chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, CSF test abnormal, Convulsion, Dementia, Encephalitis
Clinical narrative: One day post vax, the pt left for a visit to another country. Approximately 2 weeks into the trip, the child developed a "febrile illness" which resolved on its own. The pt had no reported rash or symptoms other than the fever. However, approximately 1-2 weeks after the febrile illness, the child developed seizures followed by "progressive neurological deterioration". He returned home and was hospitalized in August. MRI and CT scan were normal, however the child continued to deteriorate neurologically. The physician stated that the pt is now at the "lever of a 6 month old infant" and has completely regressed. He is incontinent, unable to feed himself, unable to walk etc. Additionally she stated he appears to have some form of dementia. Numerous cultures and lab results are pending including a test for the West Nile virus. The physician stated that she does not think the child's experience was related to the vaccination with varicella, but she wants to explore every possible avenue. Additional information has been requested.  Follow up on 03/28/2001: "Patient date of birth and Lot # for vaccine 1 is not provided."
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Nervous system disorder, Pyrexia, Urinary incontinence, Viral infection
Clinical narrative: One day post vax, the pt left for a visit to another country. Approximately 2 weeks into the trip, the child developed a "febrile illness" which resolved on its own. The pt had no reported rash or symptoms other than the fever. However, approximately 1-2 weeks after the febrile illness, the child developed seizures followed by "progressive neurological deterioration". He returned home and was hospitalized in August. MRI and CT scan were normal, however the child continued to deteriorate neurologically. The physician stated that the pt is now at the "lever of a 6 month old infant" and has completely regressed. He is incontinent, unable to feed himself, unable to walk etc. Additionally she stated he appears to have some form of dementia. Numerous cultures and lab results are pending including a test for the West Nile virus. The physician stated that she does not think the child's experience was related to the vaccination with varicella, but she wants to explore every possible avenue. Additional information has been requested.  Follow up on 03/28/2001: "Patient date of birth and Lot # for vaccine 1 is not provided."
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Nausea, Syncope vasovagal, Vomiting
Clinical narrative: The pt experienced a redness at injection site , nausea, vomiting. Probably systemic reaction to pneumonia vaccine. The pt developed vasovagal syncope after the nausea and vomiting.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Cystitis, Diarrhoea, Nasopharyngitis, Pharyngolaryngeal pain, Rash
Clinical narrative: The pt states that after receiving the 4th dose of Anthrax, she got sick on the 27th of May and saw an MD because she had a head cold with vomiting. Pt also states that at the end of July, she got sick with a sore throat and was seen by an MD on the 30th of July and also on the 1st and 2nd of August. The pt was treated with Steroids and an IV. At the end of August she noticed rash like spots above her left eye, left arm, and also torso area. The pt states that on August 11, a large rash progressed on her right upper thigh, both arms, and also the back of her neck. The MD ordered tests and told the pt to use cortizone cream and Benadryl. On September 3, the pt states she had a bladder infection along with diarrhea.  Follow up on 12/27/2000: "Patient has not recovered from adverse event.  Has been diagnosed with Gottate psoriasis.  Am currently DNIF (duty not including flying) until fully recovered.  "
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: The pt states that after receiving the 4th dose of Anthrax, she got sick on the 27th of May and saw an MD because she had a head cold with vomiting. Pt also states that at the end of July, she got sick with a sore throat and was seen by an MD on the 30th of July and also on the 1st and 2nd of August. The pt was treated with Steroids and an IV. At the end of August she noticed rash like spots above her left eye, left arm, and also torso area. The pt states that on August 11, a large rash progressed on her right upper thigh, both arms, and also the back of her neck. The MD ordered tests and told the pt to use cortizone cream and Benadryl. On September 3, the pt states she had a bladder infection along with diarrhea.  Follow up on 12/27/2000: "Patient has not recovered from adverse event.  Has been diagnosed with Gottate psoriasis.  Am currently DNIF (duty not including flying) until fully recovered.  "
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Influenza like illness, Injection site erythema, Injection site oedema
Clinical narrative: The pt experienced redness and swelling which was fairly small at first, about the size of a silver dollar. After sleeping all night, the redness had grown considerably, almost whole bicep, and experienced flu-like symptoms.
Age: 38.0
Sex: M
Vaccine: ANTH, HEP
Symptoms: Erythema, Influenza like illness, Skin burning sensation, Skin nodule
Clinical narrative: Immediately following vax, the pt experienced burning in the left arm that lasted 2-3 weeks. The pt also experienced erythema and nodule, transient flu like symptoms on day 2 and 3. The pt experienced 3 episodes lasting seconds in duration with the inability to understand speech. No LOC and was aware of surroundings.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site desquamation, Injection site oedema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: The pt has a swollen, erythematous, right upper arm, urticaria, tenderness to the touch, warm with sloughing off of dermis and a superficial rash. No other symptoms. Seen by a physician and symptoms were treated accordingly.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Rash
Clinical narrative: The pt has a swollen, erythematous, right upper arm, urticaria, tenderness to the touch, warm with sloughing off of dermis and a superficial rash. No other symptoms. Seen by a physician and symptoms were treated accordingly.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Erythema multiforme
Clinical narrative: The pt experienced severe erythema multiforme.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Anorexia, Insomnia, Irritability, Pyrexia
Clinical narrative: Loss of appetite, refusal to nurse, very fussy, unable to sleep, high fever of 104.6F and a rash. Fever ranged from 102F to 104.5F through 8/19/00. Treatment: Motrin and Tylenol.  Follow up 11/01/2000: "I don't know the lot #."
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Two months post 2nd vax, the pt's hip joints started to ache and muscles were tight in the spine. Shoulder pain was experienced also.
Age: 39.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Back pain, Balance disorder, Hypoaesthesia, Visual disturbance
Clinical narrative: Pt had 3 shots of Lymerix; 10/99, 11/99, 4/00 with follow-up after 2nd and 3rd. 10 days later, had numbness of left lower extremity and 2 months later, LLE and RLE was numb as well as upper BL, LS spine and hip pain, balance and vision affected.
Age: 43.0
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Fatigue, Headache, Infection, Joint swelling
Clinical narrative: Post 2nd dose of vax, the pt's symptoms started gradually over 2-3 month period and progressed for 6 months. Joint and muscle pain, swollen joints, headache, fatigue; no symptoms before vax.
Age: 43.0
Sex: U
Vaccine: LYME
Symptoms: Myalgia
Clinical narrative: Post 2nd dose of vax, the pt's symptoms started gradually over 2-3 month period and progressed for 6 months. Joint and muscle pain, swollen joints, headache, fatigue; no symptoms before vax.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Abasia, Arthralgia, Infection, Similar reaction on previous exposure to drug
Clinical narrative: Pt was a participant in Lyme study for 1994-1997. Post 2nd dose of vax, the pt could not walk more than 1/2 block; progressively worse.
Age: 41.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Pain
Clinical narrative: Two days post vax, the pt had pain in hip, knee, and leg; standing caused severe pain-seen in February 2000 and still had pain with exertion.
Age: 47.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Arthritis, Oedema peripheral
Clinical narrative: Two days post vax, the pt experienced joint pain. On 5/11/99, the pt's feet were swollen bilaterally; severe hip, knee, and ankle pain. Not good since then. The follow up received on 1/31/01 states concurrent medical conditions included severe premenstrual syndrome, a penicillin allergy, a family history of rheumatoid arthritis, a history of fluid retention, arthritic pain in fingers and knee caps (1987) when taking megastrol and aldactaside, and the feeling of flu-like symptoms while on aldactaside. Aldactaside was discontinued on 6/4/97. Medical records from the pt's cynacologist and gynecoendocrinologist indicated pt was complaining of multiple arthralgias at 5/6/99 visit. Lab tests revealed negative lab tests for antinuclear antibody and rheumatoid factor on 5/17/99. The pt had elevated eosinoophils 7.4%, elevated monocytes 0.4 thousand/cubic millimeter, and elevated globulins 3.4cm/dl. The information received on 1/31/01 did not provide an outcome. The adverse events of reactive arthritis and joint pain do not meet serious criteria, but are being submitted as an expedited report by special FDA request per the 6/28/00 letter.  A follow up report received 10/10/2002 adds: (in May 1999) The symptoms were treated with an anti-inflammatory, steroids, celecoxib (Celebrex) 100 mg twice daily for 1.5 weeks and nabumotone (Relafen) 750 mg every 12 hours. The info received on 06/09/1999 reported the pain was less severe, but the swelling persisted. The info received on 01/31/2001 did not provide an outcome. In a news article published 06/25/2001, a reporter stated, "The stiffness and swelling has become so severe that she is dependent on anti-inflammatory drugs to keep her mobile". The pt stated, "I just keep moving. It doesn't get rid of the pain, but it keeps me from stiffening." The outcomes of the flu-like symptoms and viral syndrome were not provided. The most recent info, received on 02/11/2002, did not provide the outcome of the reported events. The adverse event of "reactive arthritis" does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the 06/28/2000 letter.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Contusion, Erythema, Infection, Oedema peripheral, Pruritus
Clinical narrative: On 6/25/99, the pt developed a red, itchy spot on right arm. On 7/18, she had developed numerous spots on extremities; easy to bruise. On 8/5, her left leg was swollen. On 8/24, she was dx with leukocytoplastic vasculitis. Treated with oral antibiotics.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Vasculitis
Clinical narrative: On 6/25/99, the pt developed a red, itchy spot on right arm. On 7/18, she had developed numerous spots on extremities; easy to bruise. On 8/5, her left leg was swollen. On 8/24, she was dx with leukocytoplastic vasculitis. Treated with oral antibiotics.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Aplastic anaemia, Fungal infection, Respiratory disorder
Clinical narrative: The pt experienced A-Plastic anemia, invasive aspergillosis.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Chills, Fatigue, Headache, Pyrexia, Thrombocytopenia
Clinical narrative: In the evening of 9/15/00, the pt experienced rigors, an oral temp of 104 and fatigue. He was seen in the ER on 9/15/00. The pt declined to stay in the hospital. Since that time, the pt has had a fever and rigors nightly associated with a minor headache. He has also experienced daily fatigue. He was treated with acetaminophen. On 9/17/00, the pt spiked a similar temp and the rigors returned. As of 9/22/00, the pt's temp spikes had ceased. although he  continued to have a slightly elevated temperature. As of 9/25/00, the outcome of the thrombocytopenia, rigors and fatigue is unknown. The fever is ongoing. Further work-up for the causes of fever and thrombocytopenia are in progress. Follow up on 02/02/2001: "The event of headache does not meet ICH serious criteria, but is being submitted as an expedited report by special request per 06/28/2000 letter."
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Dermatitis bullous
Clinical narrative: On 9/2/00, the pt developed a rash under his left breast, left posterior ribs, and on left buttocks; patches blistery in appearance. No other areas noted at this time.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Post vax, the pt developed a local reaction consisting of urticaria. Urticaria was also located on the torso and extremities.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: On 8/13/00, the infant developed a seizure. Seizures are considered "Medically Important." Still on Phenobarb, no siezures since 11/30/2000
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Vaccine positive rechallenge
Clinical narrative: On the same evening of the vax 8/23/00, the infant developed a seizure. Seizures are considered "Medically Important" The infant developed a seizure following receipt of Prevnar, DTaP, HIB and IPV vaccines on 6/24/00. Information from follow-up report states: A company representative reported that a 4 month old received his second immunizations with Prevnar, Acel-Imune, Hib (manufacturer unknown), and IPV vaccines on 23-Aug-2000. That evening, the infant developed a seizure. Seizures are considered medically important. This infant developed a seizure following receipt of first immunizations with Prevnar, DTaP, Hib, and IPV vaccines on 24-Jun-2000. A copy of this report has been forward to the manufactuer of IPV vaccine. Follow-up information recevied from the physician on 25-Sep-2000 identified the patient and the manufacturer and lot number of concomitant vaccines. On 24-Aug-2000, she was seen by a pediatric neurologist who performed a "work-up." She recovered. OMIC
Age: 1.6
Sex: M
Vaccine: DTAP, PNC
Symptoms: Angioneurotic oedema
Clinical narrative: Within 24 hours, the pt developed a generalized urticarial reaction described as Giant urticaria. The pt was seen by the physician on 8/15/00; the child was "not sick or not toxic". He was treated with oral diphenhydramine.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Rash erythematous, Viral infection
Clinical narrative: A father reported that his 3 year old daughter received an injection of Prevnar on 8/17/00. On 8/19/00, she developed a rash characterized by red, raised bumps on her hands and feet with a few lesions on her lower legs. The reporter stated that her feet appeared "inflamed". The physician reportedly attributed the rash to a possible Coxsackievirus infection.
Sex: M
Vaccine: PNC
Symptoms: Dyspnoea
Clinical narrative: A pharmacist reported that a male child received his 1st dose of Prevnar and 48 hours, post vax, he developed shortness of breath and was taken to the ER. No further information was available as of the date of this report.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Wheezing
Clinical narrative: The grandmother of a 9 month old male reported that her grandson received his 1st dose of Prevnar on 6/6/00 and subsequently, experienced "wheezing and retracting respirations." The reporter also stated that the pt "developed a summer virus" 2 days prior to vaccination and had a fever of 102F; however, "he was afebrile" at the time of vaccination.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye swelling, Irritability, Pyrexia, Rash maculo-papular
Clinical narrative: A nurse reported that a 2 month old male received Prevnar, Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) vaccines on 8/21/00 and within 30 hours, he developed a rash characterized as red and "splotchy" that started on his face and spread to his trunk and limbs. His eyes swelled shut and he developed a fever of 102F. The infant was "very" fussy.
Age: 1.0
Sex: U
Vaccine: PNC
Symptoms: Erythema multiforme
Clinical narrative: A company representative reported that a 12 month old received an injection of Prevnar and subsequently, developed erythema multiforme. No further information was available at the date of this report. This is 1 of 2 pts from the facility who experienced an adverse event following receipt of Prevnar.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema multiforme, Hypersensitivity, Pyrexia
Clinical narrative: A nurse reported that a 15 month old male received Prevnar and Acel-Imune on 8/24/00 and subsequently, developed a fever of 101F (axillary) and a red, "infected appearing" bulls eye rash at the injection site of Prevnar administration. He was administered ibuprofen prophylactically prior to immunization. He was treated with a 10 day course of amoxicillin; however, the reporter noted that the child was prescribed the antibiotic for the treatment of a slight ear infection at the time of immunization as well.
Age: 1.5
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Dyspnoea, Wheezing
Clinical narrative: A mother reported that her 18 month old daughter received Prevnar, IPV (Aventis Pasteur SA) and DTAP vaccines on 7/20/00. On 7/23/00, she developed wheezing and shortness of breath. She was taken to the ER and monitored for 3 hours; no drugs were administered. She recovered within 24 hours.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea, Otitis media, Pyrexia, Weight decreased
Clinical narrative: A nurse reported that her 2 month old daughter received her 1st dose of Prevnar on 8/17/00. On 8/20/00, the infant developed "watery", "rip-roaring" diarrhea. The mother indicated that as of 8/31/00, the infant was losing weight and diarrhea continued, despite changing the infant's formula twice. On 9/5/00, the infant developed a fever of 101F and reportedly, a dx of ear infection was made. The infant was treated with amoxicillin. On 9/7/00, the fever "diminished". The mother stated, "My doctor feels this occurrence could be related to the Prevnar".
Age: 0.75
Sex: F
Vaccine: HIBV, PNC
Symptoms: Rash macular
Clinical narrative: A nurse reported that a 9 month old female received Prevnar and ActHIB (Aventis Pasteur SA) vaccines on 5/23/00. The infant had a runny nose at the time of IZ. On 6/3/00, the infant developed a measles-like rash on her chest and back. The rash persisted on 6/5/00 and the infant was seen by the physician, who did not prescribe any treatment.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Pyrexia, Viral infection
Clinical narrative: A nurse reported that a 9 month old male received his 2nd dose of Prevnar and Recombivax-HB (Merck) on 6/2/00. On 6/5/00, he developed a fever of 102.1F. Additional information received on 6/26/00, indicated that the pt was seen by the physician on 6/7/00 and a dx of herpangina was made. He recovered.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Pyrexia, Rash macular, Vomiting
Clinical narrative: A 9 month old female received the 1st dose of Prevnar and Recombivax-HB (MSD) on 6/15/00 and within 12 to 15 hours, post vax, developed fever of 103F, vomiting and small macules on her anterior and posterior trunk, neck and back of ears. The reporter indicated that the pt was treated with Tylenol or Motrin for the elevated temperature.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Decreased appetite, Irritability, Vaccine positive rechallenge
Clinical narrative: An 8 month old female received her first dose of Prevnar on 5/10/00 and a few days later, became fussy, irritable and cranky. Her appetite decreased. Her symptoms resolved within 3 days.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash macular
Clinical narrative: A 6 month old male received his 1st dose of Prevnar, as well as, Acel-Imune, Hib-Titer and IPV (Aventis Pasteur SA) on 6/15/00 and within "minutes of Prevnar administration", developed an erythematous, macular rash on his chest and cheeks. Two doses of Benadryl were administered. The rash resolved within a few hours.
Age: 1.5
Sex: F
Vaccine: HBHEPB, IPV, PNC
Symptoms: Rash papular, Urticaria
Clinical narrative: A physician reported that an 18 month old female received Prevnar, Comvax (Merck) and IPV (Aventis Pasteur SA) vaccines on 6/5/00. On 6/6/00, she developed a rash. The pt was examined by a dermatologist, who described the rash as a "fine papular rash with areas or lesions of urticaria". She recovered.
Age: 0.8
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Laboratory test abnormal, Pyrexia, Rash maculo-papular
Clinical narrative: A physician reported that a 10 month old female, adopted from China in June, 2000, received Prevnar, Acel-Imune, Hib-Titer, IPV (Aventis Pasteur SA) and Engerix-B (SKB) vaccines on 6/19/00. Within 24 hours, she developed a fever of 103F to 104F. The fever was treated with acetaminophen and ibuprofen and persisted until 6/26/00. On 6/27/00, her temperature was 100F. The fever resolved on 6/28/00. On 6/25/00, she developed a generalized, maculopapular rash. The rash persisted as of 6/27/00. The pt was seen by the physician on 6/27/00. The infant recovered by 7/11/00.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Abnormal behaviour, Injection site reaction, Pyrexia
Clinical narrative: A nurse reported that a 4 year old male, inadvertently, received an injection of Prevnar on 6/12/00, after receiving an injection on 5/29/00. Shortly after the 2nd dose, he developed a low-grade fever, temperament changes and an injection site reaction. As of 6/27/00, the fever and injection site reaction had resolved, but the temperament changes remained.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Nephrotic syndrome
Clinical narrative: The father of a 3 year old male reported that his son received the 1st dose of Prevnar in June, 2000. Three to 7 days, post vax, the father reported that his son began to experience symptoms of nephrotic syndrome. The reporter also indicated that his son had not been taking prednisone for the past 6 months; however, the son began another course of prednisone due to proteinuria "just before" the vaccination.
Age: 1.3
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Restlessness
Clinical narrative: A physician reported that a 16 month old male received Prevnar and ActHIB (Aventis Pasteur SA) vaccines on 7/14/00; both vaccines were injected into the upper left leg. The next morning, the child developed an injection site reaction characterized by an area of redness, swelling, and warmth measuring 5" to 6" by 2" to 3". He was also irritable, restless and sleepy. The mother reported that the child was teething. The physician instructed her to administer acetaminophen and apply warm compresses to the injection site.
Age: 1.3
Sex: M
Vaccine: HIBV, PNC
Symptoms: Somnolence
Clinical narrative: A physician reported that a 16 month old male received Prevnar and ActHIB (Aventis Pasteur SA) vaccines on 7/14/00; both vaccines were injected into the upper left leg. The next morning, the child developed an injection site reaction characterized by an area of redness, swelling, and warmth measuring 5" to 6" by 2" to 3". He was also irritable, restless and sleepy. The mother reported that the child was teething. The physician instructed her to administer acetaminophen and apply warm compresses to the injection site.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Hypokinesia, Joint swelling, Urticaria
Clinical narrative: A physician reported that a 15 month old male received Prevnar, Hib-Titer and MMR (Merck) vaccines on 7/6/00. On 7/12/00, he developed an urticarial rash and joint swelling with decreased limb movement. He recovered. This is 1 of 2 pts from this facility who developed urticaria following receipt of Prevnar.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Eczema
Clinical narrative: A physician reported that an 18 month old male received Prevnar, Acel-Imune and IPV (Aventis Pasteur SA) vaccines on 3/17/00. Seven to 10 days, post vax, he developed "diffuse" eczema. The pt recovered without treatment. The reporter indicated that 5 or 6 pts experienced this event; however, only 1 is presently identifiable.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Petechiae
Clinical narrative: A physician reported that a 4 month old male received Prevnar, Acel-Imune, Hib-Titer, and IPV (Aventis Pasteur SA) vaccines on 7/19/00. The next morning, he developed an injection site reaction characterized by tenderness, a mass, and petechiae at the site of Prevnar administration. The petechiae extended down the length of his right leg. The infant was seen by the physician.
Age: 7.0
Sex: M
Vaccine: PNC
Symptoms: Joint swelling
Clinical narrative: A physician reported that a 7 year old male received an injection of Prevnar on 7/18/00. He was hospitalized due to sickle cell pain crisis and was receiving antibiotic therapy at the time of immunization. One day, post vax, the child developed swelling of an elbow. He recovered.
Age: 0.5
Sex: F
Vaccine: HEP, HIBV, PNC
Symptoms: Decreased appetite, Irritability
Clinical narrative: The mother of a 6 month old female reported that her daughter inadvertently received a "double dose" of Prevnar on 8/1/00. The infant also, received Hib and Hep-B vaccines. That day, the infant developed irritability and a decrease in appetite. The mother treated the infant with acetaminophen.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Nausea, Vomiting
Clinical narrative: The mother of an 18 month old female reported that her daughter, inadvertently, received a subcutaneous injection of Prevnar on 7/15/00. The child also received a subcutaneous injection of TriHIBit (Aventis Pasteur Inc) "right next to" the Prevnar injection site. Fifteen days, post vax, the child developed nausea and vomiting.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A company representative reported that a child, inadvertently, received a subcutaneous injection of Prevnar. Post vax, the child developed swelling at the injection site. No further information was available at the date of this report.
Age: 1.25
Sex: F
Vaccine: MMR, PNC
Symptoms: Lymphadenopathy
Clinical narrative: A physician reported that a 15 month old female received Prevnar and MMR (Merck) vaccines on 8/8/00. On 8/9/00, she was seen by the physician, who noted "huge" cervical lymph nodes. The child was improving as of 8/24/00.
Age: 5.0
Sex: F
Vaccine: DTP, IPV, MMR, PNC
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: The mother of a 5 year old female reported that her daughter received Prevnar, MMR (Merck), IPV (Aventis Pasteur SA) and DTP vaccines on 8/3/00. The next day, she developed a fever, headache and a rash at the Prevnar injection site. She vomited on 8/5/00. As of 8/11/00, the mother reported that the child was improving.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Erythema, Hypokinesia, Oedema peripheral, Pain
Clinical narrative: A nurse reported that an 18 month old male received an injection of Prevnar on 6/29/00. The next day, he developed swelling, redness and pain in his extremities. The child would not walk. He recovered.
Age: 1.4
Sex: M
Vaccine: PNC
Symptoms: Hypokinesia
Clinical narrative: A nurse reported that a 17 month old male received his 2nd dose of Prevnar on 8/14/00. The next day, he could not bear weight on the leg into which the vaccine had been injected and he dragged the leg when he crawled.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Musculoskeletal stiffness, Stupor
Clinical narrative: The mother of a 33 month old female reported that her daughter received an injection of Prevnar on 7/10/00. That night, the child became fussy and developed an injection site reaction characterized by redness and swelling. In mid-August, the child began having episodes during which she would straighten her arms and legs and appeared to be in a trance". These episodes occurred while the child was sitting or playing. When her mother touched her, she would "snap out of it".
Age: 1.75
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that a 21 month old male received his 2nd injection of Prevnar on 7/12/00. Two days, post vax, he developed an urticarial rash, which resolved after 48 hours. This is 1 of 2 pts from this facility who developed urticaria following receipt of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Laboratory test abnormal
Clinical narrative: A physician reported that several immunodeficient children up to 9 years old received Prevnar. One month, post vax, the physician checked the children's antibody levels and found either no response or an inconsistent response. The reporter indicated that 15 children experienced this event; however, they are not presently identifiable. Additional reports will be generalized when identifying information is provided.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A nurse reported that a child received an injection of Prevnar and within 24 hours, post vax, developed a fever of 103F to 104F. No further information was available at the date of this report. The reporter indicated that 5 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. In addition, 1 of the lot numbers was reported as 47653; however, this is not a valid Lederle lot number. This is 1 of 2 reports from this facility of adverse experiences following receipt of Prevnar.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: A 10 month old male received an injection of Prevnar on 8/14/00 and within 24 hours, he developed a "very large" injection site reaction characterized by an 6cm by 8cm area of warmth, redness and a 5cm by 7cm area of induration. He was seen by the physician on 8/16/00. The reporter noted that the child received an IM injection of ceftriaxone on 8/11/00; however, he was unsure which arm the pt received the injection.
Age: 0.75
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A company representative reported that a 9 month old child received the 1st injection of Prevnar and developed a fever of 104F, which lasted 3 days, staying "around the 102F range."
Age: 0.5
Sex: U
Vaccine: DTAP, PNC
Symptoms: Erythema, Rash
Clinical narrative: A physician reported that a 6 month old infant, born at 25 weeks gestation, received Prevnar and Infanrix (SKB) vaccines on 8/16/00. Approx. 24 hours, post vax, the infant developed a red rash on the face, thighs, and lower abdomen.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Irritability, Urticaria
Clinical narrative: A physician reported that a 6 month old female received her 1st dose of Prevnar, as well as, her 2nd doses of Acel-Imune, Hib-Titer and Engerix-B (SKB) on 8/14/00. The next day, she developed a mild truncal urticarial reaction and irritability. On 8/16/00, the pt was seen in the ER and was prescribed oral diphenhydramine. The pt has a medical history of diarrhea, 2 days prior to immunization. The reporter indicated that the pt had no further diarrhea. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar (lot 471203) and Acel-Imune (lot 472655).
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: An NP reported that a 10 month old male received an injection of Prevnar on 7/25/00. That same day, the infant developed a fever of 103F.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: An NP reported that a 15 month old female received her 1st dose of Prevnar, as well as, her 4th doses of DTAP and haemophilus influenza type B vaccines and on the day of immunization, developed an injection site reaction characterized by redness and hardness. The symptoms resolved within 3 to 4 days. The reporter indicated that the immunization was administered "more lateral than vastus lateralia".
Age: 0.9
Sex: F
Vaccine: PNC
Symptoms: Rash erythematous
Clinical narrative: A nurse reported that a 10 month old female received an injection of Prevnar on 8/22/00. Six hours, post vax, she developed red, raised hives of various sizes on her face, extremities and trunk. She was treated with diphenhydramine. The hives remained as of 8/25/00.
Age: 1.4
Sex: U
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A company representative reported that a 17 month old received an injection of Prevnar and subsequently, developed hives. No further information was available at the date of this report. This is 1 of 2 pts from this facility who experienced an adverse event following receipt of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a child received an injection of Prevnar and within 24 hours, post vax, the child developed an injection site reaction characterized by swelling and redness. The redness extended "half way down the elbow". No further information was available at the date of this report. One of the lots was reported as 47653; however, this is not a valid Lederle lot number. This is 1 of 2 reports from this facility of adverse experiences following receipt of Prevnar.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: A nurse reported that a 9 month old female received an injection of Prevnar on 8/23/00 and 2 days, post vax, she developed an injection site reaction characterized by redness and swelling the size of a quarter. The physician recommended treatment of acetaminophen and applications of cold compresses. This is 1 of 5 pts from this facility who developed an adverse experience following receipt of Prevnar lot 471654. Additional information received from the physician on 9/20/00, indicated that the pt also developed mild induration at the injection site.
Age: 1.25
Sex: F
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: A nurse reported that a 19 month old female received Prevnar and ActHIB (Aventis Pasteur SA) vaccines on 8/23/00. Two days, post vax, she developed redness and swelling at the site of Prevnar administration and a generalized rash. The physician recommended treatment with diphenhydramine and applications of cold compresses. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 9 month old male received Prevnar and Hep-B vaccine on 8/17/00 and subsequently, developed redness and swelling at the site of Prevnar administration. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A 9 month old male received Prevnar and HEP-B vaccines on 8/21/00 and subsequently, developed redness and swelling at the site of Prevnar administration. The physician recommended treatment of acetaminophen and applications of cold compresses. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 3 year old male received an injection of Prevnar on 8/25/00. Immediately, post vax, he developed an injection site reaction characterized by redness and swelling. He was treated with diphenhydramine. This is 1 of 5 pts from this facility who had an adverse experience following receipt of Prevnar lot 471654.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A company representative reported that a pt received an injection of Prevnar and subsequently, developed a fever. The pt recovered within 1 day. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: A company representative reported that a pt received Prevnar and subsequently, developed a red spot at the injection site. The pt recovered. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar.
Age: 0.6
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A nurse reported that a 7 month old male received his 1st injection of Prevnar on 4/17/00. On 4/18/00, his mother reported to the nurse that the infant had developed a fever. The infant recovered.
Age: 0.5
Sex: U
Vaccine: PNC
Symptoms: Agitation, Pharyngitis, Rhinitis
Clinical narrative: A physician reported that a 6 month old received Prevnar on 6/1/00 and 3 days, post vax, the infant was "inconsolable". The infant was treated with Tylenol and recovered. The reporter noted that the infant had cold symptoms at the time of immunization.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A physician reported that a child received an injection of Prevnar. On 6/8/00, the child developed swelling at the injection site, extending to involve the entire arm. The child was treated with steroids.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: A nurse reported that a pt received Prevnar and 2 days later, the pt developed an injection site reaction characterized by an area measuring "about 22mm" of redness and warmth. The pt was treated with Tylenol and an antihistamine (unspecified) and recovered the next day. This is 1 of 10 pts from this facility who experienced an injection site reaction following receipt of Prevnar lot 471215 and 471202. The reporter indicated that 10 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A physician reported that a female received her 1st dose of Prevnar and subsequently, developed a fever. She recovered. This is 1 of 2 pts from this facility who experienced fever following receipt of Prevnar.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema
Clinical narrative: A pharmacist reported that a 12 month old male received his 1st dose of Prevnar, as well as, doses of MMR (Merck) and Varivax (Merck) on 6/13/2000. On 6/16/00, he developed injection site erythema, measuring 2" by 3", at the site of the Prevnar administration. He recovered. The lot number was reported as 171208; however, this is not a valid Lederle lot number.
Age: 0.5
Sex: M
Vaccine: DTP, HIBV, PNC
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Urticaria
Clinical narrative: The mother of a 6 month old male reported that her son received Prevnar, Hib and DTP vaccines on 6/16/00. By 00:00 AM on 6/17/00, he developed fever, "little welts on the back of the neck which looks like heat rash", decreased appetite and diarrhea. The infant was treated with acetaminophen. The fever persisted as of 6/19/00.
Age: 4.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Vomiting
Clinical narrative: An MA reported that a 4 year old male received Prevnar and Vaqta (Merck) vaccines on 6/8/00 and the next day, developed vomiting. The pt recovered. The reporter indicated that the physician did not relate this event to Prevnar. Additional information received on 7/17/00, indicated that the pt has an allergy to Penicillin.
Sex: F
Vaccine: PNC
Symptoms: Injection site pain, Irritability
Clinical narrative: A company representative reported that a female child received an injection of Prevnar and subsequently, became irritable. The irritability resolved after 24 hours. The child also experienced pain at the injection site. She recovered. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Prevnar.
Age: 1.6
Sex: F
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: A mother reported that her 19 month old daughter received an injection of Prevnar on 6/21/00. The infant had received DTAP and IPV (Aventis Pasteur SA) vaccines on 6/16/00. On 6/22/00, the infant became cranky. The vaccine provider confirmed this report on 8/7/00.
Age: 1.75
Sex: F
Vaccine: PNC
Symptoms: Injection site swelling, Pyrexia, Rash
Clinical narrative: A nurse reported that a 21 month old female received an injection of Prevnar on 6/20/00. Within 1 hour, she developed swelling at the injection site. Within 36 hours, post vax, she developed a fever. She developed a generalized rash 48 hours, post vax. She recovered.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pharyngitis, Pyrexia, Viral infection
Clinical narrative: A nurse reported that a 12 month old male received his first dose of Prevnar, MMR (Merck) and Varivax (Merck) vaccines on 6/19/00. On 6/20/00, he developed a fever of 102F. As of 6/23/00, the fever continued. Additional information received from the physician on 6/24/00, indicated that the pt received his 3rd dose of IPV (Aventis Pasteur SA) on 6/19/00. On 6/20/00, he developed an injection site reaction characterized by redness and warmth at the site of Prevnar and IPV vaccine administration. The injection site reaction resolved on 6/22/00. On 6/23/00, the fever persisted. He was seen by the physician; a dx of viral pharyngitis was made. The pt subsequently, recovered.
Sex: F
Vaccine: PNC
Symptoms: Injection site pain, Injection site swelling, Irritability
Clinical narrative: A company representative reported that a female child received an injection of Prevnar and subsequently, became irritable. The irritability resolved after 24 hours. The child also developed an injection site reaction characterized by swelling and pain. She recovered. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Prevnar.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site pain, Irritability
Clinical narrative: The mother of a 3 year old male reported that her son received an injection of Prevnar and subsequently, became irritable. The irritability resolved after 24 hours. The child also experienced pain at the injection site, which resolved after 24 hours. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Prevnar.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: A mother reported that her 9 month old son received an injection of Prevnar on 6/23/00. On 6/24/00, he experienced 2 episodes of vomiting, producing "large" amounts of emesis. He also developed a fever of 99.5F, which was treated with acetaminophen. He recovered.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: A nurse reported that a 3 month old male received Prevnar, IPV (Aventis Pasteur SA), Comvax (Merck) and Tripedia (Aventis Pasteur, Inc) vaccines on 6/27/00 and subsequently, developed a fever.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Decreased appetite, Ear pain, Irritability, Vaccine positive rechallenge
Clinical narrative: A 9 month old female received her 2nd dose of Prevnar on 6/12/00 and within 4 days, became fussy and irritable. Her appetite decreased and she began pulling on her ear. The pt has a recent history of 2 previous ear infections and was treated with antibiotics.
Sex: U
Vaccine: PNC
Symptoms: Injection site swelling
Clinical narrative: A physician reported that a child received the 1st dose of Prevnar on 6/27/00. The child subsequently, developed swelling at the injection site, the swelling extended to involve the entire arm into which the vaccinee was administered. The child was treated with diphenhydramine.
Age: 0.8
Sex: F
Vaccine: HEP, IPV, PNC
Symptoms: Rash
Clinical narrative: A physician reported that a 9 month old female received Prevnar, IPV (Aventis Pasteur SA), and Hep-B vaccines on 6/5/00. Two days, post vax, the infant's parents noticed a "very slight" rash. The rash persisted, and the infant was seen by the physician on 6/21/00. The infant recovered. This is 1 of 2 pts from this facility who developed a rash following receipt of Prevnar or the concomitantly administered vaccines.
Age: 2.0
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 24 month old child received the 1st dose of Prevnar and subsequently, developed an injection site reaction characterized by an area of redness and swelling which was "the size of a baseball". No further information was available at the date of this report. This is 1 of 2 reports from this facility of injection site reactions following receipt of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a child received an injection of Prevnar and subsequently, developed an injection site reaction characterized by an area of redness and swelling which was "about the size of a quarter". The pt recovered in less than 48 hours. No further information was available at the date of this report. The reporter indicated that 4 children experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. This is 1 of 2 reports from this facility of injection site reactions following receipt of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Dry skin, Skin discolouration, Skin exfoliation
Clinical narrative: A pharmacist reported that a pt received an injection of Prevnar and subsequently, developed dry, patchy, red, scaly skin. No further information was available at the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Two hours post vax, the pt developed a fever. This is 2 of 2 pts from this facility who experienced fever following receipt of vax.
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A company representative that a pt received an injection of Prevnar and subsequently developed a fever greater than 103. No further information was available at the date of this report. Manufacturers Comment: The reporter indicated that other pts had developed fevers following receipt of Prevnar, however they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 0.8
Sex: F
Vaccine: HEP, PNC
Symptoms: Otitis media, Pyrexia
Clinical narrative: On 7/13/00, the pt developed a fever of 104 degrees. Her mother treated her with acetaminophen and cool baths. She was seen in the physician's office on 7/14/00 where a diagnosis of acute otitis media was made. She was treated with Amoxicillin/clavulanate  and recovered.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Injection site oedema
Clinical narrative: The same day of the vax, the pt developed swelling from his shoulder to his elbow. As of 7/14/00, no further information was available.
Age: 0.25
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea
Clinical narrative: A parent reported that his 3 month old daughter received an injection of Prevnar on 7/12/00 and the next day developed diarrhea.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: Four days post vax, the pt developed a fever greater than 102.2 and a rash. She recovered.
Age: 1.75
Sex: F
Vaccine: PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: On 7/14/00 she developed a fever up to 102 degrees and became cranky.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Erythema, Rash
Clinical narrative: The pt received the vaccines on 7/14/00. Later that evening, she developed a red rash that covered her face, hands, feet. The next day, the rash spread to her trunk. As of 7/17/00, the infant was recovering.
Age: 1.25
Sex: U
Vaccine: HIBV, PNC
Symptoms: Injection site erythema
Clinical narrative: The child developed a 4-inch area of redness at each injection site. No further information was available at the date of this report.