chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Syncope
Clinical narrative: Fainted; Body chills; fever; body aches; Loss of appetite; Weakness; Sleepiness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, in the left arm on 19Mar2021 at 21:00 as a single dose for COVID-19 immunization.  Medical history included COVID-19 from an unknown date to an unknown date, prior to vaccination. The patient had a nasal swab test for COVID on 18Mar2021 with a result of negative. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccines in four weeks prior to the COVID vaccine. The patient experienced body chills, fever, body aches, loss of appetite, weakness, sleepiness and fainted on 20Mar2021 at 01:00. The patient did not receive treatment for the events. The outcome of the events was recovering.   Information on batch/lot number was requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Affect lability, Electroencephalogram normal, Fatigue, Flight of ideas, Hallucination, auditory
Clinical narrative: Patient and family noted fatigue, fever and chills 6 hours post vaccination. Approximately 24 hours post vaccination, the patient began experiencing hyperactivity, flight of ideas, emotional lability, and auditory and visual hallucinations.  She was brought to the Emergency Room at approximately 12PM (50 hours post vaccine).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hallucination, visual, Lumbar puncture normal, Magnetic resonance imaging normal, Psychomotor hyperactivity, Pyrexia
Clinical narrative: Patient and family noted fatigue, fever and chills 6 hours post vaccination. Approximately 24 hours post vaccination, the patient began experiencing hyperactivity, flight of ideas, emotional lability, and auditory and visual hallucinations.  She was brought to the Emergency Room at approximately 12PM (50 hours post vaccine).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Affect lability, Antinuclear antibody positive, Blood glucose normal, Chest X-ray normal, Chills
Clinical narrative: Patient and family noted fatigue, fever and chills 6 hours post vaccination. Approximately 24 hours post vaccination, the patient began experiencing hyperactivity, flight of ideas, emotional lability, and auditory and visual hallucinations.  She was brought to the Emergency Room at approximately 12PM (50 hours post vaccine).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Electrocardiogram normal, Electroencephalogram abnormal, Fatigue, Flight of ideas
Clinical narrative: Patient and family noted fatigue, fever and chills 6 hours post vaccination. Approximately 24 hours post vaccination, the patient began experiencing hyperactivity, flight of ideas, emotional lability, and auditory and visual hallucinations.  She was brought to the Emergency Room at approximately 12PM (50 hours post vaccine).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Hallucinations, mixed, Herpes simplex test negative, Lumbar puncture normal, Magnetic resonance imaging head normal
Clinical narrative: Patient and family noted fatigue, fever and chills 6 hours post vaccination. Approximately 24 hours post vaccination, the patient began experiencing hyperactivity, flight of ideas, emotional lability, and auditory and visual hallucinations.  She was brought to the Emergency Room at approximately 12PM (50 hours post vaccine).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Protein total normal, Psychomotor hyperactivity, Pyrexia, Thyroid function test normal
Clinical narrative: Patient and family noted fatigue, fever and chills 6 hours post vaccination. Approximately 24 hours post vaccination, the patient began experiencing hyperactivity, flight of ideas, emotional lability, and auditory and visual hallucinations.  She was brought to the Emergency Room at approximately 12PM (50 hours post vaccine).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urine analysis normal
Clinical narrative: Patient and family noted fatigue, fever and chills 6 hours post vaccination. Approximately 24 hours post vaccination, the patient began experiencing hyperactivity, flight of ideas, emotional lability, and auditory and visual hallucinations.  She was brought to the Emergency Room at approximately 12PM (50 hours post vaccine).
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Blood test, C-reactive protein, HLA marker study, Red blood cell sedimentation rate
Clinical narrative: Bilateral Uveitis with corneal edema
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rheumatoid factor, Treponema test, Uveitis
Clinical narrative: Bilateral Uveitis with corneal edema
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Corneal endotheliitis
Clinical narrative: Bilateral Uveitis with corneal edema
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Bilateral facial bell's palsy; Guillain Barre syndrome; Weakness in arms and legs; the tingling got worse and he had a lot more weakness in arms and legs; his arm started tingling; Headache/strrong headache; Arm ached; Bit sluggish; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events bilateral facial Bell's palsy/Bell's palsy, bit sluggish, arm ached, Tingling in arms and legs, weakness in arms and legs, Guillain barre syndrome and headache.     The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient went to the ER. On 06 Feb 2021, the patient experienced bit sluggish, arm ached and head ache.  On 12 Feb 2021, the patient developed a strong headache. On 13 Feb 2021, the patient developed tingling in his arms. On 14 Feb 2021, patient had tingling  in his feet.  On 15 Feb 2021, the tingling got worsened and patient experienced a lot more weakness in arms and legs.  On 16 Feb 2021, the patient was diagnosed with Guillen Barre Syndrome.  On unknown date ,patient developed  bilateral facial Bell's palsy.  Laboratory details included CAT scan and lumbar puncture.  Treatment received for the events, included IVIG treatment and steroids.   Action taken with the with mRNA-1273 in response to the event  is not applicable.  The outcome of the events bit sluggish and arm ached were resolved .  The outcome of the events headache, his arm started tingling, feel also started tingling, weakness in arms and legs, Guillain barre syndrome and bilateral facial Bell's palsy were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Bilateral facial bell's palsy; Guillain Barre syndrome; Weakness in arms and legs; the tingling got worse and he had a lot more weakness in arms and legs; his arm started tingling; Headache/strrong headache; Arm ached; Bit sluggish; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events bilateral facial Bell's palsy/Bell's palsy, bit sluggish, arm ached, Tingling in arms and legs, weakness in arms and legs, Guillain barre syndrome and headache.     The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient went to the ER. On 06 Feb 2021, the patient experienced bit sluggish, arm ached and head ache.  On 12 Feb 2021, the patient developed a strong headache. On 13 Feb 2021, the patient developed tingling in his arms. On 14 Feb 2021, patient had tingling  in his feet.  On 15 Feb 2021, the tingling got worsened and patient experienced a lot more weakness in arms and legs.  On 16 Feb 2021, the patient was diagnosed with Guillen Barre Syndrome.  On unknown date ,patient developed  bilateral facial Bell's palsy.  Laboratory details included CAT scan and lumbar puncture.  Treatment received for the events, included IVIG treatment and steroids.   Action taken with the with mRNA-1273 in response to the event  is not applicable.  The outcome of the events bit sluggish and arm ached were resolved .  The outcome of the events headache, his arm started tingling, feel also started tingling, weakness in arms and legs, Guillain barre syndrome and bilateral facial Bell's palsy were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Bell's palsy, Guillain-Barre syndrome, Headache, Lumbar puncture
Clinical narrative: Bilateral facial bell's palsy; Guillain Barre syndrome; Weakness in arms and legs; the tingling got worse and he had a lot more weakness in arms and legs; his arm started tingling; Headache/strrong headache; Arm ached; Bit sluggish; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events bilateral facial Bell's palsy/Bell's palsy, bit sluggish, arm ached, Tingling in arms and legs, weakness in arms and legs, Guillain barre syndrome and headache.     The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient went to the ER. On 06 Feb 2021, the patient experienced bit sluggish, arm ached and head ache.  On 12 Feb 2021, the patient developed a strong headache. On 13 Feb 2021, the patient developed tingling in his arms. On 14 Feb 2021, patient had tingling  in his feet.  On 15 Feb 2021, the tingling got worsened and patient experienced a lot more weakness in arms and legs.  On 16 Feb 2021, the patient was diagnosed with Guillen Barre Syndrome.  On unknown date ,patient developed  bilateral facial Bell's palsy.  Laboratory details included CAT scan and lumbar puncture.  Treatment received for the events, included IVIG treatment and steroids.   Action taken with the with mRNA-1273 in response to the event  is not applicable.  The outcome of the events bit sluggish and arm ached were resolved .  The outcome of the events headache, his arm started tingling, feel also started tingling, weakness in arms and legs, Guillain barre syndrome and bilateral facial Bell's palsy were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Sluggishness
Clinical narrative: Bilateral facial bell's palsy; Guillain Barre syndrome; Weakness in arms and legs; the tingling got worse and he had a lot more weakness in arms and legs; his arm started tingling; Headache/strrong headache; Arm ached; Bit sluggish; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events bilateral facial Bell's palsy/Bell's palsy, bit sluggish, arm ached, Tingling in arms and legs, weakness in arms and legs, Guillain barre syndrome and headache.     The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient went to the ER. On 06 Feb 2021, the patient experienced bit sluggish, arm ached and head ache.  On 12 Feb 2021, the patient developed a strong headache. On 13 Feb 2021, the patient developed tingling in his arms. On 14 Feb 2021, patient had tingling  in his feet.  On 15 Feb 2021, the tingling got worsened and patient experienced a lot more weakness in arms and legs.  On 16 Feb 2021, the patient was diagnosed with Guillen Barre Syndrome.  On unknown date ,patient developed  bilateral facial Bell's palsy.  Laboratory details included CAT scan and lumbar puncture.  Treatment received for the events, included IVIG treatment and steroids.   Action taken with the with mRNA-1273 in response to the event  is not applicable.  The outcome of the events bit sluggish and arm ached were resolved .  The outcome of the events headache, his arm started tingling, feel also started tingling, weakness in arms and legs, Guillain barre syndrome and bilateral facial Bell's palsy were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Guillain-Barre syndrome, Headache, Lethargy, Muscular weakness
Clinical narrative: Bilateral facial bell's palsy; Guillain Barre syndrome; Weakness in arms and legs; the tingling got worse and he had a lot more weakness in arms and legs; his arm started tingling; Headache/strrong headache; Arm ached; Bit sluggish; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events bilateral facial Bell's palsy/Bell's palsy, bit sluggish, arm ached, Tingling in arms and legs, weakness in arms and legs, Guillain barre syndrome and headache.     The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient went to the ER. On 06 Feb 2021, the patient experienced bit sluggish, arm ached and head ache.  On 12 Feb 2021, the patient developed a strong headache. On 13 Feb 2021, the patient developed tingling in his arms. On 14 Feb 2021, patient had tingling  in his feet.  On 15 Feb 2021, the tingling got worsened and patient experienced a lot more weakness in arms and legs.  On 16 Feb 2021, the patient was diagnosed with Guillen Barre Syndrome.  On unknown date ,patient developed  bilateral facial Bell's palsy.  Laboratory details included CAT scan and lumbar puncture.  Treatment received for the events, included IVIG treatment and steroids.   Action taken with the with mRNA-1273 in response to the event  is not applicable.  The outcome of the events bit sluggish and arm ached were resolved .  The outcome of the events headache, his arm started tingling, feel also started tingling, weakness in arms and legs, Guillain barre syndrome and bilateral facial Bell's palsy were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Bilateral facial bell's palsy; Guillain Barre syndrome; Weakness in arms and legs; the tingling got worse and he had a lot more weakness in arms and legs; his arm started tingling; Headache/strrong headache; Arm ached; Bit sluggish; A spontaneous report was received from a consumer concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events bilateral facial Bell's palsy/Bell's palsy, bit sluggish, arm ached, Tingling in arms and legs, weakness in arms and legs, Guillain barre syndrome and headache.     The patient's medical history was not provided. No relevant concomitant product use was reported.  On 09 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient went to the ER. On 06 Feb 2021, the patient experienced bit sluggish, arm ached and head ache.  On 12 Feb 2021, the patient developed a strong headache. On 13 Feb 2021, the patient developed tingling in his arms. On 14 Feb 2021, patient had tingling  in his feet.  On 15 Feb 2021, the tingling got worsened and patient experienced a lot more weakness in arms and legs.  On 16 Feb 2021, the patient was diagnosed with Guillen Barre Syndrome.  On unknown date ,patient developed  bilateral facial Bell's palsy.  Laboratory details included CAT scan and lumbar puncture.  Treatment received for the events, included IVIG treatment and steroids.   Action taken with the with mRNA-1273 in response to the event  is not applicable.  The outcome of the events bit sluggish and arm ached were resolved .  The outcome of the events headache, his arm started tingling, feel also started tingling, weakness in arms and legs, Guillain barre syndrome and bilateral facial Bell's palsy were unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, and excluding other etiologies, a causal relationship cannot be excluded
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Electroencephalogram, Fatigue, Status epilepticus
Clinical narrative: pain on the first day after the second vaccine dose was as bad as it was the first day after surgery; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 13:15 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunization. Medical history included major orthopedic knee surgery on 26Aug2020, atypical trigeminal neuralgia since 2009. The patient had pre-existing pain issues that also continued to be elevated on the 2nd and 3rd day after surgery but not nearly as bad as the first. The patient has known allergies to cephalosporins and elemental nickel. Other medical history: complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, epilepsy-prone, many more; rest will be provided if full list is needed. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included tapentadol, amphetamine and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had the 1st dose of bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), via an unspecified route of administration, administered in left arm on 26Feb2021 03:00 PM (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. The patient was tired after the first dose on days 2-3, and had a major seizure on day 8 of dose one despite nearly no history of seizures but that has been attributed to other issues by his doctor. The patient had a major orthopedic knee surgery on 26Aug2020 and his pain on the first day after the second vaccine dose (after getting the dose on 19Mar2021, going to bed, and waking up the next day) was as bad in Mar2021 as it was the first day after surgery, and his atypical trigeminal neuralgia (had since 2009) was as bad in Mar2021 as it has ever been. The patient mentioned he would advise and recommend for patients to speak to their doctors before the second dose to obtain a few days of higher dose pain medication. The events resulted in: emergency room/department or urgent care and was considered serious due to life threatening illness (immediate risk of death from the event). No treatment given for events. Outcome of events recovered.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Pain, Trigeminal neuralgia
Clinical narrative: pain on the first day after the second vaccine dose was as bad as it was the first day after surgery; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; my atypical trigeminal neuralgia (had since 2009) was as bad as it has ever been; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), dose 2 via an unspecified route of administration, administered in left arm on 19Mar2021 13:15 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunization. Medical history included major orthopedic knee surgery on 26Aug2020, atypical trigeminal neuralgia since 2009. The patient had pre-existing pain issues that also continued to be elevated on the 2nd and 3rd day after surgery but not nearly as bad as the first. The patient has known allergies to cephalosporins and elemental nickel. Other medical history: complex regional pain syndrome (CRPS), attention deficit hyperactivity disorder (ADD), anxiety, depression, asthma, epilepsy-prone, many more; rest will be provided if full list is needed. The patient was not diagnosed of COVID prior vaccination and has not been tested for COVID post vaccination. Concomitant medication included tapentadol, amphetamine and candesartan cilexetil, hydrochlorothiazide (CANDESARTAN HCTZ); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive other vaccine in four weeks. The patient had the 1st dose of bnt162b2 (Pfizer/Bio-N-tech COVID vaccine), via an unspecified route of administration, administered in left arm on 26Feb2021 03:00 PM (Batch/Lot Number: EN6204) as single dose for COVID-19 immunization. The patient was tired after the first dose on days 2-3, and had a major seizure on day 8 of dose one despite nearly no history of seizures but that has been attributed to other issues by his doctor. The patient had a major orthopedic knee surgery on 26Aug2020 and his pain on the first day after the second vaccine dose (after getting the dose on 19Mar2021, going to bed, and waking up the next day) was as bad in Mar2021 as it was the first day after surgery, and his atypical trigeminal neuralgia (had since 2009) was as bad in Mar2021 as it has ever been. The patient mentioned he would advise and recommend for patients to speak to their doctors before the second dose to obtain a few days of higher dose pain medication. The events resulted in: emergency room/department or urgent care and was considered serious due to life threatening illness (immediate risk of death from the event). No treatment given for events. Outcome of events recovered.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Death within 60 days of vaccine, irrespective of reason.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death within 60 days of vaccine, irrespective of reason.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Epistaxis, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordinary nosebleed; restless legs; tingling sensations in my legs; This is a spontaneous report received from a physician (also the patient). A 38-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 08:30 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a workplace clinic. The patient medical history includes: Graves Disease, Lupus, O- Blood, RH-, allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at time of vaccination. Concomitant medication (reported as any other medications the patient received within 2 weeks of vaccination) included gabapentin taken for an unspecified indication, start and stop date were not reported. It was reported that (reported as within first 4 hours of vaccine) on 03Feb2021, the patient experienced restless legs.  On 06Feb2021, the patient experienced an out of the ordinary nosebleed. From then until 21Feb2021, the patient would experience tingling sensations in my legs and then on 21Feb2021 found a bruise on right leg near knee. On 26Feb2021 blood work revealed platelet count 73,000; 03Mar2021 blood work revealed platelet count 33,000 (results received on March 5), significant nosebleed on 04Mar2021, hospitalized with 29,000 platelet count on 05Mar2021. The outcome of the event tingling sensations in my legs was recovered on 21Feb2021; for all other events was recovering. The treatment received was a steriod IV. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 4 days (from 05Mar2021 to 09Mar2021).; Sender's Comments: A causal relationship cannot be completely excluded between BNT162B2 injection and serious reported events only due to close chronological sequence. Other evidence or argument supporting a causal relationship  cannot be established, so far. Otherwise, multi-morbid current conditions, and concomitant medication may have played as contributory factors to the serious reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Restless legs syndrome
Clinical narrative: blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordinary nosebleed; restless legs; tingling sensations in my legs; This is a spontaneous report received from a physician (also the patient). A 38-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 08:30 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a workplace clinic. The patient medical history includes: Graves Disease, Lupus, O- Blood, RH-, allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at time of vaccination. Concomitant medication (reported as any other medications the patient received within 2 weeks of vaccination) included gabapentin taken for an unspecified indication, start and stop date were not reported. It was reported that (reported as within first 4 hours of vaccine) on 03Feb2021, the patient experienced restless legs.  On 06Feb2021, the patient experienced an out of the ordinary nosebleed. From then until 21Feb2021, the patient would experience tingling sensations in my legs and then on 21Feb2021 found a bruise on right leg near knee. On 26Feb2021 blood work revealed platelet count 73,000; 03Mar2021 blood work revealed platelet count 33,000 (results received on March 5), significant nosebleed on 04Mar2021, hospitalized with 29,000 platelet count on 05Mar2021. The outcome of the event tingling sensations in my legs was recovered on 21Feb2021; for all other events was recovering. The treatment received was a steriod IV. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 4 days (from 05Mar2021 to 09Mar2021).; Sender's Comments: A causal relationship cannot be completely excluded between BNT162B2 injection and serious reported events only due to close chronological sequence. Other evidence or argument supporting a causal relationship  cannot be established, so far. Otherwise, multi-morbid current conditions, and concomitant medication may have played as contributory factors to the serious reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Epistaxis, Paraesthesia, Platelet count, Platelet count decreased
Clinical narrative: blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordinary nosebleed; restless legs; tingling sensations in my legs; This is a spontaneous report received from a physician (also the patient). A 38-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 08:30 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a workplace clinic. The patient medical history includes: Graves Disease, Lupus, O- Blood, RH-, allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at time of vaccination. Concomitant medication (reported as any other medications the patient received within 2 weeks of vaccination) included gabapentin taken for an unspecified indication, start and stop date were not reported. It was reported that (reported as within first 4 hours of vaccine) on 03Feb2021, the patient experienced restless legs.  On 06Feb2021, the patient experienced an out of the ordinary nosebleed. From then until 21Feb2021, the patient would experience tingling sensations in my legs and then on 21Feb2021 found a bruise on right leg near knee. On 26Feb2021 blood work revealed platelet count 73,000; 03Mar2021 blood work revealed platelet count 33,000 (results received on March 5), significant nosebleed on 04Mar2021, hospitalized with 29,000 platelet count on 05Mar2021. The outcome of the event tingling sensations in my legs was recovered on 21Feb2021; for all other events was recovering. The treatment received was a steriod IV. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 4 days (from 05Mar2021 to 09Mar2021).; Sender's Comments: A causal relationship cannot be completely excluded between BNT162B2 injection and serious reported events only due to close chronological sequence. Other evidence or argument supporting a causal relationship  cannot be established, so far. Otherwise, multi-morbid current conditions, and concomitant medication may have played as contributory factors to the serious reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Restless legs syndrome
Clinical narrative: blood work revealed platelet count 73,000; found a bruise on right leg near knee; an out of the ordinary nosebleed; restless legs; tingling sensations in my legs; This is a spontaneous report received from a physician (also the patient). A 38-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Right on 03Feb2021 08:30 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunization. The patient was vaccinated at a workplace clinic. The patient medical history includes: Graves Disease, Lupus, O- Blood, RH-, allergies to codeine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient is not pregnant at time of vaccination. Concomitant medication (reported as any other medications the patient received within 2 weeks of vaccination) included gabapentin taken for an unspecified indication, start and stop date were not reported. It was reported that (reported as within first 4 hours of vaccine) on 03Feb2021, the patient experienced restless legs.  On 06Feb2021, the patient experienced an out of the ordinary nosebleed. From then until 21Feb2021, the patient would experience tingling sensations in my legs and then on 21Feb2021 found a bruise on right leg near knee. On 26Feb2021 blood work revealed platelet count 73,000; 03Mar2021 blood work revealed platelet count 33,000 (results received on March 5), significant nosebleed on 04Mar2021, hospitalized with 29,000 platelet count on 05Mar2021. The outcome of the event tingling sensations in my legs was recovered on 21Feb2021; for all other events was recovering. The treatment received was a steriod IV. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 4 days (from 05Mar2021 to 09Mar2021).; Sender's Comments: A causal relationship cannot be completely excluded between BNT162B2 injection and serious reported events only due to close chronological sequence. Other evidence or argument supporting a causal relationship  cannot be established, so far. Otherwise, multi-morbid current conditions, and concomitant medication may have played as contributory factors to the serious reported events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: nocturnal seizures; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 17:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included Epilepsy (free for two years before the vaccine). No other vaccine in four weeks. Concomitant medications included zonisamide (ZONISAMIDE), sertraline hydrochloride (ZOLOFT), valproate semisodium (DEPAKOTE), ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took lamictal and experienced allergy. The patient experienced nocturnal seizures and extreme fatigue on 22Mar2021. The event nocturnal seizures was serious due to Life threatening. Detail clinical course was reported as the patient had epilepsy, she was seizure free for two years before the vaccine. Three days after the first shot, she began having nocturnal seizures, which have never happened before. All her past seizures have been while she was awake. Seven days later, she was still experiencing extreme fatigue and seizures. Nocturnal seizures result in Doctor or other healthcare professional office/clinic visit (Life threatening illness (immediate risk of death from the event)], and treatment included increased dosages of anti-convulsion medications. The event outcome was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Seizure
Clinical narrative: nocturnal seizures; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 17:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included Epilepsy (free for two years before the vaccine). No other vaccine in four weeks. Concomitant medications included zonisamide (ZONISAMIDE), sertraline hydrochloride (ZOLOFT), valproate semisodium (DEPAKOTE), ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took lamictal and experienced allergy. The patient experienced nocturnal seizures and extreme fatigue on 22Mar2021. The event nocturnal seizures was serious due to Life threatening. Detail clinical course was reported as the patient had epilepsy, she was seizure free for two years before the vaccine. Three days after the first shot, she began having nocturnal seizures, which have never happened before. All her past seizures have been while she was awake. Seven days later, she was still experiencing extreme fatigue and seizures. Nocturnal seizures result in Doctor or other healthcare professional office/clinic visit (Life threatening illness (immediate risk of death from the event)], and treatment included increased dosages of anti-convulsion medications. The event outcome was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aggression, Atrial fibrillation, Back pain, Blood pressure abnormal, Blood test
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram thorax, Critical illness, Discomfort, Encephalopathy
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrostomy, Guillain-Barre syndrome, Heart rate increased, Magnetic resonance imaging spinal, Mechanical ventilation
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal disorder, Nervous system disorder, Noninfective encephalitis, Pain in extremity, Plasmapheresis
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pneumonia, Sedative therapy, Tracheostomy
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Atrial fibrillation, Back pain, Computerised tomogram, Dizziness
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Encephalopathy, Guillain-Barre syndrome, Magnetic resonance imaging, Mechanical ventilation, Nausea
Clinical narrative: Patient was having lower leg pain which then moved to lower back. In addition, patient started to experience increase heart rate so went to emergency room and was later admitted on 3/18/21. A series of tests including CAT scans of the brain and chest area were completed to check for possible blood clots or strokes. Afib and blood pressure were out of control which caused the patient to become very uncomfortable as well as combative about pulling out IVs. Patient was then given a sedative that eventually cause inflammation to the brain or encephalopathy. During the hospital stay the patient then developed pneumonia and had to be put on a ventilator in order the stabilize and she fell to critical condition at that