chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Electrocardiogram normal, Magnetic resonance imaging normal, Syncope
Clinical narrative: syncopal episode; Initial information was received regarding an unsolicited valid serious case from a nurse via The agency (Reference number- 00344229) and transmitted to Sanofi on 03-Nov-2020.  This case involves a 12-year-old male patient who had a syncopal episode (syncope), after he received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL).  The patient had no history of seizures. The patient's past medical treatment(s), vaccination(s) and family history were not reported.   Concomitant medications were not reported.  On 29-Oct-2020, the patient received a 0.5 ml first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6874AA and expiration date 21-Feb-2022) via an intramuscular route in the left deltoid and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (dosing details, batch number and expiration date not reported) for prophylactic vaccination.  On 29-Oct-2020, the patient developed serious syncopal episode (syncope), 20 to 25 minutes following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. This event was assessed as medically significant. The patient had a possible seizure following administration of the vaccines. The patient visited to emergency department for this event where Electrocardiogram and magnetic resonance imaging done, and neurology dismissed the event of syncope.  Other relevant laboratory test were not reported.  No corrective treatment were given.  At the time of reporting, the outcome of the event was unknown.  The reporter wanted to know whether the patient should avoid this vaccine in the future.; Sender's Comments: This case concerns a 12-year-old patient who had syncope, 20 to 25 minutes after vaccination with MENACTRA. The time to onset is compatible. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 74.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Injection site rash
Clinical narrative: Rash at Injection site and going down to elbow. Patient is to take 50 mg of benedryl and apply ice at the injection site.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was out of date. exp.11/01/2020, child did not have any reaction or problems
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MENB
Symptoms: Wrong product administered
Clinical narrative: Patient was given Meningococcal B vaccine. Patient is 11 years old and should have received the Meningococcal conjugate Menveo but was given Bexsero.
Age: 76.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Biopsy, Lichenoid keratosis, Pruritus
Clinical narrative: Developed spots everywhere and itching.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Impaired work ability, Injection site swelling, Mobility decreased, Pain
Clinical narrative: Patient called on 11/12/2020 around 11am to report of adverse events related to her vaccination on 11/11/2020.  She reported swelling at both injection sites on the left arm.  Patient said in the evening she developed a headache and body pain.  She had arm soreness in the evening and into the night which caused her not to sleep well.  This morning she wasn't able to move her arm (lift arm up) and had to call out of work.  Patient took a dose of ibuprofen 600mg which she had in the house to help with the pain.  She also had starting placing an ice pack at the site of injection before calling the pharmacy.  Patient will contact her doctor if the pain and arm soreness continues.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient called on 11/12/2020 around 11am to report of adverse events related to her vaccination on 11/11/2020.  She reported swelling at both injection sites on the left arm.  Patient said in the evening she developed a headache and body pain.  She had arm soreness in the evening and into the night which caused her not to sleep well.  This morning she wasn't able to move her arm (lift arm up) and had to call out of work.  Patient took a dose of ibuprofen 600mg which she had in the house to help with the pain.  She also had starting placing an ice pack at the site of injection before calling the pharmacy.  Patient will contact her doctor if the pain and arm soreness continues.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hallucination, Malaise, Pyrexia, Swelling face
Clinical narrative: by the evening, she had a fever, hallucinations, swelling in face, dizziness and general malaise.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Cheilitis, Herpes simplex test negative, Lip blister, Lip pain, Oral pain
Clinical narrative: Mouth pain and lip pain the evening of the vaccine; woke up Saturday morning with blisters on lips. Painful to eat and/or drink, but no difficulty swallowing or c/o sore throat.   At office visit on 11/6 (when she received the Flu vaccine) we had applied Canthacur on warts on her left thumb and finger and the Dr. felt like she may have put her fingers near on her lips after that application which would have possibly caused the sores/blisters.
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Burning sensation, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Developed chills after 1st vaccine around 5 pm. Chills worsened over night and developed fever and achiness. Next morning still achy and fever. Fever broke the next morning. Symptoms lasted almost 15 hours. 10 days later, developed burning sensation on neck and side of back. Burning where shirt was touching and left arm which lasted one day.   2nd vaccine-Developed headache around 4-5 pm. Chills, fever, sweating over in the night. Yesterday fatigue, achy, and tired.
Age: 58.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Developed chills after 1st vaccine around 5 pm. Chills worsened over night and developed fever and achiness. Next morning still achy and fever. Fever broke the next morning. Symptoms lasted almost 15 hours. 10 days later, developed burning sensation on neck and side of back. Burning where shirt was touching and left arm which lasted one day.   2nd vaccine-Developed headache around 4-5 pm. Chills, fever, sweating over in the night. Yesterday fatigue, achy, and tired.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Headache, low-grade fever,  overall muscle aches, stiff neck that started about 8-9  hours after reciving the vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Nausea, Pain
Clinical narrative: Fever, chills, severe body aches, nausea all night. The next morning, it wasn't as bad, but two days later and I'm still very tired and not myself. I'm usually very active playing tennis or running and don't feel like I could do either one. I just wish I had been warned by the pharmacist. He only told me that my arm would be sore, which it was but I could handle that.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, severe body aches, nausea all night. The next morning, it wasn't as bad, but two days later and I'm still very tired and not myself. I'm usually very active playing tennis or running and don't feel like I could do either one. I just wish I had been warned by the pharmacist. He only told me that my arm would be sore, which it was but I could handle that.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Severe headache, nausea, fever, shivering onset around 11:00 a.m. on 11/10/20 and continuing until early evening 11/11/20.  Headache continued until 11/12/20 a.m. and fatigue still a problem.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossodynia, Pain
Clinical narrative: Patient experience soreness for 3 to 5 days but had an unusual symptom of tongue soreness and pain at the tip of the tongue.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: MORNING FOLLOWING EVENING VACCINATION PATIENT NOTICED SMALL AMOUNT OF REDNESS DIRECTLY AROUND THE INJECTION SITE, REDNESS PROGRESSIVLY GOT WORSE THROUGHOUT TUESDAY. PATIENT CONTACTED THE PHARMACY WEDNESDAY AFTERNOON TO INFORM OF THE REACTION. PATIENT ALSO NOTED LOW GRADE FEVER TUESDAY (99.7) WHICH HAD RESOLVED BY WEDNESDAY MORNING. PATIENT WAS COUNSELLED ON POSSIBLE REACTIONS TO VACCINATION AND WAS TOLD TO DRAW A LINE OF DEMARKATION AROUND THE REDNESS. WEDNESDAY EVENING PATIENT PRESENTED AT PHARMACY WITH REDNESS SPANNING JUST OVER 3 INCHES IN DIAMETER, WITH REDNESS MOVING OUTSIDE OF THE LINE MARKED EARLIER. PATIENT WAS COUNSELLED TO TAKE BENADRYL, ICE THE AREA, AND USE TOPICAL HYDROCORTISONE WITH ALOE. PATIENT WAS ALSO INSTRUCTED TO CONTACT PCP TO INFORM THEM OF REACTION. PATIENT WAS CONTACTED THURSDAY MORNING AND REPORTED NO ADDITIONAL FEVER, REDNESS MOVING MORE DOWN THE LEFT ARM SURPASSING THE LINE DRAWN BY ABOUT AN INCH. PATIENT WAS AGAIN INSTRUCTED TO CONTACT PCP.
Age: 73.0
Sex: M
Vaccine: FLU4, PPV, VARZOS
Symptoms: Diplegia, Hypoaesthesia
Clinical narrative: On 10/24 at 2200 patient could not feel his legs, there was a period of paralysis of his legs then spreading to his arms over the 12 -24 hours after administration with symptoms relieving and patient just sleeping thereafter for 2 days
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Mobility decreased, Pain
Clinical narrative: Immediately when given the flu shot had extreme pain in arm. I have had several flu shots in my life and nothing felt like this. My arm was  sore for a few days and then after a week had extreme pain in left arm with movement and cannot sleep on my left side. The injection was given quite high on my arm and may have gone into my joint capsule. I continue to have pain and have to go to PT to help with  movement and pain.  I also have numbness and tingling in my left hand.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia, Sleep disorder, X-ray normal
Clinical narrative: Immediately when given the flu shot had extreme pain in arm. I have had several flu shots in my life and nothing felt like this. My arm was  sore for a few days and then after a week had extreme pain in left arm with movement and cannot sleep on my left side. The injection was given quite high on my arm and may have gone into my joint capsule. I continue to have pain and have to go to PT to help with  movement and pain.  I also have numbness and tingling in my left hand.
Age: 73.0
Sex: M
Vaccine: FLU4, UNK
Symptoms: Abdominal pain upper, Balance disorder, Headache, Vision blurred
Clinical narrative: After an hour was unable to catch balance. Blurred vision, minor headaches, severe stomach pains.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Paraesthesia, Tremor
Clinical narrative: TINGLING IN ARMS AND HANDS BILATERALLY FOR 5 MINUTES DIRECTLY AFTER VACCINES WERE ADMINISTERED.  THEN, C/O "SHAKING ON THE INSIDE" ONLY IN LT ARM AND HAND FOR ABOUT 5 MORE MINUTES. BENADRYL 12.5MG GIVEN PO ABOUT 5 MINUTES AFTER ADMINISTRATION OF VACCCINES. MONITORED CLIENT FOR 30 MINUTES WHILE IN CLINIC. EDUCATED MOTHER AND CLIENT ON SIDE EFFECTS AND ADVERSE REACTIONS TO ALL 3 VACCINES AND WHEN TO SEEK FURTHER MEDICAL CARE BEFORE CLIENT LEFT CLINIC. VERBALIZED UNDERSTANDING.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient complained of hives showing up on the left side of his body, patient came down to clinic to be looked at and was given Benadryl. Patient did not show any symptoms of any other adverse reaction. Patient did say he had pizza that night.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal X-ray, Adenovirus test, Alanine aminotransferase increased, Alpha 1 globulin increased, Alpha 2 globulin normal
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Angiogram, Anion gap, Arteriogram carotid normal, Arthralgia, Aspartate aminotransferase increased
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bacterial test negative, Basophil count normal, Basophil percentage, Beta 2 globulin
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood calcium decreased, Blood chloride increased
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol normal, Blood creatinine normal, Blood culture, Blood folate increased, Blood glucose normal
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood magnesium normal, Blood pH normal, Blood phosphorus normal, Blood potassium normal, Blood sodium normal
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone normal, Blood triglycerides decreased, Blood urea normal, Blood urine present, Bordetella test negative
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Borrelia test negative, CSF culture, CSF glucose normal, CSF lymphocyte count increased, CSF protein increased
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: CSF red blood cell count positive, CSF test, CSF white blood cell count negative, Carbon dioxide normal, Chest X-ray
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Chlamydia test negative, Coma, Computerised tomogram head, Confusional state
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Coronavirus test negative, Cryptococcus test, Culture urine, Encephalopathy, Endotracheal intubation
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Eosinophil count normal, Eosinophil percentage, Glomerular filtration rate, Glucose urine absent, Gram stain
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hepatobiliary scan, Herpes simplex test negative, High density lipoprotein decreased
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Human metapneumovirus test, Human rhinovirus test, Immunoglobulins, Influenza A virus test negative, Influenza B virus test
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza virus test negative, Intensive care, International normalised ratio normal, Liver function test increased, Lymphocyte count normal
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphocyte percentage, Magnetic resonance imaging brain normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Mean platelet volume increased, Memory impairment, Monocyte count increased, Monocyte percentage increased, Neutrophil count normal
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Neutrophil percentage, PCO2 normal, Platelet count normal, Polymerase chain reaction, Poor quality sleep
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Protein total decreased, Protein urine absent, Prothrombin time prolonged, Pyrexia, Red blood cell count decreased
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell nucleated morphology, Red blood cells urine, Red cell distribution width normal, Respiratory syncytial virus test negative, Scan with contrast
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Scan with contrast normal, Seizure, Specific gravity urine normal, Staphylococcus test negative, Thrombocytopenia
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Troponin normal, Ultrasound abdomen, Unresponsive to stimuli, Urinary casts, Urine ketone body absent
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Urobilinogen urine, Very low density lipoprotein normal, Viral test negative, Vitamin B12 normal, White blood cell count increased
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cells urine positive, pH urine normal
Clinical narrative: 6 days after the Shingrix vaccine, my wife found me acutely confused and unable to answer simple questions at home in the afternoon on 9/17/2020. I had complained about having a bad night of sleep with pains in my joints and chills. I was taken to the Emergency Room at Hospital where I developed progressively worsening encephalopathy to the point of coma followed by a seizure. I was subsequently intubated for airway protection and remained unresponsive for 3 days until my coma lifted day 5. I developed fevers on hospital day 3. Lumbar puncture showed a lymphocytic pleocytosis. My initial platelet count was normal but I developed moderate thrombocytopenia (was receiving prophylactic heparin) and a moderate LFT elevation which have both since resolved. MRI of the brain, head CT, and CT neck angiography were all normal. I do not recall anything of the above. My recollections returned when I awoke in the ICU on 9/21/2020. Following some critical illness weakness initially, I have recovered completely. Attached is a complete list of all the tests performed while I was in Hospital. Of note, I have been working from home and have minimal contacts outside of a very small group of family since the pandemic began.
Age: 8.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Product administered to patient of inappropriate age, Vaccination error
Clinical narrative: three siblings in room and two of them were to receive Kinrix and Proquad along with flu vaccines and they were 4 and 5 years of age.  The eight year old sibling was added on to get a flu vaccine. The vaccines were ordered correctly and verified by a contemporary but when the LPN  went in the exam room she had the 8 year old on the exam table first and gave the Kinrix and Proquad and the flu vaccine.  The LPN realized her mistake immediately and notified mother who was in room and the Pediatrician.  We had the discussion about verifying patient identity using two identifiers and we brought this up at the staff meeting yesterday as a teaching tool to all staff to slow down and make sure correct vaccine/medication going to correct patient.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: No additional AE reported; M-M-R II was administered by the intramuscular route instead of subcutaneous; This spontaneous report was received from a physician regarding to a patient of unknown age and gender. Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On 27-OCT-2020, the patient was vaccinated  by the intramuscular route instead of subcutaneous with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II), 0.5 milliliter, lot # S037499, expiration date 20-NOV-2021 .    No additional AE reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: M-M-R II was administered to 3 patients on 10/26/2020 after a temperature excursion and prior to having vaccines evaluated; This spontaneous report as received from other health professional refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-OCT-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (lot number: S031482, expiration date: 07-OCT-2021, dose and route of administration were not provided) after a temperature excursion and prior to having the vaccine evaluated (improper storage of product in use). The vaccine was stored in temperature below 36 degrees Fahrenheit (2 degrees Celsius) (0.9 to 1.9 degrees Celsius) for 10 hours and above 47 degrees Fahrenheit (9 degrees Celsius) (9.1 degrees Celsius) for 30 minutes. There was no previous temperature excursion. Digital data lodger was not involved.  This is one of the three reports from the same reporter.; Sender's Comments:  US-009507513-2010USA010872: US-009507513-2010USA010939: