chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Transient global amnesia, Urine analysis
Clinical narrative: SLEPT MORE THAN NORMAL; TRANSIENT GLOBAL AMNESIA; FLUID IN BOTH LUNGS; DISORIENTED FOR 5 DAYS POST HOSPITALZATION; VERY TIRED FOR 5 DAYS POST HOSPITALZATION; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included arthritis, and reaction to penicillin, and concurrent conditions included non smoker, alcohol use, and tree pollen allergies, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse / illicit drug use.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, patient had sudden onset of long and short term memory loss her neighbor further took her emergency room and diagnosed with transient global amnesia. She had many immunizations without any side effects. The patient reported she used to sleep more than normal for 2 days, during hospitalization patient was identified with fluid in both of her lungs, and got discharged on 08-APR-2021. She felt very tried and disoriented for 5 days post hospitalization. She had no cough and no runny nose. Symptoms lasted for approximately for 8 hours on 07-APR-2021 and she started regaining her memory at around 7-8 hours and was able to recall the activities. Laboratory data included: Blood sugar abnormal (NR: not provided) Unknown, complete blood count (NR: not provided) Unknown, Computerized tomogram scan (NR: not provided) Head neck normal, Chest X-ray (NR: not provided) Unknown, Drug screen (NR: not provided) Unknown, Electrocardiogram (NR: not provided) Unknown, Electroencephalogram (NR: not provided) Unknown, Echocardiogram (NR: not provided) Unknown, Low density lipoprotein cholesterol high (NR: not provided) Unknown, MRI (NR: not provided) Brain no contrast, TSH (NR: not provided) Unknown, and Urine analysis (NR: not provided) Unknown.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from transient global amnesia, fluid in both lungs and  slept more than normal and had not recovered from disoriented and very tired. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-Transient global amnesia, Fluid in both lungs, Slept more than normal. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Dysarthria, Dysphagia, Epistaxis, Guillain-Barre syndrome
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Mastication disorder, Myalgia, Pain in extremity
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysarthria, Dysphagia, Epistaxis, Guillain-Barre syndrome, Headache
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Mastication disorder
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nerve conduction studies, Pain in extremity
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ageusia, Anti-ganglioside antibody negative, Antiacetylcholine receptor antibody, Aptyalism, Areflexia
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF white blood cell count negative, Diplegia, Dysarthria, Dysphagia
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electromyogram abnormal, Eyelid function disorder, Facial paresis, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Motor neurone disease, Myopathy, Nerve conduction studies abnormal, Neurological examination abnormal, Peripheral motor neuropathy
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram, Antibody test, CSF protein, CSF test abnormal, Chest X-ray
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Coma scale, Computerised tomogram head, Guillain-Barre syndrome, Magnetic resonance imaging head, Neurological examination
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Physical examination, Sensory level
Clinical narrative: Woke up with slurred speech, difficulty swallowing and bilateral facial weakness. She denied any other weakness/numbness. She endorsed loss of taste that is slowly resolving and decreased salivation. Neurological exam showed severely slurred speech, weak gag reflex,  unable to close eyes, facial weakness bilaterally (bilateral cranial nerve 7 lower motor neurone weakness).  She was diagnosed with Guillain-Barre: facial diplegia variant. Labs significant for albuminocytologic dissociation & IgA level of 163. Treated with 10 doses of intravenous immunoglobulin (IVIG at 0.4g/kg). Patient improved after 10 diseases and was discharged and followed up with outpatient neurology
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram pelvis, Cyst, Magnetic resonance cholangiopancreatography, Mesenteric vein thrombosis
Clinical narrative: Acute necrotizing pancreatitis; Thrombosis of SMV; Thrombosis of splenic vein; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PANCREATITIS NECROTISING (Acute necrotizing pancreatitis), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS NECROTISING (Acute necrotizing pancreatitis) (seriousness criterion medically significant), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) (seriousness criterion medically significant) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) (seriousness criterion medically significant). At the time of the report, PANCREATITIS NECROTISING (Acute necrotizing pancreatitis), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is available at this time. Further information has been requested.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is available at this time. Further information has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis necrotising, Splenic vein thrombosis
Clinical narrative: Acute necrotizing pancreatitis; Thrombosis of SMV; Thrombosis of splenic vein; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PANCREATITIS NECROTISING (Acute necrotizing pancreatitis), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS NECROTISING (Acute necrotizing pancreatitis) (seriousness criterion medically significant), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) (seriousness criterion medically significant) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) (seriousness criterion medically significant). At the time of the report, PANCREATITIS NECROTISING (Acute necrotizing pancreatitis), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is available at this time. Further information has been requested.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is available at this time. Further information has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Mesenteric vein thrombosis, Pancreatitis necrotising, Splenic vein thrombosis
Clinical narrative: Acute necrotizing pancreatitis; Thrombosis of SMV; Thrombosis of splenic vein; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PANCREATITIS NECROTISING (Acute necrotizing pancreatitis), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS NECROTISING (Acute necrotizing pancreatitis) (seriousness criterion medically significant), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) (seriousness criterion medically significant) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) (seriousness criterion medically significant). At the time of the report, PANCREATITIS NECROTISING (Acute necrotizing pancreatitis), MESENTERIC VEIN THROMBOSIS (Thrombosis of SMV) and SPLENIC VEIN THROMBOSIS (Thrombosis of splenic vein) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is available at this time. Further information has been requested.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Very little information is available at this time. Further information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia, Pain, Peripheral swelling, Thrombosis
Clinical narrative: DIFFICLUTY WALKING; SWOLLEN FEETS; BLOOD CLOT; NUMBNESS IN LEFT TOE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, metoprolol tartrate for high blood pressure, and levothyroxine for hypothyroidism. On 11-MAR-2021, the patient experienced numbness in left toe. On 13-APR-2021, the patient was hospitalized. Laboratory data included: Diagnostic ultrasound (NR: not provided) 2 blood clots. On an unspecified date, the patient experienced blood clot, swollen feets, and difficluty walking which required emergency room visit and got hospitalized. Treatment medications (dates unspecified) included: enoxaparin sodium, and apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, swollen feets, numbness in left toe and difficluty walking was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 65 White year-old female with medical history significant for high blood pressure and hypothyroidism was hospitalized 33 days after receiving the Janssen Covid-19 vaccine. Concomitant medications included amlodipine, metoprolol, and levothyroxine. On the same day as vaccination, the patient experienced numbness in her left toe. Thirty-three days later, she went to the emergency room for swollen feet and difficulty walking.  An ultrasound found 2 blood clots. Additional diagnostic tests were not reported. She was admitted to the hospital and treated with enoxaparin and apixaban and discharged. Outcome was not reported. Based on the available information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: DIFFICLUTY WALKING; SWOLLEN FEETS; BLOOD CLOT; NUMBNESS IN LEFT TOE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, metoprolol tartrate for high blood pressure, and levothyroxine for hypothyroidism. On 11-MAR-2021, the patient experienced numbness in left toe. On 13-APR-2021, the patient was hospitalized. Laboratory data included: Diagnostic ultrasound (NR: not provided) 2 blood clots. On an unspecified date, the patient experienced blood clot, swollen feets, and difficluty walking which required emergency room visit and got hospitalized. Treatment medications (dates unspecified) included: enoxaparin sodium, and apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, swollen feets, numbness in left toe and difficluty walking was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 65 White year-old female with medical history significant for high blood pressure and hypothyroidism was hospitalized 33 days after receiving the Janssen Covid-19 vaccine. Concomitant medications included amlodipine, metoprolol, and levothyroxine. On the same day as vaccination, the patient experienced numbness in her left toe. Thirty-three days later, she went to the emergency room for swollen feet and difficulty walking.  An ultrasound found 2 blood clots. Additional diagnostic tests were not reported. She was admitted to the hospital and treated with enoxaparin and apixaban and discharged. Outcome was not reported. Based on the available information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Peripheral swelling, Thrombosis, Ultrasound scan
Clinical narrative: DIFFICLUTY WALKING; SWOLLEN FEETS; BLOOD CLOT; NUMBNESS IN LEFT TOE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, metoprolol tartrate for high blood pressure, and levothyroxine for hypothyroidism. On 11-MAR-2021, the patient experienced numbness in left toe. On 13-APR-2021, the patient was hospitalized. Laboratory data included: Diagnostic ultrasound (NR: not provided) 2 blood clots. On an unspecified date, the patient experienced blood clot, swollen feets, and difficluty walking which required emergency room visit and got hospitalized. Treatment medications (dates unspecified) included: enoxaparin sodium, and apixaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot, swollen feets, numbness in left toe and difficluty walking was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 65 White year-old female with medical history significant for high blood pressure and hypothyroidism was hospitalized 33 days after receiving the Janssen Covid-19 vaccine. Concomitant medications included amlodipine, metoprolol, and levothyroxine. On the same day as vaccination, the patient experienced numbness in her left toe. Thirty-three days later, she went to the emergency room for swollen feet and difficulty walking.  An ultrasound found 2 blood clots. Additional diagnostic tests were not reported. She was admitted to the hospital and treated with enoxaparin and apixaban and discharged. Outcome was not reported. Based on the available information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.
Age: 59.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Painful respiration, Pyrexia
Clinical narrative: Approximately 24 hours after my vaccine with Pfizer I had excruciating heart pain that felt like I was having a heart attack along with felt like my throat was closing. That reaction lasted for 4 days with no ease of the chest pain.  My temperature after the 24-hour period was 102, the next day 101, the next day 100.2, and then the last day of 99.5
Age: 59.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Approximately 24 hours after my vaccine with Pfizer I had excruciating heart pain that felt like I was having a heart attack along with felt like my throat was closing. That reaction lasted for 4 days with no ease of the chest pain.  My temperature after the 24-hour period was 102, the next day 101, the next day 100.2, and then the last day of 99.5
Age: 59.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Body temperature increased, Chest pain, Throat tightness
Clinical narrative: Approximately 24 hours after my vaccine with Pfizer I had excruciating heart pain that felt like I was having a heart attack along with felt like my throat was closing. That reaction lasted for 4 days with no ease of the chest pain.  My temperature after the 24-hour period was 102, the next day 101, the next day 100.2, and then the last day of 99.5
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring normal, Erythema, Flushing, Pruritus
Clinical narrative: Red, hot rash over entire body.  Went to emergency room. Doctor prescribed a shot of prednisone and Benadryl. That afternoon severe abdominal cramping for approximately 1/2 hour. Next afternoon once again red, hot to touch rash over entire body. Took 50 mg of Benadryl and 60 mg of prednisone. Extreme tiredness. Slept almost constantly through Saturday afternoon.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Fatigue, Rash, Rash erythematous, Skin warm
Clinical narrative: Red, hot rash over entire body.  Went to emergency room. Doctor prescribed a shot of prednisone and Benadryl. That afternoon severe abdominal cramping for approximately 1/2 hour. Next afternoon once again red, hot to touch rash over entire body. Took 50 mg of Benadryl and 60 mg of prednisone. Extreme tiredness. Slept almost constantly through Saturday afternoon.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Pneumonia
Clinical narrative: HOSPITALIZED WITH PNEUMONIA; SEVERE DIARRHEA; HEADACHE; DIZZINESS; NEWLY DIAGNOSED WITH HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse nor illicit drug use. The patient was previously treated with sulfanilamide sodium/sulfadiazine/sulfadimidine/sulfamerazine for drug used for unknown indication, and codeine for drug used for unknown indication. The patient was allergic to sulfa and Codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 on left deltoid for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.  On 9-Mar-2021 patient experienced dizziness. On 10-Mar-2021 patient had severe diarrhea and headache. On 23-Mar-2021 the patient was hospitalized with pneumonia and was newly diagnosed with high blood pressure. Multiple labs drawn during hospital stay for pneumonia, lab results were unknown at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from pneumonia on 28-MAR-2021, and the outcome of diarrhea, headache and dizziness was not recovered not resolved. The outcome of  blood pressure increased was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210431980- covid-19 vaccine ad26.cov2.s-pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Hypertension, Laboratory test
Clinical narrative: HOSPITALIZED WITH PNEUMONIA; SEVERE DIARRHEA; HEADACHE; DIZZINESS; NEWLY DIAGNOSED WITH HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse nor illicit drug use. The patient was previously treated with sulfanilamide sodium/sulfadiazine/sulfadimidine/sulfamerazine for drug used for unknown indication, and codeine for drug used for unknown indication. The patient was allergic to sulfa and Codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 on left deltoid for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.  On 9-Mar-2021 patient experienced dizziness. On 10-Mar-2021 patient had severe diarrhea and headache. On 23-Mar-2021 the patient was hospitalized with pneumonia and was newly diagnosed with high blood pressure. Multiple labs drawn during hospital stay for pneumonia, lab results were unknown at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from pneumonia on 28-MAR-2021, and the outcome of diarrhea, headache and dizziness was not recovered not resolved. The outcome of  blood pressure increased was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210431980- covid-19 vaccine ad26.cov2.s-pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: HOSPITALIZED WITH PNEUMONIA; SEVERE DIARRHEA; HEADACHE; DIZZINESS; NEWLY DIAGNOSED WITH HIGH BLOOD PRESSURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient had no drug abuse nor illicit drug use. The patient was previously treated with sulfanilamide sodium/sulfadiazine/sulfadimidine/sulfamerazine for drug used for unknown indication, and codeine for drug used for unknown indication. The patient was allergic to sulfa and Codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 on left deltoid for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.  On 9-Mar-2021 patient experienced dizziness. On 10-Mar-2021 patient had severe diarrhea and headache. On 23-Mar-2021 the patient was hospitalized with pneumonia and was newly diagnosed with high blood pressure. Multiple labs drawn during hospital stay for pneumonia, lab results were unknown at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from pneumonia on 28-MAR-2021, and the outcome of diarrhea, headache and dizziness was not recovered not resolved. The outcome of  blood pressure increased was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210431980- covid-19 vaccine ad26.cov2.s-pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood pressure increased, Ecchymosis, International normalised ratio normal
Clinical narrative: Hypertensive crisis; ecchymosis; dermatology scales around shot site.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Prothrombin time normal
Clinical narrative: Hypertensive crisis; ecchymosis; dermatology scales around shot site.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ecchymosis, Hypertensive crisis, Injection site reaction, Skin exfoliation
Clinical narrative: Hypertensive crisis; ecchymosis; dermatology scales around shot site.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy bone marrow, Blood test abnormal, Computerised tomogram head, Contusion, Immunoglobulin therapy
Clinical narrative: This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810 and expiration date not provided), via an unspecified route of administration, in right arm, on 05Mar2021 12:30 (at the age of 85-year-old), at single dose, for COVID-19 immunization. Medical history included diabetes, atrial fibrillation (AFib), congestive heart failure (CHF), blood pressure high (HBP) and obesity. Patient had no known allergies. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medications included rivaroxaban (XARELTO), lisinopril, metoprolol, metformin, and atorvastatin calcium (ATORVASTIN). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265 and expiration date not provided), via an unspecified route of administration, in right arm, on 12Feb2021 11:30  (at the age of 85-year-old), at single dose, for COVID-19 immunization. On 01Apr2021, the patient experienced "platelet count of 14,000/ low as 7,000 and high as 30,000". On 01Apr2021, patient had routine 3 month blood work done for follow up doctor visit. On 02Apr2021, results revealed platelet count of 14,000, doctor called and said to go to ER (platelet count was 77,000 in Jan2021). Patient was still in hospital as of 20Apr2021 in declining condition despite multiple doses of immunoglobulins (IVIG), prednisone, romiplostim (NPLATE), and platelet infusions. Patient's platelet had been as low as 7,000 and high as 30,000 during his time in the hospital. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 18 days. No COVID tested post vaccination. Other medications reported as glipizide, ergocalciferol (VIT D), furosemide, potassium chloride ER. The outcome of the event was not recovered.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Ultrasound abdomen
Clinical narrative: This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810 and expiration date not provided), via an unspecified route of administration, in right arm, on 05Mar2021 12:30 (at the age of 85-year-old), at single dose, for COVID-19 immunization. Medical history included diabetes, atrial fibrillation (AFib), congestive heart failure (CHF), blood pressure high (HBP) and obesity. Patient had no known allergies. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medications included rivaroxaban (XARELTO), lisinopril, metoprolol, metformin, and atorvastatin calcium (ATORVASTIN). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265 and expiration date not provided), via an unspecified route of administration, in right arm, on 12Feb2021 11:30  (at the age of 85-year-old), at single dose, for COVID-19 immunization. On 01Apr2021, the patient experienced "platelet count of 14,000/ low as 7,000 and high as 30,000". On 01Apr2021, patient had routine 3 month blood work done for follow up doctor visit. On 02Apr2021, results revealed platelet count of 14,000, doctor called and said to go to ER (platelet count was 77,000 in Jan2021). Patient was still in hospital as of 20Apr2021 in declining condition despite multiple doses of immunoglobulins (IVIG), prednisone, romiplostim (NPLATE), and platelet infusions. Patient's platelet had been as low as 7,000 and high as 30,000 during his time in the hospital. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 18 days. No COVID tested post vaccination. Other medications reported as glipizide, ergocalciferol (VIT D), furosemide, potassium chloride ER. The outcome of the event was not recovered.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810 and expiration date not provided), via an unspecified route of administration, in right arm, on 05Mar2021 12:30 (at the age of 85-year-old), at single dose, for COVID-19 immunization. Medical history included diabetes, atrial fibrillation (AFib), congestive heart failure (CHF), blood pressure high (HBP) and obesity. Patient had no known allergies. No other vaccine in four weeks, no COVID prior vaccination. Concomitant medications included rivaroxaban (XARELTO), lisinopril, metoprolol, metformin, and atorvastatin calcium (ATORVASTIN). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265 and expiration date not provided), via an unspecified route of administration, in right arm, on 12Feb2021 11:30  (at the age of 85-year-old), at single dose, for COVID-19 immunization. On 01Apr2021, the patient experienced "platelet count of 14,000/ low as 7,000 and high as 30,000". On 01Apr2021, patient had routine 3 month blood work done for follow up doctor visit. On 02Apr2021, results revealed platelet count of 14,000, doctor called and said to go to ER (platelet count was 77,000 in Jan2021). Patient was still in hospital as of 20Apr2021 in declining condition despite multiple doses of immunoglobulins (IVIG), prednisone, romiplostim (NPLATE), and platelet infusions. Patient's platelet had been as low as 7,000 and high as 30,000 during his time in the hospital. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Patient was hospitalized for 18 days. No COVID tested post vaccination. Other medications reported as glipizide, ergocalciferol (VIT D), furosemide, potassium chloride ER. The outcome of the event was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: BLOOD CLOTS IN LEFT TEMPORAL LOBE/BRAIN; STROKE; LEFT SIDE FACIAL NUMBNESS; This spontaneous report received from a patient concerned a 67 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the patient experienced blood clots in her left temporal lobe/brain that lead to stroke. On an unknown date APR/2021, she occasionally had left side facial numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in left temporal lobe/brain, stroke and left side facial numbness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 67-year-old African American (non-Hispanic/Latino) female was found to have "blood clots in left temporal lobe/brain that lead to stroke" 5 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. No other details was reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information as requested.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Hypoaesthesia
Clinical narrative: BLOOD CLOTS IN LEFT TEMPORAL LOBE/BRAIN; STROKE; LEFT SIDE FACIAL NUMBNESS; This spontaneous report received from a patient concerned a 67 year old African American, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the patient experienced blood clots in her left temporal lobe/brain that lead to stroke. On an unknown date APR/2021, she occasionally had left side facial numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in left temporal lobe/brain, stroke and left side facial numbness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 67-year-old African American (non-Hispanic/Latino) female was found to have "blood clots in left temporal lobe/brain that lead to stroke" 5 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. No other details was reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information as requested.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Anticoagulant therapy, Arteriogram coronary normal, Chest pain, Echocardiogram abnormal
Clinical narrative: Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events.  Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. 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.