chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Tremor
Clinical narrative: A three year old female pt with no previous medical conditions, developed seizures following treatment with RabAvert. The reporter states that the pt has no history of head trauma and no family history of seizures. The pt was bitten by a grondhog in Oct 01 and given the first dose on 10/22/01. She was given subsequent doses on days 3, 7, 14, and 28. The pt developed seizures in Jan 02 described as foaming at the mouth with tremors. She later had a grand mal seizure in May 02 lasting 20 minutes. The pt was taken to the emergency room after that and diagnosed with febrile seizures. After the first grand mal, she had 4 or 5 seizures. In May 03, the reporter approached the physician to re-examine the pt. On 7/1/03, she was diagnosed with epilepsy. The pt has been treated with Lamictal, Trileptal and Depakote on different regimens. She is currently on Depakote and Trileptal. The reporter also stated that the pt had mental and motor skills of a 3 1/2 year old child, but was thought to be advanced for her age prior to groundhog bite and RabAvert injections. Follow up received 8/12/04: The patient received RabAvert on the following dates, 10/22/01, 10/25/01, 10/29/01, 11/5/01, and 11/19/01. The patient was diagnosed with intractable epilepsy.
Age: 3.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Convulsion
Clinical narrative: A three year old female pt with no previous medical conditions, developed seizures following treatment with RabAvert. The reporter states that the pt has no history of head trauma and no family history of seizures. The pt was bitten by a grondhog in Oct 01 and given the first dose on 10/22/01. She was given subsequent doses on days 3, 7, 14, and 28. The pt developed seizures in Jan 02 described as foaming at the mouth with tremors. She later had a grand mal seizure in May 02 lasting 20 minutes. The pt was taken to the emergency room after that and diagnosed with febrile seizures. After the first grand mal, she had 4 or 5 seizures. In May 03, the reporter approached the physician to re-examine the pt. On 7/1/03, she was diagnosed with epilepsy. The pt has been treated with Lamictal, Trileptal and Depakote on different regimens. She is currently on Depakote and Trileptal. The reporter also stated that the pt had mental and motor skills of a 3 1/2 year old child, but was thought to be advanced for her age prior to groundhog bite and RabAvert injections. Follow up received 8/12/04: The patient received RabAvert on the following dates, 10/22/01, 10/25/01, 10/29/01, 11/5/01, and 11/19/01. The patient was diagnosed with intractable epilepsy.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis left upper arm. Swelling began night of vaccination and skin became red, hard and shiny; associated with tenderness. Seen in urgent care 2 days later and admitted to hospital. Site warm to touch; patient afebrile. The hospital discharge summary received on 2/25/04 states positive rechallenge.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness, Vaccine positive rechallenge
Clinical narrative: Cellulitis left upper arm. Swelling began night of vaccination and skin became red, hard and shiny; associated with tenderness. Seen in urgent care 2 days later and admitted to hospital. Site warm to touch; patient afebrile. The hospital discharge summary received on 2/25/04 states positive rechallenge.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Cellulitis, Injection site erythema, Skin discolouration, Skin nodule, Swelling
Clinical narrative: Cellulitis of his right upper extremity. Mom noticed swelling on right thigh the day after vaccination; rapidly progressed over the day. Admitted to hospital 2 days after vaccination with 8cmx5cm area of erythema and mild color, with central area of induration. This is second episode of vaccine associated cellulitis. Given Ancef/Keflex 250mg for 10 days.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Abscess, Injection site erythema, Injection site haemorrhage, Injection site swelling
Clinical narrative: Abscess. Patient received 2 month immunizations 9/27/02 in left thigh. Afterwards, increasingly swollen, erythematous/ecchymotic. Seen in ER on 12/27/02; sent home with warm soaks. 1/6 Seen in Peds clinic for 4 month immunizations, however vaccination held and referred to surgeon for evaluation I & D.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: On 1/16/04, patient came to the ER with redness and swelling to left arm. Patient received vaccines 2 days ago (DTaP, IPV, MMR). Site slightly painful, low grade temperature. Diagnosed with cellulitis; admitted for 1 day for IV Ancef. Discharged on Keflex 375mg for 7 days. The hospital discharge summary received on 2/25/04 states low grade fever.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Asthma, Bacterial infection, Drug ineffective, Influenza
Clinical narrative: Pt developed pneumococcal pneumonia post receiving 4 doses of Prevnar. Was in ICU, on ventilator. The hospital discharge summary received on 3/23/04 states failure to thrive, influenza, oculogyric crisis, RAD.
Age: 1.0
Sex: M
Vaccine: PNC
Symptoms: Oculogyration, Pneumonia, Sepsis
Clinical narrative: Pt developed pneumococcal pneumonia post receiving 4 doses of Prevnar. Was in ICU, on ventilator. The hospital discharge summary received on 3/23/04 states failure to thrive, influenza, oculogyric crisis, RAD.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia, Stomatitis
Clinical narrative: "Funny feeling" around mouth and extended down right side of neck beginning within 10 min after injection. Symptoms lasted for several hours particularly around mouth. Patient did no treatment, did report to primary care physician at next regularly scheduled appointment.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Rash papular
Clinical narrative: Second pox developed approximately 3 inches distal to vaccine site.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site rash, Injection site vesicles
Clinical narrative: Pt bumped small, hot site that evening large vesicle that popped later. When seen in time vesicle with clear-fluid about 4cm with erythema about 3-4cm behind. Indurated tx for cellulitis.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site warmth
Clinical narrative: Pt bumped small, hot site that evening large vesicle that popped later. When seen in time vesicle with clear-fluid about 4cm with erythema about 3-4cm behind. Indurated tx for cellulitis.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Severe rash-whole body requiring emergency room visit same day of injection- Had local erythema/swelling at site of Hib injection -but not at DTaP injection site. Rash has recurred for more than 2 weeks controlled by a 12-24 feet treatment with Benadryl.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Pharyngitis, Pyrexia
Clinical narrative: Tiredness- "not herself"- Day 1-5. Vomiting and Diarrhea- Day 2 & 3. Fever of 100.2 and Fussiness- Day 5. Cold symptoms- Day 7-8.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Rhinitis, Vomiting
Clinical narrative: Tiredness- "not herself"- Day 1-5. Vomiting and Diarrhea- Day 2 & 3. Fever of 100.2 and Fussiness- Day 5. Cold symptoms- Day 7-8.
Age: 0.58
Sex: F
Vaccine: IPV
Symptoms: Abnormal behaviour, Diarrhoea, Feeling abnormal, Irritability, Pharyngitis
Clinical narrative: Day 1: Fussiness "Not herself". Day 3: Vomiting and Diarrhea. Day 5: Fever 101.3 - Cold symptoms. Day 7-14 Full blown cold - very fussy- started "banging head",  definately not herself. Hives day 1 and day 2.
Age: 0.58
Sex: F
Vaccine: IPV
Symptoms: Pyrexia, Rhinitis, Vomiting
Clinical narrative: Day 1: Fussiness "Not herself". Day 3: Vomiting and Diarrhea. Day 5: Fever 101.3 - Cold symptoms. Day 7-14 Full blown cold - very fussy- started "banging head",  definately not herself. Hives day 1 and day 2.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Patient received four months vaccinations on 8/11/03 in clinic. On 8/12/03 morning mom took patient's temperature and it was 101.5 F (Registered). Mom reported that upper thighs (both sides) were red swollen at site of injection and hard. Right thigh was warm. Mom gave patient Tylenol at 7:00 am and brought patient to the clinic at 9:30 am. The doctor diagnosed "cellulitis at vaccination site" and gave Keflex 60 mg, orally, three times daily for seven days and Tylenol for fever.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Patient received four months vaccinations on 8/11/03 in clinic. On 8/12/03 morning mom took patient's temperature and it was 101.5 F (Registered). Mom reported that upper thighs (both sides) were red swollen at site of injection and hard. Right thigh was warm. Mom gave patient Tylenol at 7:00 am and brought patient to the clinic at 9:30 am. The doctor diagnosed "cellulitis at vaccination site" and gave Keflex 60 mg, orally, three times daily for seven days and Tylenol for fever.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Patient received DTaP vaccine on 8/7/03 and began to have pain on right arm at night. On 8/8/03 morning, mother noticed right arm was very red/warm and swollen. No fever, nausea, vomiting or diarrhea. Patient was brought to the clinic and received Keflex every six hours for 1 week and Tylenol if needed. Next day, patient was brought to ER and diagnosed as right arm cellulitis, continued same drug (antibiotic and Tylenol).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: On 8/6/03, patient received multiple vaccines (DTaP, IPV, MMR) and PPD test. On 8/7/03, mother noticed that patient's upper arm is swollen and red. Patient had no history of vaccine reaction before. Patient had no fever, diarrhea or vomit. On 8/8/03, patient visited clinic and received Duricef 250 mg twice a day for 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Eye swelling, Feeling hot, Pyrexia, Swelling
Clinical narrative: Patient received DTap, IPV, MMR and PPD on 8/4/03. Next day, 8/5/03, the patient developed fever (100 degrees F) at night. He had right arm erythema/warmth/swelling. He also developed redness and puffiness around right eye. Mother called doctor and was told to give Benadryl, gave 2 dose of Benadryl. Patient visited clinic on 8/6/03. Doctor recommended to give Benadryl ever 6 hours. Pt was assessed on 8/8/03 again. Right arm now resolved.
Age: 1.6
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: Cellulitis right leg, Keflex for 10 days.  Pt returned to clinic 2 days later for additional vaccines (IPV, Prevnar).  Right thigh noted to be red and swollen.  Left thigh was slightly swollen, non-tender.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Cellulitis, Injection site abscess, Irritability
Clinical narrative: Mild cellulitis, abscess right leg-I & D with Keflex.  Seen in Peds ER for right thigh abscess for 1 week.  2 day history of increased irritability.  Give per mouth antibiotics-Keflex.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus, Pyrexia
Clinical narrative: Pt returned to urgent care for complaints of redness, swelling to left arm.  Received 4 year old vaccine 01/13/04 (DTAP, IPV, MMR).  Tactile temperature at home.  (-) pain (+) pruritis.  Benadryl 26 hours return to clinic if fever, pain or swelling, redness increases.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt came to urgent care 01/23/04 for complaints of redness, swelling, warmth to left arm.  Received 4 year old vaccine (DTAP, IPV) left arm, MMR right arm 01/22/04.  No fever.  Benadryl 25mg per mouth given and then to be given every 6 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Erythema, induration, pruritis, warmth at vaccination site (left arm).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Pt received vaccines on 09/10/03, on 09/11, father noticed swelling with redness on right arm. Father brought child to clinic on 09/12/03 for increased redness, warmth, swelling, no fever.  Pt started on Keflex for 10 days, follow up in ER for increased swelling, redness.
Age: 10.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives on stomach, back 2 days after 12 (lasted 2 weeks).  Temperature: 102 same day (3-4 days).  Never saw MD-consulted ER with MD by phone. Adverse event from 03/11/02.  Immunization not reported to health department until 02/02/04.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Dyspnoea
Clinical narrative: About 1 hour after receiving Td (b), MMR (2), she called to complain of "trouble breathing", known asthmatic. Ventolin inhaler not giving relief, advised she be seen in ER or with PMD.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt received Pneumovax left arm 2 days later mom called stating pt's arm was red and swollen.  Told Motrin for pain and lukewarm compress to arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Pt received DTAP vaccine in his leg. Dad called next AM stating leg was swollen and red at injection site.  MD told parent put lukewarm compresses and Motrin for pain.  Swelling subsided and went away after 2 days.
Age: 0.9
Sex: F
Vaccine: HEP, IPV, PNC
Symptoms: Cyanosis, Erythema, Pallor, Rash macular, Vomiting
Clinical narrative: Upon administration, shots Hep B, IPV, Prevnar, pt with in 1 minute pt broke out in red spots over face and entire body.  MD administered epi penyvin or bump and red spots left.  But pt started vomiting and turn pale, lips blue, oxygen was then given 911 call pt went to hospital stable.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Child exposed to shingles 2 weeks ago. Chicken pox rash appeared 02/08/04.  Child received Varicella vaccine 06/18/1999.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Pt received MMR right deltoid 01/20/04 on 01/30/04.  Fever 102.7 oral for 3 days.  01/31/04: facial rash, spread to rest of body by 02/02/04.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Mild localized reaction.
Age: 1.7
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Left thigh redness, swelling.
Age: 0.9
Sex: F
Vaccine: HBHEPB
Symptoms: Pyrexia
Clinical narrative: Pt developed fever to 103 the evening after receiving vaccine.  Persisted to 102 in AM.  Mother treated with Tylenol and Motrin.  Appears well when fever down.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Rec'd 18 mo shots DTaP & IPV on 2/4/04. On 2/5 mom noticed increased redness and swelling. On 2/6 it was more red and swollen at injection site. Seen 2/6 diagnosis cellulitis of L arm presumed reaction to DTaP.
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Urticaria
Clinical narrative: Hives 2 days after shot given.
Age: 21.0
Sex: M
Vaccine: HEP, TYP, YF
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Approximately 1 hour post injections pt returned to medical desk c/o SOB, itching. One adult epi pen administered to L thigh-transported to hospital via EMS.
Age: 46.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site pain
Clinical narrative: Vaccinee without complaints post vax on 7/31/03: soreness at vax site, take at 7 days. during fit testing physical exam on 10/7/03, EKG with new LBBB (CT to nrl EKG on 11/11/02). VAccinee denies any cardiac/ respiratory symptoms. Echo. stress test on 10/13 all wnl.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Erythema, Face oedema, Pyrexia, Urticaria
Clinical narrative: Patient developed swelling in the cheeks and chin. There were 4 areas that were red and about 1 inch in diameter. This occured 48hrs after the MMR vaccine. 1 week and 24hours after vaccine, patient developed fever of 103.9R and hives all over body.
Age: 19.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Feeling cold, Headache, Hot flush, Influenza like illness
Clinical narrative: Symptoms are: extreme fatigue, headaches,hot/cold flashes, vertigo, and flu-like symptoms
Age: 19.0
Sex: F
Vaccine: LYME
Symptoms: Laboratory test abnormal, Vertigo
Clinical narrative: Symptoms are: extreme fatigue, headaches,hot/cold flashes, vertigo, and flu-like symptoms
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Asthenia, Back pain, Injection site mass, Shoulder pain
Clinical narrative: On 2-5-04 client stated right arm really sore had a small knot as day went on went to extreme soreness in shoulders, back, arms, hips, knees, ankles, all joints.  Denies fever or N& V by 2-6-04 Left side joints fine but right side still sore and weak. To see doctor today 2-6-04
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hemiparesis, Hypoaesthesia, Pain, Thermal burn
Clinical narrative: About 10 days after recieving the flu vaccine I noticed pain, numbness, and superficial burning sensation along the lateral side of my left arm extending to the small finger.  These symptoms continued for about 1.5 months.  I tool ibuprofen 400 mg about every 12-24 hours to control symptoms.  These symptoms have subsided.  I now have persistent weakness in my left arm and mild soreness along the outaspect of my left lower from below the deltoid to my midforearm.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Discomfort, Pain, Paraesthesia, Pyrexia
Clinical narrative: Saw pt. in ER less than 24 hours after immunizations; patient had fever (controlled by ibuprofen), also c/o snakes crawling over his legs / chasing him, pain or discomfort in feet and legs.  Normally very independent but constantly running towards / jumping on mom for comfort.  Consolable.  ? paresthesias.
Age: 61.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Patient complained of severe itching for three days, "like if had hot water poured on him". He informed me of this when it was time for the second injection, therefore no treatment was done.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Candidiasis, Ear disorder, Rash, Sudden infant death syndrome
Clinical narrative: Information has been received from a health professional concerning a 17 week old male with no known concurrent disease and who was born at 36 weeks gestation who on 29-DEC-2003 was vaccinated with a dose of Hib conj vaccine (OMPC) (batch UEO2AA) (manufacturer unknown). Suspect concomitant therapy included a dose of Daptacel and a dose of Synagis (Batch TA5370B). On 30-DEC-2003, the next morning, the pt was found dead in bed with the mother. The mother had taken the pt to bed with her at 0730 that morning and found him lifeless at 1030. The autopsy status is unknown. On 19Feb04 it was noted that no new medical information had been reported. Information was received from a business partner that on 14Apr04 additional information was received that reported the pt's birth weight, number of siblings, place of vaccination and how the vaccine was purchased (details not provided). No new medical information was provided. Other business numbers include E200400416. No further information is expected. The case is considered closed.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a 17 week old male with no known concurrent disease and who was born at 36 weeks gestation who on 29-DEC-2003 was vaccinated with a dose of Hib conj vaccine (OMPC) (batch UEO2AA) (manufacturer unknown). Suspect concomitant therapy included a dose of Daptacel and a dose of Synagis (Batch TA5370B). On 30-DEC-2003, the next morning, the pt was found dead in bed with the mother. The mother had taken the pt to bed with her at 0730 that morning and found him lifeless at 1030. The autopsy status is unknown. On 19Feb04 it was noted that no new medical information had been reported. Information was received from a business partner that on 14Apr04 additional information was received that reported the pt's birth weight, number of siblings, place of vaccination and how the vaccine was purchased (details not provided). No new medical information was provided. Other business numbers include E200400416. No further information is expected. The case is considered closed.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Cardiac failure congestive, Cellulitis, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from al licensed practical nurse concerning 5 female patient's, all over 60 years old with some 70 to 80 years old, all with medical history, who in 2003 were each vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). All of the patients had concomitant medications. At least two of the patient's received a prior dose of pneumococcal 23v polysaccharide vaccine. Subsequently in 2003, the patient's developed injection site reactions the size of a saucer that were red and inflamed. Unspecified medical attention was sought. Subsequently, all of the patients fully recovered. A product quality complaint was not involved. The reporter stated the doctor was concerned because all patients received the same lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. One of the female patients had a larger injection site reaction that also included blisters. This patient was treated with sulfamethoxazole (+) trimethoprim bid for seven days. Follow up information received from the licensed practical nurse concerning the female patient treated with sulfamethoxazole (+) trimethoprim. The patient was an 86 year old Caucasian female patient with COPD, HTN, anemia, hypothyroidism and PVD who on 11/19/03 at 13:00 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). There was no illness at the time of vaccination. On 11/20/03 at 15:45, the patient developed red, swollen, cellulitis and was treated with sulfamethoxazole (+) trimethoprim. On 1/1/04, the patient died from congested heart failure. Cellulitis was considered to be an other important medical event (OMIC). One of the other female patients was treated with cephalexin. Another one of the female patient received no treatment. The remaining two female patients were treated with diphenhydramine hydrochloride and cold packs. Additional information is not expected. The hospital discharge summary received on 2/18/04 states influenza, fever, respiraotry distress, and altered mental status.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site vesicles, Pyrexia, Stupor, Viral infection
Clinical narrative: Information has been received from al licensed practical nurse concerning 5 female patient's, all over 60 years old with some 70 to 80 years old, all with medical history, who in 2003 were each vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). All of the patients had concomitant medications. At least two of the patient's received a prior dose of pneumococcal 23v polysaccharide vaccine. Subsequently in 2003, the patient's developed injection site reactions the size of a saucer that were red and inflamed. Unspecified medical attention was sought. Subsequently, all of the patients fully recovered. A product quality complaint was not involved. The reporter stated the doctor was concerned because all patients received the same lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. One of the female patients had a larger injection site reaction that also included blisters. This patient was treated with sulfamethoxazole (+) trimethoprim bid for seven days. Follow up information received from the licensed practical nurse concerning the female patient treated with sulfamethoxazole (+) trimethoprim. The patient was an 86 year old Caucasian female patient with COPD, HTN, anemia, hypothyroidism and PVD who on 11/19/03 at 13:00 was vaccinated IM in the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647681/0986N). There was no illness at the time of vaccination. On 11/20/03 at 15:45, the patient developed red, swollen, cellulitis and was treated with sulfamethoxazole (+) trimethoprim. On 1/1/04, the patient died from congested heart failure. Cellulitis was considered to be an other important medical event (OMIC). One of the other female patients was treated with cephalexin. Another one of the female patient received no treatment. The remaining two female patients were treated with diphenhydramine hydrochloride and cold packs. Additional information is not expected. The hospital discharge summary received on 2/18/04 states influenza, fever, respiraotry distress, and altered mental status.
Sex: M
Vaccine: OPV
Symptoms: Apnoea, Dyspnoea, Lung neoplasm malignant, Pericardial effusion, Pleural effusion
Clinical narrative: Information regarding Orimune Vaccine (poliovirus vaccine live oral trivalent solution) (manufacturer unknown) was received from an attorney regarding a male patient who experienced mesothelioma. The patient received a dose on an unspecified date sometime during 1959 or in the early 1960's. Relevant medical history was not provided. Indication for Orimune vaccine was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. On or about 3/02, the decedent was reportedly diagnosed with mesothelioma. The decedent's history included exposure to asbestos and asbestos-containing products. The legal complaint states that the decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. On 1/27/03, he died. The death certificate received on 2/19/04 states respiraotry failure, pleural effusion and pericardial effusion.
Age: 77.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Angina pectoris, Apnoea, Chest pain, Dyspnoea, Oedema peripheral
Clinical narrative: Initial SAE report received on 08/Dec/2003. Additional information received on 16/Dec/2003. This subject is a 77 year old male, who was admitted to the hospital due to SOB and peripheral edema while enrolled in a study. The subject received a dose of RSV or placebo and flu vaccine on 21/Oct/2003. The subject developed increased SOB and peripheral edema, 42 days post immunization. A CXR confirmed CHF and subject was admitted to ICU the same day, 2/Dec/2003. Subject was transferred to the floor and continued to have burning substernal chest pain and unstable angina. Treatment included a cardiac catheterazation on 10/Dec/2003. Subject developed acute renal failure possible secondary to the dye. A hemodialysis catheter was inserted on 15/Dec/2003 and dialysis was started. The subject's outcome is ongoing. It is unknown if they continued in the trial. The SOB and peripheral edema was reported by the investigator as unrelated to the study vaccine. Additional information received on 10/Feb/2004. The subject's spouse informed the investigator that her husband died while in the hospital on 8/Feb/2004. Subject died 68 days after admission to the hospital and 110 days post immunization. Cause of death is unknown at present. Information will be forward when available. The death was reported by the investigator as unrelated to the study vaccine. The hospital discharge summary received on 2/26/04 states respiratory failure and septicema.
Age: 77.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Renal failure, Sepsis
Clinical narrative: Initial SAE report received on 08/Dec/2003. Additional information received on 16/Dec/2003. This subject is a 77 year old male, who was admitted to the hospital due to SOB and peripheral edema while enrolled in a study. The subject received a dose of RSV or placebo and flu vaccine on 21/Oct/2003. The subject developed increased SOB and peripheral edema, 42 days post immunization. A CXR confirmed CHF and subject was admitted to ICU the same day, 2/Dec/2003. Subject was transferred to the floor and continued to have burning substernal chest pain and unstable angina. Treatment included a cardiac catheterazation on 10/Dec/2003. Subject developed acute renal failure possible secondary to the dye. A hemodialysis catheter was inserted on 15/Dec/2003 and dialysis was started. The subject's outcome is ongoing. It is unknown if they continued in the trial. The SOB and peripheral edema was reported by the investigator as unrelated to the study vaccine. Additional information received on 10/Feb/2004. The subject's spouse informed the investigator that her husband died while in the hospital on 8/Feb/2004. Subject died 68 days after admission to the hospital and 110 days post immunization. Cause of death is unknown at present. Information will be forward when available. The death was reported by the investigator as unrelated to the study vaccine. The hospital discharge summary received on 2/26/04 states respiratory failure and septicema.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: The autopsy report received on 3/30/04 states SIDS.
Age: 1.5
Sex: M
Vaccine: HEP
Symptoms: Autism, Disturbance in attention, Drug toxicity, Dyskinesia, Impaired healing
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report number A0492211A. This report concerned an 18 month old male with no reported medical history or concurrent conditions who was vaccinated in July 2000 with a first dose of hep B virus vaccine, in August 2000 with a second dose of 0.5ml of hep B virus vaccine (Engerix B) (lot 330A2) and on an unspecified date with a third dose of hep B virus vaccine. Concomitant therapy on unspecified dates included a series of Infanrix (961A2, 975A2, and 970A2) respectively. On 2/2/02 the pt was diagnosed with autism and "mercury in his body he can not excrete." The events were unresolved. Upon internal review autism and "mercury in his body he can not excrete" were considered to be other important medical events (OMIC). Additional info has been requested. This report was originally reported by a RN. It was reported that in approximately February 2002, at the child's decreased vocabulary. He only said "mama." If he wanted soething he would go and get it, but he did not verbalize his needs.  A developmental pediatric referral was given. On 02FEB2002, the patient was diagnosed with autism and "mercury in his body he cannot excrete". ON 07MAR2002 the patient had an audiology consult and mild hearing impairment was noted. In November 2002, at 28 months old, the patinet was seen by a developmental specialist. It was reported that he had delayed speech, sensory issues, distractibility, social impairment, communicaiton impairment, repetitive and restrictive interests, preoccupation, finger posturing, "mild stereotypes" and repetitive motor movements. He was diagnosed with autistic spectrum disorder. The patient was also given a diagnosis of pervasive developmental disorder. The nurse reported that the "mercury he can not excrete in his body" was a concern of the patient's mother. The mother ha dbeen asking about preservatives in vaccines and thought that htis may be his problem. Lab tests were never done and the nursd did not think that they planned to do any testing. It was also noted that at 3 years old in approximately June 2003, the child had acute shortness of breath and a cough after eating peanut butter. The patient went to the emergency room, was given diphenhydramine and epinephrine and was discharged. She indicated that he now keep epinephrine with him. Upon internal review, Autistic Spectrum Disorder, Pervasive Developmental Disorder, "mercury in his body he cannot excrete", and mild hearing impairment were considered to be other important medical events (OMIC). Additional information has been requested. This report was originally reported by a registered nurse. Follow up information received on 16MAR2004 contained the following adverse experience: cold symptoms (October 2001). This was origianlly reported by a registered nurse. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEP
Symptoms: Influenza like illness, Laboratory test abnormal, Movement disorder, Posturing, Psychomotor hyperactivity
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report number A0492211A. This report concerned an 18 month old male with no reported medical history or concurrent conditions who was vaccinated in July 2000 with a first dose of hep B virus vaccine, in August 2000 with a second dose of 0.5ml of hep B virus vaccine (Engerix B) (lot 330A2) and on an unspecified date with a third dose of hep B virus vaccine. Concomitant therapy on unspecified dates included a series of Infanrix (961A2, 975A2, and 970A2) respectively. On 2/2/02 the pt was diagnosed with autism and "mercury in his body he can not excrete." The events were unresolved. Upon internal review autism and "mercury in his body he can not excrete" were considered to be other important medical events (OMIC). Additional info has been requested. This report was originally reported by a RN. It was reported that in approximately February 2002, at the child's decreased vocabulary. He only said "mama." If he wanted soething he would go and get it, but he did not verbalize his needs.  A developmental pediatric referral was given. On 02FEB2002, the patient was diagnosed with autism and "mercury in his body he cannot excrete". ON 07MAR2002 the patient had an audiology consult and mild hearing impairment was noted. In November 2002, at 28 months old, the patinet was seen by a developmental specialist. It was reported that he had delayed speech, sensory issues, distractibility, social impairment, communicaiton impairment, repetitive and restrictive interests, preoccupation, finger posturing, "mild stereotypes" and repetitive motor movements. He was diagnosed with autistic spectrum disorder. The patient was also given a diagnosis of pervasive developmental disorder. The nurse reported that the "mercury he can not excrete in his body" was a concern of the patient's mother. The mother ha dbeen asking about preservatives in vaccines and thought that htis may be his problem. Lab tests were never done and the nursd did not think that they planned to do any testing. It was also noted that at 3 years old in approximately June 2003, the child had acute shortness of breath and a cough after eating peanut butter. The patient went to the emergency room, was given diphenhydramine and epinephrine and was discharged. She indicated that he now keep epinephrine with him. Upon internal review, Autistic Spectrum Disorder, Pervasive Developmental Disorder, "mercury in his body he cannot excrete", and mild hearing impairment were considered to be other important medical events (OMIC). Additional information has been requested. This report was originally reported by a registered nurse. Follow up information received on 16MAR2004 contained the following adverse experience: cold symptoms (October 2001). This was origianlly reported by a registered nurse. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: HEP
Symptoms: Sensory disturbance, Speech disorder
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report number A0492211A. This report concerned an 18 month old male with no reported medical history or concurrent conditions who was vaccinated in July 2000 with a first dose of hep B virus vaccine, in August 2000 with a second dose of 0.5ml of hep B virus vaccine (Engerix B) (lot 330A2) and on an unspecified date with a third dose of hep B virus vaccine. Concomitant therapy on unspecified dates included a series of Infanrix (961A2, 975A2, and 970A2) respectively. On 2/2/02 the pt was diagnosed with autism and "mercury in his body he can not excrete." The events were unresolved. Upon internal review autism and "mercury in his body he can not excrete" were considered to be other important medical events (OMIC). Additional info has been requested. This report was originally reported by a RN. It was reported that in approximately February 2002, at the child's decreased vocabulary. He only said "mama." If he wanted soething he would go and get it, but he did not verbalize his needs.  A developmental pediatric referral was given. On 02FEB2002, the patient was diagnosed with autism and "mercury in his body he cannot excrete". ON 07MAR2002 the patient had an audiology consult and mild hearing impairment was noted. In November 2002, at 28 months old, the patinet was seen by a developmental specialist. It was reported that he had delayed speech, sensory issues, distractibility, social impairment, communicaiton impairment, repetitive and restrictive interests, preoccupation, finger posturing, "mild stereotypes" and repetitive motor movements. He was diagnosed with autistic spectrum disorder. The patient was also given a diagnosis of pervasive developmental disorder. The nurse reported that the "mercury he can not excrete in his body" was a concern of the patient's mother. The mother ha dbeen asking about preservatives in vaccines and thought that htis may be his problem. Lab tests were never done and the nursd did not think that they planned to do any testing. It was also noted that at 3 years old in approximately June 2003, the child had acute shortness of breath and a cough after eating peanut butter. The patient went to the emergency room, was given diphenhydramine and epinephrine and was discharged. She indicated that he now keep epinephrine with him. Upon internal review, Autistic Spectrum Disorder, Pervasive Developmental Disorder, "mercury in his body he cannot excrete", and mild hearing impairment were considered to be other important medical events (OMIC). Additional information has been requested. This report was originally reported by a registered nurse. Follow up information received on 16MAR2004 contained the following adverse experience: cold symptoms (October 2001). This was origianlly reported by a registered nurse. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: FLUX, HEP, HEPA, IPV, MEN, SMALL
Symptoms: Asthenia, Chest discomfort, Chest pain, Coronary artery disease, Dyspnoea
Clinical narrative: Pt is a 55 year old who received his first anthrax vaccination without any local adverse effects. On 2/15th, he received a smallpox vaccination as well "a whole bunch of shots." Approximately three weeks after receiving his vaccinations, while sitting in the "chow" hall after supper, he says, "my whole body started shaking and I felt weak." He was admitted to hospital where he received an EKG and a stress test. He was told that he had "flutters" and was kept overnight. The following morning he was told that both studies were normal and he was discharged. Approximately 1 week after he again experienced several episodes of "shaking and feeling weak," sometimes accompanied by SOB and pressure across his chest (5-6/10 on pain scale). He was seen there by medics and given a NTG that "helped" but did not completely relieve his chest discomfort. These episodes continued and he was airevacuated on 4/27th where a cardiac cath showed a high-grade mid-LAD stenosis. He was to be transferred to another hospital for a stent placement, but he began experiencing additional "left-sided chest pain" (1-2/10) and on 5/6th a PCI and stent of his mid-LAD lesion was performed. A "low-level exercise test" performed 5/8th showed normal hemodynamic response and no EKG changes or symptoms. He was admitted to hospital 5/9/03 and followed by Dr. -minimal amount of redness and swelling.
Age: 56.0
Sex: M
Vaccine: FLUX, HEP, HEPA, IPV, MEN, SMALL
Symptoms: Tremor
Clinical narrative: Pt is a 55 year old who received his first anthrax vaccination without any local adverse effects. On 2/15th, he received a smallpox vaccination as well "a whole bunch of shots." Approximately three weeks after receiving his vaccinations, while sitting in the "chow" hall after supper, he says, "my whole body started shaking and I felt weak." He was admitted to hospital where he received an EKG and a stress test. He was told that he had "flutters" and was kept overnight. The following morning he was told that both studies were normal and he was discharged. Approximately 1 week after he again experienced several episodes of "shaking and feeling weak," sometimes accompanied by SOB and pressure across his chest (5-6/10 on pain scale). He was seen there by medics and given a NTG that "helped" but did not completely relieve his chest discomfort. These episodes continued and he was airevacuated on 4/27th where a cardiac cath showed a high-grade mid-LAD stenosis. He was to be transferred to another hospital for a stent placement, but he began experiencing additional "left-sided chest pain" (1-2/10) and on 5/6th a PCI and stent of his mid-LAD lesion was performed. A "low-level exercise test" performed 5/8th showed normal hemodynamic response and no EKG changes or symptoms. He was admitted to hospital 5/9/03 and followed by Dr. -minimal amount of redness and swelling.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Bacterial infection, CSF test abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: Approximately 12/14 or 12/15/03 onset numbness of right side (arm and leg). Numbness in R arm gradually resolved. Numbness extended to L leg. Pt experienced sensory changes including dragging leg. Increased weakness. MRI showed inflammation of spinal cord. Hospitalized and treated with steroids. Discharged home. Rested at home while strength returned. Improved; returned to work then 1/15/04 developed unsteady gait and readmitted to hospital on 1/16/04. Medical record states urinary retention. msv
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal, Movement disorder, Sensory disturbance, Urinary retention, Urinary tract infection
Clinical narrative: Approximately 12/14 or 12/15/03 onset numbness of right side (arm and leg). Numbness in R arm gradually resolved. Numbness extended to L leg. Pt experienced sensory changes including dragging leg. Increased weakness. MRI showed inflammation of spinal cord. Hospitalized and treated with steroids. Discharged home. Rested at home while strength returned. Improved; returned to work then 1/15/04 developed unsteady gait and readmitted to hospital on 1/16/04. Medical record states urinary retention. msv
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site reaction, Injection site warmth, Pruritus
Clinical narrative: Information regarding influenza virus vaccine was received from a 60 year old male consumer who received a dose in November 1964. The patient's concurrent illnesses include syncope vasovagal, anxiety, allergy to animal, hypersensitivity, and food allergy. Indication for influenza virus vaccine formula was immunization. Product was administered in November 1964. Dose regimen was not provided. Concomitant therapy included Clonazepam. The patient reported that he developed an injection site reaction, injection site arm redness, injection site arm hot, and injection site arm itching in November 1964. All symptoms resolved within 24 hours, without treatment. No additional information was available at the time of this report.
Age: 1.0
Sex: M
Vaccine: DTPHIB, FLU3, MMR, PNC, VARCEL, DTAPH, MMR, PNC, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: Medical center called this nurse and stated child presented there with rash from head to foot.  Blanching and raised onset was about 3 days ago. Child received 5 immunizations on 01/28/04 at this clinic (see item 13) with no immediate adverse reaction advised parent of potential reaction to MMR.  Nurse follow up on 08/19/04 states: "Viral exanthum."
Age: 1.0
Sex: M
Vaccine: DTPHIB, FLU3, MMR, PNC, VARCEL, DTAPH, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Medical center called this nurse and stated child presented there with rash from head to foot.  Blanching and raised onset was about 3 days ago. Child received 5 immunizations on 01/28/04 at this clinic (see item 13) with no immediate adverse reaction advised parent of potential reaction to MMR.  Nurse follow up on 08/19/04 states: "Viral exanthum."
Age: 1.1
Sex: M
Vaccine: DTAP, HBHEPB, HEP, IPV, MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective
Clinical narrative: Developed varicella rash about 7 days after vaccination.  Rash lasted approximately 1 week.  Treated with hydroxyzine syrup for itching.  Resolved completely without problems.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Amnesia, Arthralgia, Depression, Dyspnoea, Epistaxis
Clinical narrative: Shortness of breath; nose bleed; Headache; tremors; Migraines; Tinnitus; Hearing loss; joint pain; memory loss; depression; All events in box 7 are the same for box 14.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Hearing impaired, Migraine, Tinnitus, Tremor
Clinical narrative: Shortness of breath; nose bleed; Headache; tremors; Migraines; Tinnitus; Hearing loss; joint pain; memory loss; depression; All events in box 7 are the same for box 14.
Age: 49.0
Sex: M
Vaccine: ANTH
Symptoms: Vaccine positive rechallenge
Clinical narrative: Shortness of breath; nose bleed; Headache; tremors; Migraines; Tinnitus; Hearing loss; joint pain; memory loss; depression; All events in box 7 are the same for box 14.
Age: 23.0
Sex: M
Vaccine: ANTH, FLU3, SMALL
Symptoms: Blood testosterone decreased, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Following smallpox vaccination (2 weeks-fever, diarrhea, nausea).  Also have Anthrax vaccine day this time.  History of experienced seen fatigue.  Work up to date-Normal except low testosterone level.  Anthrax shots started 03/02/03 and as listed below. Pt relates illness to immunizations.  Will send to clinic.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The arm in which the injection was given was swollen and red. Zyrtec 10mg ever day for 5 days was given.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash erythematous, Rash pustular
Clinical narrative: Erythematous postule on the face, chest.  No lesion, no itching developed 3-5 minutes after shots.  No sneezing, wheezing or respiratory distress. Temperature 97.5.  Benadryl 2cc given by mouth.  Erythema disappear within 5 minutes.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Laboratory test abnormal, Nasal congestion, Oral intake reduced, Pharyngitis, Pyrexia
Clinical narrative: Mother reported to office on 02/12/04 that child had fever 105.5 per ear thermometer on the evening of 02/10/04 after immunizations that day.  On 02/13/03 continued with temperature 101.1 rect, not drinking/eating well, had nasal congestion and pharyngitis.
Age: 0.6
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: White blood cell disorder
Clinical narrative: Mother reported to office on 02/12/04 that child had fever 105.5 per ear thermometer on the evening of 02/10/04 after immunizations that day.  On 02/13/03 continued with temperature 101.1 rect, not drinking/eating well, had nasal congestion and pharyngitis.