chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Back pain, Diarrhoea, Fatigue, Headache
Clinical narrative: After 1st Anthrax, sought treatment on 1/11/91. On 1/21/91, I returned to the Medical Aid Station still complaining of throbbing pain in the lower left back to left testicle. On 1/22/91, I returned again, with lower left back pain and abdominal cramping. During the exam, the prostate felt burning on palpation and was boggy, 2-3cm. I was to return for a follow-up in 7 days. On 1/29/91, I received the Anthrax 2 vaccine. The next day, I returned for a follow-up. Doxycycline (known treatment for the side affects of P. B. pills and the Persian Gulf Syndrome) was still continued for 14 days. When each 1 of these exposures (Anthrax, environmental chemicals, warfare and P. B. pills) are administered individually, the toxicity levels have been reported to be bad enough! Being exposed to these exposures within a 3 week time span (exposure to some for longer periods), can reportedly multiply the toxicity level 25 to 35 times more! Given the known side affects of some exposures and the unknown long term affects of other exposures, combined with a cocktail of all these exposures, I feel it is safe to say that I acquired an unknown illness/Persian Gulf Syndrome! Dx's given in the past were just actual symptoms of an unknown illness/Persian Gulf Syndrome. The unknown illness/Persian Gulf Syndrome is a probable result of a series of exposures that I was exposed to, that have very little or no data on side affects, thus Undiagnosed Illness. I feel that I should be awarded 100% Service Connection since 4/3/98, when the MD signed a set of severe limitations in which he indicated that I was unable to do 98% of the physical requirements of my job, which eventually led to the termination of my job!. This is my complete statement of what happened to me. I have documentation to uphold this statement! Have been seeking treatment from VA since 10/96 until the present and ongoing treatment.  A follow up report received 04/11/2001 adds: (Current symptoms:) Numbness in fingers and toes, muscle cramps and spasms, muscle aches, joint pain and discomfort, back pain with lower back pain dominant, headaches, fatigue, sensitivity to light, abdominal cramps, chronic diarrhea and occasional burning sensation while urinating.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Hypoaesthesia, Muscle spasms, Prostatic disorder, Testicular disorder
Clinical narrative: After 1st Anthrax, sought treatment on 1/11/91. On 1/21/91, I returned to the Medical Aid Station still complaining of throbbing pain in the lower left back to left testicle. On 1/22/91, I returned again, with lower left back pain and abdominal cramping. During the exam, the prostate felt burning on palpation and was boggy, 2-3cm. I was to return for a follow-up in 7 days. On 1/29/91, I received the Anthrax 2 vaccine. The next day, I returned for a follow-up. Doxycycline (known treatment for the side affects of P. B. pills and the Persian Gulf Syndrome) was still continued for 14 days. When each 1 of these exposures (Anthrax, environmental chemicals, warfare and P. B. pills) are administered individually, the toxicity levels have been reported to be bad enough! Being exposed to these exposures within a 3 week time span (exposure to some for longer periods), can reportedly multiply the toxicity level 25 to 35 times more! Given the known side affects of some exposures and the unknown long term affects of other exposures, combined with a cocktail of all these exposures, I feel it is safe to say that I acquired an unknown illness/Persian Gulf Syndrome! Dx's given in the past were just actual symptoms of an unknown illness/Persian Gulf Syndrome. The unknown illness/Persian Gulf Syndrome is a probable result of a series of exposures that I was exposed to, that have very little or no data on side affects, thus Undiagnosed Illness. I feel that I should be awarded 100% Service Connection since 4/3/98, when the MD signed a set of severe limitations in which he indicated that I was unable to do 98% of the physical requirements of my job, which eventually led to the termination of my job!. This is my complete statement of what happened to me. I have documentation to uphold this statement! Have been seeking treatment from VA since 10/96 until the present and ongoing treatment.  A follow up report received 04/11/2001 adds: (Current symptoms:) Numbness in fingers and toes, muscle cramps and spasms, muscle aches, joint pain and discomfort, back pain with lower back pain dominant, headaches, fatigue, sensitivity to light, abdominal cramps, chronic diarrhea and occasional burning sensation while urinating.
Age: 35.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL, HEP, MMR, TD, VARCEL
Symptoms: Infection, Joint stiffness, Urticaria
Clinical narrative: On 9/14/00 had hives and chickenpox from vaccines, especially on lips. On 10/10/00, had persistent hives, joint stiffness, treated with Decadron and Depo-Medrol. On 10/13/00, was give prednisone. On 11/16/00, continued with hives, especially on face. On 1/09/01, had hives all over and was treated with Decadron and Depo-Medrol. Doc 215203 states the following: "I have called x2 & not received a return reply to my message. Spouse answered phone but was unaware of any problems associated with the 12's.
Age: 35.0
Sex: F
Vaccine: HEP, MMR, TD, VARCEL, HEP, MMR, TD, VARCEL
Symptoms: Infection, Urticaria
Clinical narrative: On 9/14/00 had hives and chickenpox from vaccines, especially on lips. On 10/10/00, had persistent hives, joint stiffness, treated with Decadron and Depo-Medrol. On 10/13/00, was give prednisone. On 11/16/00, continued with hives, especially on face. On 1/09/01, had hives all over and was treated with Decadron and Depo-Medrol. Doc 215203 states the following: "I have called x2 & not received a return reply to my message. Spouse answered phone but was unaware of any problems associated with the 12's.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness
Clinical narrative: This patient lost sight in his left eye. (Nothing else attached).     The follow up received on 7/3/01 states, "this is a 53 year old pt who was referred by Dr, to "try to help me." "I'm losing my vision; I basically lost my vision in my left eye." "I first noticed the loss of vision on January 5, I took the flu shot about 2:00 in the afternoon, and about 7:30 or 8:00, I went down to read a book and it was fuzzy." He checked the eyes individually and found that the fuzziness was only OS. When he awoke the next morning, it was still fuzzy. The same morning, Saturday, January 6, he was seen by Dr, an optometrist. "She basically said I needed to go see an ophthalmologist." It sounds like he was told that he had AION. On Monday, January 8, he was seen by Dr and "he basically told me I had the same problem but he wanted to go ahead and run various blood tests and an MRI." The MRI scan was done on January 9. "It was all good except he had sinusitis." "I didn't have any vision in the upper half." "This past Sunday (1/14), it started in the lower half, and since then it's just about to the point where it's all gone." "There is a mild swelling-like or puffy-like sensation." There has been no real pain; no pain on motility. "In driving down here yesterday, there was a lot of strain on it." "It just feels like your eye is weak, it's worn out, you just want to close it." "There has been no problem with vision OD. He has had some mild hypertension. "It's high when I first have it tested, but by the time I leave the office, it's down to around 140/90." Four days ago he was started on Norvasc. There is no history of diabetes, ASCVD, angina, MI, CVA, focal motor weakness, or cigarette consumption. He has been on Decadron for 2 years for "Meniere's disease." There was no prior MRI scan."
Age: 1.25
Sex: M
Vaccine: DTAP, PNC
Symptoms: Insomnia, Pyrexia
Clinical narrative: This child's fever was up to 101 F for 5 days and sleeplessness after receiving Prevnar dose # 1 and DTaP dose #4, on 11/16/00.
Age: 1.37
Sex: M
Vaccine: DTAP, HIBV, IPV, TTOX
Symptoms: Erythema, Injection site induration, Injection site pain, Injection site warmth, Urticaria
Clinical narrative: The right leg has elevated erythema, induration, heat, pain, and some surrounding urticaria.
Age: 0.5
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Decreased appetite, Eye disorder, Muscle spasticity, Neurodevelopmental disorder
Clinical narrative: On 11/13/00, this patient received: DTaP, Comvax, IPV, and Prevnar. On 01/01, the mother noticed poor eye contact, decreased appetite, spasticity mostly in lower extremities, progressive development delay.
Age: 31.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: 2 1/4 inch by 1 1/4 inch, red raised area, on the right arm. The area was elongated; slightly tender to touch; no fever.  Follow up:  Patient has partially recovered from adverse event.  There is still a lump and bruise on arm.  However, there aren't and never were septemic symptoms.  Patient never missed work.  Patient has been evaluated by a physician or health care provider.  Patient did not receive any more shots since reported event."
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: This patient received the flu shot on 12/20/00. No elevated discomfort at the time of the injection. Within 24 hours, the patient experienced alot of discomfort in the deltoid to elbow region. Discomfort limits range of motion at times. The patient did not have fever at anytime, but discomfort persists. The patient took Tylenol one time with some measure of relief. No redness or induration noted  at the left deltoid area. The patient referred to the PMD for evaluation.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphadenopathy, Oedema
Clinical narrative: This patient received a flu shot on 12/28/00. He presented 01/22/01 to the clinic with history of 4 weeks of left arm edema which started after the flu shot. He had edema in the arm after the flu shot 2 years prior but also cleared on its own. This time it didn't. He underwent CT Scan, and venogram to r/o DVT or a mass effect causing lymphadenoma; all were negative. Arm still very swollen.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypotension, Influenza, Injection site pain, Oedema
Clinical narrative: Severe Pain at the injection site on the left arm. The arm was warm to touch. Vitals were taken at 1:45 PM as followed Temp 97.4, P 84, R 16, B/P 72/60. On 12/11/00, per phone call; the patient complained of generalized swelling of the upper arm. On 12/06/00 she had a temp of 101 F for 2 days with pain at the injection site. On 12/05/00 she had itching for 1 1/2 days after the injection. No additional medical follow up. Treatment of cool compresses and Ibuprofen taken by the patient. Presently feeling much better. Enc medical care if needed. In later October 2000, the patient was diagnosed and hospitalized with Influenza. Complained of weakness, elevated temp, and a sore throat. Treated with antibiotics names unknown.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Pruritus, Pyrexia
Clinical narrative: Severe Pain at the injection site on the left arm. The arm was warm to touch. Vitals were taken at 1:45 PM as followed Temp 97.4, P 84, R 16, B/P 72/60. On 12/11/00, per phone call; the patient complained of generalized swelling of the upper arm. On 12/06/00 she had a temp of 101 F for 2 days with pain at the injection site. On 12/05/00 she had itching for 1 1/2 days after the injection. No additional medical follow up. Treatment of cool compresses and Ibuprofen taken by the patient. Presently feeling much better. Enc medical care if needed. In later October 2000, the patient was diagnosed and hospitalized with Influenza. Complained of weakness, elevated temp, and a sore throat. Treated with antibiotics names unknown.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This child had large local redness, and swelling at the site of the injection 4" x 3".
Age: 38.0
Sex: M
Vaccine: DTAP
Symptoms: Joint stiffness, Pain
Clinical narrative: Within 6 hours of the injection, this patient's left TMJ became stiff, and extremely painful. The pain lasted 48 hours then resolved.
Age: 36.0
Sex: F
Vaccine: HEP, TD
Symptoms: Abdominal pain, Chest pain, Chills, Face oedema, Hypoaesthesia
Clinical narrative: On 03/20/01 PM, the patient had chills, shakes, afebrile, and bilateral numbness of hands. On 03/21/01, the patient had severe abdominal, chest pain, and nausea. On 03/22/01, the patient had a loss of consciousness, hypotension, swelling of her lips, and face. On 03/22/01, prescription of Prednisone given by Family MD.
Age: 36.0
Sex: F
Vaccine: HEP, TD
Symptoms: Hypotension, Loss of consciousness, Nausea, Tremor
Clinical narrative: On 03/20/01 PM, the patient had chills, shakes, afebrile, and bilateral numbness of hands. On 03/21/01, the patient had severe abdominal, chest pain, and nausea. On 03/22/01, the patient had a loss of consciousness, hypotension, swelling of her lips, and face. On 03/22/01, prescription of Prednisone given by Family MD.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Crying, Dysphagia, Muscle twitching, Staring
Clinical narrative: Several hours after the Varicella vaccine, this infant woke up from a nap screaming. He had twitches as described by the mother and was crying. He did briefly stare at the ceiling. He never lost consciousness. He had trouble drinking fluids, this resolved after 1 hour and 45 minutes. Exam in office normal. Advil helped.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Erythema, Pyrexia, Urticaria
Clinical narrative: Per mother's report: 7 hours after immunizations were administered, the patient spiked a high fever and presented with red welts over her entire body to the ER.
Age: 1.5
Sex: M
Vaccine: DTPHIB, HIBV
Symptoms: Cyanosis, Hyperventilation, Irritability, Peripheral vascular disorder, Respiratory disorder
Clinical narrative: The patients mother took him to the ER stating that the patient was breathing funny and his hands and feet turned blue. No respiratory distress in the ER. BBSH (-), Pulse 126, Resp 44, Pulse OX 97%. Diagnosis from ER was viral syndrome vs reaction to immunization. The patient did vomit one time in the ER and was fussy. The patient was given Tylenol and discharged on clear liquids for 24 hours.
Age: 1.5
Sex: M
Vaccine: DTPHIB, HIBV
Symptoms: Viral infection, Vomiting
Clinical narrative: The patients mother took him to the ER stating that the patient was breathing funny and his hands and feet turned blue. No respiratory distress in the ER. BBSH (-), Pulse 126, Resp 44, Pulse OX 97%. Diagnosis from ER was viral syndrome vs reaction to immunization. The patient did vomit one time in the ER and was fussy. The patient was given Tylenol and discharged on clear liquids for 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Face oedema, Hypersensitivity, Respiratory distress, Wheezing
Clinical narrative: This patient had a swollen face, wheezing, respiratory distress after shots (4 year vaccines). Allergic reaction the same evening as the shots. He was taken to the ER and given Epinephrine with Benadryl and a steroid.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Infection, Rash maculo-papular
Clinical narrative: This child developed a mild chicken pox rash on 03/20/2001. No associated symptoms, no fever. the rash had increasing number of isolated, distinct erythematous macules or papules, some crusting vesicles, minimal.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This patient's injection site was very red and slightly raised. Peripheral redness to the injection site with pain and numbness experienced in the limb from injection site down to the hand.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HIBV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: This infants left leg was swollen and red.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling
Clinical narrative: Mom noted swelling of arm in morning of 3/9/01. Left arm was red from elbow to shoulder and was swollen from mid-clavicle/mid-scapula to head. Circumference of arm at elbow 3.5cm larger than right arm.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, OPV, VARCEL, HBHEPB, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: At 26 months the patient's mother called with complaints of chicken pox and would like Benadryl and calamine lotion .
Age: 1.9
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Historical date, not actually seen at our clinic for dx relayed to provider. On 7/20/00 at 14:40, in for well child check; Mom states no concerns today, other than pt got chickenpox about 2 weeks ago on 7/6/00. Recovered from chickenpox without problems. Has matting eyes every AM,  resolving. No other upper respiratory symptoms. Prescribed Polytrim ophthalmic drops, Fluoride drops, Tylenol drops and chews.
Age: 1.9
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Infection, Lacrimation increased
Clinical narrative: Historical date, not actually seen at our clinic for dx relayed to provider. On 7/20/00 at 14:40, in for well child check; Mom states no concerns today, other than pt got chickenpox about 2 weeks ago on 7/6/00. Recovered from chickenpox without problems. Has matting eyes every AM,  resolving. No other upper respiratory symptoms. Prescribed Polytrim ophthalmic drops, Fluoride drops, Tylenol drops and chews.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 3/16/01 at 19:30, mother noticed left thigh was swollen, red and hot. No fever. Child didn't demonstrate discomfort. Very active  and didn't complain of leg pain. Was taken to ER because clinic was closed. ARNP saw client. Mother states the swelling was approx. 10cm. He was Rx'd antibiotic for 10 days. On 3/17/01, much improved next AM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 03/28/01, injection site red and swelling. Full ROM. Cold compresses. On 3/29/01, treated with diphenhydramine 1 1/2 tsp every 6-8 hours.
Age: 38.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Injection site pain, Vertigo
Clinical narrative: Soreness, pain at injection site, low stamina, vertigo, tiredness. Has a history of middle ear problems and vertigo but felt got much worse after TD on 12/7/00.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Right upper leg swollen, hot to touch, itchy and painful.
Age: 2.5
Sex: F
Vaccine: DTAP, HEP
Symptoms: Injection site swelling
Clinical narrative: Size of baseball
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 4" X 3" raised, red area, tender to touch over "biceps" of left arm which lasted 5 days.
Age: 51.0
Sex: F
Vaccine: TD, TD
Symptoms: Injection site pain, Rash erythematous
Clinical narrative: 4" X 3" raised, red area, tender to touch over "biceps" of left arm which lasted 5 days.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large local reaction, 4" X 3" area, red, hot, swollen and tender.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Rash vesicular
Clinical narrative: Red area about 4cm on left thigh, small bump with clear drainage. No fever. Treated with Bactroban cream tid X 5 days, warm compresses and massage.
Age: 9.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On 2/27/01, was given varivax/SC (R0 LTR about noon. Mother noticed redness and swelling about 15:00 and was getting larger today (02/28/01) and painful. Wt 60 1/2 lbs; T-101F. Redness and swelling 6cm in diameter, center swelling and discolor 2cm, feels warm to touch. Advised children's Motrin for fever; cold compress and Benadryl elixir 25mg every 4-6 hours. Recheck tomorrow but if worsens go to ER. On 3/12/01, swelling and redness were resolved.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea haemorrhagic, Gastroenteritis, Haematemesis
Clinical narrative: Had Hep B #3, Tuesday 3/20/01. Woke up at 02:00 AM with vomiting and diarrhea. By morning, was vomiting blood and having bloody diarrhea. Pt went to ER. Dx'd with Gastroenteritis (mom stated It's a very contagious virus).
Age: 0.4
Sex: M
Vaccine: PNC
Symptoms: Bronchiolitis
Clinical narrative: A medical assistant reported that a 5 month old male who was being treated for a bronchial infection with an unspecified medication via nebulizer since 1/7/01, received his 3rd dose of Prevnar on 1/18/01. On 1/23/01, he was admitted to the hospital with a dx of bronchiolitis. On 1/27/01, he was discharged.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Cough, Dyspnoea, Injection site erythema, Injection site swelling, Laryngitis
Clinical narrative: A physician reported that a female child received Prevnar and TriHibit vaccines and subsequently, she developed a fever, stridor and retractions. The child was hospitalized and dx'd with croup. She also developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration were not reported. The child recovered.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Pyrexia, Respiratory disorder, Stridor
Clinical narrative: A physician reported that a female child received Prevnar and TriHibit vaccines and subsequently, she developed a fever, stridor and retractions. The child was hospitalized and dx'd with croup. She also developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration were not reported. The child recovered.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC, DTAP, HIBV, PNC
Symptoms: Pyrexia, Stridor
Clinical narrative: A physician reported that a female child received Prevnar and TriHibit vaccines and subsequently, she developed a fever, stridor and retractions. The child was hospitalized and dx'd with croup. She also developed an injection site reaction characterized by redness and swelling. The specific sites of vaccine administration were not reported. The child recovered.
Age: 1.0
Sex: M
Vaccine: HEP, PNC, PNC
Symptoms: Bacterial infection, Sepsis
Clinical narrative: The pt was hospitalized with suspected pneumococcal infection one month post vax. Follow-up information received on 2/26/01 from the child's physician indicated that the male child was immunized on 11/28/00. On 1/19/01, the child was hospitalized for a pneumococcal infection. A blood culture revealed the presence of Streptococcus pneumonia with resistance to PCN and cefotaxime. The child was hospitalized for 13 days and has since recovered.
Age: 1.0
Sex: M
Vaccine: HEP, PNC, PNC
Symptoms: Bacterial infection, Pneumonia
Clinical narrative: The pt was hospitalized with suspected pneumococcal infection one month post vax. Follow-up information received on 2/26/01 from the child's physician indicated that the male child was immunized on 11/28/00. On 1/19/01, the child was hospitalized for a pneumococcal infection. A blood culture revealed the presence of Streptococcus pneumonia with resistance to PCN and cefotaxime. The child was hospitalized for 13 days and has since recovered.
Age: 0.6
Sex: F
Vaccine: PNC
Symptoms: Bacterial infection, Pneumonia, Sepsis
Clinical narrative: A territory representative reported that a 7 month old female received her 2nd dose of Prevnar and subsequently was diagnosed with Streptococcus Pneumoniae bacteremia. No further information was available at the date of this report. Streptococcal septicemia is considered medically important.
Sex: U
Vaccine: PNC
Symptoms: Convulsion
Clinical narrative: Subsequent to receiving vax, the pt experienced a seizure. As of 01/09/2001, no further information was available.  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Age: 1.25
Sex: U
Vaccine: HEP, PNC
Symptoms: Bacterial infection, Sepsis
Clinical narrative: A territory representative reported that a 15 month old child received a 2nd dose of Prevnar and subsequently developed Pneumococcal bacteremia, serotype unknown. No further info was available at the date of this report. Streptococcal septicemia is considered medically important. Follow up data received from the physician on 03/20/2001 indicated the patient received Prevnar and Engerix-B vaccines on 08/14/2000. A blood culture was positive for Streptococcus pneumoniae. The patient recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: A physician reported that her 2 month old daughter received her 1st dose of Prevnar, Comvax, IPV, and DTaP vaccines in January, 2001. On 02/20/01, she was treated and released from the ER for a seizure and high fever. As of 02/22/01, she continued to receive treatment with Ceftriaxone. Seizures are considered medically important. Copies of this report have been forwarded to Merck and Aventis Pasteur, manufacturers of the concomitantly administered vaccines. Follow up received from the patient's pediatrician on 04/17/2001 indicated the vaccines were administered 02/08/2001 and she was seen in the emergency room 02/21/2001. The patient recovered.
Age: 0.2
Sex: M
Vaccine: PNC
Symptoms: Dry skin, Erythema, Rash, Seborrhoea, Skin exfoliation
Clinical narrative: Shortly after receiving vax, the pt developed a flaky red rash on his face and arms. Additional information received 02/07/2001 from the physician indicated that the pt developed a dry scaly rash on his scalp, face, chest and arms. A diagnosis of cradle cap or seborrhea was made. The pt recovered.
Age: 1.25
Sex: M
Vaccine: HBPV, HEP, MMR, PNC
Symptoms: Ecchymosis, Injection site oedema, Injection site pain, Lymphadenopathy, Pyrexia
Clinical narrative: Within one week subsequent to receiving vax, the pt developed a fever of 102 degrees F, enlarged lymph nodes on the right side of his groin, and an injection site reaction characterized by swelling and pain.  The child also experienced minimal upper respiratory symptoms and superficial ecchymosis. On 11/24/2000 the pt developed a fever of 105 degrees F and had a clear nasal discharge, moderately enlarged tonsils, and a macular reticular rash on his face and chest. On 12/05/2000, the pt developed hives for which he was treated with Benadryl. The following day, a diagnosis of bronchitis was made and Zithromax therapy was initiated. This report is one of 3 cases of injection site reactions secondary to the same lot of Prevnar reported from the same institution. Follow-up information indicated that on pt also received the third dose of Recombivax-HB vaccine. The pt first experienced fever, ecchymosis, enlarged lymph nodes, and the injection site reactions on 11/21/2000. The pt has recovered. A copy of this report has been forwarded to Merck.
Age: 1.25
Sex: M
Vaccine: HBPV, HEP, MMR, PNC
Symptoms: Rhinorrhoea, Tonsillitis, Urticaria
Clinical narrative: Within one week subsequent to receiving vax, the pt developed a fever of 102 degrees F, enlarged lymph nodes on the right side of his groin, and an injection site reaction characterized by swelling and pain.  The child also experienced minimal upper respiratory symptoms and superficial ecchymosis. On 11/24/2000 the pt developed a fever of 105 degrees F and had a clear nasal discharge, moderately enlarged tonsils, and a macular reticular rash on his face and chest. On 12/05/2000, the pt developed hives for which he was treated with Benadryl. The following day, a diagnosis of bronchitis was made and Zithromax therapy was initiated. This report is one of 3 cases of injection site reactions secondary to the same lot of Prevnar reported from the same institution. Follow-up information indicated that on pt also received the third dose of Recombivax-HB vaccine. The pt first experienced fever, ecchymosis, enlarged lymph nodes, and the injection site reactions on 11/21/2000. The pt has recovered. A copy of this report has been forwarded to Merck.
Age: 0.6
Sex: F
Vaccine: DTAP, PNC
Symptoms: Nasal congestion
Clinical narrative: One day post vax, the pt developed nasal congestion. As of 12/08/2000, the nasal congestion had not resolved.
Age: 1.5
Sex: M
Vaccine: DTP, IPV, PNC
Symptoms: Erythema multiforme
Clinical narrative: Subsequent to receiving vax, the pt was seen by a dermatologist and a diagnosis of erythema multiforme was made. Titers were drawn to rule out any infections or other causes.
Age: 1.5
Sex: M
Vaccine: IPV, PNC
Symptoms: Immunoglobulins decreased, Infection
Clinical narrative: A nurse reported that an 18 month old male received his 1st dose of Prevnar, as well as, IPV on 9/20/00 and 7 days later, developed an entire body blisters (zoster-type lesions). The pt was referred to a dermatologist and treated with alclometasone dipropionate. Additional information received on 1/23/01 included tests results.
Age: 4.0
Sex: F
Vaccine: PNC
Symptoms: Dyskinesia, Tremor
Clinical narrative: A mother who is also a nurse, reported that her 4 year old daughter received an injection of Prevnar on 12/12/00 and 2 nights later, awakened complaining of "shivers" but denied being cold. Her mother noted intermittent, involuntary jerking motions of her daughter's body. The mother reported that her daughter was afebrile, alert and oriented. Her symptoms resolved approx. 6 hours later. Additional information received on 1/25/01, from the physician indicated that the pt has had no subsequent jerky movements or episodes of altered awareness.
Age: 2.0
Sex: U
Vaccine: PNC
Symptoms: Drug ineffective
Clinical narrative: A sales representative reported that a 2 year old child received 2 doses of Prevnar and had pre and post vax sero-types drawn. Titers showed no level of response. The pt's medical history indicated that the child is "highly resistant to strep pneumonia". As of 12/15/00, no further information was available.
Sex: U
Vaccine: PNC
Symptoms: Unevaluable event
Clinical narrative: A healthcare professional reported that a pt received Prevnar and experienced an unspecified reaction. No further information was available at the date of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site erythema, Injection site swelling, Irritability, Pyrexia, Respiratory rate increased
Clinical narrative: A mother reported that her 15 month old son with a history of "reflux" received Prevnar and Hib vaccines on 12/18/00 and subsequently, vomited in the physician's office. Later that day, he vomited and slept for an unusually long time. He developed a low-grade fever, rapid breathing and he was fussy. On 12/19/00, the fever resolved. He then developed an injection site reaction characterized by redness and swelling at the site of the Prevnar injection. He was treated with diphenhydramine. On 12/20/00, his breathing was improved.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC
Symptoms: Somnolence, Vomiting
Clinical narrative: A mother reported that her 15 month old son with a history of "reflux" received Prevnar and Hib vaccines on 12/18/00 and subsequently, vomited in the physician's office. Later that day, he vomited and slept for an unusually long time. He developed a low-grade fever, rapid breathing and he was fussy. On 12/19/00, the fever resolved. He then developed an injection site reaction characterized by redness and swelling at the site of the Prevnar injection. He was treated with diphenhydramine. On 12/20/00, his breathing was improved.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, MMR, PNC
Symptoms: Agitation, Insomnia, Irritability
Clinical narrative: A mother reported that her 12 month old son received Prevnar and MMR on 12/8/00. On 12/15/00, he experienced irritability and crying. Additional information received from the physician on 1/17/01, indicated that the pt was seen in the physician's office on 12/19/00 where a physical exam was normal. Follow up info was received from the center for biologics evaluation and research on 09/04/2001. The child received his second dose of Prevnar and his first dose of MMR vaccines on 12/08/2000. On 12/15/2000, he experienced insomnia.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, MMR, PNC
Symptoms: Crying, Infection, Insomnia, Irritability
Clinical narrative: A mother reported that her 12 month old son received Prevnar and MMR on 12/8/00. On 12/15/00, he experienced irritability and crying. Additional information received from the physician on 1/17/01, indicated that the pt was seen in the physician's office on 12/19/00 where a physical exam was normal. Follow up info was received from the center for biologics evaluation and research on 09/04/2001. The child received his second dose of Prevnar and his first dose of MMR vaccines on 12/08/2000. On 12/15/2000, he experienced insomnia.
Age: 0.75
Sex: F
Vaccine: HEP, PNC
Symptoms: Injection site hypersensitivity, Injection site induration, Urticaria
Clinical narrative: A territory representative reported that a 9 month old female received an injection of Prevnar on 12/20/00. Approx. 24 hours, post vax, she developed an injection site reaction characterized by hives and induration. On 12/22/00, the reaction site measured 7cm X 5cm. Additional information received from the physician on 1/25/01, indicated that the dose of Prevnar may have been inadvertently, administered subcutaneously. She recovered.
Age: 1.25
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Rhinorrhoea
Clinical narrative: A mother reported that her 15 month old son received his 3rd dose of Prevnar on 9/23/00. He developed a runny nose and was empirically treated with amoxicillin. On 12/20/00, he returned a positive throat culture for a strain of Streptococcus pneumonia that was "resistant to antibiotics". The serotype was not specified. He recovered.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: A company representative reported that a 2 year old female received Prevnar vaccine and subsequently developed an allergic reaction including hives. She was treated with diphenhydramine (Benadryl) and recovered. The reporter noted that the pt was allergic to penicillin and cephalosporins. Follow up infomation was received from the physician on 03/05/2001 which identified the patient, date of vaccination and adverse event onset.
Age: 0.5
Sex: M
Vaccine: PNC
Symptoms: Hypoventilation, Pyrexia, Wheezing
Clinical narrative: A nurse reported that a 6 month old male received his 1st dose of Prevnar on 5/3/00. Within 2-3 days, post vax, he developed a high fever, wheezing and shallow breathing. He recovered.
Age: 0.75
Sex: M
Vaccine: PNC
Symptoms: Irritability
Clinical narrative: A mother reported that her 9 month old son received his 1st dose of Prevnar and subsequently experienced irritability and crying. He recovered.
Sex: U
Vaccine: PNC
Symptoms: Eye swelling, Irritability
Clinical narrative: A company representative reported that a child received an injection of Prevnar in 1/01. The next day, the child developed swollen eyes and was irritable, cranky, and "very" upset. No further information was available as of the date of this report.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Drug ineffective, Flatulence, Influenza, Pyrexia
Clinical narrative: A mother reported that her 26 month old son received his 1st dose of Prevnar in 10/00. Two weeks, post vax, he developed a high fever, abdominal gas, diarrhea and vomiting. The symptoms lasted 5 days. The reporter noted that the physician stated "this was flu, not related to Prevnar". Antibodies were checked 3 weeks, post vax, and reportedly, no antibody response was noted. The child has a history of ear and upper respiratory tract infections since he was 5 months old. Allergies have been ruled out by a blood test. Common variable Immune Deficiency Syndrome has been ruled out. IgA antibody tests were negative.
Age: 2.0
Sex: M
Vaccine: PNC
Symptoms: Vomiting
Clinical narrative: A mother reported that her 26 month old son received his 1st dose of Prevnar in 10/00. Two weeks, post vax, he developed a high fever, abdominal gas, diarrhea and vomiting. The symptoms lasted 5 days. The reporter noted that the physician stated "this was flu, not related to Prevnar". Antibodies were checked 3 weeks, post vax, and reportedly, no antibody response was noted. The child has a history of ear and upper respiratory tract infections since he was 5 months old. Allergies have been ruled out by a blood test. Common variable Immune Deficiency Syndrome has been ruled out. IgA antibody tests were negative.
Sex: U
Vaccine: PNC
Symptoms: Unevaluable event
Clinical narrative: Subsequent to receiving vax, the pt experienced and unevaluable reaction. It is unknown if the pt was taking concomitant therapy and medical history was not provided. The caller refused to provide any additional information and therefore, additional information is unattainable.
Sex: M
Vaccine: PNC
Symptoms: Nonspecific reaction
Clinical narrative: The pts parent reported that the pt had a very bad reaction following vaccination with Prevnar. The vaccine was given in the deltoid muscle along with another unspecified vaccine.
Age: 0.25
Sex: M
Vaccine: PNC
Symptoms: Erythema, Rash, Skin exfoliation
Clinical narrative: Subsequent to receiving vax, the pt developed a flaky red rash on his face and arms.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC
Symptoms: Decreased appetite, Nasal congestion, Pyrexia, Somnolence
Clinical narrative: A nurse reported that a 15 month old female received injections of a 1st dose of Prevnar and a dose of Infanrix on 1/12/01. The pt had a "low-grade" fever of 99F (R), prior to receiving the vaccinations. Three to four hours, post vax, the pt experienced a fever, decreased appetite, drowsiness and nasal congestion. It was noted that the nasal congestion was persisting 1 week later. Follow up information was received on 03/06/2001 that clarified the sites of vaccination injections; right thigh for Prevnar and left thigh for Infanrix. Also, the patient had received 3 previous doses of Infanrix prior to this current one. The patient received no other vaccinations within four weeks of 01/12/2001, and was receiving no other medications concomitantly. The patient's symptoms lasted until the end of January 2001.
Sex: U
Vaccine: PNC
Symptoms: Arthritis
Clinical narrative: A pediatrician reported, via a company representative, than an unidentified child received Prevnar vaccine and subsequently, developed arthritis. No further information was available as of the date of this report.
Sex: U
Vaccine: PNC
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A nurse reported that a pt received an injection of Prevnar and subsequently, developed cellulitis at the injection site. No further information was available at the date of this report. The reporter indicated that 13 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 0.75
Sex: F
Vaccine: DTAP, PNC
Symptoms: Irritability, Nasal congestion, Ocular hyperaemia, Otitis media, Pruritus
Clinical narrative: A mother reported that her 9 month old daughter received Prevnar and DTAP vaccines on 10/31/00. Approx. 1 week, post vax, she became "severely sick". She had a bright red rash from head to toe and was itchy. The rash went down her throat. She developed irritability, fevers above 103F, congestion, pink eye and was hard to wake up. As of 2/5/01, she had the rash again, and was congested. Additional information received from the physician on 03/13/2001 indicated that a diagnosis of right otitis media and sinusitis were made. The patient was treated with amoxicillin and recovered.
Age: 0.75
Sex: F
Vaccine: DTAP, PNC
Symptoms: Pyrexia, Rash, Sinusitis, Somnolence
Clinical narrative: A mother reported that her 9 month old daughter received Prevnar and DTAP vaccines on 10/31/00. Approx. 1 week, post vax, she became "severely sick". She had a bright red rash from head to toe and was itchy. The rash went down her throat. She developed irritability, fevers above 103F, congestion, pink eye and was hard to wake up. As of 2/5/01, she had the rash again, and was congested. Additional information received from the physician on 03/13/2001 indicated that a diagnosis of right otitis media and sinusitis were made. The patient was treated with amoxicillin and recovered.
Age: 1.25
Sex: F
Vaccine: FLU3, PNC
Symptoms: Contusion, Diarrhoea, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: A nurse reported that a 15 month old female received her 1st injection of Prevnar and Fluzone vaccines on 12/4/00. Later that day, the child developed an injection site reaction characterized by bruising and pain upon touching. Two days later, the child experienced viral syndrome with diarrhea and a fever of 102.5F. This report is 1 of 3 cases of injection site reactions secondary to the same lot of Prevnar reported from the same institution. See case ID #'s HQ4692111DEC2000 and HQ6902606FEB2001 for the reports on the other cases. Follow-up information received on 3/5/01 revealed the child was not receiving concomitant medications.
Age: 1.25
Sex: F
Vaccine: FLU3, PNC
Symptoms: Viral infection
Clinical narrative: A nurse reported that a 15 month old female received her 1st injection of Prevnar and Fluzone vaccines on 12/4/00. Later that day, the child developed an injection site reaction characterized by bruising and pain upon touching. Two days later, the child experienced viral syndrome with diarrhea and a fever of 102.5F. This report is 1 of 3 cases of injection site reactions secondary to the same lot of Prevnar reported from the same institution. See case ID #'s HQ4692111DEC2000 and HQ6902606FEB2001 for the reports on the other cases. Follow-up information received on 3/5/01 revealed the child was not receiving concomitant medications.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: A nurse reported that a 3 month old male received Prevnar, Comvax, IPV and DTAP vaccines on 2/2/01. That day, he developed an injection site reaction on the left leg characterized by swelling, redness and tenderness. He experienced extreme fussiness, screaming and crying when any part of his left leg was touched. Prevnar and Comvax were both injected into the left leg. He was treated with ibuprofen. He recovered.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Erythema, Injection site reaction, Irritability, Oedema
Clinical narrative: A nurse reported that a 3 month old male received Prevnar, Comvax, IPV and DTAP vaccines on 2/2/01. That day, he developed an injection site reaction on the left leg characterized by swelling, redness and tenderness. He experienced extreme fussiness, screaming and crying when any part of his left leg was touched. Prevnar and Comvax were both injected into the left leg. He was treated with ibuprofen. He recovered.
Age: 0.25
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Screaming, Tenderness
Clinical narrative: A nurse reported that a 3 month old male received Prevnar, Comvax, IPV and DTAP vaccines on 2/2/01. That day, he developed an injection site reaction on the left leg characterized by swelling, redness and tenderness. He experienced extreme fussiness, screaming and crying when any part of his left leg was touched. Prevnar and Comvax were both injected into the left leg. He was treated with ibuprofen. He recovered.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pharyngitis, Rash
Clinical narrative: An NP reported that a 4 month old child received the 1st dose of Prevnar and 2nd doses of IPV, Tripedia and Act-Hib vaccines on 2/12/01. Later that day, the child developed a red rash on the face, buttocks and extremities. Additional information received from the nurse practitioner on 03/12/2001 indicated the infant was suffering from pharyngitis at the time of vaccination.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: A mother reported that her 10 month old son with an ear infection received his 2nd dose of Prevnar on 2/1/01. That day, he developed a fever of 100F to 102F, diarrhea, nausea and vomiting. He was treated with azithromycin and cephalexin. As of 2/14/01, the fever resolved but the nausea, diarrhea and vomiting persisted.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Flushing, Injection site swelling, Swelling face
Clinical narrative: A physician reported that a 6 month old infant received Prevnar and Tripedia vaccines on 1/24/01. Within minutes, post vax, the child developed flushing, especially facial flushing, and swelling at the site of the Prevnar injection. The child was treated with diphenhydramine and recovered. Additional information received from the patient's allergist on 03/12/2001 indicated the patient also developed facial swelling.
Age: 0.08
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: A nurse reported that a 44 day old female received injections of a 1st dose of Prevnar, a dose of DTAP, IPV and COMVAX on 2/12/01. On 2/13/01, 24 hours, post vax, the pt developed an erythematous rash on her face extending down onto her neck. She also developed a fever of 102F. Follow up information received from the original reporter on 04/02/2001 who indicated the patient's symptoms reportedly resolved. The rash actually occurred 3 days following vaccination on 02/15/2001 and was "probably" unrelated to vaccination.
Age: 0.25
Sex: M
Vaccine: PNC
Symptoms: Dermatitis, Ear disorder, Infection, Sinusitis
Clinical narrative: The mother of a 3 month old male reported that her son received his 2nd dose of Prevnar in 9/00 (approx. 3 months of age when received 2nd dose). The pt recently recovered from a "chronic dermatitis around his mouth" that resolved when he was switched to a latex-free bottle. In 11/00, the pt (approx. 5 months of age) developed a bilateral ear infection and sinusitis and was prescribed Zithromax (azithromycin). In 12/00, the symptoms were not resolving and the pt was prescribed Cefzil (cefprozil). NOTE: See report HQ8556919MAR2001 for events following the 3rd dose of Prevnar.
Age: 2.75
Sex: F
Vaccine: PNC
Symptoms: Pruritus, Rash
Clinical narrative: A physician reported that a 33 month old female with a recent history of ear infection, received her 1st dose of Prevnar on 2/9/01. On 2/10/01, she developed a "mildly" itchy rash that started on her legs as small bumps and spread to her torso and then her face. The rash persisted throughout the week.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypokinesia, Injection site mass, Pyrexia
Clinical narrative: A nurse reported that a 4 month old male received Prevnar, IPV, DTAP and haemophilus B vaccines on 2/20/01. Immediately, post vax, he developed a fever. The next morning, he developed a hard knot at an unspecified injection site and his movement was restricted. He was treated with alternating doses of ibuprofen and acetaminophen. On 2/22/01, his body temperature was 98.2F.
Age: 1.25
Sex: M
Vaccine: HEP, HIBV, PNC
Symptoms: Hypokinesia, Pyrexia
Clinical narrative: This report was received on 2/21/01 from the mother of a 15 month old male who received his 1st dose of Prevnar, 3rd dose of Hib-Titer and Hep-B on 2/12/01. That same evening, the pt experienced a fever of 102F and difficulty using his legs. The pt recovered the following day. The pt was not receiving any concomitant medications and medical history was negative. Follow up information received on 04/11/2001 from the responsible physician indicating the patient did not receive Hib-Titer.
Age: 1.08
Sex: F
Vaccine: PNC
Symptoms: Rash
Clinical narrative: A mother reported that her 13 month old daughter received her 1st dose of Prevnar in mid 11/00. The child developed a rash that "looks like eczema" in mid 12/00. The rash started as dry patches on her face and has spread to her shoulders and neck. The rash is being treated with cortisone cream, which has "helped a little". The rash continues.