chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Injury
Clinical narrative: Information has been received from an attorney on behalf of a representative of the estate of a patient who, on 7/1/98, was vaccinated with a dose of hepatitis B virus vaccine. Subsequently, the patient experienced an unspecified injury. Additional information will be provided when it becomes available. (OMIC)
Age: 60.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Difficulty in walking, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: C/E after flu shot: paresthesias, numbness, inability to walk. Onset of Guillain-Barre 1 day after administration of flu shot. Transferred to ICU and IVIG administered for 2 days. Patient improved.
Age: 60.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: C/E after flu shot: paresthesias, numbness, inability to walk. Onset of Guillain-Barre 1 day after administration of flu shot. Transferred to ICU and IVIG administered for 2 days. Patient improved.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Pt developed varicella type CNS infections 2 weeks post influenza vaccine. This is 12th pt admitted with shingles or similar type infection 2 weeks after vaccine.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Infection, Influenza, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Dec-9 had DTaP, IPV, Comvax and Prevnar. On 12/10, fever 103-104 and two episodes of stiffness. Seen at hospital (+) influenzae also. Discharge Summary received on 1/13/2004 states seizure. Discharge Summary received on 1/13/2004 states influenza A positive.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Dec-9 had DTaP, IPV, Comvax and Prevnar. On 12/10, fever 103-104 and two episodes of stiffness. Seen at hospital (+) influenzae also. Discharge Summary received on 1/13/2004 states seizure. Discharge Summary received on 1/13/2004 states influenza A positive.
Age: 10.0
Sex: F
Vaccine: IPV, TD
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: 10/14/03 at end of day, arm began to be pink around injection site. Child received TD and IPV earlier in day. By the 16th, arm was very red and parents requested school nurse to examine. School nurse referred child to physician. Child was seen in ER 10/17/03 and was subsequently hospitalized and treated with Rocephin for cellulitis to arm. The hospital record received on 1/22/04 confirms diagnosis of cellulitis.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, CSF test abnormal, Coagulopathy, Diplopia, Encephalitis
Clinical narrative: ADEM. The discharge summary received on 1/12/03 states viral meningitis; decreased oral intake; headache; difficulty ambulating; UTI; urinary retention; anxiety; hyperglycemia; thrombocytopenia and coagulopathy. The neuro consult received on 1/12/04 states myalgia, diplopia, vergigo, fever, nausea/vomiting, nystagmus, 6th nerve palsy, and tremulous.  60-day follow up on 03/24/04: "It is unknown if pt recovered from adverse events."
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Headache, Hyperglycaemia, Meningitis, Myalgia
Clinical narrative: ADEM. The discharge summary received on 1/12/03 states viral meningitis; decreased oral intake; headache; difficulty ambulating; UTI; urinary retention; anxiety; hyperglycemia; thrombocytopenia and coagulopathy. The neuro consult received on 1/12/04 states myalgia, diplopia, vergigo, fever, nausea/vomiting, nystagmus, 6th nerve palsy, and tremulous.  60-day follow up on 03/24/04: "It is unknown if pt recovered from adverse events."
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Nystagmus, Paralysis, Pyrexia, Tremor
Clinical narrative: ADEM. The discharge summary received on 1/12/03 states viral meningitis; decreased oral intake; headache; difficulty ambulating; UTI; urinary retention; anxiety; hyperglycemia; thrombocytopenia and coagulopathy. The neuro consult received on 1/12/04 states myalgia, diplopia, vergigo, fever, nausea/vomiting, nystagmus, 6th nerve palsy, and tremulous.  60-day follow up on 03/24/04: "It is unknown if pt recovered from adverse events."
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection, Vertigo, Vomiting
Clinical narrative: ADEM. The discharge summary received on 1/12/03 states viral meningitis; decreased oral intake; headache; difficulty ambulating; UTI; urinary retention; anxiety; hyperglycemia; thrombocytopenia and coagulopathy. The neuro consult received on 1/12/04 states myalgia, diplopia, vergigo, fever, nausea/vomiting, nystagmus, 6th nerve palsy, and tremulous.  60-day follow up on 03/24/04: "It is unknown if pt recovered from adverse events."
Age: 0.7
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Seizure 12 hours after vaccination.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt states 2-3 hours after receiving vaccine left arm deltoid area became red, swollen and hot to touch. Swelling and redness increased on Friday. Minimal soreness. By Mon. 12/8 redness, swelling and soreness subsided.
Age: 1.92
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Urticaria
Clinical narrative: Mother reports child woke up this morning about 8:30 AM with red rash "hives" on legs, arms and face. Mother gave child 1 tsp Benadryl and is waiting for doctor's office to open at 10 AM. Mother called PP and was instructed to stay on Benadryl dosing. If child worsened then to see PP. 12/15/03 child's hives resolved in 24 hours. Did not see PP. But has well child appt in 1 week and will ask PP if second dose of flu is recommended.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling hot, Injection site erythema, Injection site warmth, Myalgia
Clinical narrative: Swelling of upper arm left hot and red. Chills, aching all over body, muscle soreness.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Swelling of upper arm left hot and red. Chills, aching all over body, muscle soreness.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Vomiting
Clinical narrative: Friday afternoon 11/21/03 Mom noted whole top of left arm was red, hard, hot and swollen, area was about size of pear. No fever, no pain. Mom called MD Sat AM and was counseled to give Benadryl every 4 hours. Vomited Sunday x3, swelling and redness much improved by Sunday. None noted Monday, only small area hard around injection site.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Headache
Clinical narrative: Information regarding FluMist (2002-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 13 year old male child who received a dose on 12/08/2003.  A consumer reported that her 13 year old male child developed a "slight, minor" headache (headache) about 15 minutes after receiving FluMist.  Headache resolved without treatment approximately 2 hours later.  No additional information was available at the time of this report.
Age: 51.0
Sex: U
Vaccine: FLUX
Symptoms: Cough, Fatigue, Feeling cold, Headache, Pain
Clinical narrative: Cold, cough, fever, aches, headache, fatigue (next day). Went into severe bronchial infection within days.
Age: 51.0
Sex: U
Vaccine: FLUX
Symptoms: Respiratory tract infection
Clinical narrative: Cold, cough, fever, aches, headache, fatigue (next day). Went into severe bronchial infection within days.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood pressure decreased, Chills, Nausea, Pyrexia
Clinical narrative: 10/28/03: 11 AM flu shot. 10/29/03: 8 AM weakness, nausea, near syncopy. 10/29/03 9 AM 2nd bout of above, BP 60/40. 10/29/03: 9:15: ambulance to ER, O2, chills. 10/29/03: 11 PM: temp 101 degrees F., chills, elevated white cell count. IV saline. 11/30/03: 9 AM: temp, BP normal.
Age: 71.0
Sex: M
Vaccine: FLUX
Symptoms: Syncope, White blood cell count increased
Clinical narrative: 10/28/03: 11 AM flu shot. 10/29/03: 8 AM weakness, nausea, near syncopy. 10/29/03 9 AM 2nd bout of above, BP 60/40. 10/29/03: 9:15: ambulance to ER, O2, chills. 10/29/03: 11 PM: temp 101 degrees F., chills, elevated white cell count. IV saline. 11/30/03: 9 AM: temp, BP normal.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Bone disorder, Guillain-Barre syndrome, Hypoaesthesia, Hyporeflexia
Clinical narrative: Approx 3 weeks after receiving flu vaccine, pt began to experience numbness and tingling in hands and feet with lack of reflex response in arms and legs. Has seen MD 3 times in last month and due to revisit this week. Still experiencing tingling/numbness and also heaviness in arms in legs. MD suspects Guiallan-Barre Syndrome. Still experiencing symptoms. The medical records received on 1/9/04 states weakness and fatigue.   Nurse follow up on 06/28/04 states: "ADD: Osteopenia."
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Paraesthesia, Sensation of heaviness
Clinical narrative: Approx 3 weeks after receiving flu vaccine, pt began to experience numbness and tingling in hands and feet with lack of reflex response in arms and legs. Has seen MD 3 times in last month and due to revisit this week. Still experiencing tingling/numbness and also heaviness in arms in legs. MD suspects Guiallan-Barre Syndrome. Still experiencing symptoms. The medical records received on 1/9/04 states weakness and fatigue.   Nurse follow up on 06/28/04 states: "ADD: Osteopenia."
Age: 13.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain, Pyrexia
Clinical narrative: Per mother, on 2nd day of pneumococcal vaccine administration, pt had redness and swelling to right deltoid area and had a "low grade fever", did not measure temp increase, and slight pain to arm. On 3rd day of vaccine administration, 12/11/03, swelling and redness diminishing and fever resolved, no more pain to left deltoid area. Used warm compresses as instructed on day of vaccination.
Age: 34.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Arthralgia, Oedema peripheral, Pain
Clinical narrative: 12/10: called day after vaccination c/o pain to right deltoid radiating to shoulder and neck. 12/11: called c/o swelling to both hands and joint pain. 12/15: continues to c/o joint pain.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness
Clinical narrative: Pt experienced stomach cramps, dizziness for 3 days. No neurological, musculoskeletal side effects. After receiving influenza vaccine, lot #U1268AA. Had stomach cramps, dizziness for three days. No neurological/musculoskeletal side effects. At the time, the vaccine was under investigation and held for immunizations. Patient was doing OK afterwards. No sequelae. No allergy.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Chest pain, Dizziness, Injection site reaction, Skin burning sensation
Clinical narrative: Large local reaction, burning sensation. Substernal chest pressure and lightheadedness x1 hour. See attached Clinical Summary.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site induration
Clinical narrative: Induration, early cellulitis.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever to 101.4, emesis.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer
Clinical narrative: Chicken pox - 30 lesions.
Age: 6.0
Sex: F
Vaccine: HEP
Symptoms: Convulsion, Tremor
Clinical narrative: 6 year old female received Hep B vaccination and had seizure shortly after per ER record.  Parents reported child began to "shake" for 2-3 minutes.
Age: 27.0
Sex: F
Vaccine: HEPAB, IPV, MEN
Symptoms: Erythema, Face oedema, Flushing, Pruritus
Clinical narrative: Felt fine night of 11/06/03 .  10 am (11/07/03) had donut for breakfast and hands began to itch and swell.  Face and lips swelled like a balloon.  Pt's face and chest became bright red.  Pt was driven to the medical clinic where she was treated by a MD.  Pt became "shocky" and was treated with injectable epinephrine, benadryl and cortisone.  She was observed for 1/2hour and was sent home with oral Benadryl for 3 weeks and oral cortisone for 10 days.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: Swollen arm at injection site.  Warm to touch, itches within 24 hours.
Sex: M
Vaccine: DTAP, HBPV, MMR, OPV
Symptoms: Rash pustular
Clinical narrative: Pustulant rash to body.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Lethargy, Oedema, Vomiting
Clinical narrative: Pt became lethargic but with no loss of consciousness normal vital signs including pox and BP's.  Face and ears became red and ears became swollen.  Had emesis.  Benadryl given initially after emesis (about 1 hour later) phenergan given.  Monitored for 1.5 hour.  No wheezing.  Pt was able to walk on own at discharge.
Age: 1.7
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cough, Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Very fussy, temperature 103, 12 hours after receiving immunizations per mouth, cough, r/n started about 24 hours after immunizations.  Using Tylenol, pushing fluids.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Fever for 3 days with onset of "chicken pox" type rash on 12/12/2003.  Marks on 12/15/03.  Started to clear today 12/16/03.  Mom estimates greater than 50 pox on face/abdomen.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Injection site abscess
Clinical narrative: In 10/04/03 receive vaccination DTAP #3, HIB #3, IPV #3, Varivax, MMR, Pneumococcal #3, TB test.  the IPV and DTAP was placed left deltoid area.  In 12/03/03, mother inform was drainage pus left deltoid.  Abscess drained spontaneously-received antibiotic, seen next day , no drainage.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Pericarditis
Clinical narrative: Suspected pericarditis
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Cellulitis, Injection site induration, Injection site reaction, Lymphadenopathy
Clinical narrative: ED MD called poison center to ask about reaction to smallpox vaccine.  Day 10 described 3cm eschert.  4 inches of induration, swollen axillary lymph node.  Treated as cellulitis with antibiotics to call for follow up.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Herpes zoster
Clinical narrative: Developed VZV (+) shingles on left arm 12/01/03.
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Wheel appeared approximately 1 inch above injection site-right arm / SC varicella and MMR.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site pain, Injection site warmth, Oedema peripheral
Clinical narrative: Left arm swollen elbow to shoulder, no redness noted at injection site arm was warm to touch and tender at site.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, MMR
Symptoms: Hypokinesia, Injection site mass, Oedema peripheral, Tenderness
Clinical narrative: Received shots on Monday.  Complained of tenderness on Tuesday evening with limited movement mom noticed swelling on Wednesday morning shoulder to elbow.  Arm reddened elbow to shoulder.  Lump about the size of a fifty cent piece.
Age: 22.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest pain
Clinical narrative: Pt given FluMist intranasally. She had no URI or illness symptoms preceding and temp=98.2. 10-15 minutes later she developed mild substernal pressure/tightness that persisted for about 1 hour and 20 minutes. She was given ibuprofen 800mg and Zyrtec 10mg 15 minutes before resolved. No recurrence and didn't go on to infectious symptoms.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC
Symptoms: Anaemia haemolytic autoimmune, Laboratory test abnormal, Oral intake reduced, Pallor, Somnolence
Clinical narrative: Patient was given immunizations on Monday, Dec 29.  She presented to the office 5 days later with poor feeding and increased sleepiness.  She appeared very pale and had an H/H of 4.1/12.4.  She was diagnosed with autoimmune hemolytic anemia and admited to hospital for transfusions.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Persistent pain in left arm and shoulder at site of injection
Age: 0.61
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Crying, Electrocardiogram abnormal, Electroencephalogram abnormal, Hypotonia
Clinical narrative: It was reported that a seven month old female pt received a dose of IPOL, route and site of administration not reported on 10/14/03. On that day, she also received her third dose of Infanrix, administered in the left leg, as well as her third dose of hep B vaccine, a dose of Prevnar, and a dose of HIB vaccine. Routes and sites of administration for these vaccines were not provided. Approximately four hours later, the pt experienced prolonged crying. Her parents contacted the physician and took the pt to an ER, but the pt was not admitted. Within 48 hrs of immunization, on 10/15/03, the pt experienced seizures and hypotonic  episodes between crying. The physician reported that the pt had a total of three physician office visits and four visits to an ER. During one of the ER visits, a physician witnessed the pt having a seizure lasting less than ten minutes, and again, the pt was not admitted to the hospital. The pt's EEG results were abnormal. Her CAT scan results were normal. The prolonged crying resolved on 10/16/03. The seizures and hypotonic episodes were unresolved as of 11/17/03. The reporting physician considered the events to be probably related to vaccination with Infanrix. The physician noted that she was trying to get the pt admitted for further testing and diagnosis as well as to be placed on anti-seizure medications. The seizures, hypotonic episodes, and abnormal EEG are considered to be medically serious (OMIC) by the other manufacturer. No other info was provided at this time. Follow up on 01/09/2004: "From additional information received on 01/02/04 from another manufacturer, the WAES # of this case is WAES0312USA02360.  Reportedly, the diagnostic exams were completed in October of 2003.  No other information was provided at this time."
Age: 0.61
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal, Hypotonia, Screaming
Clinical narrative: It was reported that a seven month old female pt received a dose of IPOL, route and site of administration not reported on 10/14/03. On that day, she also received her third dose of Infanrix, administered in the left leg, as well as her third dose of hep B vaccine, a dose of Prevnar, and a dose of HIB vaccine. Routes and sites of administration for these vaccines were not provided. Approximately four hours later, the pt experienced prolonged crying. Her parents contacted the physician and took the pt to an ER, but the pt was not admitted. Within 48 hrs of immunization, on 10/15/03, the pt experienced seizures and hypotonic  episodes between crying. The physician reported that the pt had a total of three physician office visits and four visits to an ER. During one of the ER visits, a physician witnessed the pt having a seizure lasting less than ten minutes, and again, the pt was not admitted to the hospital. The pt's EEG results were abnormal. Her CAT scan results were normal. The prolonged crying resolved on 10/16/03. The seizures and hypotonic episodes were unresolved as of 11/17/03. The reporting physician considered the events to be probably related to vaccination with Infanrix. The physician noted that she was trying to get the pt admitted for further testing and diagnosis as well as to be placed on anti-seizure medications. The seizures, hypotonic episodes, and abnormal EEG are considered to be medically serious (OMIC) by the other manufacturer. No other info was provided at this time. Follow up on 01/09/2004: "From additional information received on 01/02/04 from another manufacturer, the WAES # of this case is WAES0312USA02360.  Reportedly, the diagnostic exams were completed in October of 2003.  No other information was provided at this time."
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Anxiety, Blood pressure increased, Dizziness, Dyspnoea, Heart rate increased
Clinical narrative: From initial information received on 12/22/03 from the vaccine administrator, regarding an adverse event occurring in the USA, it was reported that a 49 year old male patient received a first dose of FLUZONE SV, lot number U1136AA, administered IM in the left deltoid on 12/11/03 at 1:00 PM. Approximately two minutes later, the patient complained of dizziness, shortness of breath, and palpitations. His blood pressure was 230/88, heart rate 123, respirations 22, and pulse oxygenation level 98%. The patient became anxious and was transferred to the hospital after 20 minutes. At the emergency room, the patient was given Benadryl IV, Lopressor, Ativan and Pepcid. The patient was released five to six hours later. The patient reportedly recovered from this event on an unspecified date. (OMIC) Additional communication was received on 1/29/04 fro a health care professional, who reported that no additional information is available at this time. Follow up 01/06/05: Medical Assessment: In the absence of another etiology, the hypothesis of an allergic like reaction could be evoked. However, there were no allerty testins reported in order to identify a potential sensitzation to one of the vaccine components.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Palpitations
Clinical narrative: From initial information received on 12/22/03 from the vaccine administrator, regarding an adverse event occurring in the USA, it was reported that a 49 year old male patient received a first dose of FLUZONE SV, lot number U1136AA, administered IM in the left deltoid on 12/11/03 at 1:00 PM. Approximately two minutes later, the patient complained of dizziness, shortness of breath, and palpitations. His blood pressure was 230/88, heart rate 123, respirations 22, and pulse oxygenation level 98%. The patient became anxious and was transferred to the hospital after 20 minutes. At the emergency room, the patient was given Benadryl IV, Lopressor, Ativan and Pepcid. The patient was released five to six hours later. The patient reportedly recovered from this event on an unspecified date. (OMIC) Additional communication was received on 1/29/04 fro a health care professional, who reported that no additional information is available at this time. Follow up 01/06/05: Medical Assessment: In the absence of another etiology, the hypothesis of an allergic like reaction could be evoked. However, there were no allerty testins reported in order to identify a potential sensitzation to one of the vaccine components.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Asthenia, Chest pain, Dyspnoea, Haemoptysis
Clinical narrative: This subject is a 74 year old female, who died while enrolled in a comparative randomized study of safety and immunogenicity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with Aluminum Phosphate when administered concomitantly with a Licensed Influenza vaccine in High-Risk > or = 65 years of age. The subject received a dose of RSV vaccine or placebo and influenza vaccine on 9/30/02. The subject died, 444 days post-immunization. The cause of death was not reported. The patient's has a history of lung mass, dyspnea, pleural effusion, smoking, asthma, and COPD. The death was reported by the investigator as unrelated to the study vaccine. THe death certificate received on 2/3/04 states metastatic lung CA. The medical record received on 2/9/04 states pain, anorexia, blood oxygen decreased, decreased mobility, respiratory distress, weakness, hemoptysis, and chest pain. Additional information received January 12, 2004 death certificate cause of death: metastic lung cancer.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Hypoxia, Lung neoplasm malignant, Pain, Skin disorder
Clinical narrative: This subject is a 74 year old female, who died while enrolled in a comparative randomized study of safety and immunogenicity of a non-adjuvanted respiratory syncytial virus vaccine versus an RSV vaccine adjuvanted with Aluminum Phosphate when administered concomitantly with a Licensed Influenza vaccine in High-Risk > or = 65 years of age. The subject received a dose of RSV vaccine or placebo and influenza vaccine on 9/30/02. The subject died, 444 days post-immunization. The cause of death was not reported. The patient's has a history of lung mass, dyspnea, pleural effusion, smoking, asthma, and COPD. The death was reported by the investigator as unrelated to the study vaccine. THe death certificate received on 2/3/04 states metastatic lung CA. The medical record received on 2/9/04 states pain, anorexia, blood oxygen decreased, decreased mobility, respiratory distress, weakness, hemoptysis, and chest pain. Additional information received January 12, 2004 death certificate cause of death: metastic lung cancer.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Bacterial infection, Infection, Osteomyelitis, Pyrexia
Clinical narrative: Pt developed a fever, followed by extreme pain in her knee joint. X-rays were normal but blood tests determined a high sedimentation rate. She was hospitalized 11/12/03 and surgery to aspirate the infection (Staph infection of bone in leg) IV medication of antibiotic (Cefazolin) every 8 hrs for 6 weeks.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Red blood cell sedimentation rate increased
Clinical narrative: Pt developed a fever, followed by extreme pain in her knee joint. X-rays were normal but blood tests determined a high sedimentation rate. She was hospitalized 11/12/03 and surgery to aspirate the infection (Staph infection of bone in leg) IV medication of antibiotic (Cefazolin) every 8 hrs for 6 weeks.
Age: 6.0
Sex: M
Vaccine: HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Abasia, Apathy, Aphasia, Autism, Cognitive disorder
Clinical narrative: Lethargy of severe nature, rash, fever, poor immunity to minor ailments, seizures, loss of speech. All vaccines make him ill: fever, loose bowels, vomiting, lethargy, apathy, seizures, neuro deficit, allergies to foods, weird viruses ie. herpangina-after varicella shot. All reactions were reported-many ER visits ensued. Hep B-caused chronic rash-not responsive to any meds. Worst reaction was at age 2- almost died-regression, seizures, aggression, insomnia, lost ability to speak, stopped walking. Diagnosis was autism and mental retardation. He was healthy and normal at birth-was a premie but only needed one week hospital stay following birth. The shots have caused neurological, immunological, digestive and developmental problems-he will never recover and there is no cure. The medical record received on 3/23/04 states autism, mental retardation, behavior problems, ADHD, sleep problems and self injury.
Age: 6.0
Sex: M
Vaccine: HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Convulsion, Diarrhoea, Gastrointestinal disorder, Hostility, Hypersensitivity
Clinical narrative: Lethargy of severe nature, rash, fever, poor immunity to minor ailments, seizures, loss of speech. All vaccines make him ill: fever, loose bowels, vomiting, lethargy, apathy, seizures, neuro deficit, allergies to foods, weird viruses ie. herpangina-after varicella shot. All reactions were reported-many ER visits ensued. Hep B-caused chronic rash-not responsive to any meds. Worst reaction was at age 2- almost died-regression, seizures, aggression, insomnia, lost ability to speak, stopped walking. Diagnosis was autism and mental retardation. He was healthy and normal at birth-was a premie but only needed one week hospital stay following birth. The shots have caused neurological, immunological, digestive and developmental problems-he will never recover and there is no cure. The medical record received on 3/23/04 states autism, mental retardation, behavior problems, ADHD, sleep problems and self injury.
Age: 6.0
Sex: M
Vaccine: HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Immune system disorder, Insomnia, Lethargy, Mental retardation severity unspecified, Nervous system disorder
Clinical narrative: Lethargy of severe nature, rash, fever, poor immunity to minor ailments, seizures, loss of speech. All vaccines make him ill: fever, loose bowels, vomiting, lethargy, apathy, seizures, neuro deficit, allergies to foods, weird viruses ie. herpangina-after varicella shot. All reactions were reported-many ER visits ensued. Hep B-caused chronic rash-not responsive to any meds. Worst reaction was at age 2- almost died-regression, seizures, aggression, insomnia, lost ability to speak, stopped walking. Diagnosis was autism and mental retardation. He was healthy and normal at birth-was a premie but only needed one week hospital stay following birth. The shots have caused neurological, immunological, digestive and developmental problems-he will never recover and there is no cure. The medical record received on 3/23/04 states autism, mental retardation, behavior problems, ADHD, sleep problems and self injury.
Age: 6.0
Sex: M
Vaccine: HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Viral infection, Vomiting
Clinical narrative: Lethargy of severe nature, rash, fever, poor immunity to minor ailments, seizures, loss of speech. All vaccines make him ill: fever, loose bowels, vomiting, lethargy, apathy, seizures, neuro deficit, allergies to foods, weird viruses ie. herpangina-after varicella shot. All reactions were reported-many ER visits ensued. Hep B-caused chronic rash-not responsive to any meds. Worst reaction was at age 2- almost died-regression, seizures, aggression, insomnia, lost ability to speak, stopped walking. Diagnosis was autism and mental retardation. He was healthy and normal at birth-was a premie but only needed one week hospital stay following birth. The shots have caused neurological, immunological, digestive and developmental problems-he will never recover and there is no cure. The medical record received on 3/23/04 states autism, mental retardation, behavior problems, ADHD, sleep problems and self injury.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Bacterial infection, Dyskinesia, Eye movement disorder, Febrile convulsion, Feeling hot
Clinical narrative: Patient felt warm at supper time. He was afebrile prior to this. His eye then rolled back and he had tonic/clonic movements of extremities common with seizure activity. Temperature 102. This was a febrile seizure occurrence. The medical record received on 1/8/04 states strep pharyngitis.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Pharyngitis
Clinical narrative: Patient felt warm at supper time. He was afebrile prior to this. His eye then rolled back and he had tonic/clonic movements of extremities common with seizure activity. Temperature 102. This was a febrile seizure occurrence. The medical record received on 1/8/04 states strep pharyngitis.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Pt started with temp of 102 approx 2 1/2 hours after administration of influenza vaccine. Temp up to 105 the following day.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Face oedema, Oedema, Pruritus, Rash erythematous
Clinical narrative: 10/28/03: Awoke with swollen mouth, lip, cheek on right side. Later that day swollen, raised white areas from 1" diameter to 6" diameter over entire body. When they turned red they itched. Other lip followed. This continued 1 month. Now 6 weeks later still raised areas over body that come and go. Tx Benadryl. No decrease in severity.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Hemiparesis
Clinical narrative: Right arm weakness since flu shot given on 10/23/2003. Follow up 1/19/04: Follow up visits with patient are much more consistent with rotator cuff pathology as the etiology of his shoulder paina nd weakness than his initial assertion that it was due to his flu shot.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: AM of 10/30/03 noted that injection site was very sore, hot to touch and swelling 7cm x 5cm. 5 days before swelling and soreness resolved.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscular weakness, Pain
Clinical narrative: "Ache" in left humerus. Left 4th ring finger numb and weak. Left arm numb and weak. It began about 2 weeks post shot. Shot given 11/12/2003.
Age: 10.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 6 x 8cm erythematous induration right upper arm at site of immunization.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal discomfort, Oedema peripheral
Clinical narrative: Vaccine caused very bad swelling in arm and knot in muscle, affected joints, shoulder, knees, back.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Musculoskeletal discomfort, Oedema peripheral
Clinical narrative: Vaccine caused bad swelling in arm and knot in muscle. Affected joints, shoulder, knees, back. Took one month to recover.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth, Pain
Clinical narrative: Approx 8 hours after injection pt reported throbbing and swelling at injection site. Redness, irritation and pain moved from injection site down past elbow. Pt also reported heat in the affected area.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Skin irritation
Clinical narrative: Approx 8 hours after injection pt reported throbbing and swelling at injection site. Redness, irritation and pain moved from injection site down past elbow. Pt also reported heat in the affected area.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Received 4 year old immunizations at 2:30 PM: DTaP, IPV, MMR, left with no problems. Went to MD c/o hives, no difficulty breathing. Bendarex tsp given.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Pruritic polymorphae rash on torso, arms, legs with fever for 2 days of 12/17/03. Seen by MD 12/19/03. Instructed Tx with Caladryl and Benadryl. RTC 7 to 10 days for F/U.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Insomnia, Irritability
Clinical narrative: Unusually fussy, worsening sleep x 4 nights, Tylenol no help, no fever. Tx: continue Tylenol, observe.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR
Symptoms: Lethargy, Pyrexia
Clinical narrative: 104.3 highest temp, only went down to 102.3 after Tylenol and Motrim regimen. Fever lasted a week. Finally broke after 3rd dose of an antibiotic. Very lethargic, lowest temp before antibiotic 101.3. Mother reported that visit was made to emergency room on 11-18-03 and doctor visit was made on 11-20-03 for unresolved fever and lethargy. Antibiotic prescribed. Fever returned to normal on 11-21-03.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Chills, Erythema, Fatigue, Headache
Clinical narrative: Injection given in right arm approx 3:30 PM. By 8 PM, stiff neck, severe headache, body aches, muscle aches, chills, body temp 96 degrees, right arm and hand red and extremely swollen, hot to touch, extreme exhaustion. Too ill to see Dr for 3 days, then went to Urgent Care and was told I got more reaction than expected. Was advised by 2 doctors to not get flu shot this year.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Myalgia, Oedema peripheral, Pain
Clinical narrative: Injection given in right arm approx 3:30 PM. By 8 PM, stiff neck, severe headache, body aches, muscle aches, chills, body temp 96 degrees, right arm and hand red and extremely swollen, hot to touch, extreme exhaustion. Too ill to see Dr for 3 days, then went to Urgent Care and was told I got more reaction than expected. Was advised by 2 doctors to not get flu shot this year.
Age: 1.83
Sex: M
Vaccine: DTAP, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 33mm reddened swollen area LMT noticed by pt's mother today. No treatment by mother at this time.
Age: 12.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Wheezing
Clinical narrative: Per father, through interpreter: child developed wheezing about 6 hours after immunizations, was brought to ER with treatment of Nebs and Prednisone. Was discharged from ER to home.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Rash vesicular
Clinical narrative: Local reaction with redness and swelling followed by varicella like rash x 3 days on chest (not seen by health provider).
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Tremor, Urticaria
Clinical narrative: Hives, shaking of body, no real seizures.
Age: 19.0
Sex: F
Vaccine: MEN
Symptoms: Fall, Loss of consciousness
Clinical narrative: Approx 10 minutes after meningococcal vaccine given, pt was waiting in line to check out, leaning against wall and suddenly fell to floor hitting chin on the counter top, pt unconscious for about 1 minutes; pt alert and oriented upon nurse arrival. Vital signs WNL. Rescue squad arrived and transported to hospital.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial infection, Dermatitis bullous, Infection
Clinical narrative: 11/1/03: Pt developed severe varicella with secondary strep/staph infection and required acyclovir and Keflex therapy. Pt also had varicella lesion in eyes requiring opthmalogy visit.
Age: 1.92
Sex: F
Vaccine: UNK
Symptoms: Infection, Pruritus, Rash vesicular
Clinical narrative: Seen 12/31/03 at our office with attenuated varicella. Pruritic, vesicular rash on pink base of face, scalp, trunk, extremities.
Age: 33.0
Sex: M
Vaccine: ANTH, MEN, SMALL, YF
Symptoms: Chest pain, Injection site erythema, Injection site oedema, Pain
Clinical narrative: 7 days post vaccination, redness, soreness and swelling at vaccination site. 8-10 days post vax, local pain with chest pain, pain scale (6), no breathing difficulty. Resolved with Tylenol.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash
Clinical narrative: Within 2-3 hours of receiving flu mist vaccine pt erupted with an exanthematous light pink rash covering the lower torso and legs - not pruritic or urticarial. Mostly resembles a viral exanthem.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: That evening (10/28/03) broke out in erythematous rash all over body.  Denied any tongue swelling or difficulty breathing.  Required IV steroids and Atarax at ER.  Is on a prescription for steroids orally (tapering dose.  Currently with minimal rash left 10/30/03.  report made by her PMD.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: uncomfortable, unconsable, crying bagan 12-31-03 2:00 am to 4 AM. Resumed 9:00 AM to 12:00 noon. No local inflammation at injection site - very passive baby - event muck unlike nature of child and course of sibling immunizations.
Age: 1.53
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy, Rash
Clinical narrative: He was given the MMR vaccine on Monday, December 22 and about a 7 days later had swollen lymph nodes in his groin and broke out in a systemic rash-small red bumps a day or so after that.  He was treated with childrens liquid Benadryl (1/4 tsp every 6 hours for three days).
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Agitation, Crying, Pyrexia
Clinical narrative: Persistant unconsolable crying from afternoon 12-16-03 to this am 12-18-03 - mother voices temp range from 99.1 to 102 - tylenol given every 4 to 6 hours. To doctor on 12-17-03 Dx DTP reaction
Age: 4.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Blood pressure decreased, Contusion, Crying, Heart rate increased, Injury
Clinical narrative: 15 minutes after receiving MMR and influenza vaccine, fell suddenly to the floor while watching sister receiving a vaccine. Noted bruising and small laceration over right ear.  Child was crying and stated his head hurt.  BP=80/60; Pulse=100; R=20.  EMS transported child to ER. Report will follow.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR
Symptoms: Loss of consciousness
Clinical narrative: 15 minutes after receiving MMR and influenza vaccine, fell suddenly to the floor while watching sister receiving a vaccine. Noted bruising and small laceration over right ear.  Child was crying and stated his head hurt.  BP=80/60; Pulse=100; R=20.  EMS transported child to ER. Report will follow.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Developed hives on face and back within 10 minuters of vaccine administration. Patient remained alert and talkative.  No respiratory symptoms.  Hives diminished within 20 minutes. No other symptoms or complaints.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Erythema, Nasal congestion, Rash papular, Rash pruritic, Skin ulcer
Clinical narrative: 17 days after primary SPV, patient developed pruritic erythematous papules and pustules on his lower back.  Over the next 3-4 days, he developed additional papules on his chest, thighs, and arms.  Lesions do not have the appearance of vaccinial lesions.  No other complaints except for URI sx (stuffy nose).  Dx. Non-viral pustulosis Tx. Plan/ Recommendations: 1. Rx for sx relief:  Allegra 180 mg po QD # 30 with no refills. 2. Reinforced education on care of the SPV vaccination to prevent transfer of the Vaccinia virus.   3. In a pre-event setting, this service member should be exempt from all future smallpox vaccinations unless direct exposure occurs.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Erythema, Pruritus, Rash, Upper respiratory tract infection
Clinical narrative: 17 days after primary SPV, patient developed pruritic erythematous papules and pustules on his lower back.  Over the next 3-4 days, he developed additional papules on his chest, thighs, and arms.  Lesions do not have the appearance of vaccinial lesions.  No other complaints except for URI sx (stuffy nose).  Dx. Non-viral pustulosis Tx. Plan/ Recommendations: 1. Rx for sx relief:  Allegra 180 mg po QD # 30 with no refills. 2. Reinforced education on care of the SPV vaccination to prevent transfer of the Vaccinia virus.   3. In a pre-event setting, this service member should be exempt from all future smallpox vaccinations unless direct exposure occurs.
Age: 54.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Developed pain and erythema at the site of yellow fever injection.  Diameter approximately 10cm.  Had reactive pain in muscles, shoulder and side.  Had mild, occasional, residual pain at site one month afterwards. Did not seek medical attention.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Baby present D.O.A. to ER 4 days after vaccine admin. Was healthy and behaving normal several hours prior to death. The autopsy report received on 1/14/04 states SIDS.
Age: 1.02
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Convulsion, Pharyngitis, Pyrexia
Clinical narrative: One year old female with previous URI symptoms and low grade fever since 12/10/03. She received Varivax and PCV7 vaccines on 12/12/03 and on 12/15/03 she developed high fever and seizures. Seen at hospital ER where full sepsis w/up done and transferred to another hospital.
Age: 12.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Ocular hyperaemia
Clinical narrative: Two types of rash big, raised hives, swelling of hands and feet, sore muscles, achy, slight fever, joints hurt, red eyes, headaches, tired within hours of vaccines. Was diagnosed with vasculitis, JRA, lupus after vaccines.
Age: 12.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Oedema peripheral, Pain, Pyrexia, Rash, Rheumatoid arthritis
Clinical narrative: Two types of rash big, raised hives, swelling of hands and feet, sore muscles, achy, slight fever, joints hurt, red eyes, headaches, tired within hours of vaccines. Was diagnosed with vasculitis, JRA, lupus after vaccines.
Age: 12.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Systemic lupus erythematosus, Urticaria, Vasculitis
Clinical narrative: Two types of rash big, raised hives, swelling of hands and feet, sore muscles, achy, slight fever, joints hurt, red eyes, headaches, tired within hours of vaccines. Was diagnosed with vasculitis, JRA, lupus after vaccines.
Age: 13.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Joint range of motion decreased, Oedema peripheral, Pain
Clinical narrative: Right arm swollen, tender, decreased movement secondary to pain. No redness, no warmth, no decreased sensation, NL radial and ulnar pulse, no discolor. Tx: ice, elevation x1 day, then movement.
Age: 7.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Fall, Oedema, Pallor, Syncope
Clinical narrative: Pt was administered flu vaccination when fainted, fell to floor, airway patent, became alert within 30 seconds, pallor, P-108, weakness, swollen area on back of head after fainting. Observed for 40 minutes, took fluids, alert and oriented. Sent via EMS to ER for further evaluation.
Age: 7.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Chest pain, Coma, Contusion, Fall
Clinical narrative: Pt was administered flu vaccination when fainted, fell to floor, airway patent, became alert within 30 seconds, pallor, P-108, weakness, swollen area on back of head after fainting. Observed for 40 minutes, took fluids, alert and oriented. Sent via EMS to ER for further evaluation.
Age: 7.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Nausea, Pallor, Syncope
Clinical narrative: Pt was administered flu vaccination when fainted, fell to floor, airway patent, became alert within 30 seconds, pallor, P-108, weakness, swollen area on back of head after fainting. Observed for 40 minutes, took fluids, alert and oriented. Sent via EMS to ER for further evaluation.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash, severe itching. ER 12.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain, Pyrexia
Clinical narrative: 10 hours after receiving vaccine, began to experience severe leg pain bilaterally. Pain increased over next 3 hours and remained constant for 2 days followed by 2 days of lesser amount of leg pain. Also at 12 hours began to experience generalized weakness and aches to entire body with temperature of 99.9. All symptoms unrelieved with Motrin or Tylenol.
Age: 1.83
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: + urticaria (diffuse) within 24 hours. No hx egg allergy.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site oedema, Oedema peripheral, Paraesthesia
Clinical narrative: After #3 Anthrax shot, left arm began to swell from site of shot down to mid forearm. Swelling began approx 24 hours after shot. Left hand also began tingling. Still swollen, possibly, 2 days later.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Oedema peripheral, Urticaria
Clinical narrative: Then 2 days ago, left elbow and left biceps area swelling, urticarial, had chills today.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Hypersensitivity, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: Cutaneous lesions following anthrax vaccine #2 consistent with delayed hypersensitivity reaction - see attached clinical summary. Developed dry, pruritic, raised rash that started on his feet, and later spread to his groin, axilla and wrists approx 2 weeks later. Treated with Calamine lotion with minimum relief. After he contacted clinic on 12/12/03, he started taking Benadryl prn, which has helped with the itching. Local: red, swollen, with minimal tenderness x 2-3 days; small knot under skin x 1 week.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Pruritus, Rash, Skin ulcer
Clinical narrative: Cutaneous lesions following anthrax vaccine #2 consistent with delayed hypersensitivity reaction - see attached clinical summary. Developed dry, pruritic, raised rash that started on his feet, and later spread to his groin, axilla and wrists approx 2 weeks later. Treated with Calamine lotion with minimum relief. After he contacted clinic on 12/12/03, he started taking Benadryl prn, which has helped with the itching. Local: red, swollen, with minimal tenderness x 2-3 days; small knot under skin x 1 week.
Age: 53.0
Sex: M
Vaccine: TTOX
Symptoms: Chills, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Site of injection red, swollen c/o body aches and chills.
Age: 3.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Skin ulcer, Urticaria
Clinical narrative: 2 days post vaccine, presence of urticarial lesions were noted on trunk and extremities.