chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Chills, Hypoaesthesia, Syncope, Vision blurred
Clinical narrative: syncope
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: syncope
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: syncope
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: thigh swelled to almost twice normal diameter. Red rash on entire thigh. Itching and burning sensations. Mostly subsided within 6 days, but still itches and tender 5 weeks after the shot.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Peripheral swelling, Pruritus, Rash erythematous, Tenderness
Clinical narrative: thigh swelled to almost twice normal diameter. Red rash on entire thigh. Itching and burning sensations. Mostly subsided within 6 days, but still itches and tender 5 weeks after the shot.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pelvic mass
Clinical narrative: suspected pelvic mass/lower pelvic pain that progressed into severe pain over the next day/Pelvic mass/pain with bowel movements/difficulty to sit/ weight loss/ internal pelvic pulling sensation; This is a spontaneous report received from a contactable physician (reporting on herself). A 43-years-old Non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EL1284 and Expiration date was not reported), via an unspecified route of administration in Arm Left on 07Jan2021 12:00 (at the age of 43 years), as SINGLE DOSE for covid-19 immunization. Medical history included Latex_contact, laparoscopic surgery and Prior to vaccination, the patient was diagnosed with COVID-19 other medical history was none. Concomitant medication(s) included (within 2 weeks of vaccination) multivitamins (MULTIVITAMINS) daily. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not pregnant at the time of vaccination. It was reported that the evening after 1st pfizer covid 19 vaccine injection on 07Jan2021, Patient developed lower pelvic pain that progressed into severe pain over the next day requiring medical attention first at urgent care. Patient was then referred to the emergency department and found to have a suspected pelvic mass. Pain controlled with medication, improved but continued to have dull pelvic pain, pain with bowel movements, difficulty to sit, weight loss, internal pelvic pulling sensation. Follow up involved referral to specialist with imaging confirmed pelvic mass with plan for surgery. Patient received 2nd pfizer covid 19 vaccine given on 28Jan2021, 4 hours after injection developed again the severe pain experienced after the first injection require pain management. Underwent laparoscopic surgery for removal of pelvic mass and lysis of adhesions of intestines. Prior to the 1st vaccine on 07Jan2021 she had no pelvic pain or intestinal issues, no prior surgery and had maintained a very active lifestyle. Since the vaccination, patient was not tested for COVID-19. The outcome of the event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product  bnt162b2 to the reported event 'Pelvic Mass" cannot be excluded. However, more information is needed regarding the Pelvic mass. The case will be reassessed once new information such as biopsy reports, tumor markers , Complete blood picture are available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Adrenal haemorrhage, Adrenal mass, Asthenia, Cerebral haemorrhage
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal, Headache, Mental status changes, Nausea
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Renal haemorrhage, Retching, Subarachnoid haemorrhage
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain herniation, Brain oedema, Computerised tomogram abdomen, Computerised tomogram head abnormal, Computerised tomogram thorax
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Fibrin D dimer increased, Haemorrhage intracranial, Mental status changes, Neurosurgery
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Adrenal haemorrhage, Brain injury, Cerebral haemorrhage, Computerised tomogram abdomen abnormal
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Death, Deep vein thrombosis, Dependence on respirator, Diarrhoea
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Life support, Malaise, Platelet count decreased, Pulmonary embolism
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Surgery, Thrombosis, Unresponsive to stimuli, Vomiting
Clinical narrative: Patient received vaccine 3/5/21 presented to the hospital with thrombocytopenia on 3/16 initially felt to be related to an adrenal mass hemorrhage.  Later that night patient experienced acute mental status changes.  Stat CT showed  cerebral edema, herniation, intracranial hemorrhage, urgent neurosurgery intervention completed.  Patient terminally extubated on 3/18 and expired.   Concern for possible cerebral venous sinus thrombosis.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: The shot within a few days made my Tinnitus worse. I will not be getting the second shot.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated
Clinical narrative: The shot within a few days made my Tinnitus worse. I will not be getting the second shot.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Brain death, Brain herniation, Cerebral haematoma, Cerebral haemorrhage
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral mass effect, Cerebral venous thrombosis, Cerebral ventricle dilatation, Computerised tomogram head abnormal, Endotracheal intubation
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hemiparesis, Mental status changes, Posturing, Retching
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram, Death, Headache, Hemiparesis
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count, Retching, Thrombocytopenia
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Headache
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Death
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram abnormal, Angiogram cerebral abnormal, Antinuclear antibody negative, Blood fibrinogen decreased, Brain death
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Death, Feeling abnormal, Fibrin D dimer increased
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Gene mutation identification test negative, Headache, Lethargy, Nausea, Platelet count decreased
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, Transverse sinus thrombosis
Clinical narrative: Patient developed severe headache and was taken to local hospital, transferred to another hospital due to massive stroke. 10 days after vaccine (J&J)
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Brain death, Brain herniation, Cerebral haematoma, Cerebral haemorrhage
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral mass effect, Cerebral venous thrombosis, Cerebral ventricle dilatation, Computerised tomogram head abnormal, Endotracheal intubation
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Hemiparesis, Mental status changes, Posturing, Retching
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram, Death, Headache, Hemiparesis
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet count, Retching, Thrombocytopenia
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Headache
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Death
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram abnormal, Angiogram cerebral abnormal, Antinuclear antibody negative, Blood fibrinogen decreased, Brain death
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Computerised tomogram head abnormal, Death, Feeling abnormal, Fibrin D dimer increased
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Gene mutation identification test negative, Headache, Lethargy, Nausea, Platelet count decreased
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, Transverse sinus thrombosis
Clinical narrative: patient had a stroke two days after taking the  vaccine and was pronounced dead one day after being administered to  hospital with blood on her brain.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Fatigue, Full blood count
Clinical narrative: They think she has Guillen barre; severe neck pain and pain on the side of neck; numbness across the shoulders and down the arms and leg numbness; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intervertebral disc operation (She had a surgical procedure done year and half ago where two artificial discs were put in her neck.).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) (seriousness criterion medically significant), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever). At the time of the report, GUILLAIN-BARRE SYNDROME (They think she has Guillen barre), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.  Treatment included prednisone for 15 days and cephalexin (500mg) for 7 days (both for unknown indication) and gabapentin (for neck pain). The patient is scheduled for cervical and brain MRI  and also had cervical x-ray (results not reported). The patient opted not to have spinal tap.  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.  However the event of Guillen barre has not been confirmed. Additional information has been requested; Sender'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.  However the event of Guillen barre has not been confirmed. Additional information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Metabolic function test, Neck pain, Paraesthesia
Clinical narrative: They think she has Guillen barre; severe neck pain and pain on the side of neck; numbness across the shoulders and down the arms and leg numbness; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intervertebral disc operation (She had a surgical procedure done year and half ago where two artificial discs were put in her neck.).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) (seriousness criterion medically significant), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever). At the time of the report, GUILLAIN-BARRE SYNDROME (They think she has Guillen barre), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.  Treatment included prednisone for 15 days and cephalexin (500mg) for 7 days (both for unknown indication) and gabapentin (for neck pain). The patient is scheduled for cervical and brain MRI  and also had cervical x-ray (results not reported). The patient opted not to have spinal tap.  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.  However the event of Guillen barre has not been confirmed. Additional information has been requested; Sender'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.  However the event of Guillen barre has not been confirmed. Additional information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Toothache
Clinical narrative: They think she has Guillen barre; severe neck pain and pain on the side of neck; numbness across the shoulders and down the arms and leg numbness; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intervertebral disc operation (She had a surgical procedure done year and half ago where two artificial discs were put in her neck.).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) (seriousness criterion medically significant), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever). At the time of the report, GUILLAIN-BARRE SYNDROME (They think she has Guillen barre), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.  Treatment included prednisone for 15 days and cephalexin (500mg) for 7 days (both for unknown indication) and gabapentin (for neck pain). The patient is scheduled for cervical and brain MRI  and also had cervical x-ray (results not reported). The patient opted not to have spinal tap.  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.  However the event of Guillen barre has not been confirmed. Additional information has been requested; Sender'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.  However the event of Guillen barre has not been confirmed. Additional information has been requested
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Neck pain, Pyrexia
Clinical narrative: They think she has Guillen barre; severe neck pain and pain on the side of neck; numbness across the shoulders and down the arms and leg numbness; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intervertebral disc operation (She had a surgical procedure done year and half ago where two artificial discs were put in her neck.).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (They think she has Guillen barre) (seriousness criterion medically significant), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever). At the time of the report, GUILLAIN-BARRE SYNDROME (They think she has Guillen barre), NECK PAIN (severe neck pain and pain on the side of neck), HYPOAESTHESIA (numbness across the shoulders and down the arms and leg numbness) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant product use was not provided.  Treatment included prednisone for 15 days and cephalexin (500mg) for 7 days (both for unknown indication) and gabapentin (for neck pain). The patient is scheduled for cervical and brain MRI  and also had cervical x-ray (results not reported). The patient opted not to have spinal tap.  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.  However the event of Guillen barre has not been confirmed. Additional information has been requested; Sender'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.  However the event of Guillen barre has not been confirmed. Additional information has been requested
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysstasia, Feeling abnormal, Malaise, Muscular weakness, Throat tightness
Clinical narrative: she felt like her throat was, like somebody was choking her; could not stand; Extreme weakness; Her jaw felt like it was getting huge; Blood pressure went up to 170; Rash on her back; Hives on her legs; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ET7534), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 86years) as single dose for Covid-19 immunization. Medical history included diabetes mellitus, blood pressure high, multiple sclerosis, and wheelchair user; all from an unknown date and unknown if ongoing. Concomitant medications included ongoing baclofen (10mg, three times a day), metformin (750 mg, twice a day), amlodipine besilate (10mg, once a day), losartan (50 mg, once a day), magnesium (two times a day), metoprolol (50 mg, 3x/day), cyanocobalamin (VITAMIN B 12), and glimepiride (takes 1mg in one meal and as another meal she takes half of a mg); and Statin (unspecified) 10 mg, once a day; all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received Pfizer Covid vaccine on 18Mar2021 and she did fine but an hour later when she got home, the reporter tried to help her up off of her wheelchair onto another chair and she could not stand. She had extreme weakness and then she felt like her throat was, like somebody was choking her, like their hands around her throat and then her jaw felt like it was getting huge. Then, her blood pressure went up to 170, the patient was given lots of continuous water and blood pressure pill. She started to feel better after that. The reporter further stated, "She has had various different problems. I do not know if it is allergies or what from what she already has but she did have a lot of it and exhausting stuff afterwards. There is mainly that choking feeling that is frightening that she had one hour after". It was also reported that the patient developed some rash on her back and hives on her legs. It was not right away. It was kind of a day or two after. The outcome of events was unknown.  Follow-up attempts needed. Further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Choking sensation, Dysstasia
Clinical narrative: she felt like her throat was, like somebody was choking her; could not stand; Extreme weakness; Her jaw felt like it was getting huge; Blood pressure went up to 170; Rash on her back; Hives on her legs; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ET7534), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 86years) as single dose for Covid-19 immunization. Medical history included diabetes mellitus, blood pressure high, multiple sclerosis, and wheelchair user; all from an unknown date and unknown if ongoing. Concomitant medications included ongoing baclofen (10mg, three times a day), metformin (750 mg, twice a day), amlodipine besilate (10mg, once a day), losartan (50 mg, once a day), magnesium (two times a day), metoprolol (50 mg, 3x/day), cyanocobalamin (VITAMIN B 12), and glimepiride (takes 1mg in one meal and as another meal she takes half of a mg); and Statin (unspecified) 10 mg, once a day; all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received Pfizer Covid vaccine on 18Mar2021 and she did fine but an hour later when she got home, the reporter tried to help her up off of her wheelchair onto another chair and she could not stand. She had extreme weakness and then she felt like her throat was, like somebody was choking her, like their hands around her throat and then her jaw felt like it was getting huge. Then, her blood pressure went up to 170, the patient was given lots of continuous water and blood pressure pill. She started to feel better after that. The reporter further stated, "She has had various different problems. I do not know if it is allergies or what from what she already has but she did have a lot of it and exhausting stuff afterwards. There is mainly that choking feeling that is frightening that she had one hour after". It was also reported that the patient developed some rash on her back and hives on her legs. It was not right away. It was kind of a day or two after. The outcome of events was unknown.  Follow-up attempts needed. Further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Swelling face, Urticaria
Clinical narrative: she felt like her throat was, like somebody was choking her; could not stand; Extreme weakness; Her jaw felt like it was getting huge; Blood pressure went up to 170; Rash on her back; Hives on her legs; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ET7534), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 86years) as single dose for Covid-19 immunization. Medical history included diabetes mellitus, blood pressure high, multiple sclerosis, and wheelchair user; all from an unknown date and unknown if ongoing. Concomitant medications included ongoing baclofen (10mg, three times a day), metformin (750 mg, twice a day), amlodipine besilate (10mg, once a day), losartan (50 mg, once a day), magnesium (two times a day), metoprolol (50 mg, 3x/day), cyanocobalamin (VITAMIN B 12), and glimepiride (takes 1mg in one meal and as another meal she takes half of a mg); and Statin (unspecified) 10 mg, once a day; all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received Pfizer Covid vaccine on 18Mar2021 and she did fine but an hour later when she got home, the reporter tried to help her up off of her wheelchair onto another chair and she could not stand. She had extreme weakness and then she felt like her throat was, like somebody was choking her, like their hands around her throat and then her jaw felt like it was getting huge. Then, her blood pressure went up to 170, the patient was given lots of continuous water and blood pressure pill. She started to feel better after that. The reporter further stated, "She has had various different problems. I do not know if it is allergies or what from what she already has but she did have a lot of it and exhausting stuff afterwards. There is mainly that choking feeling that is frightening that she had one hour after". It was also reported that the patient developed some rash on her back and hives on her legs. It was not right away. It was kind of a day or two after. The outcome of events was unknown.  Follow-up attempts needed. Further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dizziness, Dyspnoea, Hypoaesthesia oral, Lip swelling
Clinical narrative: Patient recieved 1st dose of Pfizer COVID19 vaccine at 1443, she developed tingling to her lips, and tightness in her throat minutes after receiving the vaccine. She was given 0.3mg Epinephrine and transported to ED via ambulance, there she was given methylprednisolone inj and monitored. Her symptoms improved and she was discharged
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Patient recieved 1st dose of Pfizer COVID19 vaccine at 1443, she developed tingling to her lips, and tightness in her throat minutes after receiving the vaccine. She was given 0.3mg Epinephrine and transported to ED via ambulance, there she was given methylprednisolone inj and monitored. Her symptoms improved and she was discharged
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Patient recieved 1st dose of Pfizer COVID19 vaccine at 1443, she developed tingling to her lips, and tightness in her throat minutes after receiving the vaccine. She was given 0.3mg Epinephrine and transported to ED via ambulance, there she was given methylprednisolone inj and monitored. Her symptoms improved and she was discharged
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Computerised tomogram abnormal, Laboratory test, Lymphadenopathy
Clinical narrative: Severe drop in platelets and blood clots.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Platelet count decreased, Pyrexia
Clinical narrative: Severe drop in platelets and blood clots.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Platelet count decreased, Thrombosis
Clinical narrative: Severe drop in platelets and blood clots.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Night sweats, Pain, Platelet count, Platelet count decreased
Clinical narrative: Severe drop in platelets and blood clots.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rash erythematous, Thrombosis
Clinical narrative: Severe drop in platelets and blood clots.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute sinusitis, Angiogram cerebral normal, Arteriogram carotid normal, Burning sensation, Echocardiogram abnormal
Clinical narrative: Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; This is a spontaneous report from a contactable health care professional and consumer. A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 25Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes type 2, hypertension. The concomitant medications included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162B2 (lot number EN6204; 46-year-old) on 04Mar2021 09:00, at Left arm. The patient received within 2 weeks of vaccination included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. On 25Mar2021 at 09:15 on same day (as reported), the patient experienced burning, tingling, and numbness on left arm, shoulder and face. Patient went to emergency room/department or urgent care due to event. The patient was treated with oral steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 25Mar2021, Test Name: COVID-19 PCR, Test type: Nasal Swab, result was Negative. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Laboratory test
Clinical narrative: Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; This is a spontaneous report from a contactable health care professional and consumer. A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 25Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes type 2, hypertension. The concomitant medications included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162B2 (lot number EN6204; 46-year-old) on 04Mar2021 09:00, at Left arm. The patient received within 2 weeks of vaccination included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. On 25Mar2021 at 09:15 on same day (as reported), the patient experienced burning, tingling, and numbness on left arm, shoulder and face. Patient went to emergency room/department or urgent care due to event. The patient was treated with oral steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 25Mar2021, Test Name: COVID-19 PCR, Test type: Nasal Swab, result was Negative. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging head abnormal, Paraesthesia, Sinus disorder, Sinusitis
Clinical narrative: Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; This is a spontaneous report from a contactable health care professional and consumer. A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 25Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes type 2, hypertension. The concomitant medications included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162B2 (lot number EN6204; 46-year-old) on 04Mar2021 09:00, at Left arm. The patient received within 2 weeks of vaccination included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. On 25Mar2021 at 09:15 on same day (as reported), the patient experienced burning, tingling, and numbness on left arm, shoulder and face. Patient went to emergency room/department or urgent care due to event. The patient was treated with oral steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 25Mar2021, Test Name: COVID-19 PCR, Test type: Nasal Swab, result was Negative. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular hypertrophy
Clinical narrative: Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; This is a spontaneous report from a contactable health care professional and consumer. A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 25Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes type 2, hypertension. The concomitant medications included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162B2 (lot number EN6204; 46-year-old) on 04Mar2021 09:00, at Left arm. The patient received within 2 weeks of vaccination included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. On 25Mar2021 at 09:15 on same day (as reported), the patient experienced burning, tingling, and numbness on left arm, shoulder and face. Patient went to emergency room/department or urgent care due to event. The patient was treated with oral steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 25Mar2021, Test Name: COVID-19 PCR, Test type: Nasal Swab, result was Negative. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; Burning, tingling, and numbness on left arm, shoulder, face; This is a spontaneous report from a contactable health care professional and consumer. A 46-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EP7533 and expiry date was not provided), via an unspecified route of administration, in the left arm, on 25Mar2021 at 08:45 (at the age of 46-years-old) as a single dose for covid-19 immunisation. Medical history included diabetes type 2, hypertension. The concomitant medications included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. The patient did not have any allergies to medications, food or other products. The patient previously received first dose of BNT162B2 (lot number EN6204; 46-year-old) on 04Mar2021 09:00, at Left arm. The patient received within 2 weeks of vaccination included metformin 1000mg, lamotrigine 200mg. Patient did not receive other vaccine in four weeks of vaccination. On 25Mar2021 at 09:15 on same day (as reported), the patient experienced burning, tingling, and numbness on left arm, shoulder and face. Patient went to emergency room/department or urgent care due to event. The patient was treated with oral steroid. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 25Mar2021, Test Name: COVID-19 PCR, Test type: Nasal Swab, result was Negative. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.