chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dizziness, Dysgeusia, Nausea, Vaccine positive rechallenge
Clinical narrative: She received Hepatitis B #3 adult dose 2/24/11 at her work address. She complained of dizziness, numbness in lips, stomach cramps, nausea & a metallic taste in mouth 5 minutes after her shot but she did not report this until 2/25/11 when she was seen at health center. Diagnosis was possible vaso-vagal reaction to Hep B vaccine.
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Abdominal pain upper, Dizziness, Dysgeusia, Hypoaesthesia oral, Nausea
Clinical narrative: She received Hepatitis B #3 adult dose 2/24/11 at her work address. She complained of dizziness, numbness in lips, stomach cramps, nausea & a metallic taste in mouth 5 minutes after her shot but she did not report this until 2/25/11 when she was seen at health center. Diagnosis was possible vaso-vagal reaction to Hep B vaccine.
Age: 10.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Crying, Diarrhoea, Insomnia, Lethargy, Oropharyngeal pain
Clinical narrative: Between February 25 and today's date March 1, 2011: Lethargic, rash, restless/difficulty sleeping, diarrhea, sore throat, excessive crying (even while sleeping), complaints of body aches (head, stomach, arms, legs) fever (102.2).
Age: 10.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Pain, Pyrexia, Rash, Restlessness
Clinical narrative: Between February 25 and today's date March 1, 2011: Lethargic, rash, restless/difficulty sleeping, diarrhea, sore throat, excessive crying (even while sleeping), complaints of body aches (head, stomach, arms, legs) fever (102.2).
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash generalised
Clinical narrative: Rash began on stomach and legs consisting of small red circles. Within 24 hours the rash spread across entire body.
Age: 1.26
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Coordination abnormal, Fall, Gait disturbance
Clinical narrative: Had trouble walking - seemed discoordinated would pull up and try to walk but would fall.  No fever, no irritability and shots were given in arm not leg.  Returned to normal next day.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Chest X-ray, Loss of consciousness, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever, Nausea, Vomiting, LOC
Age: 56.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Joint range of motion decreased, Swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 56 year old female patient with no drug reaction or allergies, who on 17-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665904/0866Z EXP 04-JUL-2011) IM.  On 17-FEB-2011, within 2 hours post vaccination, the patient developed reddness and swelling at the site of injection.  On 18-FEB-2011, "within 24 hours", she had a 4 inch band of swelling around the circumference of the arm.  She also had difficulty in range of motion in the arm and difficulty lifting the arm.  The patient went to an immediate care center and was told to use ice and BENADRYL.  The patient recovered on 20-FEB-2011.  There were no diagnostic laboratories studies performed.  Reddness and swelling at the site of injection, difficulty in range of motion in the arm and difficulty lifting the arm were considered to be disabling by the pharmacist.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site induration, Joint range of motion decreased, Mobility decreased, Pain
Clinical narrative: Information has been received from a registered pharmacist concerning a 56 year old female patient with no drug reaction or allergies, who on 17-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665904/0866Z EXP 04-JUL-2011) IM.  On 17-FEB-2011, within 2 hours post vaccination, the patient developed reddness and swelling at the site of injection.  On 18-FEB-2011, "within 24 hours", she had a 4 inch band of swelling around the circumference of the arm.  She also had difficulty in range of motion in the arm and difficulty lifting the arm.  The patient went to an immediate care center and was told to use ice and BENADRYL.  The patient recovered on 20-FEB-2011.  There were no diagnostic laboratories studies performed.  Reddness and swelling at the site of injection, difficulty in range of motion in the arm and difficulty lifting the arm were considered to be disabling by the pharmacist.  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 56 year old female patient with no drug reaction or allergies, who on 17-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665904/0866Z EXP 04-JUL-2011) IM.  On 17-FEB-2011, within 2 hours post vaccination, the patient developed reddness and swelling at the site of injection.  On 18-FEB-2011, "within 24 hours", she had a 4 inch band of swelling around the circumference of the arm.  She also had difficulty in range of motion in the arm and difficulty lifting the arm.  The patient went to an immediate care center and was told to use ice and BENADRYL.  The patient recovered on 20-FEB-2011.  There were no diagnostic laboratories studies performed.  Reddness and swelling at the site of injection, difficulty in range of motion in the arm and difficulty lifting the arm were considered to be disabling by the pharmacist.  Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 78 year old male patient with diabetes, high cholesterol, hypertension and no drug reactions or allergies who on 20-JUL-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 666639/0564Z, expire date 09-OCT-2011), 0.5 ml, subcutaneously.  Concomitant therapy included metformin, GLYPRIDE, DIOVAN, simvastatin (manufacturer unknown), CELEXA, aspirin, minerals (unspecified) (+) CENTRUM SILVER, cholecalciferol and omeprazole.  Certified medical assistant stated that on 20-JUL-2010 post-administration of PNEUMOVAX 23, the patient complained of right arm swelling at and around the area of the injection site.  The area was hot, red and sore to the touch.  The nurse practitioner assessed the area.  She noted that there was 17 cm of heat and bright to little pink skin under the ulnar aspect of the arm to a few inches below the axilla to a few inches past the elbow.  The patient stated that he had to sleep in a recliner chair because the pain was so intense.  There were no laboratory diagnostics studies performed.  The patient was treated with antihistamines of unknown origin and the patient recovered fully the beginning of August 2010.  Right arm swelling at and around the area of injection site, 17 cm of heat and bright to lite pink skin under ulnar aspect of the arm to a few inches below the axilla to a few inches past the elbow, red and sore to the touch were considered to be disabling "for a few days" by the certified medical assistant.  This is one of two reports received from the same source.  Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Angioedema, Cough, Skin test positive, Urticaria, Wheezing
Clinical narrative: Initial report received from a physician on 23 February 2011. A 5 year-old male patient (date of birth not reported) who had no reported medical history had received in May 2010 a 4th dose of IPOL, 5th dose of DTaP (manufacturer unknown) and a dose of PREVNAR (Wyeth) vaccine. The lot numbers were not reported for any of the vaccines. Several hours post vaccination, the patient experienced coughing, wheezing, urticaria and angioedema requiring a emergency room and/or doctor visit. He subsequently had a skin test (date not reported) that was positive for DAPTACEL and FLUZONE. Treatments received and other diagnostic/laboratory test performed were not reported. Outcome was not reported. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Pt noted rash 2 days after immunization received. Rash began along armpit & across chest. Pt will take ZYRTEC but declined steroid trial of triamcinolone. Pt will follow up as needed.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 4 days after injection upper (R) arm site became reddened & swollen - then painful.
Age: 60.0
Sex: M
Vaccine: FLU3, HEPAB
Symptoms: Pain in extremity
Clinical narrative: Pt rec'd TWINRIX vaccine 9/22/10 & 10/28/10. Denied any problem w/ 9/22/10 vaccine. On 2/17/11 he contacted the health dept. to report severe upper arm pain after the 10/28/10 injection. Denied having any redness, swelling or other signs of inflammation. Pain lasted about 3 months. Pain had resolved by 2/28/11. Pt. did not seek medical care.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Starting shortly after the shot I became dizzy light headed and nauseated with a rash on my neck and chest with a fever of 101.87 very weak and lethargic. Later that night experienced vomiting and diarrhea no appetite. The next morning still had my fever still feeling dizzy no appetite very pale and with head ache still lethargic. Day three I had a fever of 99.7 still very dizzy had small rash and I was very weak went to Urgent Care. It is now March 2 2011 I am still experiencing no appetite nausea small fever and fatigue.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Lethargy, Nausea, Pallor, Pyrexia
Clinical narrative: Starting shortly after the shot I became dizzy light headed and nauseated with a rash on my neck and chest with a fever of 101.87 very weak and lethargic. Later that night experienced vomiting and diarrhea no appetite. The next morning still had my fever still feeling dizzy no appetite very pale and with head ache still lethargic. Day three I had a fever of 99.7 still very dizzy had small rash and I was very weak went to Urgent Care. It is now March 2 2011 I am still experiencing no appetite nausea small fever and fatigue.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Rash, Vomiting
Clinical narrative: Starting shortly after the shot I became dizzy light headed and nauseated with a rash on my neck and chest with a fever of 101.87 very weak and lethargic. Later that night experienced vomiting and diarrhea no appetite. The next morning still had my fever still feeling dizzy no appetite very pale and with head ache still lethargic. Day three I had a fever of 99.7 still very dizzy had small rash and I was very weak went to Urgent Care. It is now March 2 2011 I am still experiencing no appetite nausea small fever and fatigue.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Diarrhoea, Myalgia, Pyrexia, Rash erythematous, Vomiting
Clinical narrative: Starting shortly after the shot I became dizzy light headed and nauseated with a rash on my neck and chest with a fever of 101.87 very weak and lethargic. Later that night experienced vomiting and diarrhea no appetite. The next morning still had my fever still feeling dizzy no appetite very pale and with head ache still lethargic. Day three I had a fever of 99.7 still very dizzy had small rash and I was very weak went to Urgent Care. It is now March 2 2011 I am still experiencing no appetite nausea small fever and fatigue.
Age: 1.72
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Swollen leg with redness, heat x 2 d diffuse papular urticaria rash legs, trunk, and scattered on arms.
Age: 1.72
Sex: F
Vaccine: DTAP
Symptoms: Urticaria papular
Clinical narrative: Swollen leg with redness, heat x 2 d diffuse papular urticaria rash legs, trunk, and scattered on arms.
Age: 0.46
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erosion, Injection site papule, Injection site pruritus, Injection site rash
Clinical narrative: Papular rash lateral thighs at site of imms some excoriation suggestive of itching no treatment.
Age: 46.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling/redness on R lower part of upper arm. pt states 0 discomfort.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood glucose increased, Dizziness, Erythema, Gait disturbance
Clinical narrative: Pain by administering to the left arm - completely red whole area covered by band aid for 3-4 weeks. Appeared weak. Rabies - head swollen - saliva - dizzy weak hard to walk (ribcage trouble/ nonstop developing.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal disorder, Nuclear magnetic resonance imaging, Pain in extremity, Rabies, Salivary hypersecretion
Clinical narrative: Pain by administering to the left arm - completely red whole area covered by band aid for 3-4 weeks. Appeared weak. Rabies - head swollen - saliva - dizzy weak hard to walk (ribcage trouble/ nonstop developing.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Pain by administering to the left arm - completely red whole area covered by band aid for 3-4 weeks. Appeared weak. Rabies - head swollen - saliva - dizzy weak hard to walk (ribcage trouble/ nonstop developing.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Arthralgia, Arthritis, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Pt is a 60 yr old female who presents for possible vaccine reaction. Pt complains of lower extremity and back muscle pains, rated 10 on 1-10 scale. Vaccines given in left arm on 2/14/11. Medications and allergies reviewed. Pt blood sugar checked as she is diaphoretic, results 197, one hour post prandial. Pt states woke up at 3 am on 2/15 with severe myalgia and fever, HA and left arm soreness. States fever was 101.0; since then, fevers continue (this am 100.3) and arthralgia and myalgia worse to full body but not similar to usual arthritis/myalgia pain. Took Methotrexate on 2/14/11 in evening. Received ADACEL and PNEUMOVAX on 2/14/11 to left arm.
Age: 60.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt is a 60 yr old female who presents for possible vaccine reaction. Pt complains of lower extremity and back muscle pains, rated 10 on 1-10 scale. Vaccines given in left arm on 2/14/11. Medications and allergies reviewed. Pt blood sugar checked as she is diaphoretic, results 197, one hour post prandial. Pt states woke up at 3 am on 2/15 with severe myalgia and fever, HA and left arm soreness. States fever was 101.0; since then, fevers continue (this am 100.3) and arthralgia and myalgia worse to full body but not similar to usual arthritis/myalgia pain. Took Methotrexate on 2/14/11 in evening. Received ADACEL and PNEUMOVAX on 2/14/11 to left arm.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Gait disturbance, Injection site swelling, Pyrexia
Clinical narrative: Fever about 12 hrs after vaccine given (T 103 degrees F) refused to walk at home. Swelling at area of injection, no redness or bruise.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Breast swelling, Diarrhoea, Swelling face, Vomiting
Clinical narrative: Vomiting diarrhea next day of administration associated with facial swelling as well as (L) breast swelling.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Gait disturbance
Clinical narrative: Dad reported the day after injection pt refused to walk for a few hours, possible swelling.
Age: 49.0
Sex: F
Vaccine: FLUN3
Symptoms: Cheilitis, Lip swelling, Rash pustular
Clinical narrative: Individual was vaccinated on Jan 21, 2011 with the FLUMIST vaccine. She began to develop a redness and swelling on her upper lip with 4 pustules. She went to see her PCM. She did not miss any work and the condition resolved after one week.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: (L.) anterior thigh with a 15-20cm diameter patch of erythema, centrally with 12-15 vesicular lesions, no drainage. Area warm and indurated, but no pain on palpatation. Temp-97.7 no itching, no discomfort. Treatment - Benadryl q 6 hours PRN.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: (L.) anterior thigh with a 15-20cm diameter patch of erythema, centrally with 12-15 vesicular lesions, no drainage. Area warm and indurated, but no pain on palpatation. Temp-97.7 no itching, no discomfort. Treatment - Benadryl q 6 hours PRN.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Injection site haematoma, Injection site swelling
Clinical narrative: Bruise and area of swelling on (L) thigh at site of injection.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 5" red swollen, hot area to (L) deltoid next day. TX antihistamines, x 24 hours, KEFLEX added on 2nd day.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Rash, Rash erythematous, Swelling face
Clinical narrative: On 2/9/11 after imz pt right shoulder became red rashy & swollen. On am of 2/10/11 spread to back chest & face.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: Local reaction of large 1 1/2 x 3" red, warm & itchy spot - lasting 3 days.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Influenza like illness, Injection site erythema
Clinical narrative: Pt called with c/o redness, pain & swelling in (R) arm. Flu like symptoms of fever > 101.0 fatigue, muscle aches, red & swollen (R) deltoid 5x4 inches with mass or hard lump. Nausea chills body aches.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Myalgia, Nausea
Clinical narrative: Pt called with c/o redness, pain & swelling in (R) arm. Flu like symptoms of fever > 101.0 fatigue, muscle aches, red & swollen (R) deltoid 5x4 inches with mass or hard lump. Nausea chills body aches.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt called with c/o redness, pain & swelling in (R) arm. Flu like symptoms of fever > 101.0 fatigue, muscle aches, red & swollen (R) deltoid 5x4 inches with mass or hard lump. Nausea chills body aches.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient experienced pain with the vaccine injection. Since that time she has experienced pain and tingling in the arm, neck, shoulder, and fingers and is losing mobility with  her left arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11 x 17 cm area of erythema, swelling, mild warmth & tenderness over (L) shoulder/upper arm treated with BACTRIM. No fever.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: 11 x 17 cm area of erythema, swelling, mild warmth & tenderness over (L) shoulder/upper arm treated with BACTRIM. No fever.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Aggression, Dyskinesia, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Given 0.5 ml TDAP in (R) deltoid IM, 0.5 ml MENACTRA (L) deltoid IM. Pt slumped over 30 seconds after 2nd vaccine, was unresponsive with a few body jerks x 20-30 seconds. Became aware but argumentative for 1 or 2 minutes.
Age: 0.63
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Computerised tomogram normal, Grand mal convulsion
Clinical narrative: Vaccine received on 2/22/11 to ER on 2/23/11, early AM with generalized tonic clonic seizure. No studies done - felt related to vaccine.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received PENTACEL, PREVNAR 13, ENGERIX and Rotavirus on 1/31/11 and again on 2/18/11 - This was spaced too closely. No adverse response noted. Parents informed. Clinic physician examined patient, prolonged observation period of 20+ minutes.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Aphonia, Chest pain, Cough, Eye discharge, Eye irritation
Clinical narrative: 24-48 hrs after injection eyes dripping pus - very red scratchy & irritated - lasting for 2-3 days 1 week after injection all over body aches - fever lost voice heavy aching in chest lasting 7 days. Have had cold cough and sinus infection 3 times since.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Nasopharyngitis, Ocular hyperaemia, Pain, Pyrexia, Sinusitis
Clinical narrative: 24-48 hrs after injection eyes dripping pus - very red scratchy & irritated - lasting for 2-3 days 1 week after injection all over body aches - fever lost voice heavy aching in chest lasting 7 days. Have had cold cough and sinus infection 3 times since.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Following imm pt slept for 2-3 hours when woke up was very irritated legs red & swollen.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Oedema peripheral
Clinical narrative: Pt developed adverse injection site reaction. Arm of injection swelled to the size of a grapefruit. Pt called pharmacy advised to take BENADRYL. Followed up with pt the following day swelling reduced. Advised pt to take ADVIL and ice 20 min on/20 min off. Left message with MD to report AE.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: 8:30 am on 2/23/2011. C/o feeling pain. Mild fever (101) very tired. Did not go to school stayed home & slept on couch all day. Parents gave TYLENOL to help with symptoms.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Patient displayed signs of allergic reaction after administering ZOSTAVAX vaccine. Gave EPIPEN and called 911. Paramedics took pt. to hospital.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Eye swelling, Hypersensitivity, Injection site erythema, Injection site induration
Clinical narrative: Patient displayed signs of allergic reaction after administering ZOSTAVAX vaccine. Gave EPIPEN and called 911. Paramedics took pt. to hospital.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Lacrimation increased, Ocular hyperaemia, Oedema mouth
Clinical narrative: Patient displayed signs of allergic reaction after administering ZOSTAVAX vaccine. Gave EPIPEN and called 911. Paramedics took pt. to hospital.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling in left arm from shoulder to elbow.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: 4" circular area - redness. Sore touch itchy, started 1 wk ago after injection was given Prednisone.
Age: 1.2
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Eye discharge, Lethargy, Local swelling, Ocular hyperaemia, Photophobia
Clinical narrative: Full body rash, swollen neck & face, sensitivity to light, red & pussy eyes, lethargic, heat coming from body, but no fever. Rash lasted 2 weeks, swelling lasted 48 hrs., sensitivity to light for 4 to 5 days. Looked like the mini-measles.
Age: 1.2
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Rash generalised, Skin warm, Swelling face, Viral rash
Clinical narrative: Full body rash, swollen neck & face, sensitivity to light, red & pussy eyes, lethargic, heat coming from body, but no fever. Rash lasted 2 weeks, swelling lasted 48 hrs., sensitivity to light for 4 to 5 days. Looked like the mini-measles.
Age: 0.22
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Gastrointestinal disorder, Irritability, Weight decreased
Clinical narrative: 2-10-11 diarrhea x 1 wk. 2-19-11 continue with bowel problems, weight loss, fussy since immunizations.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Approx 10 min. after giving immunizations pt produced a rash over (B) arms (B) legs and abdomen. No wheezing noted. Pt was given oral BENADRYL, and rash faded after 25 to 30 min.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Crying, Fall, Malaise, Musculoskeletal stiffness, Syncope
Clinical narrative: Syncopal event after flu vaccine. About 1 min after receiving shot, patient was standing & waiting for his mom to get her shot. He said "I don't feel well", took a few steps and fell to floor. Arms were flexed & stiff but no clonus. He soon started crying. Entire episode lasted about 1 minute. No incontinence or postictal-like phase.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Burning sensation, Erythema, Heart rate increased, Hypoaesthesia
Clinical narrative: A few weeks after the vaccination, I experienced a high level of burning/red skin, swollen feet, legs and face, an accelerated heart rate & general irritable mood/feelings, all occurring at different times of day and for intense stretches of time, still at present time. Also numbness at times.
Age: 57.0
Sex: M
Vaccine: FLUX
Symptoms: Irritability, Oedema peripheral, Swelling face, Urine analysis
Clinical narrative: A few weeks after the vaccination, I experienced a high level of burning/red skin, swollen feet, legs and face, an accelerated heart rate & general irritable mood/feelings, all occurring at different times of day and for intense stretches of time, still at present time. Also numbness at times.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: (R) arm red, swollen, itchy & sore.
Age: 1.07
Sex: M
Vaccine: HEPA, PNC
Symptoms: Biopsy muscle, Biopsy peripheral nerve, Convulsion, Cytogenetic analysis, Dyspnoea
Clinical narrative: Started out with muscle weakness to legs, legs giving out when standing.  Then seizures started a few days after followed by inability to breathe on own.  Became vent. dependent.
Age: 1.07
Sex: M
Vaccine: HEPA, PNC
Symptoms: Dysstasia, Laboratory test, Mechanical ventilation, Muscular weakness
Clinical narrative: Started out with muscle weakness to legs, legs giving out when standing.  Then seizures started a few days after followed by inability to breathe on own.  Became vent. dependent.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Brain scan normal, Chest X-ray, Electroencephalogram, Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure - 5 minutes - fever 106 degrees F - chest X Ray, EEG - Brain ultrasound - Normal ventricular size.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Induration, Inflammation, Skin warm
Clinical narrative: An area approximately 7 cm in diameter just below inj site became inflamed, warm to touch & sl. hardened. Referred to PCP who treated with oral ATB.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Nausea, Rash, Rash pruritic
Clinical narrative: Itchy rash on arms, legs, warm face, rash on abdomen, back, dizzy, nauseated now for 7 days. Rx - Prednisone 20mg, BENADRYL 25mg, Hydrocortisone.
Age: 17.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Six vaccines were administered today - the last of which was the GARDASIL. After administration of the GARDASIL the pt. passed out. Pt was observed in clinic for about one hour. Promethazine 12.5 mg was administered.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: Redness & swelling in (R) arm within hours of shot - Temp 102, chills, tremors, fatigue, diarrhea redness and swelling from (R) axilla to mid forearm treated with KEFLEX and antihistamine.
Age: 43.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Tremor
Clinical narrative: Redness & swelling in (R) arm within hours of shot - Temp 102, chills, tremors, fatigue, diarrhea redness and swelling from (R) axilla to mid forearm treated with KEFLEX and antihistamine.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Large (egg sized) lump at site of injection on shoulder.  Lump was red and quite hot to the touch.
Age: 37.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Acupuncture, Arthralgia, Fatigue, Headache, Injection site erythema
Clinical narrative: 2/25 and 2/26: Joint pain, primarily from jaw to fingers, severe headache, fatigue  2/26 and 2/27: Injection site horribly red, swollen, itchy and painful, fatigue 2/28:  fatigue 3/1: nausea, fatigue
Age: 37.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Nausea
Clinical narrative: 2/25 and 2/26: Joint pain, primarily from jaw to fingers, severe headache, fatigue  2/26 and 2/27: Injection site horribly red, swollen, itchy and painful, fatigue 2/28:  fatigue 3/1: nausea, fatigue
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Allergic sinusitis, Ear pain, Lacrimation increased, Nasal congestion, Nasal inflammation
Clinical narrative: Patient needed to have doctor visit on the date noted above for symptoms over the "past few weeks" including sore throat, ear pain, nasal congestion and drainage, watery eyes. Patient prescribed antibiotics, dx "allergic or viral" vs "bacterial" sinusitis. Patient presented to office again on 3/2/2011, stating symptoms never really cleared after treatment in December. Having symptoms on and off, with worsening over week prior to appt.  Also notes "this happens the same time every year". (which also happens to be several weeks following her flu shot)
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Rhinorrhoea, Sinusitis bacterial, Viral sinusitis
Clinical narrative: Patient needed to have doctor visit on the date noted above for symptoms over the "past few weeks" including sore throat, ear pain, nasal congestion and drainage, watery eyes. Patient prescribed antibiotics, dx "allergic or viral" vs "bacterial" sinusitis. Patient presented to office again on 3/2/2011, stating symptoms never really cleared after treatment in December. Having symptoms on and off, with worsening over week prior to appt.  Also notes "this happens the same time every year". (which also happens to be several weeks following her flu shot)
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Rash
Clinical narrative: PATIENT SATES THAT HER MOTHER NOTICED A RASH ON HER FACE ON 1/7/11. DENIED DIFFICULTY BREATING OR ITCHING. STATES SHE BEGAN TAKING BENADRYL 1/7/11 AND THE RASH RESOLVED
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Swelling, Urticaria
Clinical narrative: GENERALIZED SWELLING/WHELPS 2/23; RELIEVED WITH BENADRYL; 2/24/11 AM GENERALIZED SWELLING HAS RETURNED; PATIENT WENT TO FACILITY AND SPOKE WITH MD; PATIENT STATES SHE HAD GENRALIZED WHELPS/SWELLING INCLUDING LIPS, BACK, BEHIND EARS, AND SOME WHELPS ON HER LEGS AND ARMS. WILL RECEIVE INJECTION OF DECADRON 2/24/2011 A.M. HAD TO RETURN TO FACILITY ON 2/25 WITH SWELLING AND INABILITY TO WALK.  MOM SAYS MD GAVE TWO PRESCRIPTION BUT SHE DOES NOT KNOW WHAT THEY WERE.  ALL SYMPTOMS RESOLVED 2/27/11.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Musculoskeletal stiffness, Neck pain, Oedema peripheral, Pain in extremity
Clinical narrative: ADACEL given 2/24/11 approximately 1pm; right arm pain (swelling, soreness) starting Friday. Rash (morbilliform) on right deltoid, biceps area. Fever over weekend. Complained of neck pain & stiffness.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: ADACEL given 2/24/11 approximately 1pm; right arm pain (swelling, soreness) starting Friday. Rash (morbilliform) on right deltoid, biceps area. Fever over weekend. Complained of neck pain & stiffness.
Age: 15.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Chills, Cough, Flushing, Headache, Injection site pain
Clinical narrative: 11 hours after PNEUMOVAX 23, HIB & influenza developed nausea followed by intense headache, rigors, 101 degree fever, recurrent vomiting, flushed face with some puffiness (resolved quickly); 4 hours later developed sore throat & slight cough; has severe soreness at inject. site x 2 days, esp (L) arm. Same reaction in 8/14/06 after MENACTRA & ADACEL.
Age: 15.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Similar reaction on previous exposure to drug, Swelling face
Clinical narrative: 11 hours after PNEUMOVAX 23, HIB & influenza developed nausea followed by intense headache, rigors, 101 degree fever, recurrent vomiting, flushed face with some puffiness (resolved quickly); 4 hours later developed sore throat & slight cough; has severe soreness at inject. site x 2 days, esp (L) arm. Same reaction in 8/14/06 after MENACTRA & ADACEL.
Age: 15.0
Sex: F
Vaccine: FLU3, HIBV, PPV
Symptoms: Vomiting
Clinical narrative: 11 hours after PNEUMOVAX 23, HIB & influenza developed nausea followed by intense headache, rigors, 101 degree fever, recurrent vomiting, flushed face with some puffiness (resolved quickly); 4 hours later developed sore throat & slight cough; has severe soreness at inject. site x 2 days, esp (L) arm. Same reaction in 8/14/06 after MENACTRA & ADACEL.
Age: 1.64
Sex: F
Vaccine: DTAP, HEPA, HIBV, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Followed Dr. orders of requested Rotavirus vaccination. Rotavirus vaccine administered at initial clinic well baby visit as 3rd dose. Mom informed day 1 post vaccine administration of unscheduled well visit vaccine per Dr. No reported adverse symptoms per Dr.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: Pt received flu shot and has been ill since that time. She has had a lot of pain and weakness in legs & arms. Doctor said she had Guillain-Barre syndrome. She is very weak and is all alone has no one to help her. Received information from her friend because pt is deaf.
Age: 35.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, YF
Symptoms: Erythema, Nausea, Pallor, Syncope
Clinical narrative: Fainted, nausea, red in face then pale - called 911 per protocol - check BP over 30 min. time.
Age: 17.0
Sex: M
Vaccine: HEPA, HPVX, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Pt reports swelling and slight itching at site of injection 2 days after receiving injection. Pt states it was worse yesterday w/ mild improvement today. Will provide rx for ibuprofen, BENADRYL PRN swelling, itching.
Age: 67.0
Sex: M
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) arm erythema from injection site to elbow (anterior aspect of (R) upper arm). Increased warmth. No pain, tenderness, pruritus, induration, swelling, or exudate. No fever or body aches. Had him take diphenhydramine 50mg; reports improved 6 hours later.
Age: 0.82
Sex: F
Vaccine: PNC
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling (L) thigh, noticed by parent this am, at site of injection given 3/1/11. Rx: warm compress/MOTRIN.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Pyrexia, Staring
Clinical narrative: Glossy eyes, fever 105.0 at daycare.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Apnoeic attack, Condition aggravated, Death, Endotracheal intubation, Hypopnoea
Clinical narrative: Threw up after a feed, then apnea monitor kept alarming. To ED - found to have slow, shallow respirations. Became apneic/pulseless - unable to resuscitate despite intubation/CPR. Time of death 4:31 PM.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Pulse absent, Respiratory rate decreased, Resuscitation, Vomiting
Clinical narrative: Threw up after a feed, then apnea monitor kept alarming. To ED - found to have slow, shallow respirations. Became apneic/pulseless - unable to resuscitate despite intubation/CPR. Time of death 4:31 PM.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Regurgitation, Respiratory arrest
Clinical narrative: Threw up after a feed, then apnea monitor kept alarming. To ED - found to have slow, shallow respirations. Became apneic/pulseless - unable to resuscitate despite intubation/CPR. Time of death 4:31 PM.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Death, Respiratory arrest
Clinical narrative: Threw up after a feed, then apnea monitor kept alarming. To ED - found to have slow, shallow respirations. Became apneic/pulseless - unable to resuscitate despite intubation/CPR. Time of death 4:31 PM.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral, Pruritus, Skin lesion, Skin warm
Clinical narrative: (R) arm warm to touch, swelling  5" x 3 1/2", lesion, itching started 3/1/11.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bacterial infection, Bacterial test positive, Blood culture positive, Blood glucose increased, CSF cell count normal
Clinical narrative: This case involves a fatal event and was considered medically important for the events of vomiting and fever.  Additional information was received that provided patient demographics, medical history, additional lot numbers, event details leading to a change in the verbatim for the code of bacterial culture positive, the additional code of streptococcal meningitis and additional laboratory results.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting, streptococcal meningitis and died due to an overwhelming sepsis from Group A Streptococcus pyogenes.  The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and a second dose of ROTATEQ (Merck).  On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room.  On 18-May-2010, a blood culture (initially reported as "a very early culture) was performed that revealed gram positive cocci in pairs and chains possibly of Streptococcal pneumoniae origin (bacterial test positive), later however the blood culture confirmed the pathogen as Group A Streptococcus pyogenes.  On the same day, a CSF culture was positive for Streptococcus pyogenes Group A.  On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes.  The cause of death was reported as streptococcal sepsis.  An autopsy was not performed.  No additional information was available at the time of this report.  Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of the migration, the follow-up report may indicate in the appropriate field that it is an initial report.  Follow-up (23FEB2011): New information received from the healthcare professional as part of VAERS annual follow-up, indicated the patient died on 21MAY2010, (originally reported as 19May2010) and updated the causes of death as sepsis and meningitis due to streptococcus pyogenes Group A. (previously, meningitis was not considered a cause of death).  Follow-up attempts completed.  No further information is expected.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: CSF glucose increased, CSF lymphocyte count abnormal, CSF monocyte count decreased, CSF protein normal, CSF white blood cell count negative
Clinical narrative: This case involves a fatal event and was considered medically important for the events of vomiting and fever.  Additional information was received that provided patient demographics, medical history, additional lot numbers, event details leading to a change in the verbatim for the code of bacterial culture positive, the additional code of streptococcal meningitis and additional laboratory results.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting, streptococcal meningitis and died due to an overwhelming sepsis from Group A Streptococcus pyogenes.  The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and a second dose of ROTATEQ (Merck).  On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room.  On 18-May-2010, a blood culture (initially reported as "a very early culture) was performed that revealed gram positive cocci in pairs and chains possibly of Streptococcal pneumoniae origin (bacterial test positive), later however the blood culture confirmed the pathogen as Group A Streptococcus pyogenes.  On the same day, a CSF culture was positive for Streptococcus pyogenes Group A.  On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes.  The cause of death was reported as streptococcal sepsis.  An autopsy was not performed.  No additional information was available at the time of this report.  Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of the migration, the follow-up report may indicate in the appropriate field that it is an initial report.  Follow-up (23FEB2011): New information received from the healthcare professional as part of VAERS annual follow-up, indicated the patient died on 21MAY2010, (originally reported as 19May2010) and updated the causes of death as sepsis and meningitis due to streptococcus pyogenes Group A. (previously, meningitis was not considered a cause of death).  Follow-up attempts completed.  No further information is expected.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Chest X-ray abnormal, Death, Meningitis streptococcal, Neutrophil count, Neutrophil percentage decreased
Clinical narrative: This case involves a fatal event and was considered medically important for the events of vomiting and fever.  Additional information was received that provided patient demographics, medical history, additional lot numbers, event details leading to a change in the verbatim for the code of bacterial culture positive, the additional code of streptococcal meningitis and additional laboratory results.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting, streptococcal meningitis and died due to an overwhelming sepsis from Group A Streptococcus pyogenes.  The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and a second dose of ROTATEQ (Merck).  On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room.  On 18-May-2010, a blood culture (initially reported as "a very early culture) was performed that revealed gram positive cocci in pairs and chains possibly of Streptococcal pneumoniae origin (bacterial test positive), later however the blood culture confirmed the pathogen as Group A Streptococcus pyogenes.  On the same day, a CSF culture was positive for Streptococcus pyogenes Group A.  On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes.  The cause of death was reported as streptococcal sepsis.  An autopsy was not performed.  No additional information was available at the time of this report.  Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of the migration, the follow-up report may indicate in the appropriate field that it is an initial report.  Follow-up (23FEB2011): New information received from the healthcare professional as part of VAERS annual follow-up, indicated the patient died on 21MAY2010, (originally reported as 19May2010) and updated the causes of death as sepsis and meningitis due to streptococcus pyogenes Group A. (previously, meningitis was not considered a cause of death).  Follow-up attempts completed.  No further information is expected.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Platelet count decreased, Protein urine present, Pyrexia, Red blood cell nucleated morphology present, Streptococcal sepsis
Clinical narrative: This case involves a fatal event and was considered medically important for the events of vomiting and fever.  Additional information was received that provided patient demographics, medical history, additional lot numbers, event details leading to a change in the verbatim for the code of bacterial culture positive, the additional code of streptococcal meningitis and additional laboratory results.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting, streptococcal meningitis and died due to an overwhelming sepsis from Group A Streptococcus pyogenes.  The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and a second dose of ROTATEQ (Merck).  On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room.  On 18-May-2010, a blood culture (initially reported as "a very early culture) was performed that revealed gram positive cocci in pairs and chains possibly of Streptococcal pneumoniae origin (bacterial test positive), later however the blood culture confirmed the pathogen as Group A Streptococcus pyogenes.  On the same day, a CSF culture was positive for Streptococcus pyogenes Group A.  On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes.  The cause of death was reported as streptococcal sepsis.  An autopsy was not performed.  No additional information was available at the time of this report.  Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of the migration, the follow-up report may indicate in the appropriate field that it is an initial report.  Follow-up (23FEB2011): New information received from the healthcare professional as part of VAERS annual follow-up, indicated the patient died on 21MAY2010, (originally reported as 19May2010) and updated the causes of death as sepsis and meningitis due to streptococcus pyogenes Group A. (previously, meningitis was not considered a cause of death).  Follow-up attempts completed.  No further information is expected.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVNAR 13.