chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Headache, Lymphadenopathy, Myocarditis
Clinical narrative: 1/25 received vaccine. Flu-like symptoms 1 week post vaccine. Saw physician; felt normal post-vaccination symptoms. 2-4 developed chest pain, came to ER and admitted on 02/05. Patient had stress test 02/07/2003. Patient to be discharged home 02/07/03 pending results of stress test. Patient to return to work on 02/17/03.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Influenza like illness, Myocarditis
Clinical narrative: 1/25 received vaccine. Flu-like symptoms 1 week post vaccine. Saw physician; felt normal post-vaccination symptoms. 2-4 developed chest pain, came to ER and admitted on 02/05. Patient had stress test 02/07/2003. Patient to be discharged home 02/07/03 pending results of stress test. Patient to return to work on 02/17/03.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Influenza like illness
Clinical narrative: 1/25 received vaccine. Flu-like symptoms 1 week post vaccine. Saw physician; felt normal post-vaccination symptoms. 2-4 developed chest pain, came to ER and admitted on 02/05. Patient had stress test 02/07/2003. Patient to be discharged home 02/07/03 pending results of stress test. Patient to return to work on 02/17/03.
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Anorexia, Chest pain, Injection site reaction, Metabolic acidosis
Clinical narrative: Within 2 hours, high fever, brown spot size of nickel at injection site, ache all over, stopped eating and drinking. 3 Advil for 3 hours for unrelieved pain. 2 weeks - abdominal pain and nausea. One week - chest pain and right shoulder pain.
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Shoulder pain, White blood cell count increased
Clinical narrative: Within 2 hours, high fever, brown spot size of nickel at injection site, ache all over, stopped eating and drinking. 3 Advil for 3 hours for unrelieved pain. 2 weeks - abdominal pain and nausea. One week - chest pain and right shoulder pain.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Anorexia, Blood urine, Vomiting, Weight decreased
Clinical narrative: Prior to vaccines baby was feeding well and gaining. Within 2D-3D of vaccines started with difficulty feeding with subsequent weight loss necessitating hospitalization. Extensive evaluation has not revealed any other cause and he continues to have problems. Had NG fdg, in hospital. Will not take bottle since 9am yesterday. Parents said he has been on nystatius for oral thrush x one week. Intake had been a little less than until he stopped yesterday. No fever, some cold symptoms previously, none now. Baby has not been fussy, just refuses to eat. Dad states "has not been same since 2 mo. shots 11/29. Seems to have gotten a little worse each day. Emesis yesterday after attempting feed. Small urine this am. Some red in diaper with urine per day. Pt alert calm, lungs clear abd. soft.
Age: 2.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Localized reaction to injection site, possibly systemic. Pt admitted to hospital. Pt is HIV positive.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Cough, Dehydration, Diabetes mellitus, Hypoglycaemia, Pollakiuria
Clinical narrative: Per mother vaccine given on 10/22/02. Three days later she noticed dry cracked lips increased thirst and urination. Seen again in office on 10/29/02 for temp 100.3 and cough x three days-diagnosed with viral URI. No treatment given. Seen on 11/20/02 for dehydration-admitted and diagnosed with diabetes. Per 60 day follow up: Pt has not recovered. Ongoing treatment for insulin dependent diabetes. Annual follow up on 02/26/04: "Pt did not recover from adverse events. Still being treated for diabetes. Parents declined any further immunizations, only had one Hep B."
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Thirst, Upper respiratory tract infection
Clinical narrative: Per mother vaccine given on 10/22/02. Three days later she noticed dry cracked lips increased thirst and urination. Seen again in office on 10/29/02 for temp 100.3 and cough x three days-diagnosed with viral URI. No treatment given. Seen on 11/20/02 for dehydration-admitted and diagnosed with diabetes. Per 60 day follow up: Pt has not recovered. Ongoing treatment for insulin dependent diabetes. Annual follow up on 02/26/04: "Pt did not recover from adverse events. Still being treated for diabetes. Parents declined any further immunizations, only had one Hep B."
Age: 45.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Local erythema, extreme soreness at inject site.
Age: 20.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Rash
Clinical narrative: PT received 0.5 cc of anthrax vaccine in left deltoid SQ, at 12 p.m. At 5:30 p.m. PT noticed his face, back, and chest had large red patches.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Dyspepsia, Headache, Rash
Clinical narrative: Less than 24 hrs of taking a shot, PT started feeling sick to the stomach and headache after headaches. Also broke out with 4-5 nickel size bumps on rear end.
Age: 35.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain, Asthenia, Chills, Dizziness, Dysmenorrhoea
Clinical narrative: Headaches, dizziness, nausea, rashes, swelling of the forearm & left hand. Extreme fatigue, stomach and abdominal cramps, and pains with dark red/brown menstrual-type bleeding. Throbbing pain behind eyes, chills, very cold, swollen neck, glands, swollen tongue, sore throat, difficult to breath, shortness of breath, mouth sores, itching all over, hoarseness, hives. Immediate swelling of same arm. Difficulty breathing and itching went away. Arthralgia one week afterwards.
Age: 35.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Dysphonia, Dyspnoea, Headache, Nausea, Oedema
Clinical narrative: Headaches, dizziness, nausea, rashes, swelling of the forearm & left hand. Extreme fatigue, stomach and abdominal cramps, and pains with dark red/brown menstrual-type bleeding. Throbbing pain behind eyes, chills, very cold, swollen neck, glands, swollen tongue, sore throat, difficult to breath, shortness of breath, mouth sores, itching all over, hoarseness, hives. Immediate swelling of same arm. Difficulty breathing and itching went away. Arthralgia one week afterwards.
Age: 35.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Oedema peripheral, Pharyngitis, Pruritus, Urticaria
Clinical narrative: Headaches, dizziness, nausea, rashes, swelling of the forearm & left hand. Extreme fatigue, stomach and abdominal cramps, and pains with dark red/brown menstrual-type bleeding. Throbbing pain behind eyes, chills, very cold, swollen neck, glands, swollen tongue, sore throat, difficult to breath, shortness of breath, mouth sores, itching all over, hoarseness, hives. Immediate swelling of same arm. Difficulty breathing and itching went away. Arthralgia one week afterwards.
Age: 35.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Abdominal pain, Arthralgia, Chills, Dyspnoea, Fatigue
Clinical narrative: Headaches, dizziness, nausea, rashes, swelling of the forearm & left hand. Extreme fatigue, stomach and abdominal cramps, and pains with dark red/brown menstrual-type bleeding. Throbbing pain behind eyes, chills, very cold, swollen neck, glands, swollen tongue, sore throat, difficult to breath, shortness of breath, mouth sores, itching all over, hoarseness, hives. Immediate swelling of same arm. Difficulty breathing and itching went away. Arthralgia one week afterwards.
Age: 35.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Hyperhidrosis, Hypoaesthesia, Lymphadenopathy, Neutropenia, Oedema
Clinical narrative: Headaches, dizziness, nausea, rashes, swelling of the forearm & left hand. Extreme fatigue, stomach and abdominal cramps, and pains with dark red/brown menstrual-type bleeding. Throbbing pain behind eyes, chills, very cold, swollen neck, glands, swollen tongue, sore throat, difficult to breath, shortness of breath, mouth sores, itching all over, hoarseness, hives. Immediate swelling of same arm. Difficulty breathing and itching went away. Arthralgia one week afterwards.
Age: 35.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Pharyngeal oedema, Pharyngolaryngeal pain, Tongue oedema, Vaginal haemorrhage
Clinical narrative: Headaches, dizziness, nausea, rashes, swelling of the forearm & left hand. Extreme fatigue, stomach and abdominal cramps, and pains with dark red/brown menstrual-type bleeding. Throbbing pain behind eyes, chills, very cold, swollen neck, glands, swollen tongue, sore throat, difficult to breath, shortness of breath, mouth sores, itching all over, hoarseness, hives. Immediate swelling of same arm. Difficulty breathing and itching went away. Arthralgia one week afterwards.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Chest pain, Conjunctivitis, Dyspnoea
Clinical narrative: Tightness in chest, shortness in breath, allergy-like symptoms, nose/eyes continuously running & watery, itchy throat, soreness, redness, itching muscle, joint aches, fatigue - seen doctor 1/29/03 - but released to work same day & prescribed Zyrtax (allergy medication) I did not work. Redness in eyes still remained, flu like symptoms present even after 2 wks from the 1st dose shot taken.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Hypersensitivity, Influenza, Lacrimal disorder, Pruritus, Rhinitis
Clinical narrative: Tightness in chest, shortness in breath, allergy-like symptoms, nose/eyes continuously running & watery, itchy throat, soreness, redness, itching muscle, joint aches, fatigue - seen doctor 1/29/03 - but released to work same day & prescribed Zyrtax (allergy medication) I did not work. Redness in eyes still remained, flu like symptoms present even after 2 wks from the 1st dose shot taken.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Encephalopathy, Screaming
Clinical narrative: 1) 5-6 episodes of seizure like activity, lasting 34-40 sec (motor) total including staring (1-16 mins), started w/in 12 hrs of vaccine administration, no seizures after 72 hrs, encephalopathy. 2) Inconsolable crying for 5 hrs.
Age: 48.0
Sex: F
Vaccine: ANTH
Symptoms: Oedema, Pain, Urticaria
Clinical narrative: Pain,  swelling, urticaria right arm from shoulder to area 6 inches below elbow.
Age: 55.0
Sex: M
Vaccine: ANTH
Symptoms: Hypertonia, Muscle spasms
Clinical narrative: During the night PT awakened with severe cramping in both legs. After one hr cramps lessened, allowing sleep. Slight muscle stiffness the following day.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Alopecia, Epistaxis, Headache, Hot flush, Joint stiffness
Clinical narrative: Pt reports headaches, lasting for hours at a time within 1 wk, rashes shin of right leg, stomach, L side underarm, neck, back of scalp with internal itching. Received hydroxyzine 25mg cetirizine 10mg. triamcinolone 60gm, rash on neck still present 1 month later. Hot flashes, nose bleed. The follow up states nose bleeds, sores in scalp, elevated hari loss, internal itching, headaches, bodyaches, stiffness and soreness in both knees, cracking, brittle finger nails and toenails.
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Pt reports headaches, lasting for hours at a time within 1 wk, rashes shin of right leg, stomach, L side underarm, neck, back of scalp with internal itching. Received hydroxyzine 25mg cetirizine 10mg. triamcinolone 60gm, rash on neck still present 1 month later. Hot flashes, nose bleed. The follow up states nose bleeds, sores in scalp, elevated hari loss, internal itching, headaches, bodyaches, stiffness and soreness in both knees, cracking, brittle finger nails and toenails.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Angioneurotic oedema, Urticaria
Clinical narrative: Angioedema, urticaria, treatment - solumedrol 125mg IV,benadryl 25mg IV, Zantac 5u IV.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Arthralgia, Fatigue, Headache, Muscular weakness, Pain
Clinical narrative: Low grade fever X 2 days. Muscle fatigue, muscle weakness, joint aches, body aches, headache, generalized fatigue X 5 to 7 days.
Age: 46.0
Sex: F
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Low grade fever X 2 days. Muscle fatigue, muscle weakness, joint aches, body aches, headache, generalized fatigue X 5 to 7 days.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Asthenia, Headache, Injection site oedema, Pyrexia
Clinical narrative: Temperature 102.7F, headache, generalized body weakness for 2 days (12/28 - 12/29). Swollen on left side (injection side). Six days (12/28/02 - 1/3/03). Patien is a medical student; took augmentin 875mg po BID for ? days (prescription by his private doctor). Report this after he returned from India vacation 1/3-1/26. Reported to me on 2/6/03.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: HIV infection, Injection site erythema, Injection site swelling
Clinical narrative: Vaccine given on 9/19/02 in village - was on way to Anchorage - next day arm was swollen (at deltoid area), redness, checked in with MD at clinic. pt is HIV positive.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Contusion, Injection site pain, Injection site swelling
Clinical narrative: Seen by Dr on 10/30/02, Rt arm deltoid area swollen, bruised, red streaks, sore. MD said it was an immune response a good thing wait over 8 yrs before next shot " ? happened last time moderately.
Age: 45.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Clinic called 1/14/03 and reported that the "TD" shot she got in her arm was red and swollen down her arm, she stated that it was painful and can not lay on the arm at night. Pt was encouraged to see PMD or ER for treatment. Follow up states: Have not received forms back from reviewing medical authority.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold
Clinical narrative: Pt stated on 1/28/03 she developed coldness in left leg after vaccination on 12/17/02.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Pt rec'd the flu shot on 1/23/03, she was getting ready for bed at 10:30pm on Friday, 1/24 when she noticed a large lump-like swelling near the area of the flu shot. It was the size of half a lemon. On Sat 1/25 at 9:00am she called the Hlth Dept where she rec'd the shot and explained why she was calling and was told they would call me back, within 15 min. a Dr called and asked me about my symptoms. He told me to put ice on the area and if I was running a fever or if the area changed colors to go to the ER. He said it was too soon to think about an infection. He also mentioned something about a hematoma. On Monday went back to Hlth Dept to have someone look at the swollen area (swelling gone down somewhat) a nsg checked it out and had someone else look at it also and they agreed it looked ok to them that it did not look swollen to them. she was given a paper on the influenza shot.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Lethargy, Paraesthesia, Pyrexia
Clinical narrative: Intense headache plus recurrent ones (back of head) nerve endings tingling (several weeks) like contact with H.D. bug killer, dizziness, slower to act, spacey , slight fever went away. headache recurrent and slowness to act. ?? No meds taken that day due to strange feeling, etc.
Age: 1.25
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Pt diagnosed with varicella post immunization on 12/3/02. Rash onset 12/1/02. Lesions on chest and face typical of chickenpox.
Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Agitation, Irritability, Musculoskeletal stiffness
Clinical narrative: Received vaccine on 12/10/02 on 12/11/02 in the pm mother states crying, stiffness lasting like 15-20 every 3-5 hr. Acted like he was irritable and mad during this time-last through 12/13/02 no fever.
Sex: M
Vaccine: DTP, HIBV, IPV
Symptoms: Erythema, Rash
Clinical narrative: Rash spread from head down to trunk and then to extremities. Rash was very red and all over body.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: 1/13/03 pt rec'd mult. vaccines. 1/16/03 return to clinic with 24 hrs of macular papular rash pruritic trunk UE and LE. Given Clarinax-res'd. 2/4/03 return to clinic with one day history of similar rash. Confluent macular papular rash trunk U and LE res'd with Clarinax.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Red, rash, pain at site, heat, Zyrtec, Cefzil. Looks like a faded bruise.
Age: 47.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Arthralgia, Hypokinesia, Joint swelling, Pain
Clinical narrative: Swelling and pain in peripheral joints, knees, wrists, MCP and IP joints of the hands. Metatarsal joints in the feet, lasted 4-5 days. Pain with work, ADL.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Cyanosis, Syncope vasovagal
Clinical narrative: Please see attached notes. Copy of PHN notes sent to family medical center. R/T has visit scheduled following day for well child. Suspects probable vasovagal also and may try to vacinate one at a time with next due dose. 1/30/03 father states baby is fine and has had no further episodes. Pt was given immz today. After all four shots given pt's LE's turned purplish/blue, baby was crying hard but still breathing. Torso, face and arms were still pink. Baby was able to move all four ext's, airway was fine and good air mumt auscultated bilat. Cyanosis resolved within 1-2 minutes spontaneously kept baby in office for observation. Baby calmed down nicely and pinked leg well and moved all four ext's equally on D/C. Dismissed s/s to watch for with parents. Baby has apt tomorrow for well child. Suspect probable vasovagal reaction today. The baby has Ho crying after and formula was changed to lacto free. Baby has many dry, rough areas on LE's and face, A and D ointment suggested and see PMD. Lacto free formula seemed to help per parents. Tylenol given with instructions.
Age: 2.6
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea, Pallor
Clinical narrative: Approx. 30 mins post injection child had trouble breathing and became pale. Epinephrine 15mg given then child sent to ER.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Neticular skin ? on trunk and scalp coutment with varicella.
Age: 2.3
Sex: F
Vaccine: PNC
Symptoms: Injection site oedema, Injection site rash
Clinical narrative: Swollen bump on L leg.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Approximately 48 hours post receiving immunizations, pt developed a fever T max 103 deg) with vomiting and diarrhea. Pt still febrile during exam 72 hrs post-immunizations (T=103 deg) although vomiting and diarrhea had ceased. Pt received supportive care only (anti-pyretics, oral hydration).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Lacrimation increased, Oedema
Clinical narrative: Eye tearing and sclera injection first, evolving into periorbital edema given 40mg IM Solueorlef and 20mg Benadryl IM sent to ER.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Pyrexia, Upper respiratory tract infection
Clinical narrative: High temp up to 103-105 deg F for two days. Possible seizure for one min on 1/28/03 pm no more since than. UTI was noted on 1/31/03.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Hypoxia, Pain, Rash
Clinical narrative: Pt was in his usual state of health when he received his four year DTaP, IPV, MMR vaccine. He walked to the parking and then  within five min c/o difficulty breathing. He was given Albut+Benadryl+steroids for aching, rash, hypoxia. He improved.
Age: 8.4
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site rash, Injection site swelling, Pruritus
Clinical narrative: 2/4/03 three red raised pimple-like lesions around vaccine site-whitish center-noted by mom-c/o itch.
Age: 0.75
Sex: F
Vaccine: IPV
Symptoms: Convulsion, Dyskinesia, Hypotonia, Laboratory test abnormal, Movement disorder
Clinical narrative: On 8/23/02 while playing pt stopped moving when mom picked her up her body went limp. Taken via ambulance to hospital. On 8/27/02 limp episode reoccurred x 1 min. 9/19/02 woke from nap with fever body became limp x 1 1/2 min. Per mom had seizure episode with jerking of body.
Age: 0.75
Sex: F
Vaccine: IPV
Symptoms: Pyrexia
Clinical narrative: On 8/23/02 while playing pt stopped moving when mom picked her up her body went limp. Taken via ambulance to hospital. On 8/27/02 limp episode reoccurred x 1 min. 9/19/02 woke from nap with fever body became limp x 1 1/2 min. Per mom had seizure episode with jerking of body.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Blanchable maculopapular rash on chest/abd/back; extending down arms (legs/diaper area).
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Redness on Rt leg with warm to touch swelling. Instructed mom Tyl, warm compress to area. If redness or swelling increases to RTC or ER.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Significant local reaction to R deltoid at 24 hrs after shot-at 48 hrs had 14x16cm erythema and warmth 3cm central induration-no fluctuance 95% resolved by five days after shot.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Drug administration error, Injection site mass
Clinical narrative: Patient given DTAP in right arm. Appears it was given into subcutaneous tissue vs. IM. Developed red, warm "quarter size" indurated area.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Somnolence, Vomiting
Clinical narrative: Patient received shot approximate 9:55am within the hour became sluggish, nauseated, vomited once. At approximately 230pm parent states family had had stomach virus in home within the last 72 hours.
Age: 65.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Six days after Td vaccine, complained of redness, swelling, itching and discomfort (not severe) injection site about 3" long and narrow redness and approximate .5" from this, redness and swelling extending 6" around arm 2.5-3" wide. Advised follow up with doctor for evaluation.
Sex: F
Vaccine: DT
Symptoms: Asthenia, Dizziness, Tremor, Vertigo
Clinical narrative: Persistent vertigo, weakness, light headedness, tremors.
Sex: M
Vaccine: TD
Symptoms: Hypokinesia, Pain
Clinical narrative: Subjective pain in shoulder with any range of motion or pressure or even at rest. Getting no better at tenth day after vaccine.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Oedema, Pyrexia, Rash, Vomiting
Clinical narrative: After 2 weeks, swollen head, rash, very high fevers four weekends in a row; over 105.4F. Vomiting ? the size of ice cubes every nights. Was very sick two months. Shots given by allergist. (Stopped all shots after this!)
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Child began to have seizures at home; was seen at medical center and seizures observed at medical center. Had follow-up visit.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Rash maculo-papular
Clinical narrative: Received Hep A vaccine on 1/24/03. On 1/26/03 at night client developed raised, red itchy rash which progressed in intensity for several days and then subsided. Rash only appeared at night. No site reaction.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: For five hours up after vaccine administration patient had cried, not consoled. Parents are first time paretns so difficult to tell if was prolonged crying or normal crying after a vaccine.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Dizziness, Pyrexia
Clinical narrative: Diarrhea, stomach cramps, dizziness, weakness, fever.
Age: 1.25
Sex: M
Vaccine: MMR, PNC
Symptoms: Diarrhoea, Urticaria, Vomiting
Clinical narrative: 4 hours after MMR and Prevnar, hives 24 hours later; vomiting and diarrhea.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Localized redness/swelling at site. Flu-like symptoms with fever, headache, muscle aches, nausea.  Follow up 02/25/2003: "Information not available to me.  She received vaccine from military."
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pyrexia
Clinical narrative: Localized redness/swelling at site. Flu-like symptoms with fever, headache, muscle aches, nausea.  Follow up 02/25/2003: "Information not available to me.  She received vaccine from military."
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Red, swollen.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Decreased appetite, Drooling, Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: Macular papular (some confluent) pruritic rash all over body; most on trunk. Temp 101, fussy, drooling, alert, poor appetite.
Sex: M
Vaccine: DTAP, PNC
Symptoms: Bacterial infection, Laboratory test abnormal
Clinical narrative: Bacteremia
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Td booster given 1/29/03. Beginning 1/31/03 area became reddened, swollen and warm to touch from injection site to elbow. Today 20mm site of injection with warmness noted to touch.
Age: 3.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: All immunizations listed were given. Child broke out in a red rash to face and arms. The rash on the arms were raised. Called EMS and patient was taken to local hospital.
Age: 1.4
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash,
Age: 2.5
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Sibling broke out with chicken pox Saturday. Now patient has them this morning 02/04/2003.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever up to 105 deg F after vaccines. Not effectively relieved by Motrin. Pain in right thigh. No noted redness or swelling on 1/30/03.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: 2/1/03 was in office broke out with c. pox.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pain, Pyrexia, Skin discolouration
Clinical narrative: Swelling from elbow to shoulder, spreading to breast, fever, extreme pain followed by discoloration of whole upper arm (purple) turning to bright yellow.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular, Rash papular
Clinical narrative: R post humeral (upper arm)-about 15 scattered and clustered pinpoint to 1/8cm pink macular and papules-bug bite appearing, starting yesterday 2/4/03 with no change.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Approx 24 hrs post immunization, swelling, warmth and redness at site injection R thigh. Placed ice with decreased swelling.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: L arm redness to use ice packs.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Pt became very ill with fever that began less than 24 hrs after vaccination. The illness was severe and lasted three to four days. The second day was the most severe.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Rash
Clinical narrative: Right wrist-2 hrs post vaccination faint red rash in 2 inch area. No itching. Area is not raised. Treated with one cap Benadryl per health officer order. Area was gone the following day. Family physician contacted per pt and did not feel it was related.
Age: 9.0
Sex: M
Vaccine: HEPA, IPV, TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema and induration in left shoulder size 20x15cm tender. Sign of infection warm, no LNS and localized area at site of injection. At site of hep A #2 and TD #3. Pt afebrile in clinic 98.2 on Tylenol. In am ? Rocephin 1gm given today with 7 day Keflex trmt (pos). pt to return to clinic if sxs increase, ER precautions given by MD>
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site inflammation, Vasodilation procedure
Clinical narrative: Cellulitis, burning redness at inject site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema, Vasodilation procedure
Clinical narrative: Pt's leg (thigh) became swollen, red and warm to touch, and covered the entire upper thigh area.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: 9 cm area of firm, slightly warm, mildly erythematous soft tissue swelling over right deltoid region first noticed by father on 2/?/02 at approximately 10 a.m. when assisting child changing clothes. No complaint of discomfort from child. Full ROM of right arm shoulder without pain. No fever or illness Symptoms diagnosed localized vaccine reaction, R/O infection Rx Keflex 25 mg 1.5 tsp R, Ax Zd. Recheck planned 2/10/03.
Age: 1.3
Sex: M
Vaccine: DTAPH
Symptoms: Pyrexia, Rash
Clinical narrative: Rash full body, fever 102.7 3 days after immunizations given. Benadryl given for rash, Tylenol given for fever - relief in 24 hrs.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Chills, Injection site pain, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, chills, no erythema or edema, tenderness at inject site. No treatment. Was afrebile at office 1/31/03.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Vasodilation procedure
Clinical narrative: Presented to the clinic on 1/23/02 for a pneumonia vaccine at 10 a.m. on 1/24/03 PT returned to the clinic complained of tenderness and redness in the left arm which started at 9 p.m. on 1/23/03. PT states "it hasn't been unbearable." PHN examined the PT's left arm, noticed redness, warm to touch. Redness on left arm is approximately 60 mm wide. Advised PT to apply warm compresses and follow up with MD. Referred back to private MD.
Age: 1.0
Sex: M
Vaccine: FLU3, IPV, MMR, PNC, VARCEL
Symptoms: Face oedema, Oedema peripheral, Pyrexia, Tremor, Urticaria
Clinical narrative: Per parent report - woke up around 2 a.m. with 102.6 deg., skin bright red all over, shaking, eye swelling, sent? to ER. Developed few hives on wrist and cheek, "heat rash" laver? extremities, feet swelling. Dx at ER with om, rash Dx viral Rx'd Zithromax. Return to "normal" skin color around 4:30 a.m. Temp decreased with Tylenol.
Age: 1.0
Sex: M
Vaccine: FLU3, IPV, MMR, PNC, VARCEL
Symptoms: Vasodilation procedure
Clinical narrative: Per parent report - woke up around 2 a.m. with 102.6 deg., skin bright red all over, shaking, eye swelling, sent? to ER. Developed few hives on wrist and cheek, "heat rash" laver? extremities, feet swelling. Dx at ER with om, rash Dx viral Rx'd Zithromax. Return to "normal" skin color around 4:30 a.m. Temp decreased with Tylenol.
Age: 1.08
Sex: U
Vaccine: HIBV, MMR, VARCEL
Symptoms: Acne
Clinical narrative: Few pimple - like lesions around immunization site (LAT) noted 1/29/03 by mom.
Age: 1.5
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Dermatitis bullous, Erythema, Rash papular, Skin ulcer
Clinical narrative: 1/28/03 10 a.m. currently with 3-4 lesions that are blanching, erythematous, papules (? look like early vesicles) probable varicella rash.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus
Clinical narrative: 1/30/03 Erythema 10 cm x 10 cm left thigh. Itching, no fever. Benadryl given. F/u exam on 2/2/03, Erythema 2cm/3cm - itching gone - no fever.
Age: 1.2
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Few pimple like lesions around immunization site (LAT) noted 1/29/03 parent.
Age: 42.0
Sex: M
Vaccine: FLU3, HEPA, TYP
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Pt had not eaten breakfast. Reports taken this AM. Had flu-typhoid vax administered. Upon giving IM hep A began to "feel faint". Los consciousness and supported pt in chair while without consciousness. Pale. Consciousness and color returned after given sugar and .5cc epinephrine at 10:15 AM. Medic on site responded with oxygen applied right upper extremity.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Rash
Clinical narrative: Rash over entire body, including face.  No fever.  Therapy: watch for fever and other worsening symptoms
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain
Clinical narrative: Large simple reaction: erythema, induration, soreness for > 23cm of upper arm and medial lower arm
Age: 39.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Abdominal distension, Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Approximately 2 to 3 days after receiving my initial Anthrax vaccine I became nauseaus and began having diarrhea and stomach pains. This continued for at least 4 days. I then received my second Anthrax injection and the day after I again began to have nausea, diarrhea, and stomach pains. I contacted the medical facility where the vaccine was administered. I was given a brief check up and blood was drawn. I continue to experience stomach pains, bloating and I have not had a solid bowel movement since receiving my second Anthrax shot.
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Headache, Myalgia, Pruritus, Pyrexia, Rash macular
Clinical narrative: RASH ON UPPER BODY, MACULES, PUSTULES, FEELING FEVERISH, MUSCLE ACHES, HEADACHES, DIFFUSE ITCHING
Age: 1.7
Sex: F
Vaccine: DTPHIB, MMR, PNC, VARCEL
Symptoms: Breath holding, Syncope, Syncope vasovagal
Clinical narrative: Simultaneous response with injection. Child held breath, passed out. Complete recovery incident lasted less than 2 minutes.  Mother was very upset and wanted an ambulance called. ER visit. Discharged.
Age: 35.0
Sex: M
Vaccine: SMALL
Symptoms: Eyelid oedema, Headache, Myalgia, Nausea, Urticaria
Clinical narrative: Urticarial rash scalp, posterior/anterior neck, and anterior chest 8 to 10 days post primary smallpox vaccination.  Patient also noted to have mild bilateral upper eyelid edema.  He also complains of myalgias, HA, and nausea.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Malaise, Oedema, Pain, Pyrexia, Rash
Clinical narrative: Redness, swelling, tenderness, and area of red streaking. Close to smallpox vaccine site. Has felt feverish, malaise pain in left axilla. Red rash on face & upper chest.
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Vasodilation procedure
Clinical narrative: Redness, swelling, tenderness, and area of red streaking. Close to smallpox vaccine site. Has felt feverish, malaise pain in left axilla. Red rash on face & upper chest.
Age: 30.0
Sex: M
Vaccine: SMALL
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: Severe diarrhea, nausea, abdominal cramps
Age: 29.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Mild erythema, POS Lymphadenopathy, low grade fever
Age: 24.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Chills, Myalgia
Clinical narrative: Chills, chest congestion, chest pain; Systemic Rxn: Total body myalgias w/in 24 hrs.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Cow pox, Headache, Influenza, Malaise
Clinical narrative: Generalized vaccinia trunk, arms, legs. Flu-like symptoms of malaise, headaches. Patient had vaccination as child without incident.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Asthenia, Dizziness, Influenza, Malaise, Myalgia
Clinical narrative: Eight days after administering smallpox vaccine, the patient developed a moderate flu-like illness with fatigue, malaise, muscle aches, dizziness and subjective fever.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Pyrexia
Clinical narrative: Eight days after administering smallpox vaccine, the patient developed a moderate flu-like illness with fatigue, malaise, muscle aches, dizziness and subjective fever.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination complication
Clinical narrative: Patient accidental implantation of third digit of right hand.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Asthenia, Dermatitis bullous, Oedema, Pain, Pyrexia
Clinical narrative: Fatigue, left axillary node swellign and pain day six and seven, then right axillary area became painful day nine. Day nine developed facial, neck rash, then more on chest day ten. Temperature of 100F. Itching. Face, neck, upper chest and back with scattered eyrthamatous papular-vesicular lesions, few pustules.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Fatigue, left axillary node swellign and pain day six and seven, then right axillary area became painful day nine. Day nine developed facial, neck rash, then more on chest day ten. Temperature of 100F. Itching. Face, neck, upper chest and back with scattered eyrthamatous papular-vesicular lesions, few pustules.
Age: 29.0
Sex: F
Vaccine: MEN, SMALL
Symptoms: Conjunctival haemorrhage, Conjunctivitis, Erythema, Eye discharge, Eye oedema
Clinical narrative: conjunctivitis and subconjunctival hemmorhage in left eye after smallpox vaccine. Symptoms of eye swelling, pain and copious yellow discharge of the left eye began approximately midnight 7 Feb 03 (day 5). She was treated at civilian ER with antibiotics. Treated with antivirals by physician. As of today drainage and pain have resolved, but redness and swelling persist. Scheduled to follow up on Friday 14 Feb 03 with opthalmology. Follow up states: Pt is now off meds, back at work and recovered. Dx was conjunctivitis and subconjuctivitis hemmorhage in left eye after smallpox vaccine. Annual follow up on 02/26/04: "Pt has recovered from adverse events."
Age: 29.0
Sex: F
Vaccine: MEN, SMALL
Symptoms: Eye pain
Clinical narrative: conjunctivitis and subconjunctival hemmorhage in left eye after smallpox vaccine. Symptoms of eye swelling, pain and copious yellow discharge of the left eye began approximately midnight 7 Feb 03 (day 5). She was treated at civilian ER with antibiotics. Treated with antivirals by physician. As of today drainage and pain have resolved, but redness and swelling persist. Scheduled to follow up on Friday 14 Feb 03 with opthalmology. Follow up states: Pt is now off meds, back at work and recovered. Dx was conjunctivitis and subconjuctivitis hemmorhage in left eye after smallpox vaccine. Annual follow up on 02/26/04: "Pt has recovered from adverse events."
Age: 25.0
Sex: F
Vaccine: SMALL
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: The patient received the smallpox vaccine on 5 Feb 2003.  Patient complained of muscle pains in the shoulders and legs.  Also noted fatigue and nausea.  Symptoms began 1 day after having vaccine.  The patient responded after 2 days to rest, fluids, and tylenol.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: PT RECIEVED 3RD ANTHRAX VACCINE 09FEB03.11FEB03 RTN TO CLINIC C/O SWELLING,REDDNESS,SORE TO TOUCH AND WARM TO TOUCH.1ST SHOT GOT A LITTLE RED,2ND WAS LIKE THIS ONE.TX:MEDROLDONE AND BENADRYL
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Cerebral haematoma, Constipation, Faeces hard, Hypertension, Injury
Clinical narrative: My son passed away on October 30, 2002 approxiametly one month after the second Hepatitis B shot was administered.  He died from a subdural hematoma with out any other evidence of trauma or stroke activity.  My son did display some of the reactions such as low birth weight, prematurity, high blood pressure during pregnancy, labor induction, jaundice, constipation, cold without fever, projectial vomitting.  I was also involved in a car accident four weeks prior to delievery and had some loss of ambiotic fluid associated with the accident.  We had also talked to his pediatrician regarding his hard, clay like stool and he was constipated two days prior to his death. Follow up per autopsy report: Subdural hematoma, abusive head trauma.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Jaundice, Nasopharyngitis, Premature baby, Small for dates baby, Subdural haematoma
Clinical narrative: My son passed away on October 30, 2002 approxiametly one month after the second Hepatitis B shot was administered.  He died from a subdural hematoma with out any other evidence of trauma or stroke activity.  My son did display some of the reactions such as low birth weight, prematurity, high blood pressure during pregnancy, labor induction, jaundice, constipation, cold without fever, projectial vomitting.  I was also involved in a car accident four weeks prior to delievery and had some loss of ambiotic fluid associated with the accident.  We had also talked to his pediatrician regarding his hard, clay like stool and he was constipated two days prior to his death. Follow up per autopsy report: Subdural hematoma, abusive head trauma.
Age: 0.1
Sex: M
Vaccine: HEP
Symptoms: Vomiting projectile
Clinical narrative: My son passed away on October 30, 2002 approxiametly one month after the second Hepatitis B shot was administered.  He died from a subdural hematoma with out any other evidence of trauma or stroke activity.  My son did display some of the reactions such as low birth weight, prematurity, high blood pressure during pregnancy, labor induction, jaundice, constipation, cold without fever, projectial vomitting.  I was also involved in a car accident four weeks prior to delievery and had some loss of ambiotic fluid associated with the accident.  We had also talked to his pediatrician regarding his hard, clay like stool and he was constipated two days prior to his death. Follow up per autopsy report: Subdural hematoma, abusive head trauma.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Headache, Nausea, Pain, Vomiting
Clinical narrative: Within one hour after his anthrax vaccination he experienced localized swelling, headache, myalgias, dizziness and vertigo. He reported the symptoms to his unit and an initial VAERS was filed. Within 72 hours his symptoms of localized swelling in the vaccinated arm, headache, and myalgias were resolved, but dizziness and vertigo remained. He sought treatment from his local emergency room and was given Antivert and Valium, which did not resolve his symptoms. He was sent to a military base where he was evaluated. Diagnosis with Benign Positional Vertigo and treated with Epley's canalith repositioning. Within an hour he was symptom free and taking no medication. He received Anthrax #3 on 2 February 2003 with no symptoms of dizziness or vertigo. He did begin experiencing flu like symptoms within a few hours of the vaccine, but they have been mild. He has experienced occasional headaches, but they are resolved with Tylenol.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dizziness, Headache, Influenza like illness, Myalgia, Oedema
Clinical narrative: Within one hour after his anthrax vaccination he experienced localized swelling, headache, myalgias, dizziness and vertigo. He reported the symptoms to his unit and an initial VAERS was filed. Within 72 hours his symptoms of localized swelling in the vaccinated arm, headache, and myalgias were resolved, but dizziness and vertigo remained. He sought treatment from his local emergency room and was given Antivert and Valium, which did not resolve his symptoms. He was sent to a military base where he was evaluated. Diagnosis with Benign Positional Vertigo and treated with Epley's canalith repositioning. Within an hour he was symptom free and taking no medication. He received Anthrax #3 on 2 February 2003 with no symptoms of dizziness or vertigo. He did begin experiencing flu like symptoms within a few hours of the vaccine, but they have been mild. He has experienced occasional headaches, but they are resolved with Tylenol.
Age: 26.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Vertigo
Clinical narrative: Within one hour after his anthrax vaccination he experienced localized swelling, headache, myalgias, dizziness and vertigo. He reported the symptoms to his unit and an initial VAERS was filed. Within 72 hours his symptoms of localized swelling in the vaccinated arm, headache, and myalgias were resolved, but dizziness and vertigo remained. He sought treatment from his local emergency room and was given Antivert and Valium, which did not resolve his symptoms. He was sent to a military base where he was evaluated. Diagnosis with Benign Positional Vertigo and treated with Epley's canalith repositioning. Within an hour he was symptom free and taking no medication. He received Anthrax #3 on 2 February 2003 with no symptoms of dizziness or vertigo. He did begin experiencing flu like symptoms within a few hours of the vaccine, but they have been mild. He has experienced occasional headaches, but they are resolved with Tylenol.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HEP, IPV, PNC, DTAP, HEP, IPV, PNC
Symptoms: Autopsy, Sudden infant death syndrome
Clinical narrative: A nurse reported that a male infant received a dose of Prevnar along with DTaP, IPOL and hep B vaccines on 9/5/02 at 4 months of age.  On 9/26/02 at 5 months of age, the infant died. SIDS was the reported cause of death. No further info was available at the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame as requested. Info regarding this event has been forwarded to manufacturer of IPOL vaccine. From initial information received at manufacturer on 03/03/2003 from another manufacturer regarding an event that happened in the U.S. concerning a 4-month-old male patient who received IPOL on 02/05/2002.  The lot number and site/route for the vaccination was not reported.  The patient died on 09/26/2002 from SUDDEN INFANT DEATH SYNDROME.  From additional information received at manufacturer on 04/24/2003, it was reported that the patient also received Prevnar, DTaP and Hepatitis B Vaccine on 09/05/2002.  The manufacturer, lot number and route/site were all not reported for Hepatitis B Vaccine and DTaP.  Prevnar was given intra-muscular.  Autopsy results showed Sudden Infant Death Syndrome (LLT, SIDS) as reported cause of death.  From additional information received on 05/13/2003 from manufacturer, it was reported that their manufacturer number be added to WAES 0305USA00241.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HEP, IPV, PNC, DTAP, HEP, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: A nurse reported that a male infant received a dose of Prevnar along with DTaP, IPOL and hep B vaccines on 9/5/02 at 4 months of age.  On 9/26/02 at 5 months of age, the infant died. SIDS was the reported cause of death. No further info was available at the date of this report. This report of a serious, labeled event is being submitted in a 15-day time frame as requested. Info regarding this event has been forwarded to manufacturer of IPOL vaccine. From initial information received at manufacturer on 03/03/2003 from another manufacturer regarding an event that happened in the U.S. concerning a 4-month-old male patient who received IPOL on 02/05/2002.  The lot number and site/route for the vaccination was not reported.  The patient died on 09/26/2002 from SUDDEN INFANT DEATH SYNDROME.  From additional information received at manufacturer on 04/24/2003, it was reported that the patient also received Prevnar, DTaP and Hepatitis B Vaccine on 09/05/2002.  The manufacturer, lot number and route/site were all not reported for Hepatitis B Vaccine and DTaP.  Prevnar was given intra-muscular.  Autopsy results showed Sudden Infant Death Syndrome (LLT, SIDS) as reported cause of death.  From additional information received on 05/13/2003 from manufacturer, it was reported that their manufacturer number be added to WAES 0305USA00241.
Sex: M
Vaccine: OPV
Symptoms: Lung neoplasm malignant, Pleural mesothelioma
Clinical narrative: An attorney reported that a 57 year old male received either IPV or OPV (manuf unk) sometime in the 1950s or 1960s. He was reportedly diagnosed with mesothelioma on or about November 2000. On 12/22/00, he died from the mesothelioma. It is alleged that, exposure to SV40 in the vaccine was a cause of the pt's mesothilioma. The reporter also noted exposure to asbestos and asbestos containing products as a cause. No further info was available at the date of this report.