chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Arthralgia, Asthenia, Chest discomfort, Chest pain, Cough
Clinical narrative: A report was received from a physician via another manufacturer (Ref WAES0501USA00553) on 17Mar05 concerning a 40 year old female vaccinee. The vaccinee has a history of asthma, seasonal bronchitis, drug hypersensitivity and migraines. She has allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (macrodontin) and prochlorperazine maleate (Compazine IV). The vaccinee has no allergies to eggs, thimerosal, contact lens solution, mercury or latex. She has no history of Guillian Barre Syndrome, neurologic conditions or reactions to flu shots. The vaccinee was not receiving immunosuppressive therapy. The vaccinees concomitant medications include antihistamines. On 10Dec03, the vaccinee received Fluvirin (batch 765885) in her left arm and Pneumovax 23, 0.5ml, in her right arm. On the same day, the vaccinee developed soreness at the Pneumovax injection site followed by a rash and hives on the right side of her body, joint pain and fatigue. At the time of vaccination, the vaccinee did not have a fever or active infection and her body temp was 97.3 deg F. On 22Dec03 the pt developed hives and a tight chest. On 23Dec03, the vaccinee experienced coughing and a tight chest. She has also developed pain in her hip, knee and up and down her spine. Her skin was also hyper tender when touched. The vaccinee appeared well and was well nourished. Progress notes indicated that the vaccines had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. The vaccinee also experienced discomfort during urination for which she was prescribed phenazopyridine hydrochloride (Uristat). On 23Dec03, the vaccinee was receiving hydroxyzine hydrochloride (Atarax). She was also receiving methyl prednisolone (Medrol Dosepak). Laboratory test read, blood pressure 136/100, body temp 98.1, total heartbeat count, 98. On 15Jan04, a laboratory test read, BSR 8. On 01Mar04, the vaccinee was seen by her physician and it was noted that her knees, shoulders, elbows and back were sore. Also her knees were swollen, the right knee more than the left and had difficulty with stairs. There was some soft tissue swelling above and lateral to her right knee and there was joint line tenderness. Her left arm and anterior chest was sore to the touch, her chest was clear and she had no spinal tenderness. It was reported that these symptoms, due to the serum sickness reaction were slowly improving. Her energy levels are returning and she is doing more, but is still uncomfortable. Arthritis was ruled out. The vaccinees medication include, carbinoxamine maleate, hydrocodone bitartrate and pseudoephedrine hydrochloride (Histex) 2 tsp every 4 hours. Laboratory tests on 01Mar04 showed, Blood pressure, 140/90 and body temperature 98.5. Further laboratory tests on 28Jun04 showed, Lyme disease assay, negative, serum ANA, negative, serum rheumatoid factor, 8.7 and ESR 2. The reported considers these events to be disabling and life threatening.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Dysuria, Fatigue, Hyperaesthesia, Injection site pain, Laboratory test abnormal
Clinical narrative: A report was received from a physician via another manufacturer (Ref WAES0501USA00553) on 17Mar05 concerning a 40 year old female vaccinee. The vaccinee has a history of asthma, seasonal bronchitis, drug hypersensitivity and migraines. She has allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (macrodontin) and prochlorperazine maleate (Compazine IV). The vaccinee has no allergies to eggs, thimerosal, contact lens solution, mercury or latex. She has no history of Guillian Barre Syndrome, neurologic conditions or reactions to flu shots. The vaccinee was not receiving immunosuppressive therapy. The vaccinees concomitant medications include antihistamines. On 10Dec03, the vaccinee received Fluvirin (batch 765885) in her left arm and Pneumovax 23, 0.5ml, in her right arm. On the same day, the vaccinee developed soreness at the Pneumovax injection site followed by a rash and hives on the right side of her body, joint pain and fatigue. At the time of vaccination, the vaccinee did not have a fever or active infection and her body temp was 97.3 deg F. On 22Dec03 the pt developed hives and a tight chest. On 23Dec03, the vaccinee experienced coughing and a tight chest. She has also developed pain in her hip, knee and up and down her spine. Her skin was also hyper tender when touched. The vaccinee appeared well and was well nourished. Progress notes indicated that the vaccines had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. The vaccinee also experienced discomfort during urination for which she was prescribed phenazopyridine hydrochloride (Uristat). On 23Dec03, the vaccinee was receiving hydroxyzine hydrochloride (Atarax). She was also receiving methyl prednisolone (Medrol Dosepak). Laboratory test read, blood pressure 136/100, body temp 98.1, total heartbeat count, 98. On 15Jan04, a laboratory test read, BSR 8. On 01Mar04, the vaccinee was seen by her physician and it was noted that her knees, shoulders, elbows and back were sore. Also her knees were swollen, the right knee more than the left and had difficulty with stairs. There was some soft tissue swelling above and lateral to her right knee and there was joint line tenderness. Her left arm and anterior chest was sore to the touch, her chest was clear and she had no spinal tenderness. It was reported that these symptoms, due to the serum sickness reaction were slowly improving. Her energy levels are returning and she is doing more, but is still uncomfortable. Arthritis was ruled out. The vaccinees medication include, carbinoxamine maleate, hydrocodone bitartrate and pseudoephedrine hydrochloride (Histex) 2 tsp every 4 hours. Laboratory tests on 01Mar04 showed, Blood pressure, 140/90 and body temperature 98.5. Further laboratory tests on 28Jun04 showed, Lyme disease assay, negative, serum ANA, negative, serum rheumatoid factor, 8.7 and ESR 2. The reported considers these events to be disabling and life threatening.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Oedema peripheral, Rash, Serum sickness, Urticaria
Clinical narrative: A report was received from a physician via another manufacturer (Ref WAES0501USA00553) on 17Mar05 concerning a 40 year old female vaccinee. The vaccinee has a history of asthma, seasonal bronchitis, drug hypersensitivity and migraines. She has allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (macrodontin) and prochlorperazine maleate (Compazine IV). The vaccinee has no allergies to eggs, thimerosal, contact lens solution, mercury or latex. She has no history of Guillian Barre Syndrome, neurologic conditions or reactions to flu shots. The vaccinee was not receiving immunosuppressive therapy. The vaccinees concomitant medications include antihistamines. On 10Dec03, the vaccinee received Fluvirin (batch 765885) in her left arm and Pneumovax 23, 0.5ml, in her right arm. On the same day, the vaccinee developed soreness at the Pneumovax injection site followed by a rash and hives on the right side of her body, joint pain and fatigue. At the time of vaccination, the vaccinee did not have a fever or active infection and her body temp was 97.3 deg F. On 22Dec03 the pt developed hives and a tight chest. On 23Dec03, the vaccinee experienced coughing and a tight chest. She has also developed pain in her hip, knee and up and down her spine. Her skin was also hyper tender when touched. The vaccinee appeared well and was well nourished. Progress notes indicated that the vaccines had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. The vaccinee also experienced discomfort during urination for which she was prescribed phenazopyridine hydrochloride (Uristat). On 23Dec03, the vaccinee was receiving hydroxyzine hydrochloride (Atarax). She was also receiving methyl prednisolone (Medrol Dosepak). Laboratory test read, blood pressure 136/100, body temp 98.1, total heartbeat count, 98. On 15Jan04, a laboratory test read, BSR 8. On 01Mar04, the vaccinee was seen by her physician and it was noted that her knees, shoulders, elbows and back were sore. Also her knees were swollen, the right knee more than the left and had difficulty with stairs. There was some soft tissue swelling above and lateral to her right knee and there was joint line tenderness. Her left arm and anterior chest was sore to the touch, her chest was clear and she had no spinal tenderness. It was reported that these symptoms, due to the serum sickness reaction were slowly improving. Her energy levels are returning and she is doing more, but is still uncomfortable. Arthritis was ruled out. The vaccinees medication include, carbinoxamine maleate, hydrocodone bitartrate and pseudoephedrine hydrochloride (Histex) 2 tsp every 4 hours. Laboratory tests on 01Mar04 showed, Blood pressure, 140/90 and body temperature 98.5. Further laboratory tests on 28Jun04 showed, Lyme disease assay, negative, serum ANA, negative, serum rheumatoid factor, 8.7 and ESR 2. The reported considers these events to be disabling and life threatening.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Arthralgia, Chest discomfort, Cough, Dysuria, Fatigue
Clinical narrative: A report was received from a physician via another manufacturer (Ref WAES0501USA00553) on 17Mar05 concerning a 40 year old female vaccinee. The vaccinee has a history of asthma, seasonal bronchitis, drug hypersensitivity and migraines. She has allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (macrodontin) and prochlorperazine maleate (Compazine IV). The vaccinee has no allergies to eggs, thimerosal, contact lens solution, mercury or latex. She has no history of Guillian Barre Syndrome, neurologic conditions or reactions to flu shots. The vaccinee was not receiving immunosuppressive therapy. The vaccinees concomitant medications include antihistamines. On 10Dec03, the vaccinee received Fluvirin (batch 765885) in her left arm and Pneumovax 23, 0.5ml, in her right arm. On the same day, the vaccinee developed soreness at the Pneumovax injection site followed by a rash and hives on the right side of her body, joint pain and fatigue. At the time of vaccination, the vaccinee did not have a fever or active infection and her body temp was 97.3 deg F. On 22Dec03 the pt developed hives and a tight chest. On 23Dec03, the vaccinee experienced coughing and a tight chest. She has also developed pain in her hip, knee and up and down her spine. Her skin was also hyper tender when touched. The vaccinee appeared well and was well nourished. Progress notes indicated that the vaccines had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. The vaccinee also experienced discomfort during urination for which she was prescribed phenazopyridine hydrochloride (Uristat). On 23Dec03, the vaccinee was receiving hydroxyzine hydrochloride (Atarax). She was also receiving methyl prednisolone (Medrol Dosepak). Laboratory test read, blood pressure 136/100, body temp 98.1, total heartbeat count, 98. On 15Jan04, a laboratory test read, BSR 8. On 01Mar04, the vaccinee was seen by her physician and it was noted that her knees, shoulders, elbows and back were sore. Also her knees were swollen, the right knee more than the left and had difficulty with stairs. There was some soft tissue swelling above and lateral to her right knee and there was joint line tenderness. Her left arm and anterior chest was sore to the touch, her chest was clear and she had no spinal tenderness. It was reported that these symptoms, due to the serum sickness reaction were slowly improving. Her energy levels are returning and she is doing more, but is still uncomfortable. Arthritis was ruled out. The vaccinees medication include, carbinoxamine maleate, hydrocodone bitartrate and pseudoephedrine hydrochloride (Histex) 2 tsp every 4 hours. Laboratory tests on 01Mar04 showed, Blood pressure, 140/90 and body temperature 98.5. Further laboratory tests on 28Jun04 showed, Lyme disease assay, negative, serum ANA, negative, serum rheumatoid factor, 8.7 and ESR 2. The reported considers these events to be disabling and life threatening.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Gait disturbance, Injection site pain, Laboratory test abnormal, Myalgia, Oedema
Clinical narrative: A report was received from a physician via another manufacturer (Ref WAES0501USA00553) on 17Mar05 concerning a 40 year old female vaccinee. The vaccinee has a history of asthma, seasonal bronchitis, drug hypersensitivity and migraines. She has allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (macrodontin) and prochlorperazine maleate (Compazine IV). The vaccinee has no allergies to eggs, thimerosal, contact lens solution, mercury or latex. She has no history of Guillian Barre Syndrome, neurologic conditions or reactions to flu shots. The vaccinee was not receiving immunosuppressive therapy. The vaccinees concomitant medications include antihistamines. On 10Dec03, the vaccinee received Fluvirin (batch 765885) in her left arm and Pneumovax 23, 0.5ml, in her right arm. On the same day, the vaccinee developed soreness at the Pneumovax injection site followed by a rash and hives on the right side of her body, joint pain and fatigue. At the time of vaccination, the vaccinee did not have a fever or active infection and her body temp was 97.3 deg F. On 22Dec03 the pt developed hives and a tight chest. On 23Dec03, the vaccinee experienced coughing and a tight chest. She has also developed pain in her hip, knee and up and down her spine. Her skin was also hyper tender when touched. The vaccinee appeared well and was well nourished. Progress notes indicated that the vaccines had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. The vaccinee also experienced discomfort during urination for which she was prescribed phenazopyridine hydrochloride (Uristat). On 23Dec03, the vaccinee was receiving hydroxyzine hydrochloride (Atarax). She was also receiving methyl prednisolone (Medrol Dosepak). Laboratory test read, blood pressure 136/100, body temp 98.1, total heartbeat count, 98. On 15Jan04, a laboratory test read, BSR 8. On 01Mar04, the vaccinee was seen by her physician and it was noted that her knees, shoulders, elbows and back were sore. Also her knees were swollen, the right knee more than the left and had difficulty with stairs. There was some soft tissue swelling above and lateral to her right knee and there was joint line tenderness. Her left arm and anterior chest was sore to the touch, her chest was clear and she had no spinal tenderness. It was reported that these symptoms, due to the serum sickness reaction were slowly improving. Her energy levels are returning and she is doing more, but is still uncomfortable. Arthritis was ruled out. The vaccinees medication include, carbinoxamine maleate, hydrocodone bitartrate and pseudoephedrine hydrochloride (Histex) 2 tsp every 4 hours. Laboratory tests on 01Mar04 showed, Blood pressure, 140/90 and body temperature 98.5. Further laboratory tests on 28Jun04 showed, Lyme disease assay, negative, serum ANA, negative, serum rheumatoid factor, 8.7 and ESR 2. The reported considers these events to be disabling and life threatening.
Age: 40.0
Sex: F
Vaccine: FLU3, PPV, FLU3
Symptoms: Rash, Serum sickness, Urticaria
Clinical narrative: A report was received from a physician via another manufacturer (Ref WAES0501USA00553) on 17Mar05 concerning a 40 year old female vaccinee. The vaccinee has a history of asthma, seasonal bronchitis, drug hypersensitivity and migraines. She has allergies to sulfisoxazole diolamine (Sulfium), nitrofurantoin (macrodontin) and prochlorperazine maleate (Compazine IV). The vaccinee has no allergies to eggs, thimerosal, contact lens solution, mercury or latex. She has no history of Guillian Barre Syndrome, neurologic conditions or reactions to flu shots. The vaccinee was not receiving immunosuppressive therapy. The vaccinees concomitant medications include antihistamines. On 10Dec03, the vaccinee received Fluvirin (batch 765885) in her left arm and Pneumovax 23, 0.5ml, in her right arm. On the same day, the vaccinee developed soreness at the Pneumovax injection site followed by a rash and hives on the right side of her body, joint pain and fatigue. At the time of vaccination, the vaccinee did not have a fever or active infection and her body temp was 97.3 deg F. On 22Dec03 the pt developed hives and a tight chest. On 23Dec03, the vaccinee experienced coughing and a tight chest. She has also developed pain in her hip, knee and up and down her spine. Her skin was also hyper tender when touched. The vaccinee appeared well and was well nourished. Progress notes indicated that the vaccines had an ongoing reaction to pneumococcal 23v polysaccharide vaccine. The vaccinee also experienced discomfort during urination for which she was prescribed phenazopyridine hydrochloride (Uristat). On 23Dec03, the vaccinee was receiving hydroxyzine hydrochloride (Atarax). She was also receiving methyl prednisolone (Medrol Dosepak). Laboratory test read, blood pressure 136/100, body temp 98.1, total heartbeat count, 98. On 15Jan04, a laboratory test read, BSR 8. On 01Mar04, the vaccinee was seen by her physician and it was noted that her knees, shoulders, elbows and back were sore. Also her knees were swollen, the right knee more than the left and had difficulty with stairs. There was some soft tissue swelling above and lateral to her right knee and there was joint line tenderness. Her left arm and anterior chest was sore to the touch, her chest was clear and she had no spinal tenderness. It was reported that these symptoms, due to the serum sickness reaction were slowly improving. Her energy levels are returning and she is doing more, but is still uncomfortable. Arthritis was ruled out. The vaccinees medication include, carbinoxamine maleate, hydrocodone bitartrate and pseudoephedrine hydrochloride (Histex) 2 tsp every 4 hours. Laboratory tests on 01Mar04 showed, Blood pressure, 140/90 and body temperature 98.5. Further laboratory tests on 28Jun04 showed, Lyme disease assay, negative, serum ANA, negative, serum rheumatoid factor, 8.7 and ESR 2. The reported considers these events to be disabling and life threatening.
Age: 33.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Arthralgia, Disturbance in attention, Fatigue, Injection site hypersensitivity, Injection site nodule
Clinical narrative: No additional shots administered, but symptoms reported on record 227280 have reappeared.  21Mar05- itching on right arm at site of injection.  Pea size nodule at site of injection reappeared.  Normal sleep pattern is 6 hrs/night.  22-25Mar05- fatigue, difficulty concentrating, sleeping 9-10hrs/night.  25-28Mar05- Fatigue, joint pain in knees.
Age: 33.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pruritus, Somnolence
Clinical narrative: No additional shots administered, but symptoms reported on record 227280 have reappeared.  21Mar05- itching on right arm at site of injection.  Pea size nodule at site of injection reappeared.  Normal sleep pattern is 6 hrs/night.  22-25Mar05- fatigue, difficulty concentrating, sleeping 9-10hrs/night.  25-28Mar05- Fatigue, joint pain in knees.
Age: 30.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Pruritus
Clinical narrative: Patient reports she received the smallpox vaccine in her right deltoid area on 6 Dec 2004.  She describes having the typical vaccine response with the scab ultimately falling off in a little less than three weeks.  On at least three different occasions since the original scab fell off, she reports that the area would begin itching, become red (mildly), and develop small vesicles filled with clear to yellowish fluid.  The lesion would never ulcerate or form a scab and would resolve on its own within one week or so.  She denies any other symptoms occurring at these times.  Specifically she denies nausea, vomiting, diarrhea, fever, chills, body aches, abdominal pain, arm pain, lymphadenopathy, or fatigue.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Laboratory test abnormal, Leukocytosis, Pulmonary embolism, Pyrexia
Clinical narrative: This case was reported by a health professional and described the occurrence of fatal pseudomonal sepsis in a 7 month old male pt who received hep B vaccine recombinant (Engerix B). On 28Sep04, the pt received a dose of Engerix B (dose number not provided). Approx six days following the admin of Engerix B, on 04Oct2004, the pt experienced pseudomonal sepsis and multiple pulmonary embolism. The pt expired on 04Oct04. It was not reported if an autopsy was performed. Report received via manf; report number HQWYE781121JAN05.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Sepsis
Clinical narrative: This case was reported by a health professional and described the occurrence of fatal pseudomonal sepsis in a 7 month old male pt who received hep B vaccine recombinant (Engerix B). On 28Sep04, the pt received a dose of Engerix B (dose number not provided). Approx six days following the admin of Engerix B, on 04Oct2004, the pt experienced pseudomonal sepsis and multiple pulmonary embolism. The pt expired on 04Oct04. It was not reported if an autopsy was performed. Report received via manf; report number HQWYE781121JAN05.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Pulmonary embolism, Sepsis
Clinical narrative: This case was reported by a health professional and described the occurrence of fatal pseudomonal sepsis in a 7 month old male pt who received hep B vaccine recombinant (Engerix B). On 28Sep04, the pt received a dose of Engerix B (dose number not provided). Approx six days following the admin of Engerix B, on 04Oct2004, the pt experienced pseudomonal sepsis and multiple pulmonary embolism. The pt expired on 04Oct04. It was not reported if an autopsy was performed. Report received via manf; report number HQWYE781121JAN05.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV, HEP, DTAP, HEP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Bacterial infection, Pulmonary embolism, Sepsis
Clinical narrative: This case was reported by a health professional and described the occurrence of fatal pseudomonal sepsis in a 7 month old male pt who received hep B vaccine recombinant (Engerix B). On 28Sep04, the pt received a dose of Engerix B (dose number not provided). Approx six days following the admin of Engerix B, on 04Oct2004, the pt experienced pseudomonal sepsis and multiple pulmonary embolism. The pt expired on 04Oct04. It was not reported if an autopsy was performed. Report received via manf; report number HQWYE781121JAN05.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Arthritis, Back pain, Balance disorder
Clinical narrative: Chronic back and joint pain, growth of bone spurs on vertebrae, loss of memory, cognitive difficulties, chronic diarrhea, sleep disorder, depression, tremors, headaches, degenerative arthritis, poor balance, sub-clinical hyperthyroidism, muscle spasms. Per follow up report received on 06/09/2005:  Patient still has all of the symptoms listed above.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Bone development abnormal, Cognitive disorder, Depression, Diarrhoea, Headache
Clinical narrative: Chronic back and joint pain, growth of bone spurs on vertebrae, loss of memory, cognitive difficulties, chronic diarrhea, sleep disorder, depression, tremors, headaches, degenerative arthritis, poor balance, sub-clinical hyperthyroidism, muscle spasms. Per follow up report received on 06/09/2005:  Patient still has all of the symptoms listed above.
Age: 37.0
Sex: F
Vaccine: ANTH
Symptoms: Hyperthyroidism, Muscle spasms, Sleep disorder, Tremor
Clinical narrative: Chronic back and joint pain, growth of bone spurs on vertebrae, loss of memory, cognitive difficulties, chronic diarrhea, sleep disorder, depression, tremors, headaches, degenerative arthritis, poor balance, sub-clinical hyperthyroidism, muscle spasms. Per follow up report received on 06/09/2005:  Patient still has all of the symptoms listed above.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Sudden infant death syndrome
Clinical narrative: Infant received immunizations. Five hours later, was not breathing. Had been asleep on grandmother's chest. Autopsy revealed SIDS death. Date of death: 1/20/05.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Anaphylactic shock, Swelling
Clinical narrative: Information has been received from a 29 year old female with sulfonamide allergy and a history of ear infection who on 3/10/05 was vaccinated IM with a first dose of hepatitis A virus vaccine inactivated (lot # 648239/0814P). Concomitant therapy included ciprofloxacin hydrochloride for an unknown indication. On 3/10/05, the patient's arm swelled up and she went into anaphylactic shock. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. At the time of the report, the patient had reportedly not recovered. Arm swelled up and anaphylactic shock were considered to be immediately life threatening and disabling. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Bacterial infection, Dehydration, Laboratory test abnormal, Lobar pneumonia
Clinical narrative: Information has been received from a physician concerning a 9 year old white female with a penicillin allergy who was vaccinated IM in the left arm with a total of 5 doses of hepatitis B virus vaccine (lot # 647487/1240N), 2 doses were given in 2003, and 3 more given in July 2004, August 2004, and last week, on 1/17/05 at 9:15 AM. It was noted that there was no illness at the time of vaccination. The physician reported that post vaccination, the child is experiencing a high fever of 103. The patient was treated with acetaminophen and ibuprofen. The patient's status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that a previous chest x-ray from 12/10/04 was unavailable for direct comparison, but the report was reviewed. The previous study described a left upper lobe pneumonia. On 1/18/05, the patient experienced a prolonged febrile illness. It was reported that the patient was admitted to the hospital and the work up showed the illness to be secondary to mononucleosis. On 1/21/05, a chest x-ray showed that the lungs were clear. Pulmonary vasculature was normal and the heart was not enlarged. The cardiothymic silhouette was not enlarged. The patient's bones were unremarkable. The impression was reported as a normal chest. The patient's white blood cell count was increased, but left shifted. Her intake was decreased and she was possibly dehydrated. The patient was prescribed azithromycin 200mg, 5ml, PO, qd for 1 day and then 4ml, PO qd, for 4 days. It was reported that the patient required 7 days of hospitalization. The patient's recovery status was reported as unknown. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Pyrexia, Viral infection, White blood cell count increased
Clinical narrative: Information has been received from a physician concerning a 9 year old white female with a penicillin allergy who was vaccinated IM in the left arm with a total of 5 doses of hepatitis B virus vaccine (lot # 647487/1240N), 2 doses were given in 2003, and 3 more given in July 2004, August 2004, and last week, on 1/17/05 at 9:15 AM. It was noted that there was no illness at the time of vaccination. The physician reported that post vaccination, the child is experiencing a high fever of 103. The patient was treated with acetaminophen and ibuprofen. The patient's status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that a previous chest x-ray from 12/10/04 was unavailable for direct comparison, but the report was reviewed. The previous study described a left upper lobe pneumonia. On 1/18/05, the patient experienced a prolonged febrile illness. It was reported that the patient was admitted to the hospital and the work up showed the illness to be secondary to mononucleosis. On 1/21/05, a chest x-ray showed that the lungs were clear. Pulmonary vasculature was normal and the heart was not enlarged. The cardiothymic silhouette was not enlarged. The patient's bones were unremarkable. The impression was reported as a normal chest. The patient's white blood cell count was increased, but left shifted. Her intake was decreased and she was possibly dehydrated. The patient was prescribed azithromycin 200mg, 5ml, PO, qd for 1 day and then 4ml, PO qd, for 4 days. It was reported that the patient required 7 days of hospitalization. The patient's recovery status was reported as unknown. Additional information has been requested.
Age: 1.67
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site swelling, Oedema genital, Priapism
Clinical narrative: Information has been received from a pharmacist concerning a 20 month old male who on 3/4/05 was vaccinated in the left thigh with a 0.5ml dose of varicella virus vaccine live. On 3/15/05, 12 days after the vaccination, the patient experienced penile swelling and injection site swelling. Medical attention was sought and the patient was seen by a pediatrician and a urologist but not admitted. He was being treated with an antibiotic. it was reported that on 3/16/05, his penis appeared huge, almost priapism and seems has a cellulitis starting. The outcome was reported as unknown. No product quality complaint was involved. The reporting pharmacist considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Arthritis, Hypokinesia, Pain, Shoulder pain
Clinical narrative: Information has been received from a physician concerning an 82 year old female who in approximately March 2005, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647655/1041P). The patient was also being treated with unspecified antibiotics for a urinary tract infection. Shortly after the vaccination, the patient developed shoulder pain above the injection site. The pain had severely restricted the range of motion of the left shoulder. The physician noted that this was the first time that she had seen someone's shoulder totally locked up like that. No swelling, redness, or warmth seemed to be present at or near the infection site. The injection site was not irritated at all, and the physician believes that this may be more a Munchausen's syndrome. The patient was treated with ibuprofen, and acetaminophen (+) codeine phosphate. X-ray results were pending. It was recommended that the patient seen an orthopedist. It was noted that the patient probably has arthritis in the joint. It was also reported that the patient had a previous vaccination with pneumococcal 23v polysaccharide vaccine and did not have a reaction at all. The patient's daughter (who is a medical assistant) had stated that her mother had at least two or three past vaccinations with pneumococcal 23v polysaccharide vaccine. The patient had stated that she had received only one other dose. At the time of report, the patient's symptoms have remained. No product quality complaint was involved. The physician noted that shoulder pain and restricted range of motion of the left shoulder were considered other important medical events (OMIC). Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Contusion, Haematoma, Leukopenia, Platelet count decreased, Rash
Clinical narrative: The child's third hepatitis B vaccine was administered 8/14/03. In early October 2003, parents noted bruises on child's arm and legs. Initially thought that these were from playing hockey. He was taken to the clinic and saw private physician. Blood was drawn and family was told he was anemic. Placed on multivitamins with iron, but took them inconsistently per mom. Parents also noted what they thought was a rash around child's waist where pants would rub against skin. On 10/5/03, child was taken back to same clinic and was seen by the doctor. Blood was drawn. On 10/6/03, mother received a phone call to pull child from school immediately, as platelet count was 15,000. Child was sent to hospital and platelet count was 4,000 at this blood draw. Child was noted to have a large hematoma on his stomach. X-rays were taken of his spleen, liver and kidneys. He was diagnosed with Idiopathic Thrombocytopenic purpura and given the drug Winrho one time. Platelet count went to 50,000. Seen again 1 week later and platelet count was 4,000. IVIG was given, but no improvement was noted. A bone marrow was done to check for leukemia and results were negative. Child placed on chemotherapy treatment with Rhitoxin times 4 weeks, 1 week apart. By the second treatment his platelets had dropped to 3,000. Prednisone was added to the chemotherapy regimen for 1 week and platelets rose to 140,000. He completed treatment with the Prednisone and Solu-Medrol. The platelets dropped again and he was placed on Vincristine for 2 weeks. Treatment was completed 1/3/05. Child is currently taking 650mg. Cyclosporin every day and will be weaned from this after 6 months of treatment. He also takes an antibiotic 3 times per week. Doctors at the clinic see him every 1-2 weeks. Follow-up: I spoke with patient's father who states patient had his spleen removed at hospital on 4/22/06 rather than undergo a second chemotherapy protocal. The physicians recommended surgery to reverse the ITP effect. Since the surgery the bruising has stopped and the platelet count has returned to normal.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Thrombocytopenia, Thrombocytopenic purpura, X-ray
Clinical narrative: The child's third hepatitis B vaccine was administered 8/14/03. In early October 2003, parents noted bruises on child's arm and legs. Initially thought that these were from playing hockey. He was taken to the clinic and saw private physician. Blood was drawn and family was told he was anemic. Placed on multivitamins with iron, but took them inconsistently per mom. Parents also noted what they thought was a rash around child's waist where pants would rub against skin. On 10/5/03, child was taken back to same clinic and was seen by the doctor. Blood was drawn. On 10/6/03, mother received a phone call to pull child from school immediately, as platelet count was 15,000. Child was sent to hospital and platelet count was 4,000 at this blood draw. Child was noted to have a large hematoma on his stomach. X-rays were taken of his spleen, liver and kidneys. He was diagnosed with Idiopathic Thrombocytopenic purpura and given the drug Winrho one time. Platelet count went to 50,000. Seen again 1 week later and platelet count was 4,000. IVIG was given, but no improvement was noted. A bone marrow was done to check for leukemia and results were negative. Child placed on chemotherapy treatment with Rhitoxin times 4 weeks, 1 week apart. By the second treatment his platelets had dropped to 3,000. Prednisone was added to the chemotherapy regimen for 1 week and platelets rose to 140,000. He completed treatment with the Prednisone and Solu-Medrol. The platelets dropped again and he was placed on Vincristine for 2 weeks. Treatment was completed 1/3/05. Child is currently taking 650mg. Cyclosporin every day and will be weaned from this after 6 months of treatment. He also takes an antibiotic 3 times per week. Doctors at the clinic see him every 1-2 weeks. Follow-up: I spoke with patient's father who states patient had his spleen removed at hospital on 4/22/06 rather than undergo a second chemotherapy protocal. The physicians recommended surgery to reverse the ITP effect. Since the surgery the bruising has stopped and the platelet count has returned to normal.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Necrosis
Clinical narrative: Subcutaneous tissue defect-resembling gradual latent onset of fat necrosis 8 mm in diameter area 3.5mm deep.
Age: 48.0
Sex: M
Vaccine: FLU3, HEPA, TD
Symptoms: Muscular weakness, Pain, Paraesthesia
Clinical narrative: On 01/27/2005 Pt reports experiencing a continous ache from shoulder to left elbow and slight loss of grip in left hand. No redness, no swelling at injection site, no fever. Used no OTC meds, no compresses, lasted 2 1/2 weeks. Then left arm ok. But 2 weeks later started experiencing tingling from shoulder to fingertips. Not continous but frequently. Has not seen a doctor. Pt states he works out at gym 3-4 times a week and does lift weights. He also travels much.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site mass, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: 29 year old Hispanic man developed large local reaction within 24 hours of receiving 2nd in Anthrax series. Previous shot (lot number FAV080) had been 15 months earlier and produced only a small transient "knot". This 2nd shot (lot number FAV086) was given on September 23,2004 into upper triceps region of his right arm. The patient describes the ensuing rash as follows: "After a couple of hours, around 4 or 5 hours later, I felt a big knot and the area was red. I did not think anything of it because that's what they tell you upon receiving the shot. That night, I noticed the area was warm to the touch and small dark red ring starting to form around the site and looks like a rash in the middle. The site itched. The next morning around the site was getting bigger and looked like a rash. On Sept. 25, 2004 the rash ring was about 4 inches long mid biceps. Arm was still red and warm to the touch and itched. On Sept 26,2004 the ring was bigger and redder almost to the elbow. On the 27 of Sept, 2004 I went in to sick call and was evaluated. The site was the same red ring and warm to the touch with redness size measured by the physician was 5.5 cm x 11cm, The redness by now was slowly turning pink, and was no longer warm to the touch. The 28 Sept, 2004 the ring of rash let up little by little. The physician who evaluated him on Sept 27,2004 described an "erythamatous patch 5.5cm x 11 cm with mild tenderness". The patient denies any systemic symptoms (fever, arthralgia, remote rash, etc.). Patient Description- At first it was a big red swollen area with a darker ring around the solid red spot. When the rash started to go away and spread to the elbow and beyond it was just a ring. The inside was light pink almost normal coloration.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Rash erythematous
Clinical narrative: 29 year old Hispanic man developed large local reaction within 24 hours of receiving 2nd in Anthrax series. Previous shot (lot number FAV080) had been 15 months earlier and produced only a small transient "knot". This 2nd shot (lot number FAV086) was given on September 23,2004 into upper triceps region of his right arm. The patient describes the ensuing rash as follows: "After a couple of hours, around 4 or 5 hours later, I felt a big knot and the area was red. I did not think anything of it because that's what they tell you upon receiving the shot. That night, I noticed the area was warm to the touch and small dark red ring starting to form around the site and looks like a rash in the middle. The site itched. The next morning around the site was getting bigger and looked like a rash. On Sept. 25, 2004 the rash ring was about 4 inches long mid biceps. Arm was still red and warm to the touch and itched. On Sept 26,2004 the ring was bigger and redder almost to the elbow. On the 27 of Sept, 2004 I went in to sick call and was evaluated. The site was the same red ring and warm to the touch with redness size measured by the physician was 5.5 cm x 11cm, The redness by now was slowly turning pink, and was no longer warm to the touch. The 28 Sept, 2004 the ring of rash let up little by little. The physician who evaluated him on Sept 27,2004 described an "erythamatous patch 5.5cm x 11 cm with mild tenderness". The patient denies any systemic symptoms (fever, arthralgia, remote rash, etc.). Patient Description- At first it was a big red swollen area with a darker ring around the solid red spot. When the rash started to go away and spread to the elbow and beyond it was just a ring. The inside was light pink almost normal coloration.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Influenza like illness, Injection site erythema, Injection site mass, Injection site reaction, Injection site warmth
Clinical narrative: Tinnitus, Flu like symptoms, then large local reaction(erythema, warmth, "knot") 3x4 " area seen by MD.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Tinnitus
Clinical narrative: Tinnitus, Flu like symptoms, then large local reaction(erythema, warmth, "knot") 3x4 " area seen by MD.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Neck pain, Pain
Clinical narrative: Client began experiencing sharp pain radiating across right shoulder, behind the ear and back of neck during week of 12/25/2004. Client states pain is a constant pain and that is reduced to an aching pain after taking Aleve every 4-6 hours and using a heating pad.
Age: 5.0
Sex: M
Vaccine: DT, IPV, MMR
Symptoms: Eye swelling
Clinical narrative: 5 year old received his 4-6 yr old shot about 10-15 minutes after, slight swelling started to appear around his eyes. Vital signs normal, no difficult breathing, no redness or swelling noticed at injection site. Dr notified, Treated with EpiPen SC .25mg, Benadryl Pt d/c in no distress.
Age: 1.56
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Difficulty in walking, Injection site mass, Muscular weakness
Clinical narrative: On upper right thigh, patient has a knot in her leg where shot was given. She is also limping on that leg and her leg seems to almost give out on her. Pt seen by CPNP on 03/22/2005 palpable mass 1 1/2cm x 1cm no redness- patient running in office without pain or limp.
Age: 39.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site oedema, Injection site pain, Pruritus
Clinical narrative: Reports 48 hours after Td booster, soreness, swelling and itching at site. 4 days after Td booster eval. in ER DX-Adverse Reaction to Td and Cellulitis.
Age: 1.34
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: vesicular rash-diffuse c/o Varicella
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Injection site pain, Neck pain, Pain
Clinical narrative: Sharp shooting pain starting at injection site and continuing across her back up her neck into her other arm at the time of injection. Pt states pain continues. ER 03/21/2005. Given Flexeril and ibuprofen, symptoms persist.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Injection site erythema, Pyrexia
Clinical narrative: Fever 102 degrees Fahrenheit, decreased appetite, redness at injection site. (right thigh)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Right arm swollen, red and hot to touch. Pt treated with Keflex 250mg/15cc 1 tsp TID x 10 days.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: Right arm swelling, red, painful, hot to touch.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Loss of consciousness, Staring
Clinical narrative: Pt given Hepatitis B injection 02/17/2005, was sitting in chair, looked dazed, stated feeling lightheaded, approximately 3 minutes after injection given, pt passed out at 11:00 AM, Pt came to immediately to voice and gently tactile stimuli. Pt continued to c/o feeling lightheaded and vision going dark, denied SOB, pain, nausea, or any other problem.  Immediately passed out again, and aroused very quickly to voice and gently tactile stimuli. I called for RN Director. We gently assisted the patient off the chair onto the floor and had him lay down. Pt repeatedly fainted then woke up easily to voice and tactile stimuli, but could not stay conscious for more than approximately 20 to 45 seconds at a time. Each time pt able to respond appropriately to questions and simple commands example, could state name, explain how he was feeling, could appropriately identify number of fingers shown to him by RN, and could appropriately hold up 1to 3 fingers as requested by RN. BP taken at around 11:05 AM and repeated approximately every 5 minutes stayed around 120's/80 to systolic of 115/??. Apical pulse ranged 80's slowed when passing out to speeding up when awakened. Respirations slowed when passed out to normal around 16 per minute while awake. Ammonia ampule used and patient woke up readily whenever used. Pt around 11:10 AM began to complain of a severe occipital Headache. Continued to pass out very frequently, every one to three minutes. Mother present, discussed with mother having child go to ER room to get checked out by MD as heart rate noted to be regularly irregular, and child could not be kept awake and was at this point c/o very severe occipital HA. Mother agreed and 911 called at 11:18 AM. Once ambulance staff member in the building responded immediately, rest of ambulance crew here in approximately 5 minutes. Pt at that time seemed to be more awake and could maintain wakefulness for much longer periods of time, still seemed dazed, c/o "HA and lightheaded", responded appropriately to questions. PT taken to ER Room at 11:45 AM. Note that mother did state that child never reacted this way to any prior vaccines. This was child's third Hepatitis vaccine of the series. During the first 20 to 25 minutes of this episode, child passed out multiple times, estimated to be over 25-30 times. ER room nurse called around 1:00 PM to let staff know that pt was diagnosed by MD as having a vasovagal response. Pt was released to go back home with parents and reportedly doing fine when left. The next day the school that the child attends, called Office Manager at the Health Dept. asking if child received vaccine. They reported the child was back in school. RN had called patients home the next day (02/18/2005) left message asking for parents to call Health Dept back for a report on child's condition, No answer back. The following week on Monday and Wednesday RN again called and left messages, but received no answer.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site haemorrhage, Injection site warmth
Clinical narrative: c/o right deltoid with mild erythema, hematoma, and warm to touch. Hematoma measured 2"x2" Advised mom to apply cold compress and will re-evaluate in 2 days.
Age: 1.26
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Erythema multiforme, Injury
Clinical narrative: Erythema multiforme day 7 after vaccine. Pt also had fire ant bite 2days prior to EM. Pt with congestion and Upper respiratory infection today (03/24/2005)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Asthenia, Erythema, Face oedema, Fatigue, Oedema peripheral
Clinical narrative: Pt experienced erythematic papule lesions on right cheek and nose. Pt mother complained of weakness and fatigue with fever prior to Pt re-evaluation. Pt mother also complains of swollen feet and cheeks.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Pt experienced erythematic papule lesions on right cheek and nose. Pt mother complained of weakness and fatigue with fever prior to Pt re-evaluation. Pt mother also complains of swollen feet and cheeks.