chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: It was reported that an infant expired during sleep on 03/11/2002, unknown time. At 9:30am on 03/11/2002 infant was vaccinated with DTaP, Comvax, IPV and Prevnar. The follow-up states that the pt was vaccinated in the right thigh with a dose of Haemophilus B conjugate vaccine+hepatitis vaccine recombinant (lot 640503/0933L). Concomitant vaccination at the same time included a seocnd dose of Tripedia (TPU0540DA) given in the left thigh, a dose of IPOL (U0179) given SC in the left thigh and a dose of PrevnAr (484132) given in the right thigh. On 03/12/02 in the morning, the pt's mother found the baby dead in the crib. The pt died within 24 hrs of the vaccines. As of 04/25/02, the health care professional has not received a copy of the autopsy report. It was reported that on 10/31/01 the pt was vaccinated with a first dose of Tripedia, IPOL, hep B, and Haemophilus B conjugate. With these vaccinations no adverse events were reported. Information was received on 05/28/02 and was assigned manufacturer control number HQ20068726APR2002. Additional info has been requested. Follow up information received on 6/26/02 provided autopsy results and identified the manufacturers, lot numbers, and injection sites of concomitant vaccines. A physician reported that a 6 month old male received his first dose of Prevnar along with Tripedia, comvax, and IPV vaccines on 3/11/02. Within 24 hours of vaccination, the infant was found dead in his sleep. An autopsy revealed the cause of death as Sudden Infant Death Syndrome. Information regarding this event has been fowarded to the manufacturers of the vaccines.
Sex: F
Vaccine: HEP, HEPA, HEP, HEPA, JEV, TYP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Small local reaction, swelling, pain.
Sex: F
Vaccine: HEP, HEPA, HEP, HEPA, JEV, TYP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Small local reaction, swelling, pain.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Mental retardation severity unspecified, Neurodevelopmental disorder
Clinical narrative: An attorney alleges that an 2 month old male received his first dose of DTaP in Jan 1990 and subsequently developed mental retardation. He received his second, third and booster doses in March 1990, May 1990 and Jun 1991 respectively. It is alleged that following his "first round" of vaccinations, the child's language and learning abilities and his capacity for accomplishing basic tasks gradually deteriorated. The child, age 12 at the date of this report, has been diagnosed as mentally retarded and he "will always require care provided by others." At the date this was reported, no further information was available. The attorney alleged that the child received DTaP in 1990 and June 1991; however, Acel-Imune was not distributed until January of 1992.
Age: 1.3
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion, Pyrexia, Roseola
Clinical narrative: On 04/25/2002, the pt had a seizure for 40 minutes requiring intubation and intensive care. Temperature elevation to 101-102 deg. F. range. The follow up received on 12/3/02 states, "mom states child developed a rash while in the PICU and was told it was roseola."
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Abasia, Dyspnoea, Fluid retention, Hypotension, Injection site infection
Clinical narrative: Received pneumonia shot. On 1/21/02, I was home for about 2 weeks sick. On 2/6/02, was in the hospital so sick that I was all swollen and could not walk and filled with fluids. I thought I was going to die and could not hardly breathe. My brother took me to another doctor. 6 pills I was on and so sick and couldn't barely eat. I still only weight 120 lbs. The doctor said I got the 1 in a thousand that was infected in pneumonia site. The discharge summary states serum sickness, hypotension, and elevated lab values. The annual follow up states "I went to doctor one year and in 6 months I see him again that pneumonia shot poisoned your whole system I was never sick in my life and this poison's your system, not much of a apposite I weigh 117 pounds my face sure got the wrinkles. I felt better before this shot I had never again will I have it. I am thinning and my arms have the veins showing. Large veins on my legs and my hands the veins get red at times.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test abnormal, Nausea, Oral intake reduced, Serum sickness, Weight decreased
Clinical narrative: Received pneumonia shot. On 1/21/02, I was home for about 2 weeks sick. On 2/6/02, was in the hospital so sick that I was all swollen and could not walk and filled with fluids. I thought I was going to die and could not hardly breathe. My brother took me to another doctor. 6 pills I was on and so sick and couldn't barely eat. I still only weight 120 lbs. The doctor said I got the 1 in a thousand that was infected in pneumonia site. The discharge summary states serum sickness, hypotension, and elevated lab values. The annual follow up states "I went to doctor one year and in 6 months I see him again that pneumonia shot poisoned your whole system I was never sick in my life and this poison's your system, not much of a apposite I weigh 117 pounds my face sure got the wrinkles. I felt better before this shot I had never again will I have it. I am thinning and my arms have the veins showing. Large veins on my legs and my hands the veins get red at times.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Cardiac arrest, Infection, Multi-organ failure, Respiratory arrest, Shock
Clinical narrative: Disseminated VZV with multi-organ failure, shock, CV arrest. Diagnosed with Superficial cellulitis, Otitis externa, hepatomegaly. 3/16/05 Autopsy report received which revealed COD to be respiratory arrest and congenital ichthyosis w/Netherton's syndrome.  Patient arrested in pediatrician's office & unable to be revived/ss
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Bacterial infection, Fungal infection, Liver function test abnormal, Renal failure, Skin ulcer
Clinical narrative: Disseminated VZV with multi-organ failure, shock, CV arrest. Diagnosed with Superficial cellulitis, Otitis externa, hepatomegaly. 3/16/05 Autopsy report received which revealed COD to be respiratory arrest and congenital ichthyosis w/Netherton's syndrome.  Patient arrested in pediatrician's office & unable to be revived/ss
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Hypotonia, Injection site erythema, Injection site swelling, Screaming
Clinical narrative: Mother states child was limp, crying before for several hours. No fever. Legs were red and swollen. Was taken to ER on 4/15/02 and put in the hospital for 24 hours for observation and Rx'd with Tylenol. Mother states baby was transferred by EMS from doctor's office on 4/15/02 and states that the child had some seizure activity also.  Mother states child is doing OK now with no problems. Will follow with doctor for future immunizations.
Age: 4.75
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: The pt came to the clinic with his father to received MMR, DTAP and IPV. No problems noted at time of injection. On 4/24/02, clinic received phone call from doctor's nurse requesting information on vaccines child received due to possible adverse reaction. The doctor's office did not provide any other information. Information given to doctor's office from routing slip. No call received from parents. On 4/29/02, an RN placed a call to the child's mother to follow-up on possible reaction. Mother states the child woke up about 02:00 on 4/12/02, after receiving immunizations on 4/11/02 PM. The child complained of arm hurting, had a fever and lump on right arm. Mother states that they took him to the doctor the next day and had tests done, then ended up in the hospital for 2 1/2 days due to cellulitis. The child was treated with IV antibiotics. Mother states child appears fine now. Has full use of right arm and only complains of tenderness on upper right arm. Mother then states she had contacted an attorney and wants to know who is going to pay the hospital bills. Informed mother that the clinic was a state program and that I would get back with her with information on who to call for follow-up after speaking to the doctor. On 4/30/02, the RN placed a call to doctor's office and was told that the child was seen by the MD who is out of the office today. Able to check and see that child was seen on 4/13/02 in the office with fever, arm swelling and arm red and painful. Blood tests done. On 5/1/02, RN called to MD's office and received information that the child was admitted on 4/13/02 to the hospital with cellulitis and treated with antibiotics. MD did no fill out VAERS form.
Age: 4.75
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia
Clinical narrative: The pt came to the clinic with his father to received MMR, DTAP and IPV. No problems noted at time of injection. On 4/24/02, clinic received phone call from doctor's nurse requesting information on vaccines child received due to possible adverse reaction. The doctor's office did not provide any other information. Information given to doctor's office from routing slip. No call received from parents. On 4/29/02, an RN placed a call to the child's mother to follow-up on possible reaction. Mother states the child woke up about 02:00 on 4/12/02, after receiving immunizations on 4/11/02 PM. The child complained of arm hurting, had a fever and lump on right arm. Mother states that they took him to the doctor the next day and had tests done, then ended up in the hospital for 2 1/2 days due to cellulitis. The child was treated with IV antibiotics. Mother states child appears fine now. Has full use of right arm and only complains of tenderness on upper right arm. Mother then states she had contacted an attorney and wants to know who is going to pay the hospital bills. Informed mother that the clinic was a state program and that I would get back with her with information on who to call for follow-up after speaking to the doctor. On 4/30/02, the RN placed a call to doctor's office and was told that the child was seen by the MD who is out of the office today. Able to check and see that child was seen on 4/13/02 in the office with fever, arm swelling and arm red and painful. Blood tests done. On 5/1/02, RN called to MD's office and received information that the child was admitted on 4/13/02 to the hospital with cellulitis and treated with antibiotics. MD did no fill out VAERS form.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Immune system disorder
Clinical narrative: Asthma and considerably poor immune system
Age: 0.3
Sex: M
Vaccine: DTAP, DTPPHIB, HBPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever to 101.2
Age: 1.3
Sex: F
Vaccine: MMR, PNC
Symptoms: Hypersensitivity, Hypotonia, Lethargy, Pallor, Urticaria
Clinical narrative: Child was vaccinated on tuesday, on wednesday morning, had hives on side of face. Otherwise ok. Friday evening, vomiting diarhea, fever through saturday morning 7:00. Hives began in left arm (side of shot) spread throughout left side then to right. Emergency room, Benadryl administered, hives cleared.  17:45, hives reappeared beginning again in left arm, side of immunization. Administered Benadryl again, hives gone, but still has diarrhea. Child was limp, pale and lethargic friday and saturday. Child was diagnosed as having allergic reaction but according to physician cause was indeterminable.
Age: 0.75
Sex: M
Vaccine: IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Given IPV #3 , Prevnat #2 on 04/30/02. Next day right thigh SQ injection site became red, hard, tender, warm to touch. Induration appeared 2 inches in diameter on 05/02/02
Age: 16.0
Sex: F
Vaccine: IPV, PNC
Symptoms: Convulsion
Clinical narrative: Tonic-clonic seizure that lasted 15-20 secs. Seen in the ER.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Insomnia, Irritability, Screaming
Clinical narrative: 24 hrs non-stopping crying, High-pitched for more than four hours. Fussiness for 2-3 days, Not sleeping well, Sleeping for 10-15 minutes at a time then would cry again.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Mother reports that when the child woke on 04/11/2002, the left arm had a purple spot about the size of a pencil eraser at the site of injection and a red ring around it. Today 04/11/2002, the arm is red approximately 3 inches below the site of injection warm to touch. No fever or other symptoms.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Developed bilateral swelling w/pain and fever 2 wks post MMR
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Lymphadenopathy
Clinical narrative: 4/29-cellulitis left deltoid with axillary lymph adenopathy 5/2-Revaluation-cellulitis resolved
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash macular
Clinical narrative: The pt developed rash, generalized macular erythematous on the trunk and extremities.
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Difficulty in walking, Injection site oedema, Injection site warmth
Clinical narrative: The pt received DTaP #2 on 04/24/2002 in left leg. HIB and IPV were given in right leg. The pt presents with marked swelling on left thigh with mild warmth, no erythema, no signs of infection. Has full range of motion of knees, hips and ankles without pain. Mom states pt would not walk or bear weight last night but now walks and bears weight without limp or evidence of pain.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: The pt developed a large area of cellulitis on right leg.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: At 4:30 pm the pt received immunizations. At 7pm mom took the pt to ER with hives covering body except none on legs.
Age: 1.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: The parent of the pt states that about six hours after vaccine administration, they noted increased swelling (double normal size) on left leg. Also noted skin red and blotchy. Next day, skin "dark purple " with swelling and pain. Taken to the physician's office on the 3rd day.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Atelectasis, Bronchiolitis, Convulsion, Injection site erythema, Injection site induration
Clinical narrative: The pt developed red, hot and hard area (8"x6") at injection site. Treated with Keflex on 04/23/2002. The pt was in ER on 04/26/2002 with seizure due to temp of 105 deg. F. but chest x-ray showed bilateral medial basilar areas of atelectasis and infiltrate and minor bronchiolitis. Follow-up on 04/29/2002, the pt's still has firm area under skin, no redness, he or swelling.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: The pt developed red, hot and hard area (8"x6") at injection site. Treated with Keflex on 04/23/2002. The pt was in ER on 04/26/2002 with seizure due to temp of 105 deg. F. but chest x-ray showed bilateral medial basilar areas of atelectasis and infiltrate and minor bronchiolitis. Follow-up on 04/29/2002, the pt's still has firm area under skin, no redness, he or swelling.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: 25 pox-No fever
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: The pt developed edema, erythema, tenderness (5x5cm) area on deltoid.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Approximately 4 hours after receiving vaccine, dizziness, headache, nausea with vomiting . Temperature 100.9 degrees F. No medical treatment, symptoms continue for approximately 32.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Coma, Drooling, Eye movement disorder, Febrile convulsion
Clinical narrative: The pt developed fever seizure with temp of 103.6 deg. F., eyes rolled back in head, non-responsive, frothy drooling, and moaning.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Urticaria
Clinical narrative: The pt developed urticarial, generalized rash two days after immunization.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: The pt developed right upper arm cellulitis (redness, swelling, tenderness) from shot site to proximal upper arm; started one day after vaccination. Received antibiotics with clinical resolution.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Skin ulcer
Clinical narrative: Onset of Varicella within 19 days of  routine Varicella vaccine
Age: 4.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: The pt developed 4 inch round erythema, warm, tender on right arm.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Abnormal behaviour, Injection site oedema, Injection site warmth
Clinical narrative: The pt's mom picked the pt up from daycare. Arm swelling, warm to the touch and was acting unusual noted.
Age: 5.2
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site reaction, Rash, Viral infection
Clinical narrative: Mother stated that she noted the child had rash on the right arm this morning. The child has had a virus past four days from Saturday 03/09 through 03/12. Diagnosed with cellulitis at site and treated with Augmentin 400 mgs per 12 hrs for 10 days/
Age: 1.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Convulsion
Clinical narrative: Brief (1-2 minutes) tonic seizures with almost immediate between to normal LOC. No fever "looked pale". Not preceded by tantrum.
Age: 6.6
Sex: M
Vaccine: UNK
Symptoms: Herpes zoster
Clinical narrative: The pt presented an early atypical varicella. It began on the evening of 05/01/2002 and no fever noted. Treated with Zovirax, and Benadryl.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Rash erythematous, Rash papular
Clinical narrative: The child presented papular erythematous rash on face, and all over the body. Other symptoms include fussiness, conjunctival injection. Rubella rash was confirmed in ER.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness andswelling in the left thigh.
Age: 25.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Injection site erythema, Injection site pain
Clinical narrative: Pt was given MMR #2 booster dose on 04/26/2002. Pt states that she noticed achy joints and sore arm at injection site on 04/28/2002. Pt returned to clinic on 04/29/2002 with report of 3x4cm erythema with drainage or discharge at the injection site. Pt states no increase in size since 04/27/2002.
Age: 11.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Erythema, Swelling face
Clinical narrative: The pt came to ER after a raccoon bite. Raccoon was unable to be found. She received vaccines at 6:30pm and returned to ER around 10pm with facial swelling and erythema on face, legs, and trunk. She was given epinephrine and Benedryl and left hospital after 1-2 hrs later. Child was bit on the left index finger. Shortness of breath was also noted.
Age: 38.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Hyperhidrosis, Nausea, Nocturia, Pharyngolaryngeal pain
Clinical narrative: nausea, diaphorectic. complained of some difficulty breathing, lump in throat. Nocturia.
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site mass, Pain, Paraesthesia, Skin discolouration
Clinical narrative: The pt was bit by a dog at left eye on 04/11/2002. The pt received a Td shot on the right upper arm. She complained of dark in color, and painful knot since 04/11/2002. Also developed 2 small knots and loss of feeling on right hand. On 05/06/2002 no swelling but had sore arm (applied ice). Started on Cipro 500 mg, Kelfinist 250 mg, and Ceptin on 05/02.
Age: 1.83
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, hard and warm local reaction, 3 1/2 inches in diameter, Left, Tylenol, Ice. Child looks/act fine
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Lethargy, Pyrexia
Clinical narrative: The pt presented dizziness, high fever of >103 deg. F. and lethargic.
Age: 0.16
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC, HBHEPB, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Sudden infant death syndrome
Clinical narrative: A pediatrician reported that a 2 month old female received a dose of Prevnar, DTAP, Comvax and IPV. On 10/14/01, at the age of 3 months, the child was found apneic. Resuscitation measures were performed by the child's mother and by EMS prior to transporting the child to a local ER where she was pronounced dead. Bacterial CSF, blood and viral culture samples yielded negative results. An autopsy returned inconclusive results but sudden infant death syndrome was possible. Per the manufacturer, this report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. From additional correspondence received on 3/4/02, it was reported that the pt also received a Tripedia vaccination on 9/27/01. The reporter's name and address was also provided. From additional correspondence received on 3/27/02, it was reported that the nurse in the physician's office stated that "this pt, who was previously healthy, received Comvax (lot 639444/0776L). It was also reported that another infant (WAES0203USA00661) received Comvax (lot 638216/1591K) and Prevnar and died. The physician's office reported that they "did not believe there was any association with the Comvax, but that both infants received the same lot of Prevnar. The reporter's phone number and lot number of Comvax were also provided along with the result of the viral cultures. This is a consolidation of 2 reports concerning the same pt. It has been determined that WAES0202USA02896 is a duplicate of WAES0201USA00430. Therefore, WAES0202USA02896 is being deleted from our files and the report consolidated into WAES0201USA00430. WAES0202USA02896 was previously submitted to the FDA on 3/7/02. From additional correspondence received on 4/22/02, it was reported: This report was also received from the Center for Biologics and Evaluation and Research and was assigned Vaers ID number 180019. From mailed correspondence received from the pt's responsible physician on 4/29/02, additional information received regarding the pt and the vaccines.
Age: 0.16
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC, HBHEPB, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: A pediatrician reported that a 2 month old female received a dose of Prevnar, DTAP, Comvax and IPV. On 10/14/01, at the age of 3 months, the child was found apneic. Resuscitation measures were performed by the child's mother and by EMS prior to transporting the child to a local ER where she was pronounced dead. Bacterial CSF, blood and viral culture samples yielded negative results. An autopsy returned inconclusive results but sudden infant death syndrome was possible. Per the manufacturer, this report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. From additional correspondence received on 3/4/02, it was reported that the pt also received a Tripedia vaccination on 9/27/01. The reporter's name and address was also provided. From additional correspondence received on 3/27/02, it was reported that the nurse in the physician's office stated that "this pt, who was previously healthy, received Comvax (lot 639444/0776L). It was also reported that another infant (WAES0203USA00661) received Comvax (lot 638216/1591K) and Prevnar and died. The physician's office reported that they "did not believe there was any association with the Comvax, but that both infants received the same lot of Prevnar. The reporter's phone number and lot number of Comvax were also provided along with the result of the viral cultures. This is a consolidation of 2 reports concerning the same pt. It has been determined that WAES0202USA02896 is a duplicate of WAES0201USA00430. Therefore, WAES0202USA02896 is being deleted from our files and the report consolidated into WAES0201USA00430. WAES0202USA02896 was previously submitted to the FDA on 3/7/02. From additional correspondence received on 4/22/02, it was reported: This report was also received from the Center for Biologics and Evaluation and Research and was assigned Vaers ID number 180019. From mailed correspondence received from the pt's responsible physician on 4/29/02, additional information received regarding the pt and the vaccines.
Age: 0.16
Sex: F
Vaccine: DTP, HBHEPB, IPV, PNC, HBHEPB, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Atrial septal defect, Petechiae, White blood cell count decreased
Clinical narrative: A pediatrician reported that a 2 month old female received a dose of Prevnar, DTAP, Comvax and IPV. On 10/14/01, at the age of 3 months, the child was found apneic. Resuscitation measures were performed by the child's mother and by EMS prior to transporting the child to a local ER where she was pronounced dead. Bacterial CSF, blood and viral culture samples yielded negative results. An autopsy returned inconclusive results but sudden infant death syndrome was possible. Per the manufacturer, this report of a serious, labeled event is being submitted in a 15-day time frame as requested by the FDA. From additional correspondence received on 3/4/02, it was reported that the pt also received a Tripedia vaccination on 9/27/01. The reporter's name and address was also provided. From additional correspondence received on 3/27/02, it was reported that the nurse in the physician's office stated that "this pt, who was previously healthy, received Comvax (lot 639444/0776L). It was also reported that another infant (WAES0203USA00661) received Comvax (lot 638216/1591K) and Prevnar and died. The physician's office reported that they "did not believe there was any association with the Comvax, but that both infants received the same lot of Prevnar. The reporter's phone number and lot number of Comvax were also provided along with the result of the viral cultures. This is a consolidation of 2 reports concerning the same pt. It has been determined that WAES0202USA02896 is a duplicate of WAES0201USA00430. Therefore, WAES0202USA02896 is being deleted from our files and the report consolidated into WAES0201USA00430. WAES0202USA02896 was previously submitted to the FDA on 3/7/02. From additional correspondence received on 4/22/02, it was reported: This report was also received from the Center for Biologics and Evaluation and Research and was assigned Vaers ID number 180019. From mailed correspondence received from the pt's responsible physician on 4/29/02, additional information received regarding the pt and the vaccines.
Age: 0.5
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Petechiae, Sudden infant death syndrome
Clinical narrative: Information has been received from a health professional concerning a 6 month old pt with no known medical history who on 3/11/02 was vaccinated with a dose of Comvax (lot 640503/0933L). Concomitant vaccination included a 2nd dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (lot U0540DA) and IPOL (lot U0179) and a dose of Prevnar (lot 484132). On 3/12/02, in the morning, the pt's mother found the baby dead in the crib. The pt died within 24 hours of the vaccines. As of 4/25/02, the health care professional has not received a copy of the autopsy report. It was reported that on 10/31/01, the pt was vaccinated with a 1st dose of DPT, IPOL, Hep-B and Hib (the reporter was not sure if this was Comvax). With these vaccinations, no adverse events were reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from a health professional concerning a 6 month old pt with no known medical history who on 3/11/02 was vaccinated with a dose of Comvax (lot 640503/0933L). Concomitant vaccination included a 2nd dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (lot U0540DA) and IPOL (lot U0179) and a dose of Prevnar (lot 484132). On 3/12/02, in the morning, the pt's mother found the baby dead in the crib. The pt died within 24 hours of the vaccines. As of 4/25/02, the health care professional has not received a copy of the autopsy report. It was reported that on 10/31/01, the pt was vaccinated with a 1st dose of DPT, IPOL, Hep-B and Hib (the reporter was not sure if this was Comvax). With these vaccinations, no adverse events were reported. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a 6 month old pt with no known medical history who on 3/11/02 was vaccinated with a dose of Comvax (lot 640503/0933L). Concomitant vaccination included a 2nd dose of diphtheria toxoid/pertussis vaccine/tetanus toxoid (lot U0540DA) and IPOL (lot U0179) and a dose of Prevnar (lot 484132). On 3/12/02, in the morning, the pt's mother found the baby dead in the crib. The pt died within 24 hours of the vaccines. As of 4/25/02, the health care professional has not received a copy of the autopsy report. It was reported that on 10/31/01, the pt was vaccinated with a 1st dose of DPT, IPOL, Hep-B and Hib (the reporter was not sure if this was Comvax). With these vaccinations, no adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Bronchospasm, Condition aggravated, Cyanosis, Lung disorder
Clinical narrative: Information has been received from a physician concerning a pt with a compromised lung who in approx. 4/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (dose series unknown). The pt had been referred to the physician by a pulmonary physician due to the compromised lung. Within 2 minutes of vaccination, the pt experienced bronchospasm and had to be taken to the ER. The pt was cyanotic and required unspecified treatment. It was unknown if the pt had any past medical history, allergies or if there were any concomitant therapies. The pt subsequently recovered. A return visit was scheduled. The physician reported that another pt developed hives after vaccination with pneumococcal vaccine 23 polyvalent (WAES0204USA02681). Upon internal review, bronchospasm was determined to be an "Other Important Medical Event". Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: MEA
Symptoms: Abscess, Injection site erythema, Injection site oedema, Injection site reaction, Laboratory test abnormal
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a healthy 42 year old HIV negative male pt with who was vaccinated with measles virus vaccine live on approximately 10/07/2001. The nurse practitioner stated that the pt had no past medical history of any problems with vaccinations. The pt had a negative titer for measles, was a hospital employee and therrefore, was immunized with measles virus vaccine live. On 10/17/2001, approximately 5-10 days post vaccination, the pt presented to the ER with a severe local reaction including redness, swelling and development of an abscess. The pt was treated with three different intravenous antibiotics. The nurse practitioner stated that one antibiotic was vancomycin and she was unsure of the other two. Subsequently, the pt had recovered from the severe local reaction including redness, swelling and abscess. Since thetime of recovery the pt developed a postivie measles titer of 6 and had been advised to not get anymore measles vaccines. The infectious idsease physician stated that he thinks that this pt developed an atypical measles response to the measles vaccine. The nurse practitioner also discussed the events of a second pt who was vaccinated with measles virus vaccine live from the same lot, and she was concerned about the particular lot of vaccine. Upon internal medical review the pt's atypical measles response to vaccine, severe local reaction, redness, swelling and abscess were considered an other medical event. Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: MEA
Symptoms: Vaccination complication
Clinical narrative: Initial and follow-up information has been received from a nurse practitioner concerning a healthy 42 year old HIV negative male pt with who was vaccinated with measles virus vaccine live on approximately 10/07/2001. The nurse practitioner stated that the pt had no past medical history of any problems with vaccinations. The pt had a negative titer for measles, was a hospital employee and therrefore, was immunized with measles virus vaccine live. On 10/17/2001, approximately 5-10 days post vaccination, the pt presented to the ER with a severe local reaction including redness, swelling and development of an abscess. The pt was treated with three different intravenous antibiotics. The nurse practitioner stated that one antibiotic was vancomycin and she was unsure of the other two. Subsequently, the pt had recovered from the severe local reaction including redness, swelling and abscess. Since thetime of recovery the pt developed a postivie measles titer of 6 and had been advised to not get anymore measles vaccines. The infectious idsease physician stated that he thinks that this pt developed an atypical measles response to the measles vaccine. The nurse practitioner also discussed the events of a second pt who was vaccinated with measles virus vaccine live from the same lot, and she was concerned about the particular lot of vaccine. Upon internal medical review the pt's atypical measles response to vaccine, severe local reaction, redness, swelling and abscess were considered an other medical event. Additional information has been requested.
Sex: F
Vaccine: HIBV, OPV, RV
Symptoms: Conjunctivitis, Diarrhoea, Pyrexia, Rash
Clinical narrative: This report concerns a female infant who on an unspecified date was vaccinated with haemophilus B conjugate vaccine. Concomitant vaccinations included rotavirus vaccine and poliovirus vaccine. Subsequently the pt experienced diarrhea. The pt also experienced conjunctivitis, rash and fever following vaccination with hepatitis B vaccine, recombinant. This was originally reported by a physician. No further information is expected.
Age: 0.4
Sex: M
Vaccine: PNC
Symptoms: Screaming
Clinical narrative: The pt developed twelve hours of excessive crying.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Vertigo, Vomiting
Clinical narrative: The pt developed vomiting and headache about 9 hrs after receiving the flu vaccine. By 11/05/2001, onset of severe vertigo for four days followed by intermittent vertigo for three months. Treated with unspecified medication and fully recovered.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Rash
Clinical narrative: Client called clinic and complained of developed fine, red, small in appearance rash from lower abdomen up to chest only. Afebrile and no other complaints. Rash develop.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Febrile convulsion
Clinical narrative: The pt's father states that his child had a febrile convulsion yesterday. He was taken to the hospital for evaluation. Diagnosed with febrile convulsion and mother treated him with Tylenol. Father also stated that the child is doing well and seizure free.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: The pt developed swollen arm, warm to touch (quarter size). The doctor advised infection from shot and possibly a reaction to vaccine. Started on antibiotic and the symptoms resolved.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth
Clinical narrative: Twenty-four hours post injection, pt's mom noticed arm to be swollen, red and hot at injection site. Treated for cellulitis by the physician.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: One week post administration of DTaP in left thigh. Mom reported a large area of erythema at site of injection. Treated for probable cellulitis.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: The pt developed cellulitis on left leg post immunization. Treated with Augmentin, warm compresses and Tylenol/Motrin for pain.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Rash
Clinical narrative: The pt developed rash over face and abdomen.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pyrexia, Swelling
Clinical narrative: The pt developed temp of 100.2 deg. F., redness, soreness, swelling (approx. 20 cm in diameter) at injection site ten days post vaccination. On 04/29 hands, face, lips began swelling and the child received Benadryl in doctor's office.
Age: 36.0
Sex: M
Vaccine: JEV
Symptoms: Arthralgia, Back pain, Fatigue, Myalgia
Clinical narrative: The pt developed muscle aches, low back and joint aches and fatigue.
Age: 4.9
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: The pt developed a large local reaction with redness and swelling at left deltoid.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: The pt developed a large local reaction with redness and swelling at right deltoid.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Large local reaction with redness extending under left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Large local reaction around the site with redness extending beneath the left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large local reaction with redness and swelling to left arm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large local reaction with redness and swelling to right deltoid.
Age: 30.0
Sex: M
Vaccine: MMR, TD
Symptoms: Injection site inflammation, Injection site reaction, Pyrexia, Rash, Tremor
Clinical narrative: On 5/3/02, received phone call from RN at MCC re: Pt having a reaction from vaccine. She reports that he had a fever, chills, shaking and a fine pin-point rash on his left arm which is also inflammed. He visited the ER on 5/2/02 and received Keflex and ibuprofen.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: Diffuse maculopapular rash, pruritic, worse on face, with a fever up to 102F that lasted 2-3 days. Treated with Motrin and Benadryl.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Condition aggravated, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: Night fever, myalgias, arthralgias and localized swelling at the site.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Night fever, myalgias, arthralgias and localized swelling at the site.
Age: 1.8
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Rash papular, Upper respiratory tract infection
Clinical narrative: Fever and URI symptoms on 4/26/02 followed by scattered papular rash on body (less than 20 lesions). Seen in office on 5/1/02.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen, erythematous and warm right arm (R 3cm more than L upper arm). Swelling to forearm. Erythema 2-3cm X 1 1/2cm diameter of arm.
Age: 13.0
Sex: M
Vaccine: MMR
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: Petechial eruption started 2 days after MMR. Platelets decreased (thrombocytopenia). Checking labs weekly, platelets increasing weekly. Pt is expected to recover completely.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Few hours after immunization became dizzy.  Later develped headache, neck and body pain, nausea and diffus myalgias, Temp of 104F. Seen as out pt. 4/23& and 4/25/25, received IV fluids and IBuprofen and hydroco. Became afebrill with resolution of myolgias by 4/28.  Still has fatigue.
Age: 21.0
Sex: M
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: Few hours after immunization became dizzy.  Later develped headache, neck and body pain, nausea and diffus myalgias, Temp of 104F. Seen as out pt. 4/23& and 4/25/25, received IV fluids and IBuprofen and hydroco. Became afebrill with resolution of myolgias by 4/28.  Still has fatigue.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Dizziness, Erythema, Gastrointestinal disorder, Headache
Clinical narrative: The pt presented continued symptoms of abdominal pain hours after receiving the shot, headaches, dizziness, skin lesions (erythematous, pruretic, macular, painless discolored lesions on his right back) on Oct 2001, tinnitus began within weeks of this 4th shot, and insomnia. In Feb 2002 muscular cramping pain began which made it difficult to walk. Per doc 182807, patient continues to have GI problems. Has been treated without relief. Patient started pain medication and has consulted with physician. An URI is scheduled for 01/25/20002.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Insomnia, Muscle spasms, Pruritus, Rash macular, Tinnitus
Clinical narrative: The pt presented continued symptoms of abdominal pain hours after receiving the shot, headaches, dizziness, skin lesions (erythematous, pruretic, macular, painless discolored lesions on his right back) on Oct 2001, tinnitus began within weeks of this 4th shot, and insomnia. In Feb 2002 muscular cramping pain began which made it difficult to walk. Per doc 182807, patient continues to have GI problems. Has been treated without relief. Patient started pain medication and has consulted with physician. An URI is scheduled for 01/25/20002.
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Multiple sclerosis
Clinical narrative: Information has been received from an LPN concerning a 17 year old male pt who in 1986 was vaccinated with a 1st dose of MMRII. Subsequently, the pt developed multiple sclerosis. The pt's multiple sclerosis persisted. Unspecified medical attention was sought. Upon internal review, multiple sclerosis was determined to be an "Other Important Medical Event". Additional information has been requested. FOLLOW-up information received indicated that the patient did not have a reacion, and that their concern was "could there be." No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Asthenia, Bacterial infection, Cystitis, Neurological symptom, Urinary incontinence
Clinical narrative: Acute onset of neurological symptoms characterized by generalized weakness necessitating ventilator support. Weakness eventually localized to the waist down. Still undergoing physical therapy for it. Diagnosed with UTI with Escherichia coli, bacteremia with escherichia coli, Neurogenic bladder, possible transverse myelitis.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Erythema, Lacrimation increased, Myalgia, Pyrexia
Clinical narrative: Same day as flu shot was administered, the pt present at ER with erythema of face, neck, upper chest, shakiness and fever. Per doc 213904, eyes watering, temp of 103, muscle pain. The discharge summary states febrile illness, reaction to vaccination.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Same day as flu shot was administered, the pt present at ER with erythema of face, neck, upper chest, shakiness and fever. Per doc 213904, eyes watering, temp of 103, muscle pain. The discharge summary states febrile illness, reaction to vaccination.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Blindness, Eye pain, Fall, Fatigue, Headache
Clinical narrative: This report states that in February 2001, the pt fell while skiing. Approximately 3 days later she began experiencing numbness of the entire left side. She received an initial evaluation from local physicians who attributed the symptoms to her fall. She was diagnosed with muscle strain, put on a 2 week profile and prescribed Tylenol. The symptoms only slightly resolved with some residual numbness in the fingers of her left hand. on 06/03/2001 she presented to the medical clinic with complaints of a headache times three weeks with increasing pain in her right eye with decreased and darkened filed of vision. Within a few days she had total loss of vision in her right eye. She was evaluated locally and referred to optometry. That same day, optometry reported a +2-3 afferent papillary defect OD and severe color vision loss OD; fundus esam of healthy retinas OU with cup-to-disk ration approximately 0.4 with physiological cupping and lamina OU. She was treated with Solumedrol 1 gran /IV for five days then put on a Prednisone taper of 60 mg x 5d, 40mg x 3 days, 20 mg x 2 d. Her eyesight slowly returned-initially seeing shadows, then light and eventually full vision. She had not had a recurrence of these symptoms. During the evaluation of the optic neuritis, an MRI of the brain showed findings consistent with a demyelinating disease such as MS or Lyme disease. Further evaluation and lab tests ruled out Lyme disease. A second MRI of the brain two weeks later showed an area of hyper intensity in the spinal cord at C4-5 consistent with demyelinating plaques as in MS. One neurologist remarked that the left-sided numbness the pt experienced in February could not be attributed to a fall that happened five days prior and considered that set of symptoms the first sign of the demyelinating disease. Furthermore, combination of symptoms was definitely multiple sclerosis. During the time of this evaluation, the pt was pregnant; therefore other neurologist were hesitant to make a definite diagnosis of MS. In December 2001, she had a normal vaginal delivery without complications. A MRI done following her delivery showed the plaques were unchanged. Treatment with medication was delayed due to breastfeeding but she is currently on Avonex injections once a week for her symptoms. She has expereinced flu-like symptoms for 24-48 hrs following both of the two Avonex injections she has received. These are fairly common effects of the medication. The pt has a history of migraine headaches; however, these headaches have become more severe. Currently she experiences these pains once or twice a week at the same level of intensity. She noticed increasing fatigue and still experienced daytime somnolence. On July 5, 1999 approximately 5-6 weeks after anthrax vaccine #4, she developed pruritic papules over her entire body and began to experience swelling over her entire body.  She also has short term memory problems.