at CT scan, MRI of the brain and spine, lumbar puncture
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Lumbar puncture, Magnetic resonance imaging, Magnetic resonance imaging head, Myalgia
Clinical narrative: within 12 hrs. fever; extreme chills; tingling allover; deep muscle pain to extremities; pain in spine, neck and head; muscle spasms and some shortness of breath. Four hours later I was completely paralyzed-I did not lose feeling, I could not move extremities or sit up. I slowly within about 2-3 hours I regained gross motor movements using a walker. I saw my MD on 9/29/21 and was sent to the ER. They did at CT scan, MRI of the brain and spine, lumbar puncture
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Stress, Tremor
Clinical narrative: within 12 hrs. fever; extreme chills; tingling allover; deep muscle pain to extremities; pain in spine, neck and head; muscle spasms and some shortness of breath. Four hours later I was completely paralyzed-I did not lose feeling, I could not move extremities or sit up. I slowly within about 2-3 hours I regained gross motor movements using a walker. I saw my MD on 9/29/21 and was sent to the ER. They did at CT scan, MRI of the brain and spine, lumbar puncture
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF protein increased, Chills, Computerised tomogram normal, Dyspnoea, Headache
Clinical narrative: within 12 hrs. fever; extreme chills; tingling allover; deep muscle pain to extremities; pain in spine, neck and head; muscle spasms and some shortness of breath. Four hours later I was completely paralyzed-I did not lose feeling, I could not move extremities or sit up. I slowly within about 2-3 hours I regained gross motor movements using a walker. I saw my MD on 9/29/21 and was sent to the ER. They did at CT scan, MRI of the brain and spine, lumbar puncture
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Movement disorder, Muscle spasms
Clinical narrative: within 12 hrs. fever; extreme chills; tingling allover; deep muscle pain to extremities; pain in spine, neck and head; muscle spasms and some shortness of breath. Four hours later I was completely paralyzed-I did not lose feeling, I could not move extremities or sit up. I slowly within about 2-3 hours I regained gross motor movements using a walker. I saw my MD on 9/29/21 and was sent to the ER. They did at CT scan, MRI of the brain and spine, lumbar puncture
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Neck pain, Paraesthesia, Paralysis, Pyrexia
Clinical narrative: within 12 hrs. fever; extreme chills; tingling allover; deep muscle pain to extremities; pain in spine, neck and head; muscle spasms and some shortness of breath. Four hours later I was completely paralyzed-I did not lose feeling, I could not move extremities or sit up. I slowly within about 2-3 hours I regained gross motor movements using a walker. I saw my MD on 9/29/21 and was sent to the ER. They did at CT scan, MRI of the brain and spine, lumbar puncture
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain
Clinical narrative: within 12 hrs. fever; extreme chills; tingling allover; deep muscle pain to extremities; pain in spine, neck and head; muscle spasms and some shortness of breath. Four hours later I was completely paralyzed-I did not lose feeling, I could not move extremities or sit up. I slowly within about 2-3 hours I regained gross motor movements using a walker. I saw my MD on 9/29/21 and was sent to the ER. They did at CT scan, MRI of the brain and spine, lumbar puncture
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Eye pain, Eye swelling, Feeling cold, Feeling hot
Clinical narrative: pt stated the next day after getting the vaccine she started shivering, shaking, developed a fever and could not get out of bed.  By that night she was able to get up and eat.  The next morning her right eye was starting to swell.  She developed a large bag under her right eye, her lips were swollen, and the entire right side side of her face was swollen.  Both cheeks were very swollen.  She contacted her PCP and was told to apply ice, take ibuprofen  and Benadryl.  Her left arm was hot red and swollen and she developed a lump the size of tennis ball at the injection site.  She still has a swollen bag beneath her right eye.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Injection site pain, Injection site swelling, Lip swelling, Pyrexia
Clinical narrative: pt stated the next day after getting the vaccine she started shivering, shaking, developed a fever and could not get out of bed.  By that night she was able to get up and eat.  The next morning her right eye was starting to swell.  She developed a large bag under her right eye, her lips were swollen, and the entire right side side of her face was swollen.  Both cheeks were very swollen.  She contacted her PCP and was told to apply ice, take ibuprofen  and Benadryl.  Her left arm was hot red and swollen and she developed a lump the size of tennis ball at the injection site.  She still has a swollen bag beneath her right eye.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face, Visual field defect
Clinical narrative: pt stated the next day after getting the vaccine she started shivering, shaking, developed a fever and could not get out of bed.  By that night she was able to get up and eat.  The next morning her right eye was starting to swell.  She developed a large bag under her right eye, her lips were swollen, and the entire right side side of her face was swollen.  Both cheeks were very swollen.  She contacted her PCP and was told to apply ice, take ibuprofen  and Benadryl.  Her left arm was hot red and swollen and she developed a lump the size of tennis ball at the injection site.  She still has a swollen bag beneath her right eye.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Eye swelling, Feeling hot, Injection site mass
Clinical narrative: pt stated the next day after getting the vaccine she started shivering, shaking, developed a fever and could not get out of bed.  By that night she was able to get up and eat.  The next morning her right eye was starting to swell.  She developed a large bag under her right eye, her lips were swollen, and the entire right side side of her face was swollen.  Both cheeks were very swollen.  She contacted her PCP and was told to apply ice, take ibuprofen  and Benadryl.  Her left arm was hot red and swollen and she developed a lump the size of tennis ball at the injection site.  She still has a swollen bag beneath her right eye.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lip swelling, Pyrexia, Swelling face, Tremor
Clinical narrative: pt stated the next day after getting the vaccine she started shivering, shaking, developed a fever and could not get out of bed.  By that night she was able to get up and eat.  The next morning her right eye was starting to swell.  She developed a large bag under her right eye, her lips were swollen, and the entire right side side of her face was swollen.  Both cheeks were very swollen.  She contacted her PCP and was told to apply ice, take ibuprofen  and Benadryl.  Her left arm was hot red and swollen and she developed a lump the size of tennis ball at the injection site.  She still has a swollen bag beneath her right eye.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Abdominal lymphadenopathy, Abdominal pain, Colonoscopy, Computerised tomogram abnormal
Clinical narrative: Watery, liquid diarrhea for 4 weeks; left sided facial and scalp numbness; left sided facial and scalp numbness; return of chronic daily migraines and overall inflammation.; return of chronic daily migraines and overall inflammation.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 16:00 (Lot number: FC3183) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish; "Chronic migraines" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing); "inflammation that were all under control" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ZONISAMIDE; CYMBALTA; PROBIOTIC; INDOMETHACIN; COMPAZINE; UBRELVY. Past drug history included: Lamictal, reaction(s): "Allergy", notes: Known allergies: Lamictal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: W0170, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Jul2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 05Sep2021 02:30, outcome "recovered" (2021), described as "Watery, liquid diarrhea for 4 weeks"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "left sided facial and scalp numbness"; MIGRAINE (non-serious), INFLAMMATION (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "return of chronic daily migraines and overall inflammation.". The events "watery, liquid diarrhea for 4 weeks", "left sided facial and scalp numbness", "left sided facial and scalp numbness", "return of chronic daily migraines and overall inflammation." and "return of chronic daily migraines and overall inflammation." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, hypoaesthesia, hypoaesthesia, migraine, inflammation.  Additional information: No other vaccine in four weeks has been administered. Unknown if the patient had diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  Follow-up attempts are completed. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Faecal calprotectin, Full blood count, Gallbladder enlargement, Hepatobiliary scan
Clinical narrative: Watery, liquid diarrhea for 4 weeks; left sided facial and scalp numbness; left sided facial and scalp numbness; return of chronic daily migraines and overall inflammation.; return of chronic daily migraines and overall inflammation.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 16:00 (Lot number: FC3183) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish; "Chronic migraines" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing); "inflammation that were all under control" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ZONISAMIDE; CYMBALTA; PROBIOTIC; INDOMETHACIN; COMPAZINE; UBRELVY. Past drug history included: Lamictal, reaction(s): "Allergy", notes: Known allergies: Lamictal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: W0170, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Jul2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 05Sep2021 02:30, outcome "recovered" (2021), described as "Watery, liquid diarrhea for 4 weeks"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "left sided facial and scalp numbness"; MIGRAINE (non-serious), INFLAMMATION (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "return of chronic daily migraines and overall inflammation.". The events "watery, liquid diarrhea for 4 weeks", "left sided facial and scalp numbness", "left sided facial and scalp numbness", "return of chronic daily migraines and overall inflammation." and "return of chronic daily migraines and overall inflammation." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, hypoaesthesia, hypoaesthesia, migraine, inflammation.  Additional information: No other vaccine in four weeks has been administered. Unknown if the patient had diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  Follow-up attempts are completed. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Oesophagogastroduodenoscopy, Ultrasound abdomen abnormal
Clinical narrative: Watery, liquid diarrhea for 4 weeks; left sided facial and scalp numbness; left sided facial and scalp numbness; return of chronic daily migraines and overall inflammation.; return of chronic daily migraines and overall inflammation.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 16:00 (Lot number: FC3183) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish; "Chronic migraines" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing); "inflammation that were all under control" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ZONISAMIDE; CYMBALTA; PROBIOTIC; INDOMETHACIN; COMPAZINE; UBRELVY. Past drug history included: Lamictal, reaction(s): "Allergy", notes: Known allergies: Lamictal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: W0170, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Jul2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 05Sep2021 02:30, outcome "recovered" (2021), described as "Watery, liquid diarrhea for 4 weeks"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "left sided facial and scalp numbness"; MIGRAINE (non-serious), INFLAMMATION (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "return of chronic daily migraines and overall inflammation.". The events "watery, liquid diarrhea for 4 weeks", "left sided facial and scalp numbness", "left sided facial and scalp numbness", "return of chronic daily migraines and overall inflammation." and "return of chronic daily migraines and overall inflammation." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, hypoaesthesia, hypoaesthesia, migraine, inflammation.  Additional information: No other vaccine in four weeks has been administered. Unknown if the patient had diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  Follow-up attempts are completed. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Computerised tomogram, Diarrhoea, Hepatobiliary scan, Hypoaesthesia
Clinical narrative: Watery, liquid diarrhea for 4 weeks; left sided facial and scalp numbness; left sided facial and scalp numbness; return of chronic daily migraines and overall inflammation.; return of chronic daily migraines and overall inflammation.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 16:00 (Lot number: FC3183) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish; "Chronic migraines" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing); "inflammation that were all under control" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ZONISAMIDE; CYMBALTA; PROBIOTIC; INDOMETHACIN; COMPAZINE; UBRELVY. Past drug history included: Lamictal, reaction(s): "Allergy", notes: Known allergies: Lamictal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: W0170, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Jul2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 05Sep2021 02:30, outcome "recovered" (2021), described as "Watery, liquid diarrhea for 4 weeks"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "left sided facial and scalp numbness"; MIGRAINE (non-serious), INFLAMMATION (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "return of chronic daily migraines and overall inflammation.". The events "watery, liquid diarrhea for 4 weeks", "left sided facial and scalp numbness", "left sided facial and scalp numbness", "return of chronic daily migraines and overall inflammation." and "return of chronic daily migraines and overall inflammation." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, hypoaesthesia, hypoaesthesia, migraine, inflammation.  Additional information: No other vaccine in four weeks has been administered. Unknown if the patient had diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  Follow-up attempts are completed. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Magnetic resonance imaging, Migraine, Oesophagogastroduodenoscopy, Ultrasound abdomen
Clinical narrative: Watery, liquid diarrhea for 4 weeks; left sided facial and scalp numbness; left sided facial and scalp numbness; return of chronic daily migraines and overall inflammation.; return of chronic daily migraines and overall inflammation.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Aug2021 16:00 (Lot number: FC3183) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish; "Chronic migraines" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "chronic fatigue" (unspecified if ongoing); "inflammation that were all under control" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL; ZONISAMIDE; CYMBALTA; PROBIOTIC; INDOMETHACIN; COMPAZINE; UBRELVY. Past drug history included: Lamictal, reaction(s): "Allergy", notes: Known allergies: Lamictal. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: W0170, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 30Jul2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 05Sep2021 02:30, outcome "recovered" (2021), described as "Watery, liquid diarrhea for 4 weeks"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "left sided facial and scalp numbness"; MIGRAINE (non-serious), INFLAMMATION (non-serious) all with onset 05Sep2021 02:30, outcome "not recovered" and all described as "return of chronic daily migraines and overall inflammation.". The events "watery, liquid diarrhea for 4 weeks", "left sided facial and scalp numbness", "left sided facial and scalp numbness", "return of chronic daily migraines and overall inflammation." and "return of chronic daily migraines and overall inflammation." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of diarrhoea, hypoaesthesia, hypoaesthesia, migraine, inflammation.  Additional information: No other vaccine in four weeks has been administered. Unknown if the patient had diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.  Follow-up attempts are completed. No further information is expected
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral normal, Arthralgia, Back pain, Chest X-ray normal, Computerised tomogram head normal
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electromyogram normal, Endotracheal intubation, Headache, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Loss of personal independence in daily activities, Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Myalgia, Neck pain, Pain, Paraesthesia
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Plasmapheresis, Respiratory distress, Respiratory tract congestion, Scan with contrast normal, Tobacco user
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tongue discomfort
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Guillain-Barre syndrome, Headache, Hypoaesthesia oral, Muscular weakness
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Neck pain, Paraesthesia, Respiratory tract congestion
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Endotracheal intubation, Gait inability, Guillain-Barre syndrome, Headache
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Intensive care, Lumbar puncture normal, Muscular weakness, Myalgia
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory distress, Respiratory symptom, Respiratory tract congestion
Clinical narrative: Patient received Janssen COVID-19 vaccine on 10/24/21 as an outpatient. Then two weeks later (11/6/21) the patient reported to the emergency room for weakness in his lower extremities. Initially he had upper respiratory tract infection symptoms (headache, myalgias, congestion), but then the weakness progressed to the point where he was unable to walk. His PCP wanted him to be evaluated for Guillan Barre Syndrome. His wife also had these symptoms but less severe despite not receiving the vaccine. Neurology diagnosed him with acute rapidly progressive weakness secondary to acute inflammatory demyelinating polyneuropathy (Guillain-Barre Syndrome). Suspected secondary to a post viral reaction given family had similar viral infection symptoms weeks prior to onset. However, given timing with COVID vaccine, it can't be ruled out that this isn't vaccine related.  Patient was treated with IVIG for 5 days. He began to develop respiratory distress and was transferred to ICU where he then had to be intubated. He is now in the long term acute care unit, and has had continual worsening weakness.
Age: 90.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: COVID-19, Decreased appetite, SARS-CoV-2 test positive
Clinical narrative: lost alot of energy, sweaty, going downhill quickly, diagnosed with covid
Age: 90.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Asthenia, COVID-19, General physical health deterioration, Hyperhidrosis
Clinical narrative: lost alot of energy, sweaty, going downhill quickly, diagnosed with covid
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Beginning at least in November, but definitely happening daily now, I am experience blood clot symptoms.  I get sharp pain for several heartbeats followed by relief.  This pain is occurring most regularly on the top of my head (between bra in and skull), next most regularly right around my heart, and then in my heart itself.  The pain is simultaneously sharp and radiant but feels like a very small point of impact.  I typically notice it clear up in about 6 heartbeats.  The pain happens seemingly on the first half of the heartbeat. It occurs at least once a day.  I am using aspirin or methyl salicylate with some regularity and it does appear to alleviate symptoms.  Note that previous adverse event of hives has not cleared up completely but is mostly going away thanks to traditional medicine.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Scratch, Urticaria
Clinical narrative: Beginning at least in November, but definitely happening daily now, I am experience blood clot symptoms.  I get sharp pain for several heartbeats followed by relief.  This pain is occurring most regularly on the top of my head (between bra in and skull), next most regularly right around my heart, and then in my heart itself.  The pain is simultaneously sharp and radiant but feels like a very small point of impact.  I typically notice it clear up in about 6 heartbeats.  The pain happens seemingly on the first half of the heartbeat. It occurs at least once a day.  I am using aspirin or methyl salicylate with some regularity and it does appear to alleviate symptoms.  Note that previous adverse event of hives has not cleared up completely but is mostly going away thanks to traditional medicine.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse event, Angina pectoris, Headache, Pain, Urticaria
Clinical narrative: Beginning at least in November, but definitely happening daily now, I am experience blood clot symptoms.  I get sharp pain for several heartbeats followed by relief.  This pain is occurring most regularly on the top of my head (between bra in and skull), next most regularly right around my heart, and then in my heart itself.  The pain is simultaneously sharp and radiant but feels like a very small point of impact.  I typically notice it clear up in about 6 heartbeats.  The pain happens seemingly on the first half of the heartbeat. It occurs at least once a day.  I am using aspirin or methyl salicylate with some regularity and it does appear to alleviate symptoms.  Note that previous adverse event of hives has not cleared up completely but is mostly going away thanks to traditional medicine.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lip swelling, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Bright red spot, there like a hive; I have got bright red spots; I have got them on my arms, I got 1 on my leg, I have got them on my chest and my shoulders.; Bright red spot, there like a hive; I have got bright red spots; I have got them on my arms, I got 1 on my leg, I have got them on my chest and my shoulders. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 (Lot number: FH8028) at the age of 57 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 20Nov2021 (Batch/Lot number: unknown) as unk, single for immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: ARNUITY ELLIPTA taken for asthma; LEVOTHYROXINE taken for thyroid disorder. The following information was reported: ERYTHEMA (non-serious), URTICARIA (non-serious) all with onset 27Nov2021, outcome "unknown" and all described as "Bright red spot, there like a hive; I have got bright red spots; I have got them on my arms, I got 1 on my leg, I have got them on my chest and my shoulders.". Therapeutic measures were not taken as a result of erythema, urticaria. Follow-Up (30Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Bright red spot, there like a hive; I have got bright red spots; I have got them on my arms, I got 1 on my leg, I have got them on my chest and my shoulders.; Bright red spot, there like a hive; I have got bright red spots; I have got them on my arms, I got 1 on my leg, I have got them on my chest and my shoulders. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 (Lot number: FH8028) at the age of 57 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 20Nov2021 (Batch/Lot number: unknown) as unk, single for immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Thyroid" (unspecified if ongoing), notes: Verbatim: Thyroid. Concomitant medication(s) included: ARNUITY ELLIPTA taken for asthma; LEVOTHYROXINE taken for thyroid disorder. The following information was reported: ERYTHEMA (non-serious), URTICARIA (non-serious) all with onset 27Nov2021, outcome "unknown" and all described as "Bright red spot, there like a hive; I have got bright red spots; I have got them on my arms, I got 1 on my leg, I have got them on my chest and my shoulders.". Therapeutic measures were not taken as a result of erythema, urticaria. Follow-Up (30Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19, FLUC4, COVID19, FLUC3
Symptoms: Eye pain, Inappropriate schedule of product administration, Ocular hyperaemia
Clinical narrative: Right eye and surrounding area became red and painful; Right eye and surrounding area became red and painful; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 9 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 17:00 (Lot number: fl0007) at the age of 9 years as dose 1, single for covid-19 immunization in Pharmacy or Drug Store; influenza vaccine inact sag 3v (FLUCELVAX), administered in arm right, administration date 29Nov2021 (Lot number: 309617) as dose 1, single. The patient's relevant medical history was not reported. There were no concomitant medications. No other vaccine in four weeks. The following information was reported: OCULAR HYPERAEMIA (medically significant), EYE PAIN (medically significant) all with onset 29Nov2021 18:15, outcome "unknown" and all described as "Right eye and surrounding area became red and painful". The event "right eye and surrounding area became red and painful" and "right eye and surrounding area became red and painful" was evaluated at the physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of ocular hyperaemia, eye pain. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the 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.