chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: ANTH, ANTH, SMALL, TYP
Symptoms: Night sweats, Paraesthesia, Respiratory tract infection, Tinnitus, Vertigo
Clinical narrative: 1) Tinnitus - 2 weeks after was first symptom of which I still have. Please refer to attached timeline for complete list of symptoms I attribute to the Anthrax series I received.
Age: 50.0
Sex: M
Vaccine: ANTH, ANTH, SMALL, TYP
Symptoms: Tinnitus
Clinical narrative: 1) Tinnitus - 2 weeks after was first symptom of which I still have. Please refer to attached timeline for complete list of symptoms I attribute to the Anthrax series I received.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14-JUL-2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25-JUL-2011) after being given his second dose ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25-JUL-2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Intussusception, Surgery
Clinical narrative: Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14-JUL-2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25-JUL-2011) after being given his second dose ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25-JUL-2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal mass, Caecum operation, Ileectomy, Intussusception
Clinical narrative: Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14-JUL-2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25-JUL-2011) after being given his second dose ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25-JUL-2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Lethargy, Surgery, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from a physician concerning an approximately 22 weeks old male patient who approximately on 14-JUL-2011, was orally vaccinated with 2 mL of the second dose of ROTATEQ (Lot# and expiration date not reported). Physician reported that 11 days (approximately on 25-JUL-2011) after being given his second dose ROTATEQ, within the last week, the patient developed intussusception. The patient was admitted to an unspecified hospital on an unspecified date and had surgery done as an emergency intervention on 25-JUL-2011. The patient was currently in the hospital. The adverse event was not diagnosed as intussusception when the patient was first admitted to the hospital. Physician reported that the adverse event improved after stopping therapy and the adverse event first occurred after reintroduction. At the time of reporting, the patient was still hospitalized but the intussusception had improved. Intussusception was determined to be an other important medical event by the physician. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypoaesthesia, Injection site anaesthesia, Lethargy, Speech disorder
Clinical narrative: After the administration of ADACEL, the patient complained of dizziness & numbness that spread from her left arm (site of injection) to lower extremities. She was also lethargic with mumbled speech. Patient fully recovered after 2 days but her hospitalization was prolonged by 2 days.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Intestinal operation, Intussusception, Small intestinal obstruction
Clinical narrative: Patient was admitted for small bowel obstruction which eventually led to operative management which found intussusception.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Computerised tomogram abnormal, Intestinal resection, Intussusception, Scan abdomen abnormal, Vomiting
Clinical narrative: Patient was admitted for small bowel obstruction which eventually led to operative management which found intussusception.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt noticed soreness and redness on arms starting the evening of 8/2 that is still present.  Pt presented in the clinic this morning for allergy injection and pt had redness in both upper extremities (worse on right side) with heat and swelling (mild but noticedable) noted.  Pt did not recieve allergy injection today.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dry skin, Feeling of body temperature change, Nervousness, Skin warm
Clinical narrative: 2:04 C/o feeling hot, then cold and shaky. Denies dizziness, LOC, trauma, nausea, vomiting, headache, SOB, or weakness to extremities. A&O x3, color good, skin warm and dry, speech clear and gait steady. States ate 100% lunch. VS: 139/88-102-24 O2Sat 100% T 98.1 (oral). 2:10 Resting: 142/79-96-20. Color good, skin warm and dry. A&O x3. 2:25 PM 128/67-75-20. "I feel better now." 2:35 PM 129/68-73-18 T 98.1 O2 Sat 99%. 2:45P "I'm OK now" Denies HA, SOB, Dizziness. 142/74- 79-20 100%. T 98.1 Gait steady, speech clear. Returned to class.
Age: 1.4
Sex: F
Vaccine: DTP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, C-reactive protein increased, Culture negative
Clinical narrative: Initial report was received via a search of the scientific literature on 25 July 2011. A 17-month-old female patient presented to the emergency department with acute onset of inability to bear weight on her left leg 10 days after she had received a DPT vaccination (date and route of administration not reported) in her left thigh during a pediatric well baby visit. She had no history of constitutional symptoms or trauma. Physical examination demonstrated a fullness with measured asymmetry to her left thigh. Laboratory and diagnostic findings included CBC results - white blood cell count of 12,300; with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. She had elevated creatine phosphokinase (CPK) and minimal elevation of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Sedimentation rate was 12, and C-reactive protein was minimally elevated. Radiographs of the left femur demonstrated soft tissue swelling, but no osseous abnormality. MRI demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. Culture of the fluid revealed no growth. Following intravenous gadolinium there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified and the marrow had normal signal characteristics. Post contrast image showed the long length of the myositis surrounding the shaft of the femur with a central area of nonenhancement representing the sterile abscess, surrounded by the ring enhancement. The patient was discharged from the hospital without receiving antibiotics or invasive surgical intervention. With conservative therapy, the pediatrician reported that the patient returned to normal activity within seven days. Documents held by sender: None.
Age: 1.4
Sex: F
Vaccine: DTP
Symptoms: Eosinophil count, Injection site abscess sterile, Injection site oedema, Injection site reaction, Lymphocyte count
Clinical narrative: Initial report was received via a search of the scientific literature on 25 July 2011. A 17-month-old female patient presented to the emergency department with acute onset of inability to bear weight on her left leg 10 days after she had received a DPT vaccination (date and route of administration not reported) in her left thigh during a pediatric well baby visit. She had no history of constitutional symptoms or trauma. Physical examination demonstrated a fullness with measured asymmetry to her left thigh. Laboratory and diagnostic findings included CBC results - white blood cell count of 12,300; with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. She had elevated creatine phosphokinase (CPK) and minimal elevation of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Sedimentation rate was 12, and C-reactive protein was minimally elevated. Radiographs of the left femur demonstrated soft tissue swelling, but no osseous abnormality. MRI demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. Culture of the fluid revealed no growth. Following intravenous gadolinium there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified and the marrow had normal signal characteristics. Post contrast image showed the long length of the myositis surrounding the shaft of the femur with a central area of nonenhancement representing the sterile abscess, surrounded by the ring enhancement. The patient was discharged from the hospital without receiving antibiotics or invasive surgical intervention. With conservative therapy, the pediatrician reported that the patient returned to normal activity within seven days. Documents held by sender: None.
Age: 1.4
Sex: F
Vaccine: DTP
Symptoms: Monocyte count, Myositis, Neutrophil count, Nuclear magnetic resonance imaging abnormal, Oedema peripheral
Clinical narrative: Initial report was received via a search of the scientific literature on 25 July 2011. A 17-month-old female patient presented to the emergency department with acute onset of inability to bear weight on her left leg 10 days after she had received a DPT vaccination (date and route of administration not reported) in her left thigh during a pediatric well baby visit. She had no history of constitutional symptoms or trauma. Physical examination demonstrated a fullness with measured asymmetry to her left thigh. Laboratory and diagnostic findings included CBC results - white blood cell count of 12,300; with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. She had elevated creatine phosphokinase (CPK) and minimal elevation of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Sedimentation rate was 12, and C-reactive protein was minimally elevated. Radiographs of the left femur demonstrated soft tissue swelling, but no osseous abnormality. MRI demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. Culture of the fluid revealed no growth. Following intravenous gadolinium there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified and the marrow had normal signal characteristics. Post contrast image showed the long length of the myositis surrounding the shaft of the femur with a central area of nonenhancement representing the sterile abscess, surrounded by the ring enhancement. The patient was discharged from the hospital without receiving antibiotics or invasive surgical intervention. With conservative therapy, the pediatrician reported that the patient returned to normal activity within seven days. Documents held by sender: None.
Age: 1.4
Sex: F
Vaccine: DTP
Symptoms: Red blood cell sedimentation rate increased, Weight bearing difficulty, White blood cell count normal, X-ray limb abnormal
Clinical narrative: Initial report was received via a search of the scientific literature on 25 July 2011. A 17-month-old female patient presented to the emergency department with acute onset of inability to bear weight on her left leg 10 days after she had received a DPT vaccination (date and route of administration not reported) in her left thigh during a pediatric well baby visit. She had no history of constitutional symptoms or trauma. Physical examination demonstrated a fullness with measured asymmetry to her left thigh. Laboratory and diagnostic findings included CBC results - white blood cell count of 12,300; with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. She had elevated creatine phosphokinase (CPK) and minimal elevation of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). Sedimentation rate was 12, and C-reactive protein was minimally elevated. Radiographs of the left femur demonstrated soft tissue swelling, but no osseous abnormality. MRI demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. Culture of the fluid revealed no growth. Following intravenous gadolinium there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified and the marrow had normal signal characteristics. Post contrast image showed the long length of the myositis surrounding the shaft of the femur with a central area of nonenhancement representing the sterile abscess, surrounded by the ring enhancement. The patient was discharged from the hospital without receiving antibiotics or invasive surgical intervention. With conservative therapy, the pediatrician reported that the patient returned to normal activity within seven days. Documents held by sender: None.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pain, Swelling, Tenderness
Clinical narrative: Local reaction redness swelling tenderness pain
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Developed a rash following vaccines- questionable reaction? Rash started on face and went down body. Went to MD on 6-29-11 and was given a steroid shot and told to continue Benadryl. Patient has been swimming in a cloudy pool and been in a hot tub on 6-26-11- and complaints started 6-27-11.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Injection site was swollen, red, tender, and felt like a hard lump, about the size of a half dollar and lasted about 10 days.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Anaphylactic shock, Dermatitis, Rash generalised
Clinical narrative: Information has been received from a consumer concerning a 5 year old male patient (currently 7 years old) with no pertinent medical history and no known drug reactions or allergies, who on 13-NOV-2008 was vaccinated with a dose of MMR II (dose and route not reported) and lot # 658340/1011X. There was no concomitant medication. The consumer reported that when given the MMR II shot, on 13-NOV-2008 the patient experienced anaphylactic shock and dermatitis; he had a rash all over his body for about a year and was hospitalized (date not reported). Treatment for the adverse event included EPIPEN. Laboratory diagnostics studies were not performed. At the time of the report, on an unspecified date, the patient recovered from dermatitis and anaphylactic shock and it was also reported that the "rash lasted a year" (on 13-NOV-2009). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage
Clinical narrative: Information has been received from a doctor of science, the author of an article published in the journal in June 2011, who reported that the analysis of side effects of GARDASIL (lot numbers not reported) showed that there were "236 cases of pregnant women who were stricken, most of them suffering miscarriages or bleeding". The patients' outcomes were unknown. Upon internal review, miscarriages were considered to be other important medical events. No further information is available.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed area approx 4" x 3" at injection site of slight swelling, slightly raised area; area is slightly red, warm, and tender to the touch.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Viral test
Clinical narrative: Apparent localized shingles outbreak on skin of left arm near vaccine site. Patient started on VALTREX treatment.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Erythema, Injection site erythema, Injection site haemorrhage, Injection site induration, Injection site swelling
Clinical narrative: Pt given vaccination on 7/28/11. Mom reports pt woke up w/right upper arm very red & swollen on 7/29/11. Right arm - 1cm area of ecchymosis around injection site. Has about 8.5-9.0 cm by 5.5-6.0 cm of induration below injection site. (+) swelling, (+) erythema, (+) warm, (-) painful to palpation. Pt treated w/KEFLEX BID x 10 days.
Age: 11.0
Sex: M
Vaccine: HPVX, MNQ
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Pt given vaccination on 7/28/11. Mom reports pt woke up w/right upper arm very red & swollen on 7/29/11. Right arm - 1cm area of ecchymosis around injection site. Has about 8.5-9.0 cm by 5.5-6.0 cm of induration below injection site. (+) swelling, (+) erythema, (+) warm, (-) painful to palpation. Pt treated w/KEFLEX BID x 10 days.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Mom reports 4-5 hives localized to trunk and armpits. Occurred same day and resolved within 1 day.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Rash generalised
Clinical narrative: Mom brought pt. in 7/28/11 (Thurs) and pt received MENACTRA and ADACEL. On 8/2/11 (Tues) mom return with pt. and pinpoint rash noted over body. Dr. instructed mom to give pt. OTC Loratadine during the daytime and BENADRYL at night.
Age: 1.5
Sex: F
Vaccine: DTP
Symptoms: Abscess sterile, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, C-reactive protein increased
Clinical narrative: This case was reported in a literature article and described the occurrence of myositis in a 17-month-old female subject who was vaccinated with DTP vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTP vaccine (route unknown, left thigh, batch number not provided). 10 days after vaccination with DTP vaccine, the subject experienced myositis, edema, unable to bear weight on her left leg, soft tissue swelling (without osseous abnormality) and sterile abscess. No constitutional symptoms, fever, weight loss, night sweats, rash or history of trauma. The subject was hospitalised and discharged without receiving antibiotic therapy or invasive surgical procedure. Physical exam demonstrated a fullness with measured asymmetry to her left thigh. Radiographs of the left femur demonstrated soft tissue swelling but no osseous abnormality. The initial concern was for a soft tissue neoplasm such as lipoma, lipoblastoma, rhabdomyosarcoma, liposarcoma, or metastatic neuroblastoma. Although there was no history of witnessed trauma, hematoma was an additional consideration. Complete blood count yielded a white blood cell count of 12,300 with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. There was elevation of the creatine phosphokinase and minimal elevation of the aspartate aminotransferase and alanine aminotransferase. Sedimentation rate was 12 and c-reactive protein was minimally elevated. Magnetic resonance imaging demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. The subject was treated with gadolinium. After that, there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified. Within 7 days, the events were resolved.
Age: 1.5
Sex: F
Vaccine: DTP
Symptoms: Eosinophil count, Fluid retention, Lymphocyte count, Monocyte count, Myositis
Clinical narrative: This case was reported in a literature article and described the occurrence of myositis in a 17-month-old female subject who was vaccinated with DTP vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTP vaccine (route unknown, left thigh, batch number not provided). 10 days after vaccination with DTP vaccine, the subject experienced myositis, edema, unable to bear weight on her left leg, soft tissue swelling (without osseous abnormality) and sterile abscess. No constitutional symptoms, fever, weight loss, night sweats, rash or history of trauma. The subject was hospitalised and discharged without receiving antibiotic therapy or invasive surgical procedure. Physical exam demonstrated a fullness with measured asymmetry to her left thigh. Radiographs of the left femur demonstrated soft tissue swelling but no osseous abnormality. The initial concern was for a soft tissue neoplasm such as lipoma, lipoblastoma, rhabdomyosarcoma, liposarcoma, or metastatic neuroblastoma. Although there was no history of witnessed trauma, hematoma was an additional consideration. Complete blood count yielded a white blood cell count of 12,300 with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. There was elevation of the creatine phosphokinase and minimal elevation of the aspartate aminotransferase and alanine aminotransferase. Sedimentation rate was 12 and c-reactive protein was minimally elevated. Magnetic resonance imaging demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. The subject was treated with gadolinium. After that, there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified. Within 7 days, the events were resolved.
Age: 1.5
Sex: F
Vaccine: DTP
Symptoms: Neutrophil count, Nuclear magnetic resonance imaging abnormal, Oedema, Oedema peripheral, Red blood cell sedimentation rate increased
Clinical narrative: This case was reported in a literature article and described the occurrence of myositis in a 17-month-old female subject who was vaccinated with DTP vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTP vaccine (route unknown, left thigh, batch number not provided). 10 days after vaccination with DTP vaccine, the subject experienced myositis, edema, unable to bear weight on her left leg, soft tissue swelling (without osseous abnormality) and sterile abscess. No constitutional symptoms, fever, weight loss, night sweats, rash or history of trauma. The subject was hospitalised and discharged without receiving antibiotic therapy or invasive surgical procedure. Physical exam demonstrated a fullness with measured asymmetry to her left thigh. Radiographs of the left femur demonstrated soft tissue swelling but no osseous abnormality. The initial concern was for a soft tissue neoplasm such as lipoma, lipoblastoma, rhabdomyosarcoma, liposarcoma, or metastatic neuroblastoma. Although there was no history of witnessed trauma, hematoma was an additional consideration. Complete blood count yielded a white blood cell count of 12,300 with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. There was elevation of the creatine phosphokinase and minimal elevation of the aspartate aminotransferase and alanine aminotransferase. Sedimentation rate was 12 and c-reactive protein was minimally elevated. Magnetic resonance imaging demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. The subject was treated with gadolinium. After that, there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified. Within 7 days, the events were resolved.
Age: 1.5
Sex: F
Vaccine: DTP
Symptoms: Weight bearing difficulty, White blood cell count normal, X-ray abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of myositis in a 17-month-old female subject who was vaccinated with DTP vaccine (manufacturer unspecified). On an unspecified date, the subject received an unspecified dose of DTP vaccine (route unknown, left thigh, batch number not provided). 10 days after vaccination with DTP vaccine, the subject experienced myositis, edema, unable to bear weight on her left leg, soft tissue swelling (without osseous abnormality) and sterile abscess. No constitutional symptoms, fever, weight loss, night sweats, rash or history of trauma. The subject was hospitalised and discharged without receiving antibiotic therapy or invasive surgical procedure. Physical exam demonstrated a fullness with measured asymmetry to her left thigh. Radiographs of the left femur demonstrated soft tissue swelling but no osseous abnormality. The initial concern was for a soft tissue neoplasm such as lipoma, lipoblastoma, rhabdomyosarcoma, liposarcoma, or metastatic neuroblastoma. Although there was no history of witnessed trauma, hematoma was an additional consideration. Complete blood count yielded a white blood cell count of 12,300 with 32 neutrophils, 49 lymphocytes, 9 monocytes and 10 eosinophils. There was elevation of the creatine phosphokinase and minimal elevation of the aspartate aminotransferase and alanine aminotransferase. Sedimentation rate was 12 and c-reactive protein was minimally elevated. Magnetic resonance imaging demonstrated myositis involving the vastus medialis, vastus intermedius and vastus lateralis muscles with edema and a central serpigenous collection of fluid. The subject was treated with gadolinium. After that, there was prompt hyperemic enhancement of the muscles, with an area of low signal representing the abscess and surrounding ring enhancement. There was no mass identified. Within 7 days, the events were resolved.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction on (R) thigh measuring 6 in x 5 in; warm; raised and tender to touch. No fluctuance. Child active/alert & playful.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash generalised, Sneezing, Urticaria
Clinical narrative: Child started with sneezing and then developed a generalized rash and urticaria. Treatment included Oxygen, 18.75 mg of Diphenhydramine HCl, and ORAPRED 15mg orally. Child observed in office for over 1 hour.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness to (L) upper arm, followed by redness & warmth at injection site.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Pt came in our office on 8/3/11 c/o (L) arm swollen. Pt was seen by one of our providers got treated w/KEFLEX 250mg/5 & children's MOTRIN. An appt for follow up has been schedule in 3 days.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site swelling, Pyrexia
Clinical narrative: Cellulitis (R) arm, swollen. Mild fever to 100.3 F started around 8 pm on 8/2/11. Pt was treated with KEFLEX 250 mg/ml 8 ml po BID x 7d and Hydrocortisone 2.5% apply to affected area BID.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Convulsion, Dyskinesia, Fall, Head injury, Staring
Clinical narrative: Patient had a seizure 2 minutes after receiving the shot. He has never had a seizure before. He stared blankly and collapsed to the floor and started having jerking movements. This lasted about a minute total. As he was coming to, he yelled and then came out of it. He hit his head on the clinic floor when he fell.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient had a seizure 2 minutes after receiving the shot. He has never had a seizure before. He stared blankly and collapsed to the floor and started having jerking movements. This lasted about a minute total. As he was coming to, he yelled and then came out of it. He hit his head on the clinic floor when he fell.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Irritability, Nausea, Pain
Clinical narrative: Complaints of headache, nausea, body ache, fever of 101, irritability, and mild tenderness at the injection site.
Age: 39.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Complaints of headache, nausea, body ache, fever of 101, irritability, and mild tenderness at the injection site.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pyrexia, Vomiting
Clinical narrative: Vomiting, fatigue and fever.  Lasted around 12 hours.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Teen noted soreness and swelling of Left Upper Arm. Mother took teen to ER evening of 08/03/2011. ER told teen to continue taking Claritin everyday for seasonal allergies and gave Rx for Septra for 10 days. At this point mother has noted small difference.
Age: 0.17
Sex: M
Vaccine: 6VAX-F, HIBV, PNC13, RV5
Symptoms: Rash generalised, Rash papular
Clinical narrative: Papular erythematous rash began on his chest, then spread to his abdomen, extremities and face within 72 hours
Age: 15.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Fatigue, Headache, Nausea
Clinical narrative: After obtaining Tdap vacination on drive home patient became fatigued.  At approx. 4 pm temp 100.4 F, took two Aleve, 8 pm temp increased to 104 F, on 8/04/11 2 am temp 103.9, at 10 am temp 103.1.  Complaint of Head ache and fatigue since 4 pm on 8/03/11 and slight nausa.  No vomiting, no diarrhea, no swelling, pain or heat at injection site.  Denies any illness prior to vaccination.  Denies any preexisting illness.  Denies any known drug allergies or previous reactions to any medication or vaccines.  Male sibling also recieved Tdap vaccination same date, no reaction.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: 100.6 degree fever; rash on chest and back; 2 vesicular lesions
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Blood test abnormal, Hepatic enzyme increased
Clinical narrative: This case was reported by a consumer and described the occurrence of increased liver enzymes in a 44-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health professional has not verified this report. Concurrent medical conditions included allergy to alcohol. Concurrent medications included Vitamin supplement. In May 2011, November 2010 and an unspecified date the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown). Approximately 1 month after vaccination with the 3rd dose of ENGERIX B, in June 2011, the subject experienced increased liver enzymes. This case was assessed as medically serious by GSK. Bloodwork for a physical performed in June 2011 showed an increase in liver enzymes. The subject had two repeat liver enzyme follow-up tests which still showed an increase. At the time of reporting the event was unresolved.
Age: 0.7
Sex: F
Vaccine: DTAP, UNK
Symptoms: Methaemoglobinaemia, Vomiting
Clinical narrative: This case was reported by a consumer (the subject's mother) and described the occurrence of vomiting in a 9-month-old female subject who was vaccinated with DTAP vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject's medical history included vomiting following previous unspecified vaccinations. Concurrent medical conditions included allergy to animal proteins and gelatin. Concurrent vaccination included three to four unspecified vaccines (unknown vaccines, manufacturers unspecified) given the same day as DTAP vaccine. Concurrent medications included Zantac. On an unspecified date the subject received 1st dose of DTAP vaccine (unknown route, unknown thigh) Forty-eight hours after vaccination with DTAP vaccine, the subject experienced vomiting. The subject vomited for 48 hours. The subject was hospitalised for 8 days. The mother reported that the subject "almost died". It took 3 to 4 days for the subject to get back to normal and 7 days total until she could eat. The subject was treated with pedialyte before going back onto food. The subject was also diagnosed with methemoglobinemia. The mother noted that the subject had been "severely" ill since infancy. At the time of reporting the vomiting was resolved and the outcome of the methemoglobinemia was unspecified. The mother noted that all the vaccines administered contained gelatin, and had delayed taking her daughter to the doctor to receive the next dose of vaccine for fear of her getting sick again. She reported that she intended to make sure that the subject was only given one vaccine at a time and that it dose not contain gelatin.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist concerning a 71 year old female patient who on 01-SEP-2010 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). On 03-SEP-2010, the patient got redness in the injection site. The outcome of the patient was not reported. Patient did not seek medical attention. Redness in the injection site were considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 60 year old female with antibiotic allergy (specific name unspecified) who in approximately August 2010, was vaccinated with a dose of ZOSTAVAX (Merck). In approximately August 2010 ("approximately 1 month ago"), the patient had an anaphylactic reaction following administration in the office. She was treated for the reaction, however it had occurred again and she was admitted into the hospital for this event. It was unspecified what the length of stay was in the hospital. At the time of the report, the outcome was unknown. Anaphylactic reaction was considered to be immediately life-threatening by the reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with asthma, diabetes and hypertension and no drug reactions or allergies who on 12-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On 16-OCT-2010 the patient presented to physician's office with flu like symptoms and a "chickenpox" like rash all over his body. The patient was admitted to a hospital. At the time of reporting, the patient had not recovered. Flu like symptoms and a "chickenpox" like rash all over his body were considered to be other important medical events by the reporter. Additional information has been requested. The patient was admitted to Hospital.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Headache, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her 65 year old mother with cervical cancer and high blood pressure who on approximately 15-OCT-2010 "mid October 2010", was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant medications included high blood pressure medication (unspecified). It was reported that on approximately 16-OCT-2010 "a day after receiving the vaccine" the consumer's mother experienced headaches and at the time of the report she was hospitalized. The patient had a blood work and a magnetic resonance imaging (MRI) performed (results not provided). At the time of the report the patient's outcome was unknown. No further information is available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Pain of skin, Quality of life decreased, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 74 year old male with "cardiac status problems" and glaucoma who in February 2010 also reported as about "1 year ago", was vaccinated with ZOSTAVAX (Merck) (dose, route and lot # not reported) (from another provider). In approximately May 2010, "about three months post vaccine", the patient began to develop a rash-fine, red, "extremely itchy all the time". Amount of body surface covered by the rash unspecified. The rash had become extremely debilitating to the patient's quality of life. The patient had visited a dermatologist and immunologist, who prescribed prednisone (steroids). The steroid treatment did seem to help the rash, but when it was discontinued, the rash reappeared. The patient also stated that he was instructed to use a sunblock, with higher SPF, however, he burned extremely easy and the burns were painful. The patient had been experiencing this rash for "about nine months". Biopsy was performed (results not provided). At the time of the report, the patient's status was not recovered. According to the nurse, the patient's rash was considered to be disabling with lifestyle affected. No further information is available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Sunburn
Clinical narrative: Information has been received from a bachelor of science in nursing concerning a 74 year old male with "cardiac status problems" and glaucoma who in February 2010 also reported as about "1 year ago", was vaccinated with ZOSTAVAX (Merck) (dose, route and lot # not reported) (from another provider). In approximately May 2010, "about three months post vaccine", the patient began to develop a rash-fine, red, "extremely itchy all the time". Amount of body surface covered by the rash unspecified. The rash had become extremely debilitating to the patient's quality of life. The patient had visited a dermatologist and immunologist, who prescribed prednisone (steroids). The steroid treatment did seem to help the rash, but when it was discontinued, the rash reappeared. The patient also stated that he was instructed to use a sunblock, with higher SPF, however, he burned extremely easy and the burns were painful. The patient had been experiencing this rash for "about nine months". Biopsy was performed (results not provided). At the time of the report, the patient's status was not recovered. According to the nurse, the patient's rash was considered to be disabling with lifestyle affected. No further information is available.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Haematuria, Hypertension, Hypoalbuminaemia, Proteinuria
Clinical narrative: Diarrhea, facial swelling, hematuria, proteinuria, hypoalbuminemia, URI symptoms (runny nose, congestion), hypertension
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Respiratory tract congestion, Rhinorrhoea, Swelling face, Upper respiratory tract infection
Clinical narrative: Diarrhea, facial swelling, hematuria, proteinuria, hypoalbuminemia, URI symptoms (runny nose, congestion), hypertension
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Rash, Rash macular
Clinical narrative: Blotchy rash on back, face, and neck.  Many of the rash lesions are small like mosquito bites and raised a little.  Mom noticed this when she picked her up from daycare 8/04/11 around 6:00 PM.  Treatment:  topical hydrocortisone or topical Benadryl.  Call is symptoms worsen.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Aspiration biopsy, Blister, Rash pustular, Skin induration, Skin lesion
Clinical narrative: Small indurated palpable lesion with a pustule - needle aspiration did not yield any fluid; area around induration was a bumpy texture with 2-3 small visible vessicular lesions.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Gastrointestinal haemorrhage, Haematochezia, Rash
Clinical narrative: 07/29/2011-BLOODY DIARRHEA/HEMATOCHEZIA 08/01/2011-EMESIS, SEIZURE-LIKE ACTIVITY 08/02/2011-HOSPITAL ADMISSION
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Seizure like phenomena, Vomiting
Clinical narrative: 07/29/2011-BLOODY DIARRHEA/HEMATOCHEZIA 08/01/2011-EMESIS, SEIZURE-LIKE ACTIVITY 08/02/2011-HOSPITAL ADMISSION
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Cough, Dysphagia, Pyrexia, Throat irritation
Clinical narrative: Fever over 103F for 2 days, kept at or below 103 by ice packs.  Pulse jumped from a regular 70/min to over 100/min, and persists to present, even after fever.  Occasional chest pain over heart area.  Irregular growth or damage in throat that causes irritation with every swallow.  After fever, there is irregular but frequent weak coughing fits.  Have not seen doctor due to lack of insurance, hoping for recovery.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction
Clinical narrative: Injection reaction.  Redness, itchiness, and leathery patch over injection location.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase increased, C-reactive protein normal, Cardiac function test, Chest pain
Clinical narrative: 19 y/o male received primary Smallpox Vaccine (SPV), Anthrax (AVA#1), Typhoid VICPs o 06JUN11 in preparation for deployment in SEP 2011. He experienced a syncopal episode & nausea during PT on 21JUN2011 (Day #15 s/p receipt SPV). SM reports presyncopal episode & nausea the next day (22JUN11) while doing inventory at work- on feet, bending, lifting, etc. Went to ED for evaluation. Treated for "Possible Heat Exhaustion" with IV 2L NS IV fluids and ZOFRAN. No cardiac enzymes, ESR or CRP drawn. CBC and CMP WNL. EKG obtained in ED interpreted as "normal" NSR, normal p axis, V-rate 50-99, " consider left atrial abnormality- wide or notched P waves, PR 120 with baseline wander in Lead V4. SM experienced a recurrent sensation of presyncope & nausea after participating in 4-mile run on 01JUL11. SM also reports a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes w/o radiation to jaw, throat, neck or left arm, accompanied by SOB and sensation of heart "skipping a beat". Cardiac Panel (08JUL11) with + CK of 524 U/L (55-170); CKMB of 5.0 U/L WNL (2-16); CRP 0.1 WNL (Ref. 1.0 mg/dl) and ESR was 6 WNL (0-15 mm/hr). SM initially denied positional worsening of CP/SOB in supine position, but reported  a recurrent episode of similar CP on SAT 09JUL11 when lying down on bed in barracks, which last 5-10 minutes. Cardiology Consult to r/o underlying cardiac dysfunction, valvular dz, or dysrhythmias. Clinical presentation of SM's CP does not seen c/w Vaccinia Myopericarditis, but this must be considered in Differential Dx, as SM's sx occurred w/in a 30-day window of primary SPV immunization & other vaccines mentioned. Therefore, could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the SPV. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of SPV, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram.
Age: 19.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Dyspnoea, Electrocardiogram P wave normal, Electrocardiogram PR interval, Electrocardiogram normal, Extrasystoles
Clinical narrative: 19 y/o male received primary Smallpox Vaccine (SPV), Anthrax (AVA#1), Typhoid VICPs o 06JUN11 in preparation for deployment in SEP 2011. He experienced a syncopal episode & nausea during PT on 21JUN2011 (Day #15 s/p receipt SPV). SM reports presyncopal episode & nausea the next day (22JUN11) while doing inventory at work- on feet, bending, lifting, etc. Went to ED for evaluation. Treated for "Possible Heat Exhaustion" with IV 2L NS IV fluids and ZOFRAN. No cardiac enzymes, ESR or CRP drawn. CBC and CMP WNL. EKG obtained in ED interpreted as "normal" NSR, normal p axis, V-rate 50-99, " consider left atrial abnormality- wide or notched P waves, PR 120 with baseline wander in Lead V4. SM experienced a recurrent sensation of presyncope & nausea after participating in 4-mile run on 01JUL11. SM also reports a rather atypical history of occasional, intermittent, sharp, midsternal chest pain lasting seconds to a few minutes w/o radiation to jaw, throat, neck or left arm, accompanied by SOB and sensation of heart "skipping a beat". Cardiac Panel (08JUL11) with + CK of 524 U/L (55-170); CKMB of 5.0 U/L WNL (2-16); CRP 0.1 WNL (Ref. 1.0 mg/dl) and ESR was 6 WNL (0-15 mm/hr). SM initially denied positional worsening of CP/SOB in supine position, but reported  a recurrent episode of similar CP on SAT 09JUL11 when lying down on bed in barracks, which last 5-10 minutes. Cardiology Consult to r/o underlying cardiac dysfunction, valvular dz, or dysrhythmias. Clinical presentation of SM's CP does not seen c/w Vaccinia Myopericarditis, but this must be considered in Differential Dx, as SM's sx occurred w/in a 30-day window of primary SPV immunization & other vaccines mentioned. Therefore, could plausibly be associated with peak cytokine/inflammatory effect of the vaccinations, in particular the SPV. However, clinical presentation and diagnostic criteria must support this consideration as well. Typically, Vaccinia Myopericarditis is confirmed not only by temporal association with receipt of SPV, but by presence of elevated Troponin, CK, CKMB, as well as ST/T wave abnormalities and/or depressed LV function on echocardiogram.