chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Upper respiratory tract infection, Vision blurred
Clinical narrative: The pt states that 2 days, post vax, she developed severe headache, lightheadedness, blurred vision and increased fatigue. She also complained of respiratory symptoms of congestion.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Blood pressure increased, Chest pain, Heart rate increased, Lacrimation increased, Lethargy
Clinical narrative: At 16:00, the pt displayed symptoms of itchy throat, watery eyes, lethargic, PR-110, R-20, BP-140/80 and complained of mid-sternal chest pain and wheezing. O2 via mask was given at 3L/minute IV, NS, Epinephrine .3mg SC. EMS called and responded. Pt taken to ER; alert and responsive with decreased chest pain.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Throat tightness, Wheezing
Clinical narrative: At 16:00, the pt displayed symptoms of itchy throat, watery eyes, lethargic, PR-110, R-20, BP-140/80 and complained of mid-sternal chest pain and wheezing. O2 via mask was given at 3L/minute IV, NS, Epinephrine .3mg SC. EMS called and responded. Pt taken to ER; alert and responsive with decreased chest pain.
Age: 0.75
Sex: M
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Received IPV #3 on 12/17/01 and developed generalized urticaria on 12/18/01, in the afternoon. Treated with Benadryl.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: 11/16/2001 Called to report itching/whelps starting today. Taking Benadryl with some relief. Has follow up appointment on 12/10/2001 for hoarseness and swelling of throat. Taking Nexium 40 mg PO. 1/02/2002 Pt advised she saw MD and he did not feel there was relationship to itching and hep B. felt it was due to Nexium has been discontinued.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site hypersensitivity, Screaming
Clinical narrative: Immunization site red. Infant crying hysterically. Tylenol every 4 hours and warm compress.
Sex: F
Vaccine: PNC
Symptoms: Inflammation
Clinical narrative: Pt experienced inflammatory reaction following Prevnar vaccination.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site inflammation
Clinical narrative: Three days after flu vaccine administration, developed cellulitis, inflammation at injection site adverse reaction.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Pt seen in our office on 12/28/2001. Stated she received flu vaccine 10 prior. Diagnosed with herpes zoster. Treated with Acyclovir, prednisone and Vicodin.
Age: 0.5
Sex: F
Vaccine: IPV, PNC
Symptoms: Pyrexia, Screaming
Clinical narrative: Inconsolable crying for 24 hours. 100-101.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Crying, Erythema, Opisthotonus, Salivary hypersecretion
Clinical narrative: A nurse reported that a 2 month old male received an injection of Prevnar along with Infanrix, Comvax and IPV vaccines on 9/4/01. On 9/5/01, the infant experienced a "probable post-vaccination seizure" and was hospitalized overnight for observation. Follow-up information received on 9/28/01 indicated that prior to his seizure, the infant had been napping. According to the mother, the infant awoke crying and then arched his back, thrust his head backward and turned red. His tongue was blue and he was foaming at the mouth. He also had a "momentary" blank stare. The events lasted less than 30 seconds. Approx. 5 minutes later, the mother contacted a physician, noting that the infant appeared "OK" but "a little bit out of it". The same day, the infant was seen in the physician's office, where he appeared to be sleepy; however, the mother indicated that it was the infant's usual "sleepy time". The infant recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Somnolence, Staring, Tongue discolouration
Clinical narrative: A nurse reported that a 2 month old male received an injection of Prevnar along with Infanrix, Comvax and IPV vaccines on 9/4/01. On 9/5/01, the infant experienced a "probable post-vaccination seizure" and was hospitalized overnight for observation. Follow-up information received on 9/28/01 indicated that prior to his seizure, the infant had been napping. According to the mother, the infant awoke crying and then arched his back, thrust his head backward and turned red. His tongue was blue and he was foaming at the mouth. He also had a "momentary" blank stare. The events lasted less than 30 seconds. Approx. 5 minutes later, the mother contacted a physician, noting that the infant appeared "OK" but "a little bit out of it". The same day, the infant was seen in the physician's office, where he appeared to be sleepy; however, the mother indicated that it was the infant's usual "sleepy time". The infant recovered.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Flushing, Opisthotonus, Staring, Tongue discolouration
Clinical narrative: A nurse reported that a 2 month old male received an injection of Prevnar along with Infanrix, Comvax and IPV vaccines on 9/4/01. On 9/5/01, the infant experienced a "probable post-vaccination seizure" and was hospitalized overnight for observation. Follow-up information received on 9/28/01 indicated that prior to his seizure, the infant had been napping. According to the mother, the infant awoke crying and then arched his back, thrust his head backward and turned red. His tongue was blue and he was foaming at the mouth. He also had a "momentary" blank stare. The events lasted less than 30 seconds. Approx. 5 minutes later, the mother contacted a physician, noting that the infant appeared "OK" but "a little bit out of it". The same day, the infant was seen in the physician's office, where he appeared to be sleepy; however, the mother indicated that it was the infant's usual "sleepy time". The infant recovered.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Convulsion, Irritability, Pyrexia
Clinical narrative: A nurse reported that a 12 month old male received a 1st dose of Prevnar vaccine on 9/27/01. Additional suspect medication included Varivax and MMRII. On 10/5/01, the child developed a fever and seizures. He was admitted to the hospital. These events continued until the morning of 10/8/01. No additional information was available as of the date of this report. Follow-up information received on 11/28/01. On 10/3/01, the child developed a temperature ranging from 101F to 102F. On 10/4/01, his temperature increased to 103F. On 10/5/01, the child became "very fussy" and was treated with acetaminophen (Tylenol). That evening, at 20:45, he developed a seizure. He was taken to ER and his temperature measured 104F. He was admitted to the hospital for 24 hours observation.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Hypokinesia, Pallor
Clinical narrative: A 2 month old female received her 1st doses of Prevnar, Tripedia, Act-Hib and IPV on 10/26/01. On 11/2/01, the pt was found apneic and pale at daycare; mouth-to-mouth resuscitation was initiated. She was taken to the ER where she presented with decreased activity and color. As of the date of this report, no further information was available.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot
Clinical narrative: Erythema area right deltoid injection site palpable warmth. Improved sinse friday by history.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Otitis media, Rash
Clinical narrative: Previous to vaccines, child had OM and was being treated with Keflex. Eight days post vaccination, he broke out in rash on back, chest, thighs. Treated with Tylenol for fever of 103 degrees F. No Dr visit. Child has a cough-Recommended visit to PCP
Age: 33.0
Sex: M
Vaccine: HEPAB, IPV, MEN, RAB
Symptoms: Chest pain, Hyperhidrosis, Laboratory test abnormal, Pain, Pyrexia
Clinical narrative: sweats, chills, aches, low grade temp, chest pain
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Eye oedema, Pruritus, Tremor
Clinical narrative: About 1 hour after Hep B # 3 injection, feeling shaky, itchy, puffy eyes. Went to ER where he reports he had a shot.
Sex: F
Vaccine: DTAP, HBHEPB, PNC, VARCEL
Symptoms: Cellulitis, Urticaria
Clinical narrative: Received quarter size red raised welt on leg where varivax was given, 2 day day history, treatment with antibiotic and cortizone. ? reaction or cellulitis.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Rash
Clinical narrative: I have had a reoccurring rash for two weeks. It started two days after my flu shot. I've also had chest pains every few days.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Immediately after injection, redness appeared and proceeded to get redder As the day wore on until it was down to the elbow by 3 pm and slightly raised . Redness lasted one week.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying
Clinical narrative: Two hours after vaccines patient began crying inconsolably and refused to breastfeed. This episode lasted from 10:30 to 7:00 am the following day.
Age: 1.08
Sex: M
Vaccine: HIBV, IPV, PNC, VARCEL
Symptoms: Infection
Clinical narrative: Chicken pox
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Face oedema, Oedema peripheral, Rash
Clinical narrative: 12/31/2001-Received vaccine 01/01/2002-developed red spot than red rash on inner thigh which spread upward to trunk /01/02/2002 hands swollen, lower lips swollen, no breathing problems. took Benadryl po. saw M.D. 01/02/2002-No cause of reaction determined, told to not get flu & pneumonia vaccines again.
Age: 1.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC
Symptoms: Rash
Clinical narrative: 01/10/02 rash on legs, arms, trunk, back, face, temperature 98.5, eating well, not fussy, normal behavior, happy, cooing, sleeping well, not irritabl
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pneumonia
Clinical narrative: An ASPP (Anonymised Single Patient Print) was received from the MCA (regulatory authority) on 01/03/2002, concerning a 55 year old female patient who experienced bronchopneumonia, 2 days after receiving the Fluvirin vaccine on 10/15/2001.  The receiving was receiving diclofenac concomitantly. The patient has no other medical problems, no allergies and no previous drug reactions.   On 10/15/2001, the patient received the Fluvirin vaccine. On 10/17/2001, the patient experienced bronchopneumonia. She was treated with steroids and antibiotics. The patient recovered on 11/30/2001 after treatment.   there was insufficient information to determine the reporter's casualty assessment.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain
Clinical narrative: A report was received on 02-JAN-2002 from concerning a 51 year old male pt who was hospitalized for chest pain after receiving Fluvirin vaccine on 11-DEC-2001.
Sex: F
Vaccine: PNC
Symptoms: Meningitis, Viral infection
Clinical narrative: A pediatrician reported that a Native American female child received her 2nd dose of Prevnar on an unspecified date. Approx. 2 1/2 weeks later, the child was hospitalized with meningitis. No further information was available at the time of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: A physician reported that a 2 month old infant received an injection of Prevnar (first dose) on 11-OCT-2001. Subsequently, the pt was hospitalized and on 14-OCT-2001, the infant died. No further information was available at the date of this report. This is 1 of 2 pts from this facility who died after receipt of Prevnar lot 475-385. Cause of Death as per autopsy report was SIDS. Initial autopsy showed no cause of death. Final results were not received. The reporter noted that this was the healthier twin.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hyperbilirubinaemia, Hypoglycaemia, Premature labour, Sudden infant death syndrome
Clinical narrative: A physician reported that a 2 month old infant received an injection of Prevnar (first dose) on 11-OCT-2001. Subsequently, the pt was hospitalized and on 14-OCT-2001, the infant died. No further information was available at the date of this report. This is 1 of 2 pts from this facility who died after receipt of Prevnar lot 475-385. Cause of Death as per autopsy report was SIDS. Initial autopsy showed no cause of death. Final results were not received. The reporter noted that this was the healthier twin.
Age: 1.08
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Pneumonia, Pyrexia, Viral infection
Clinical narrative: A nurse reported that a 13 month old male received his fourth dose of Prevnar on 05-OCT-2001. The following day, the child developed a "high" fever. ON 07-OCT-2001, he was seen in an ER and hospitalized with a diagnosis of  "streptococcal pneumonia." The reporter did note that the child was discharged "later that same day." Follow-up information received from the physician on 20-NOV-2001 indicated that the child received his fourth dose of Prevnar and HIB-TITER along with MMR II and Varivax vaccines on 05-OCT-2001. The child recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eructation, Insomnia, Irritability
Clinical narrative: A father reported that his 2 month old daughter inadvertently received 2 doses of Prevnar on 10/16/01. On 10/17/01, she became fussy, with an increase in "wet burps" and restless sleep. Additional information received on 11/7/01 indicated that she also received Hib-Titer, IPOL and Tripedia on 10/16/01. She recovered.
Age: 0.8
Sex: F
Vaccine: DTAP, PNC
Symptoms: Platelet count decreased, Thrombocytopenia, Viral infection
Clinical narrative: A physician reported that a 15 month old female received a 3rd dose of Prevnar vaccine on 2/19/01. Concomitant therapy included Tripedia. On 6/22/01, she developed clinical bilateral pneumonia. A bronchoalveolar lavage was performed for persistence. She was hospitalized overnight with prolonged "PO ATB". She also developed thrombocytopenia and received a platelet transfusion once. The reporter considered these events to be life-threatening. No additional information was available as of the date of this report.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Petechiae
Clinical narrative: A physician reported that a 4-month-old male received his second dose of Prevnar and subsquently developed petechiae on his lower legs. Follow-up information received from the physician on 11/07/2001 indicated that the patient was a 4 month-old female who received her second dose of Prevnar, Comvax (MSD), IPV (Aventis Pasteur SA), and Tripedia (Aventis Pasteur) vaccines on 08/22/2001. That same day, she developed petechiae on her lower extremities. On 08/24/2001, the infant's WBC count was 4,600 cells/cubic mm, and her platelet count was 512,000 cells/cubic mm. She recovered
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bronchitis, Hepatomegaly, Laboratory test abnormal, Listless, Meningitis
Clinical narrative: A physician reported that a 5 month old female received her 2nd dose of Prevnar in 5/01. On 11/9/01, at 11 months of age, the infant developed a fever and viral infection. On 11/16/01, she was seen in an ER where she was dx'd with meningitis. The infant was admitted for hospitalization. Additional information received from the same reporter on 11/20/01, indicated that the infant received her 2nd dose of Prevnar along with DTAP, IPV and haemophilus b conjugate vaccines on 5/23/01. Approx. 1 1/2 weeks prior to admission, the infant had been dx'd with bronchitis and treated with an unspecified decongestant. On 11/16/01, she developed a fever of 101.6F and was listless. The infant was seen by a physician who sent the infant directly to an ER. She was treated with vancomycin and ceftriaxone. On 11/18/01, the infant was examined by a physician who noted that the infant's neck was stiff and unable to flex. Her abdomen was bulging with an enlarged liver and an additional dx of hepatomegaly was made.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Musculoskeletal stiffness, Platelet count increased, Pyrexia, Viral infection, White blood cell count increased
Clinical narrative: A physician reported that a 5 month old female received her 2nd dose of Prevnar in 5/01. On 11/9/01, at 11 months of age, the infant developed a fever and viral infection. On 11/16/01, she was seen in an ER where she was dx'd with meningitis. The infant was admitted for hospitalization. Additional information received from the same reporter on 11/20/01, indicated that the infant received her 2nd dose of Prevnar along with DTAP, IPV and haemophilus b conjugate vaccines on 5/23/01. Approx. 1 1/2 weeks prior to admission, the infant had been dx'd with bronchitis and treated with an unspecified decongestant. On 11/16/01, she developed a fever of 101.6F and was listless. The infant was seen by a physician who sent the infant directly to an ER. She was treated with vancomycin and ceftriaxone. On 11/18/01, the infant was examined by a physician who noted that the infant's neck was stiff and unable to flex. Her abdomen was bulging with an enlarged liver and an additional dx of hepatomegaly was made.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: A physician reported that a 4 month old male received his second dose of Prevnar on 16-JAN-2001. He received his first dose on 10-OCT-2000. On 08-SEP-2001 at the age of 1 year, he developed pneumonia with bacteremia and was hospitalized. The organism was identified as Streptococcus pneumoniae, serotype 14. No further information was available as of the date of this report. Additional info received on 12/19/2001 provided past medical history. The child recovered.
Sex: U
Vaccine: PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: A physician reported that a child developed a fever and experienced a seizure. No further information was available at the date of this report. Seizure is considered medically important. Follow-up info received from the physician on 01/02/2002 indicated that the child did not experience a seizure. The pt did develop a fever of 104 deg. F. As a result of this follow-up info, this report has been reclassified as non-serious. As a result of additiona follow-up info received on 01/10/2002 and verification by telephone from the physician on 01/15/2002, no adverse experience occurred. Consequently, this case has been cancelled.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Laboratory test abnormal, Otitis media, Pneumonia, Pyrexia
Clinical narrative: A physician reported that a 10-month old female received 3 injections of Prevnar (dates not specified). The patient's medical history included macrocephaly, "mild" gross motor delay and low carnitine levels. Concomitant therapy included carnitine. The patient experienced pneumococcal bacteremia and was said to be " very sick with fevers to 105 without a source". A blood culture revealed " many and early" Streptococcus pneumoniae. A repeat blood culture prior to initiation of antibiotic therapy was negative. The patient also experienced otitis. she was treated with 10 days of amoxicillin therapy and the events resolved. The events were considered to be "medically important" Follow-up info received on 01/02/2002 clarified the pt's age to be 9 months and the lot number of the vaccine.
Sex: U
Vaccine: PNC
Symptoms: Peritonitis
Clinical narrative: A physician reported that a child (age and gender unspecified) with nephrotic syndrome received a dose of Prevnar and subsequently developed perionitis, possibly due to Streptococcus pneumoniae. The event was considered medically important. No further information was available at the date of this report
Sex: F
Vaccine: PNC
Symptoms: Cough, Dyspnoea, Rales, Respiratory distress, Sleep disorder
Clinical narrative: A physician reported that an 18-month old female received her second dose of Prevnar on 06/13/2001. On 06/19/2001, she was seen by her pediatrician for a chronic cough. Physical exam revealed rales on her left side, but otherwise, the child was in no acute distress. She was diagnosed with pneumonia and treated with Zithromax. The physician noted that if condition continued, a diagnosis of asthma may be considered. On 07/05/2001, she was again seen by the physician for an irritability cough, shortness of breath, wheezing, not sleeping well and some retractions. The child was in mild to moderate respiratory distress. Her exam was consistent with reactive airway distress. She received Albuterol via nebulizer and responded well. There was a decrease in her respiratory rate and an increase in breath sounds. On 07/12/2001, the child was seen for a recheck. Physical exam was within normal limits and her lungs were entirely clear. The physician indicated that "her original pneumonia most likely was an episode of asthma". She was placed on Flovent 44 mcg BID and Albuterol PRN. The physician noted "It is my opinion that this is not a vaccine related reaction".
Sex: F
Vaccine: PNC
Symptoms: Wheezing
Clinical narrative: A physician reported that an 18-month old female received her second dose of Prevnar on 06/13/2001. On 06/19/2001, she was seen by her pediatrician for a chronic cough. Physical exam revealed rales on her left side, but otherwise, the child was in no acute distress. She was diagnosed with pneumonia and treated with Zithromax. The physician noted that if condition continued, a diagnosis of asthma may be considered. On 07/05/2001, she was again seen by the physician for an irritability cough, shortness of breath, wheezing, not sleeping well and some retractions. The child was in mild to moderate respiratory distress. Her exam was consistent with reactive airway distress. She received Albuterol via nebulizer and responded well. There was a decrease in her respiratory rate and an increase in breath sounds. On 07/12/2001, the child was seen for a recheck. Physical exam was within normal limits and her lungs were entirely clear. The physician indicated that "her original pneumonia most likely was an episode of asthma". She was placed on Flovent 44 mcg BID and Albuterol PRN. The physician noted "It is my opinion that this is not a vaccine related reaction".
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Crying
Clinical narrative: A physician reported, via a company representative, that a 4 year old male received Prevnar vaccine and subsequently developed persistent crying, that evening, for 2 hours. He also was requesting medication because he did not feel right. His behavior was noted to be unusual. The child recovered. No additional information was available as of the date of this report.
Age: 0.75
Sex: F
Vaccine: PNC
Symptoms: Rash erythematous, Rash macular, Urticaria
Clinical narrative: A nurse reported that a 9-month-old female received an injection of Prevnar on 09/11/2001. Subsequently, the infant developed a "hive-like" rash on her face and arms. She was treated with Benadryl (diphenhytamine). No further information was available at the the date of this report. Information regarding this event has been forwarded to MSD, manufacturer of Recombivax-HB. Follow-up information received on 10/26/2001 from the physician indicated that the infant developed an erythematous, macular, diffuse rash. She was seen by the physician on 09/13/2001 and has subsequently recovered.
Age: 6.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Feeling hot, Headache, Injection site oedema, Pyrexia
Clinical narrative: A physician reported via a company representative that a 6-year-old female received an inrjection of Prevnar on 09/17/2001. On 09/18/2001, the child developed a fever, a headache, and an injection site reaction characterized by swelling and warmth. Follow-up information received from the physician on 11/12/2001 indicated that the child recovered.
Age: 6.0
Sex: F
Vaccine: PNC, PNC
Symptoms: Erythema, Headache, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: A physician reported via a company representative that a 6-year-old female received an inrjection of Prevnar on 09/17/2001. On 09/18/2001, the child developed a fever, a headache, and an injection site reaction characterized by swelling and warmth. Follow-up information received from the physician on 11/12/2001 indicated that the child recovered.
Sex: F
Vaccine: PNC, PNC
Symptoms: Feeling hot, Headache, Injection site oedema, Pyrexia
Clinical narrative: A physician reported that a female patient received Prevnar vaccine on 17-SEP-2001. On 18-SEP-2001, she developed headache, fever, swelling and an injection site reaction characterized by redness and heat. She recovered. No additional information was available as of the date of this report.
Sex: F
Vaccine: PNC, PNC
Symptoms: Erythema, Headache, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: A physician reported that a female patient received Prevnar vaccine on 17-SEP-2001. On 18-SEP-2001, she developed headache, fever, swelling and an injection site reaction characterized by redness and heat. She recovered. No additional information was available as of the date of this report.
Age: 0.3
Sex: M
Vaccine: HIBV, PNC
Symptoms: Rash
Clinical narrative: A mother reported that her 4-month-old son received his second doses of Prevnar and haemophilus influenzae type B (manufacturer unknown) vaccines on 09/21/2001. The patient developed a generalized rash "like tiny bubbles" He was seen by the physician on 09/24/2001 and a diagnosis of chicken pox was made. No treatment was prescribed. See related report; HQ6379125SEP2001. Additional information received 10/09/2001 indicated that the patient received his second doses of Prevnar and Act-HIb (Aventis Pasteur SA) on 09/21/2001. The reporter also indicated that the patient was exposed to chicken pox
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Crying
Clinical narrative: A physician reported that a 2-month-old male received Prevnar, Tripedia, ActHIB and IPV vaccines on 27-SEP-2001. That same day, the infant had a 4 to 5 hour episode of "non-stop" crying. He also developed fussiness lasting "all night long". The infant was "better" the next day. This is 1 of 4 patients from this facility who had an adverse experience following receipt of Prevnar lot 481-817. Information regarding this event has been forwarded to the manufacturer of the concomitant vaccines.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Agitation, Irritability
Clinical narrative: A physician reported that a 2-month-old male received Prevnar, Tripedia, ActHIB and IPV vaccines on 27-SEP-2001. That same day, the infant had a 4 to 5 hour episode of "non-stop" crying. He also developed fussiness lasting "all night long". The infant was "better" the next day. This is 1 of 4 patients from this facility who had an adverse experience following receipt of Prevnar lot 481-817. Information regarding this event has been forwarded to the manufacturer of the concomitant vaccines.
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Contusion, Injection site oedema, Injection site swelling
Clinical narrative: A physician reported that a female child received Prevnar vaccine on 01-OCT-2001. She subsequently developed an injection site reaction characterized by swelling, bruising and puffiness for 48 hours. No additional information was available as of the data of this report.
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Contusion, Injection site induration, Injection site swelling
Clinical narrative: A physician reported that a female child received Prevnar vaccine on 01-OCT-2001. She subsequently developed an injection site reaction characterized by swelling, bruising and puffiness for 48 hours. No additional information was available as of the data of this report.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Contusion, Injection site oedema, Injection site swelling
Clinical narrative: A physician reported that a 12-month-old female received doses of Prevnar and Variclla vaccines, along with a tuberculin test on 01-OCT-2001. Later that day, the child developed an injection site reaction characterized by swelling, bruising and induration and became fussy for 48 hours. The sites of vaccine administration were not specified. On 03-OCT-2001, she was seen by the physician who noted that the child was "better" and less fussy; however, the bruise and induration remained. The child recovered.   Manufacturer's comment: This is one of 4 children from this facility who experienced an adverse event following receipt of Prevnar (lot number not proivided). Additional reports will be generated when identifying information is available. Additional information received from the child's pediatrician on 26-OCT-2001 provided the prevnar lot number.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Contusion, Injection site induration, Injection site swelling
Clinical narrative: A physician reported that a 12-month-old female received doses of Prevnar and Variclla vaccines, along with a tuberculin test on 01-OCT-2001. Later that day, the child developed an injection site reaction characterized by swelling, bruising and induration and became fussy for 48 hours. The sites of vaccine administration were not specified. On 03-OCT-2001, she was seen by the physician who noted that the child was "better" and less fussy; however, the bruise and induration remained. The child recovered.   Manufacturer's comment: This is one of 4 children from this facility who experienced an adverse event following receipt of Prevnar (lot number not proivided). Additional reports will be generated when identifying information is available. Additional information received from the child's pediatrician on 26-OCT-2001 provided the prevnar lot number.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Injection site mass, Pyrexia, Rash
Clinical narrative: A mother reported that her 3-month-old received a 1st dose of Prevnar vaccine in July 2001. Additional suspect vaccine included DTaP vaccine (diptheria and tetanus toxoids and acellular pertussis) (manufacturer unknown). The physician told the mother that the nurse had inadvertently injected the Prevnar into the infant's fat, not her muscle. Several hours post immunization, the infant developed a fever and an injection site reaction characterized by rash, redness and a hard, golf ball size, lump. The lump under the skin lasted for several weeks. No additional information was available as of the date of this report. Follow-up info received on 12/12/2001. The infant was seen in Urgent Care on 08/17/2001. She was treated with symptomatic local care of cold compresses and Tylenol prn.
Age: 0.3
Sex: F
Vaccine: PNC
Symptoms: Hypersensitivity
Clinical narrative: A mother reported  that her child rec'd her second dose of Prevnar vaccine and subsequently developed a hypersensitivity reaction. The reporter declined to provide further information and declined to grant permission for follow up. She also indicated that she had submitted this report directly to VAERS.
Age: 1.75
Sex: F
Vaccine: PNC
Symptoms: Rash papular
Clinical narrative: A physician reported that a pt rec'd first dose of Prevnar in October 2001 and developed a rash two days later. On 10/27/01, a fine red papular rash was noted 1cm below the injection site. This rash spread to the infant's hands, feet, and part of her trunk. Additional information rec'd on 11/26/01, the infant had no pre-existing illnesses and was receiving no concomitant medications at the time of vaccination.
Age: 0.3
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Body temperature decreased, Screaming
Clinical narrative: A coordinator in an Infectious Disease dept reported that a child rec'd her 3rd dose of Prevnar, along with IPV(manufacturer unknown), Hib (manufacturer unknown), DTaP (manufacturer unknown) and Hepatitis B (manufacturer unknown) vaccines. Six hrs post immunization, the infant developed a fever < than 38 degrees C and a high-pitched cry which lasted for 3 days. The infant's pediatrician later reported, that in a follow-up visit, the infant's temperature was subnormal (95.1degrees F). Additional information was rec'd from the child's current pediatrician on 11/26/01 and 11/28/01. It provided the infant's date of birth and stated that the child was first seen by this pediatrician when the child was 7 months old  for an upper respiratory infection. The child's mother relayed to the physician the adverse event experienced by her child 3 months earlier.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Cyanosis
Clinical narrative: A nurse reported that a infant rec'd her 1st dose of Prevnar, Infanrix (GSK), Act-HIB (Aventis Pasteur SA) and IPOL (Aventis Pasteur SA) vaccines on 8/28/01. That same day, the infant experienced cyanosis of her legs and she screamed. The cyanosis resolved within 10 minutes. She was seen by the reporter and recovered. This report was rec'd from Glaxo Smith Kline (ref. #2001021044-1).
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Skin hyperpigmentation
Clinical narrative: A nurse reported that a infant rec'd Prevnar and IPV (Aventis Pasteur SA) vaccines on 9/20/01. Both vaccines were administered in her R thigh 1 inch from each other. Now the pt has a 2 1/2 cm area of hyperpigmentation at the site. as of the date of this report, no further information was available. Follow-up info received 12/31/2001 indicated that the pt received her first doses of Prevnar, Hib-Titer, Tripedia and IPV on 09/20/2001 and that she recovered from this event.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Skin discolouration
Clinical narrative: A nurse reported that a infant rec'd Prevnar and IPV (Aventis Pasteur SA) vaccines on 9/20/01. Both vaccines were administered in her R thigh 1 inch from each other. Now the pt has a 2 1/2 cm area of hyperpigmentation at the site. as of the date of this report, no further information was available. Follow-up info received 12/31/2001 indicated that the pt received her first doses of Prevnar, Hib-Titer, Tripedia and IPV on 09/20/2001 and that she recovered from this event.
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Immunoglobulins decreased, Laboratory test abnormal, Pneumonia
Clinical narrative: A physician reported that a male child (age unclear) rec'd his 5th dose of Prevnar on an unspecified date. Subsequently, an immunoglobulin G titer returned with a low level of Streptococcus pneumonia, serotype 19F. This child also developed a positive blood culture for Streptococcus pneumonia, serotype 19F following the second dose of Prevnar. See HQ8985729NOV2001. No further information was available at the date of this report.
Age: 0.2
Sex: F
Vaccine: HEP, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: A pediatricians office assistant reported that an infant rec'd her first dose of Prevnar and a dose of hepatitis B (manufacturer unknown) vaccine on 9/17/01. the following evening, the infant developed a fever of 100.8F (axillary temperature) and experienced irritability. She was treated with tylenol (paracetamol) and seemed better the next morning. On 09/19/01, she developed slight swelling at the injection site. On 09/20/02, her temperature was 100.2 F
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, IPV
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: A mother reported that her infant son received  his first doses of Prevnar, diphtheria, tetanus and acellular pertussis (manufacturer unknown), haemophilus influenzae type B (manufacturer unknown) and IPV (Aventis Pasteur SA) vaccines on 8/2/012 and that same day, began crying and developed an injection site reaction characterized by redness, swelling and hardness. As of the date of this report, no further information was available. Information regarding this event has been forwarded to Aventis Pasteur, manufacturer of IPV. See related report:HQ6416326SEP2001. Additional information rec'd 10/9/01 indicated that the pt recovered. The lot number for Acel-imune was reported as UO515AA; the lot number for Hib-TITER was reported as UA604AA; however, these are not valid Lederle lot numbers.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, IPV
Symptoms: Crying, Injection site reaction
Clinical narrative: A mother reported that her infant son received  his first doses of Prevnar, diphtheria, tetanus and acellular pertussis (manufacturer unknown), haemophilus influenzae type B (manufacturer unknown) and IPV (Aventis Pasteur SA) vaccines on 8/2/012 and that same day, began crying and developed an injection site reaction characterized by redness, swelling and hardness. As of the date of this report, no further information was available. Information regarding this event has been forwarded to Aventis Pasteur, manufacturer of IPV. See related report:HQ6416326SEP2001. Additional information rec'd 10/9/01 indicated that the pt recovered. The lot number for Acel-imune was reported as UO515AA; the lot number for Hib-TITER was reported as UA604AA; however, these are not valid Lederle lot numbers.
Sex: U
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: A hlth care professional reported that a pt rec'd an injection of Prevnar and developed fussiness. No further information was available at the date of this report. Manufacturer's Comment: The reporter was unable to specify the number of pt's who experienced this event. Additional reports will be generated when identifying information is provided.
Age: 1.5
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: A physician reported that an infant rec'd an injection of Prevnar on 9/27/01. That same day, the child developed swelling at the injection site. On 9/29/01, he was seen by the physician who noted that the child had developed a 5cm by 13cm area of erythema and induration at the injection site. The child recovered. This is 1 of 4 pt's from this facility who had an adverse experience following receipt of Prevnar lot 481-817.
Age: 0.75
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: A physician reported that a pt rec'd Prevnar, Tripedia (Aventis Pasteur Inc), ActHIB (Aventis Pasteur SA), and IPV (Aventis Pasteur SA) vaccines on 9/25/01. The following day, the infant developed a fever of 103 to 104F and vomiting. He also developed an injection site reaction characterized by swelling and redness. The infant was better by 9/28/01 and subsequently recovered. This is 1 of 4 pt's from this facility who had an adverse experience following receipt of Prevnar lot 481-817. Information regarding this event has been forwarded to Aventis Pasteur, manufacturer of the concomitant vaccines.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that an infant rec'd Prevnar, Hib-Titer, and Acel-Imune vaccines on 4/6/01. That day, she developed urticaria. Additional information rec'd from the physician on 10/30/01 indicated that the infant recovered.
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A pharmacist reported that a child (age/gender unknown) experienced a rash on the face and body approximately 3 weeks after vaccination with Prevnar (third dose). The child was vaccinated on 9/7/01; the event began on 9/24/01. The child did not experience a rash after the first two injections. No further information was provided.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that an infant rec'd Prevnar, Hib-Titer, and Acel-Imune vaccines on 1/31/01. That day, she developed urticaria.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: A physician reported that an infant rec'd Prevnar, DTaP (manufacturer unknown), IPV , and Comvax vaccines. Approximately 2 to 3 hrs post vaccination, the infant developed a fever of 106F, which persisted for 18 hrs and then a fever of 102F which also persisted for 18 hrs. No further information was available at the date of this report. Additional information rec'd on 10/19/01 indicated that the pt was a 4 month old female who rec'd her second dose of Prevnar along with DTaP (manufacturer unknown), IPV and Comvax vaccines on 10/15/01. That same day, the infant developed a fever of 102F. Follow-up info received on 12/17/2001 indicated that the infant was a 2 month old female who received these vaccines on 08/21/2001. That same day, she developed a fever.
Age: 0.25
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that a 2 month old infant developed hives following  immunization with Prevnar (dose 1). The infant had no difficulty breathing and did recover. No further information was provided. *See HQ8984029NOV2001 for information regarding a subsequent report of hives. FOLLOW-UP information received on 12/20/2001: Prevnar was administered on 07/19/01. The event occurred on 07/23/01. The infant received IPV, Hib and DTaP vaccines (manufacturer unknown) on 06/19/01. The male infant's date of birth was 04/05/01
Sex: U
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A physician reported that a pt received a dose of Prevnar vaccine (date not specified) and subsequently developed a fever of more than 101 degrees F. No further information was available a the date of the report. The reporter indicated that other patients experienced this event but was unable to specify the number of patients involved. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that an infant received Prevnar and subsequently, developed urticaria. At the date of this report, no further information was available.
Age: 1.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A mother reported that her 12 month old daughter received her fourth dose of Prevnar and subsequently developed a fever of 101.7 deg. F. The fever resolved after two days. The reporter declined to provide any additional information and declined to grant permission for follow-up investigation.
Sex: U
Vaccine: PNC
Symptoms: Laboratory test abnormal
Clinical narrative: A physician reported that a patient, who has HIV infection, received Prevnar. A blood culture was performed and was positive for serotype 6B. As of the date of this report, no further information was available.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: A physician reported that a 4 month old infant developed hives following immunization with Prevnar (dose 2). The infant experienced hives following Prevnar vaccination dose one at 2months of age. The hives were more "severe" after the second immunization. The infant had no difficulty breathing and did recover. No further information was provided. ADDITIONAL information received on 12/20/01: Prevanr, along with Tripedia and ActHib were administered on 09/28/01. The infant received IPV within 4 weeks. The event occurred on 09/30/2001 Date of birth, gender (male), name and address of the infant were also provided.
Sex: M
Vaccine: HEP, PNC
Symptoms: Bacterial infection, Pneumonia, Sepsis
Clinical narrative: A physician reported that a 12 month old child received his second dose of Prevnar on an unspecified date. Subsequently, the child developed a blood culture positive to Streptococcus pneumoniae, serotype 19F. The child received the remaining doses and following the fifth dose, an IgG titer for Streptococcus pneumoniae, serotype 19F, returned a "particularly" low level. See HQ8996429NOV2001. FOLLOW-UP received on 01/25/02 indicates the vaccine was administered on 08/28/00. Concomitant vaccination included Hepatitis B (manufacturer unknown. The positive blood culture was obtained on 10/22/00 and a diagnosis of pneumococcal bactermia was made. the patient has since recovered. Upon receipt of follow - up information, this report has been upgraded to a serious report.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Abnormal sleep-related event, Feeding disorder neonatal, Feeling cold, Lung disorder, Nervous system disorder
Clinical narrative: Fed poorly at midnight. Slept with mother. Mother found baby cold in mother's bed when mother awoke. Taken to ER by ambulance. Baby DOA though some resuscitation attempted. COD: complications of prematurity as per autopsy report F/U on 5/22/02, shows changes in the lungs consistent with bronchopulmonary dysplasia with proliferation of the epithelium and uneven opening of the alveolar spaces. The brain is very small; it's size is more appropriate for a neonate. This may be explained by history of prematurity.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Premature baby
Clinical narrative: Fed poorly at midnight. Slept with mother. Mother found baby cold in mother's bed when mother awoke. Taken to ER by ambulance. Baby DOA though some resuscitation attempted. COD: complications of prematurity as per autopsy report F/U on 5/22/02, shows changes in the lungs consistent with bronchopulmonary dysplasia with proliferation of the epithelium and uneven opening of the alveolar spaces. The brain is very small; it's size is more appropriate for a neonate. This may be explained by history of prematurity.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Feeling cold
Clinical narrative: Fed poorly at midnight. Slept with mother. Mother found baby cold in mother's bed when mother awoke. Taken to ER by ambulance. Baby DOA though some resuscitation attempted. COD: complications of prematurity as per autopsy report F/U on 5/22/02, shows changes in the lungs consistent with bronchopulmonary dysplasia with proliferation of the epithelium and uneven opening of the alveolar spaces. The brain is very small; it's size is more appropriate for a neonate. This may be explained by history of prematurity.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac arrest, Coma
Clinical narrative: The pt received influenza vaccine during AM hours. The pt seemed fine for several hours but was found unresponsive by a neighbor that afternoon. Resuscitation efforts failed and the pt was pronounced dead at 17:52 on 11/14/00. Her death was felt to be sudden cardiac death with a history of diabetes and hypertension. Please not the date of the event, 11/14/01, is the correct date. The pt died on the same day he received influenza immunization.
Age: 37.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Erythema, Pruritus, Rash maculo-papular
Clinical narrative: The pt developed an erythematous, maculopapular rash all over her body, including her palms and soles of her feet. It was also pruritic. Treated it with cetirizine and it resolved.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Area of injection site became red, inflammed, hard/firm, warm to touch and slightly sore. The area of induration and erythema measured approx. 3" across. Seen in a walk-in clinic by ER physician. Treatment: Benadryl.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Febrile convulsion, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: The pt received his 1st flu shot on 12/20/01. That PM, he had a fever to 102F and a febrile seizure. The next day, he continued to have a fever plus a headache, stiff neck and vomiting. He also had neck pain and chills. At the ER, the doctor gave him an antibiotic shot and told us he did not have meningitis since his WBC was over twice the normal amount.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: The pt received his 1st flu shot on 12/20/01. That PM, he had a fever to 102F and a febrile seizure. The next day, he continued to have a fever plus a headache, stiff neck and vomiting. He also had neck pain and chills. At the ER, the doctor gave him an antibiotic shot and told us he did not have meningitis since his WBC was over twice the normal amount.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Anorexia, Asthenia, Chest pain, Chills
Clinical narrative: Pain in left arm, heaviness in chest, weakness, discomfort in abdomen, loss of appetite, sleeplessness, restless, sporadic trembling and shivering.