chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Hypersensitivity, Infection, Oedema peripheral, Urticaria
Clinical narrative: Case number PHHY2012US010253 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 443968) website on 07 Feb 2012 and a follow up received from quality assurance department (reference number 146568) on 03 Apr 2012. This report refers to a 66-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1102601) intramuscularly in the left arm and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 1420AA) intramuscularly in the right arm on 11 Nov 2011. On an unspecified date, she showed signs of erythema, hives and other allergy signs down length of upper arm. It was very swollen. She went to emergency room and was informed of allergic reaction and infection. The outcome of the events was reported as complete recovery as of 21 Nov 2011. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1102601 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the quality assurance department (reference number: 146568) on 03 Apr 2012. Batch review report updated.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Cough, Dizziness, Hypoaesthesia
Clinical narrative: Right arm was numb day after vaccine was administered. Pt felt weak; like passing out. Also, pt coughed x 4 days. (Vaccine was given (R) arm).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a young male patient who on an unknown date was vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The patient was admitted to the hospital for intussusception 2 days after ROTATEQ was given. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Barium enema normal, Blood creatinine normal, Intussusception, Laboratory test normal, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician concerning a young male patient who on an unknown date was vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The patient was admitted to the hospital for intussusception 2 days after ROTATEQ was given. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Ultrasound scan abnormal, Vomiting projectile
Clinical narrative: Information has been received from a physician concerning a young male patient who on an unknown date was vaccinated with a dose of ROTATEQ (dose, route and lot # not reported). The patient was admitted to the hospital for intussusception 2 days after ROTATEQ was given. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Paraesthesia
Clinical narrative: Initial report was received from a health care professional on 30 March 2012. An 11-year-old female patient had received the following vaccinations on an unknown date: ADACEL, sanofi pasteur Ltd., lot number C3915 (sanofi pasteur Inc. lot number U3979BA), FLUZONE, sanofi pasteur Inc., lot number UH455AD, MENACTRA, sanofi pasteur Inc., lot number U4028AH and VARIVAX, Merck, lot number not reported (sites and routes not reported) and an unspecified amount of time later the patient experienced tingling in feet. The tingling had slightly improved. Illness at the time of vaccination, concomitant medications and past medical history was unknown. The patient's outcome was not recovered. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Cough, Headache, Nausea, Respiratory tract congestion
Clinical narrative: Initial report was received from a health care professional on 23 March 2012. A 15-year-old male patient had received an injection of MENACTRA (lot number, route, site and date of administration unknown) and an unspecified amount of time later experienced headache, congestion, cough, wheezing, nausea and joint aches. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Wheezing
Clinical narrative: Initial report was received from a health care professional on 23 March 2012. A 15-year-old male patient had received an injection of MENACTRA (lot number, route, site and date of administration unknown) and an unspecified amount of time later experienced headache, congestion, cough, wheezing, nausea and joint aches. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster, Pain, Rash, X-ray
Clinical narrative: Vaccine was not received. I am vaccinating pharmacist and also immunosuppressed (REMICADE, IMURAN, Prednisone). Developed shingles within 6 weeks of starting to handle the ZOSTAVAX vaccine.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Abdominal X-ray, Faeces discoloured, Intestinal operation, Intussusception, Lethargy
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Ultrasound abdomen, Vomiting
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Barium enema abnormal, Crying, Decreased activity
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Diarrhoea, Diet refusal, Enema administration, Faeces discoloured, Intussusception
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Lethargy, Lymphoblast count, Monoblast count increased, Monocyte percentage increased, Neutrophil count increased
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Neutrophil percentage increased, Occult blood positive, Somnolence, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: White blood cell count increased
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 0.27
Sex: M
Vaccine: HIBV, RV5, HIBV, RV5, RV5
Symptoms: Intussusception
Clinical narrative: Onset vomiting, lethargy, black stools 3/31/12. Dx: Right upper quadrant intussusception. Tx: Reduction of the right upper quadrant intussusception.
Age: 1.53
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was given KINRIX in error. Should have received DTaP. No adverse events reported.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Progressive shoulder pain over the following 3 weeks, nature of pain and location of vaccination site suggest bursal or joint injection.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Injection site erythema, Irritability
Clinical narrative: Mom noticed redness on leg surrounding injection site after patient woke up from nap @ 3:30 PM today. No fever, acting slightly more fussy, no cough or breathing changes. Upon arriving at office, CPNP describes reaction as mild erythema on right thigh 2" x 2.5" in diameter surrounding the injection site, no fluctuance, no pain on palpation. She stated the redness seemed to "come and go" while she was in the room. Mom and dad stated the redness was "much less" when in office than it was earlier.
Age: 95.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site scab, Scab
Clinical narrative: Patient notified me beginning of April 2012 and stated she had had a "sore" at the injection site ever since receiving injection. Upon showing me it appears to be a scaly scab.  Patient says it gets crusty then gets caught on clothing and will fall off --but then keeps coming back.  She reports it is sore when touched.  She says it never gets any better but not any worse either.  She has not sought any medical attention.  I advised her to have her primary physician take a look at it.  As of yet she has not been in to see MD and reported any other updates to me.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness, Head injury, Nausea, Syncope
Clinical narrative: Case number PHEH2012US007219 is an initial spontaneous report received from a nurse on 30 Mar 2012 with the follow-up received on 30 Mar 2012: This case refers to 11-years-old male child. He was vaccinated with MENVEO (batch number: unknown) intramuscularly and TDAP (other manufacturer) on an unspecified date. He felt "sick to his stomach" within five minutes after vaccination. He put his head down at his knees for a little bit and stomach ache and nausea gone away. Within ten minutes after vaccination, he fainted and hit the back of his head on the floor. He was treated with ice and received oxygen. He went home and slept for hours. He was dizzy at night, but recovered completely by the next day. Reporter suspected the events were related to MENVEO and TDAP. Follow-up received from a nurse on 30 Mar 2012: Updated adverse events and event outcome.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Pain
Clinical narrative: Throat felt tight - like something stuck in it/coughing without relief from water. Began vomiting during drive home (40 min commute). 1 episode explosive diarrhea by 4:30 pm then shaking, chills, hurting all over & weak. I took liquid BENADRYL & TYLENOL.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Sensation of foreign body, Throat tightness, Tremor, Vomiting
Clinical narrative: Throat felt tight - like something stuck in it/coughing without relief from water. Began vomiting during drive home (40 min commute). 1 episode explosive diarrhea by 4:30 pm then shaking, chills, hurting all over & weak. I took liquid BENADRYL & TYLENOL.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Headache, Musculoskeletal stiffness
Clinical narrative: 54 yr old F pt was given Zostavax injection 4/10 at 1000 hr.  Pt called the facility at 4/11 0045 hr.  Pt c/o stiff neck and shivering.  Pt denied fever. Follow up call 4/11 at 1013 hr.  Pt was enroute to hospital.  Pt c/o severe stabbing h/a and max temp of 103.0 f.  Case was reviewed with Toxicologist and plan to f/u with pt & hospital.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure about 3 days after administration of Hep A vaccine. Fever started 2 days after vaccine.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Pt. broke out in hives day after shots. Pt carried to ER & ordered to administer BENADRYL. Followed up at office & ordered to continue BENADRYL.
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: In doctor office at hospital. Just starting to give vaccinations for VFC. Got the T-dap instead of Dtap for a 4 year old. Will watch more closely in getting the right vaccine for the age group. Also moved the tdap to the bottom shelf since it is not for children under 10 years of age,
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint pain, Muscular weakness, Pain
Clinical narrative: PNEUMOVAX Dec 16th, 2011. (Rt) shoulder area painful abduction & local pain developed next day. Now weak (Rt) supraspinatus & sl weak (Rt) infraspinatus. No prior shoulder problems. Also weight lifts.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Localised oedema, Pruritus
Clinical narrative: Pruritus; localized edema suspected drug #1 dosing 0.5 ml IM once. Treatment drugs Used: Diphenhydramine 25  MG TID PO. Naproxen dose: 250 MG BID PO. Cephalexin 500 MG QID PO.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Activities of daily living impaired, Alanine aminotransferase increased, Arthralgia, Aspartate aminotransferase increased, Balance disorder
Clinical narrative: Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood urine present, Cognitive disorder, Dizziness
Clinical narrative: Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Fall, Fatigue, Hyperaesthesia, Impaired work ability, Joint range of motion decreased
Clinical narrative: Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Laboratory test abnormal, Memory impairment, Mobility decreased, Muscle atrophy, Muscle tightness
Clinical narrative: Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Muscular weakness, Musculoskeletal stiffness, Myoglobin blood increased, Oedema peripheral, Pain in extremity
Clinical narrative: Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Palpitations, Paraesthesia, Pneumonia, Postural orthostatic tachycardia syndrome, Protein urine present
Clinical narrative: Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Age: 34.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Quality of life decreased, Rhabdomyolysis, Tilt table test
Clinical narrative: Received anthrax #4 and the typhoid vi vaccines on 17 Sept '03. He was clinically well at the time, had no chronic illnesses and took no medications. No one in the family had had recent illnesses or infections. About 4 hours after receiving the vaccinations, he developed swelling in the arms and soreness in the upper extremity joints. He felt "tightness" and weakness in the arms and could not hold his infant. Although his memory of that day and those following it are limited, he remembers he felt "off balance" and "fell back into the car" when attempting to exit his vehicle. In the next 2-3 days his swelling and weakness became worse and his arms "doubled in size". After he developed blood in his urine on 21 Sept '03 he went to emergency room for evaluation. He was told he had protein in the urine and his CK was elevated and he was admitted overnight. LABS: AST: 750, ALT 232, CKMB 17.7, CK 32182, Myoglobin >4K. He was discharged the next day but soon was re-admitted due to continuing symptoms. The arm swelling had diminished by 50 % from the initial event but the swelling extending beyond the elbow and he was unable to bend his arms. They were acutely painful and sensitive to the touch. His chest also developed sensitivity. CK: 55194, Myoglobin 161K. Diagnosis was rhabdomyolysis. His subsequent hospitalization was for 2.5 weeks and records are not available. After discharged from the hospital he remembers continuing stiffness and pain in the arms and decreased mobility. His memory was still impaired. By Dec 03 he was able to return to work doing only desk work. By this time he had developed muscle wasting in the arms through non-use. By Jan 04 he had developed more arm mobility but had never regained his premorbid upper extremity muscle size. From 2004-2009 he performed his required employment duties but never regained his pre-illness level of functioning. In 2009 his symptoms worsened after he developed pneumonia. Now he has palpitations, orthostatic lightheadedness, fatigue, paresthesias, extremity pain, and cognitive dysfunction. He has been diagnosed with POTS: postural orthostatic tachycardia syndrome, a form of autonomic nervous system disorder, and is on multiple medications. Patient has been unable to work since Nov 2010 and is pending medical separation from work. Quality of life is poor.
Sex: U
Vaccine: DTAPIPVHIB, IPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Medical Assistant gave the patient a 0.5ml dose of PENTACEL and a 0.5ml dose of IPV to pediatric patient when the provider ordered a Dtap and IPV. This was a medication error. No injuries or adverse reaction reported, the patient is fine. This is a Federally Qualified Health Center. Medical assistant realized the error when she was documenting what she gave. Medical Assistant will double check the medication she pulled with the provider's order and she will check what she draw up with the provider order to make sure she have the correct medications ordered. Medical assistant to review the age appropriate vaccine schedule. The nurse verified the medical assistant is aware of which vaccines are included in PENTACEL.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Wrong drug administered
Clinical narrative: A three year old patient was given an adult dose of Hep A vaccine (HAVRIX) for dose number two. The order was for private Hep A as the patient was non VFC. This office does not purchase private pedi Hep A vaccine. The nurse administered the vaccine from the private inventory not realizing that the dose was incorrect.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Papule, Rash
Clinical narrative: Localize warmth, (rash on chest) arm, trace papules resolved by 4/3/12.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pruritus, Pyrexia
Clinical narrative: Itching, burning, fever, red in middle swollen, small bumps/blisters, wheezing. M.D. diagnosed as skin infection on 4/9/12 treated with heat compress, steroids, antibiotics.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin infection, Swelling, Wheezing
Clinical narrative: Itching, burning, fever, red in middle swollen, small bumps/blisters, wheezing. M.D. diagnosed as skin infection on 4/9/12 treated with heat compress, steroids, antibiotics.
Sex: U
Vaccine: HEPAB
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: X/XX/12 - TWINRIX administered to a patient at the XXXXXXXX county department of health that had already had full series of Hep B shots. TWINRIX lot # AHABB225AA, 1cc administered left deltoid. Pt notified. No adverse reactions noted. Series of Hep B not given at XXXXXXXXX county department of health, I will make sure to check NCIR before administering immunizations.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Human chorionic gonadotropin negative, Human chorionic gonadotropin positive, Maternal exposure during pregnancy
Clinical narrative: On 04/10/2012 in the clinic the said patient came into the clinic and did a urine HCG test with negative results at 0830. At this time she requested a serum HCG to be performed and this test was ordered and drawn. At this time she was asked if there was any reason why she would think that this test would show different results then the negative urine HCG had and she said no. She had not even missed a menses at this time. She then came back at 1513 and received her 2nd Anthrax dose. At 0730 on 04/11/2012 we received the report from the lab that the serum HCG came back positive. She came into the clinic and received her counseling from the PA and the nursing staff. The chief of Preventive Medicine has been informed and the unit has been informed that the said patient cannot deploy.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Headache, Hypertension
Clinical narrative: Swelling of arm, shortness of breath, pain in shoulder, severe headache, nausea, hypertension. Was given Prednisone & Zyrtec. I left the hospital around 9:30 PM.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Nausea, Oedema peripheral, X-ray
Clinical narrative: Swelling of arm, shortness of breath, pain in shoulder, severe headache, nausea, hypertension. Was given Prednisone & Zyrtec. I left the hospital around 9:30 PM.
Age: 0.5
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: 6mo old child came to health department for immunizations. Was inadvertently given FLUARIX 0.5ml (3yr and up) instead of Hep B, 0.5 ml. Packaging colors are similar. Child had left the office - event was discovered while entering data in electronic record. Incident was reported to the state immunization program. Mother was notified and advised to observe child closely, give TYLENOL q4hrs for 24-48 hours, contact pediatrician/take child to the emergency room for any other adverse events. Since it is late in the flu season, my action was to move flu vaccine stock to the back of the refrigerator to prevent further incidents.
Sex: U
Vaccine: RV5
Symptoms: Oral administration complication, Vomiting
Clinical narrative: Patient received first dose of RVS and vomited twice, second dose and subsequent doses were held.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: First rotavirus/rv5 vaccine was ordered after 17 weeks of age and given. No adverse reaction noted to patient.
Sex: U
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: An expired dose of MENACTRA was given to a patient the dose expired on X/XX/2012 and dose was given on X/XX/2012 (next day). We have removed the vaccine from the fridge and the patient will be revaccinated.
Age: 1.26
Sex: M
Vaccine: DTAPIPV, HEPAB
Symptoms: Wrong drug administered
Clinical narrative: Patient received KINRIX in error. Should have received DTaP.
Age: 19.0
Sex: M
Vaccine: TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site pruritus, Pain in extremity
Clinical narrative: 4-2-12 Pt. was give 2 injections (Tdap & Yellow fever) and 4 oral typhoid pills. After taking 3 pills of typhoid noted redness and itching on left arm. Had finished all four pills before calling 4-9-12 when arm began hurting. Advised cortisone cream to itching and BENADRYL. Pt. thinks this is due to typhoid pills but being only in area of YF shot that may be source.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Pruritic urticaria of face, chest, arms and shoulders. No respiratory or cardiac issues. IM Epinephrine and po Benadryl given. Transported to Emergency Room via ambulance for further observation and treatment.
Age: 15.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Hives 10/23/10.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Anosmia, Computerised tomogram head, Nuclear magnetic resonance imaging brain, Parosmia
Clinical narrative: Kept smelling cigarette smoke (I was not around cigareettes) for a few weeks; Then I kept smelling burnt popcorn for a few weeks and was not around that smell either. No one else smelled this except me..then I got up one morning and had no sense of smell at all. Still cannot smell anything at all.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Swelling, redness, tenderness, warmth. Ice packs and elevation.
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Oedema peripheral, Rash, Rash erythematous
Clinical narrative: 9 AM got vaccine afternoon rash swollen arm. Pt states had a swollen red arm after vaccine given and a fine (on arm) red rash the afternoon after vaccine given today still slight swelling & redness not certain from vaccine but timing is right.
Age: 3.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: (Per mom) Fever 104.3 24 hrs after vaccinations, local reaction -> redness, edema, warm to touch. (L) lat. thigh. Hosp ER report: T 98.6, cellulitis, KEFLEX.
Age: 3.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Pyrexia
Clinical narrative: (Per mom) Fever 104.3 24 hrs after vaccinations, local reaction -> redness, edema, warm to touch. (L) lat. thigh. Hosp ER report: T 98.6, cellulitis, KEFLEX.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood glucose normal, Convulsion, Dyskinesia, Gaze palsy, Presyncope
Clinical narrative: Post-Syncope Seizure, 30 seconds after receiving GARDASIL 0.5 ml left deltoid patient had vasovagal reaction - fainted eyes rolled back. Tongue protruded, full body jerking for 15 seconds, patient unresponsive during seizure activity, EMS notified.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Protrusion tongue, Syncope, Unresponsive to stimuli
Clinical narrative: Post-Syncope Seizure, 30 seconds after receiving GARDASIL 0.5 ml left deltoid patient had vasovagal reaction - fainted eyes rolled back. Tongue protruded, full body jerking for 15 seconds, patient unresponsive during seizure activity, EMS notified.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Abnormal behaviour, Decreased eye contact, Unresponsive to stimuli
Clinical narrative: Information has been received from the mother of a consumer concerning her 8 weeks old infant son who on 08-JAN-2010, was vaccinated with a dose of ROTATEQ (dose, route and lot number not reported). Concomitant therapy included Hib conj vaccine (manufacturer unknown), PENTACEL (unspecified) and TYLENOL. The consumer stated that her son had an adverse event after receiving ROTATEQ. "Immediately after" he was fine at 11AM on 08-JAN-2010. The infant felt asleep and was still fine. At 9 PM the consumer reported that they gave him on dose of TYLENOL. He was not responding and did not bubble or coo and he did not take eye contact with him or interact. The consumer called her physician about the TYLENOL. On the 6th day (on 14-JAN-2010), he started eye contact again. The consumer stated that her son was fully resolved after three weeks (on approximately 29-JAN-2010). The consumer stated that at the fourth month vaccine series, he did not had the TYLENOL and had no symptoms. It was unknown if the patient sought medical attention. The patient did not receive any treatment for the event. At the time of the report the patient had recovered. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Paralysis
Clinical narrative: Immunization provided for employer group as part of an onsite immunization clinic. Employees were invited to receive flu shots sponsored by employer. I do not have many specifics because I did not speak to the patient. Instead, the employer is working with the patient and they only indicated that the patient "got ill after the flu shot and eventually had some type of partial paralysis." I do not know the timeline of this occurence, the severity, or whether it still exists. The employee received the flu shot in Oct 2010 and we were notified by the employer yesterday, 4/10/2012 (approx 1.5 years later).
Age: 0.17
Sex: F
Vaccine: DPP, HIBV, RVX
Symptoms: Vomiting
Clinical narrative: Vomiting every 1 1/2 to 2 hours for 8 days.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Bilirubin conjugated increased, Blood bilirubin increased, Chest X-ray, Erythema, Haemoglobin decreased
Clinical narrative: Fever, redness and swelling, shotty lymph nodes, headache.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Lymphadenopathy, Pyrexia, Reticulocyte count increased, Swelling
Clinical narrative: Fever, redness and swelling, shotty lymph nodes, headache.
Age: 12.0
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Fever, redness and swelling, shotty lymph nodes, headache.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Genital herpes, Skin lesion
Clinical narrative: Lesions on penis. Diagnosed with herpes but there was no sexual contact with anyone.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash generalised
Clinical narrative: Lesions on penis. Diagnosed with herpes but there was no sexual contact with anyone.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Started with body aches and soreness followed by chills in the evening. Woke up around 2 AM with fever of 102.5. Took Advil and water but fever kept rising to 103.5 by morning. Called DR, went in, he put me on Tylenol and a five day course of Prednisone. Arm remained red and sore from elbow to shoulder for 5-6 days.  Still somewhat stiff today.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Started with body aches and soreness followed by chills in the evening. Woke up around 2 AM with fever of 102.5. Took Advil and water but fever kept rising to 103.5 by morning. Called DR, went in, he put me on Tylenol and a five day course of Prednisone. Arm remained red and sore from elbow to shoulder for 5-6 days.  Still somewhat stiff today.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count, Lymphadenopathy, Pain, Palatal disorder, Pyrexia
Clinical narrative: Achy, feverish, swelling of soft palate and lymph nodes.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HBHEPB, RVX
Symptoms: Crying, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: Thigh swollen, red, & warm.  Fussiness, uncontrolled crying.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Body temperature increased, Headache, Influenza like illness, Malaise
Clinical narrative: Malaise, flu like body aches, low grade temp and headache.  Followed by a papular (1 mm papules) red rash on palms, then extensor surface of hands/knees/elbows (nowhere else).  Somewhat pruritic.  Bilateral arthralgias in joints, but mostly in hands.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Malaise, flu like body aches, low grade temp and headache.  Followed by a papular (1 mm papules) red rash on palms, then extensor surface of hands/knees/elbows (nowhere else).  Somewhat pruritic.  Bilateral arthralgias in joints, but mostly in hands.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Local reaction
Clinical narrative: Pt. return to clinic - localized reaction. Induration size of 25 cents, redness 2 1/2 in x 2 1/2 in. Advised to use cool compress, TYLENOL or BENADRYL.
Age: 41.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Feeling hot, Oedema, Tenderness
Clinical narrative: Local erythema, edema, tenderness, warmth within 12 hrs treated with antihistamines & cool compress.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Rash
Clinical narrative: On Lt thigh (KINRIX given). 4in x 3in redness, warm to touch - 4/11/12 at 9:10am appeared 4/10/12. Tiredness. Rash on Lt cheek (Monday) almost gone now. Mother given BENADRYL, Ibuprofen, cool compresses. No SOB.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: (On 4/3/12) The morning after receiving a vaccination (Varicella), patient presented with swollen, red, hard lump. At site of injection. By the following day, symptoms had spread, extending length of under side of upper arm. Itchy, hot to the touch. Given BENADRYL and started on BACTRIM D.S, symptoms resolved by 4/9/12.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Chest X-ray, Computerised tomogram abdomen, Drug administered at inappropriate site, Electrocardiogram, Erythema
Clinical narrative: Initial report received from a healthcare professional on 29 March 2012. A (questionably) 47-year-old female received a (questionably) left arm injection of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) at the employee health office on a day (questionably in February) 2012. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. Sometime after injection (on a date not specified), the patient developed left arm numbness and weakness, which the patient has now had for seven weeks. The reporter did not have patient information or vaccination information at time of call. The patient's outcome was not recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Haematoma, Hypoaesthesia, Nephrolithiasis, Nuclear magnetic resonance imaging, Oedema peripheral
Clinical narrative: Initial report received from a healthcare professional on 29 March 2012. A (questionably) 47-year-old female received a (questionably) left arm injection of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) at the employee health office on a day (questionably in February) 2012. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. Sometime after injection (on a date not specified), the patient developed left arm numbness and weakness, which the patient has now had for seven weeks. The reporter did not have patient information or vaccination information at time of call. The patient's outcome was not recovered. Documents held by sender: None.
Age: 47.0
Sex: F
Vaccine: TDAP, TDAP, TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia, Skin warm, X-ray limb
Clinical narrative: Initial report received from a healthcare professional on 29 March 2012. A (questionably) 47-year-old female received a (questionably) left arm injection of ADACEL, sanofi pasteur Ltd., (lot number, and route not reported) at the employee health office on a day (questionably in February) 2012. The patient's medical history, any concomitant medications, and any illnesses at the time of vaccination, and any adverse event following prior vaccinations were not reported. Sometime after injection (on a date not specified), the patient developed left arm numbness and weakness, which the patient has now had for seven weeks. The reporter did not have patient information or vaccination information at time of call. The patient's outcome was not recovered. Documents held by sender: None.