chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: 7 days subsequent to receiving one dose of varicella virus vaccine live the pt experienced a local injection site rash on the right leg. It was described as a red, not raised, hard and approximately the size of a half dollar. The pt sought unspecified medical treatment. Follow up information indicated the pt experienced swelling, erythema and itching at the injection site. The skin was indurated 2 X 2 cm and warm and the puncture site was prominent. The pt recovered. No further information is available.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: 15 days post vax the pts mother noticed one quarter sized red wheal at the injection site. The wheal was described as gigantic spot on right arm at injection site. Looks like a bite, red and is quarter size. It was noted that the pt was afebrile. The pt sought unspecified medical attention. It was indicated that the pts mother was advised to apply warm compresses on the pt as well as administer Benadryl. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a rash on the upper shoulder area with no vesicular outbreak. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt presented to a physician with herpes zoster of the ophthalmic division of the trigeminal nerve on left side. He has no reported fever or other signs/symptoms. A viral culture specimen obtained showed negative and direct immunoflourescence was positive for varicella. The pt recovered.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: 3 days post vax the pt developed 100 - 200 generalized lesions on his torso, legs, arms, neck and face which later became maculopapular. He also experienced a fever of 101.5F. The pt was seen by a communicable disease nurse at which time nearly all of his lesions had resolved. The nurse was not sure whether the child had chickenpox, but felt that the rash was the result of some viral infection. A throat culture was done with results pending. The child's fever persisted and he continued to feel poorly. No further information is available.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: One dose of vax was received on 05/27/99. Subsequent to receiving varicella virus vaccine live, on 06/08/99, the pt developed generalized vesicular, papular rash. It was indicated that the pt sought medical attention for the symptoms. Subsequently, the pt recovered. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Influenza like illness, Rash, Rhinorrhoea
Clinical narrative: Information recieved form a man concerning his son who in July 1999 recieved vax. Approximately 24 days post vax the pt experienced sniffling, flu like symptoms and seven marks. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Twelve days post vax, on 08/25 the pt developed a generalized classic rash that consisted of an unknown number of lesions. The pt was afebrile. Follow up information from a physician reported that the pt went elsewhere for his diagnostic and work up. No further information available on the pt.
Age: 1.4
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Anorexia, Blister, Erythema, Mouth ulceration, Pharyngolaryngeal pain
Clinical narrative: This pt had an otic infection at the time of vax. She received vax on 08/20/99. Six days post vax the pt experienced cold sores in each corner of the mouth. The pt was not eating or sleeping well. The pts mother was exceptionally concerned that this may be secondary to varicella vaccine and that someone may catch it from her. It was also noted extremely concerned that it could be possible herpes and there could be significant consequences. It was also reported that the pts family had a history of immunodeficiency. Follow up was received from an LPN. On 08/30, four days post onset the pharynx was erythematous with come viral type vesicle on the soft palate. She had cracking and irritation in the corner of the mouth and was teething all four molars. This was felt to be possible viral pharyngitis. The physician felt the symptoms were unrelated to varicella virus vaccine live. No further information is available.
Age: 1.4
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Sleep disorder, Viral infection
Clinical narrative: This pt had an otic infection at the time of vax. She received vax on 08/20/99. Six days post vax the pt experienced cold sores in each corner of the mouth. The pt was not eating or sleeping well. The pts mother was exceptionally concerned that this may be secondary to varicella vaccine and that someone may catch it from her. It was also noted extremely concerned that it could be possible herpes and there could be significant consequences. It was also reported that the pts family had a history of immunodeficiency. Follow up was received from an LPN. On 08/30, four days post onset the pharynx was erythematous with come viral type vesicle on the soft palate. She had cracking and irritation in the corner of the mouth and was teething all four molars. This was felt to be possible viral pharyngitis. The physician felt the symptoms were unrelated to varicella virus vaccine live. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: On 7/16/99, the pt developed clinical varicella, greater than fifty papulovesicular lesions, and a little oozing. The pt was seen by a physician. The eruptions lasted 2 weeks and cleared and then reappeared. There was no fever present. The reporter had a concern about the lot number of the vaccine. Follow-up information from a registered pharmacist reported that his son's experience was not an adverse experience.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: On 11/24/98, this pt recieved vax. Subsequent to receiving one dose of varicella virus vax, in 08/99, the pt experienced clinical varicella with more than 50 papulovesicular lesions with oozing. The eruptions lasted 2 weeks, cleared then reappeared.  The pt was afebrile. The pt sought unspecified medical treatment. Additionally the pharmacist reported that his other child experienced a similar reaction. Follow up information received from the physician indicated that on 08/11/1999 the pt experienced atypical varicella. The pt's sibling experienced the same reaction on 07/28/1999. On an unspecified date the pt recovered. No further information is available.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: One day post vax the pt developed varicella like rash. It was indicated that the pt had approximately fifty lesions located mainly on his arm. No medical attention was sought. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash papular
Clinical narrative: This child received the vax in either November or December 1998. Eight to nine months post one dose of varicella virus vaccine live, on 08/25/99, the pt experienced clinical varicella with greater than 50 papulovesicular lesions with oozing. The pt was afebrile. The pt sought unspecified medical treatment. Additionally the pharmacist noted that his other child experienced a similar reaction.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash morbilliform
Clinical narrative: On 8/15/99, the pt experienced a very faint morbilliform rash that began on her arms and upper neck. The rash was not pruritic initially but the next day did become pruritic, however, the pt did note that she had been out in the sun that day. Additionally, it was noted that the pt had just finished a course of Sulfatrim for a UTI. On 8/27/99, the rash had spread to the pt's face, arm, feet, and neck and was pruritic. The physician dx the condition as an allergic reaction and stated the rash is not varicella like, however, not sure which agent caused it. The pt was treated with Atarax. On 8/31/99, the pt recovered. No further information is available.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Less than one month subsequent to receiving vax the pt developed approximately 50 varicella lesions and was place in isolation. The rash was described as papules vesicle located mainly on his face, chest, abdomen, rectal area, and legs. In addition he developed a fever of 102.1 (taken rectally), however the pt is known to have poor thermoregulatory control. The reporter expressed concern with the vaccine lot administered to the pt. The pt recovered. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Nine days post vax the pt developed approximately less than 50 generalized chickenpox lesions located mainly on his trunk and face. The pt was afebrile. On presentation to a physician he was placed on therapy with Benadryl and Aveeno lotion. Follow up information indicated that the pt recovered.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Pruritus, Pyrexia
Clinical narrative: Approximately 3 weeks post vax the pt developed about 75-100 generalized varicella lesions with fever of 100.9 F. The rash was described as pruritus, papule vesicle. The pt sought unspecified medical attention. The reporter expressed concern with the vaccine lot administered to the pt. Subsequently the pt recovered. No further information is available.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Pyrexia
Clinical narrative: Subsequent to receiving second dose of varicella virus vaccine live the pt experienced continuous extreme fatigue and an unexplained fever one day per week which peaks at 4PM to 7PM. the pt sought unspecified medical treatment. Additional information had been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash
Clinical narrative: Subsequent to receiving varicella virus vaccine live on 06/10/99, the pt presented to her physicians office in 08/99 with a "diffuse case of chickenpox." It was reported that the child had "many lesions and a low grade fever." Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity
Clinical narrative: Subsequent to receiving varicella virus vaccine live the pt experienced pox at the injection site. The pt sought unspecified medical treatment. Additional information has been requested. Further information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity
Clinical narrative: Subsequent to receiving varicella virus vaccine live the pt developed a local reaction characterized by erythema. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live ont 02/05/98, the pt experienced between 40-50 spots on her legs, vagina, buttocks and belly on 08/20/99. The pt was very itchy and had a fever of 102F. The pt sought unspecified medical treatment and was treated with Tylenol. Her fever went down to 101F. Additional information has been requested.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Subsequent to receiving varicella virus vaccine live on 08/18/98, the pt developed 8-10 lesions on neck with several on arms and chest on 08/25/99. It was noted that the pt has not been exposed to chickenpox or shingles. Additionally the pt had a fever of 99.7. Follow up information from a registered nurse reported that the pt recovered.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Approximately 8 hours post vax received on 08/30/99, the pt experienced fever of 102F. Two days post vax on 09/01, the pt developed approximately 100 fluid filled vesicular rash. It was noted that the pt was never seen or evaluated by a physician, she telephoned the clinic to report the events. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: Subsequent to receiving varicella virus vaccine live, laboratory evaluation revealed failure to seroconvert following vaccination. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Seven children ages 3 - 9 years old who were exposed to other children who were vaccinated with varicella virus vaccine live and who had not experienced a post vax rash experienced herpes zoster. Subsequently the pts experienced herpes zoster. The pts did not have known exposure to chickenpox nor had they received varicella virus vaccine live. The physician believed the occurrences of herpes zoster had occurred within 30 days of the vaccinee's vaccination. No further information is available.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Rash papular, Rash vesicular
Clinical narrative: Approximately 2 weeks post vax the pt developed a low grade fever and broke out in a rash. The pt was seen by a physician who reported that the pt was covered with very, very small papular lesions. The lesions were all over the child's body and she definitely has more than 50. Additionally the physician reported that the pt developed coryza. The physician expressed a concern about the lot number. Follow up information from a physician reported the rash became generalized and was small vesicular and pruritic is nature. The physician was unable to obtain fluid culture as the vesicles were reportedly too small. The pt was treated conservatively. The pt recovered without sequelae.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Rhinitis
Clinical narrative: Approximately 2 weeks post vax the pt developed a low grade fever and broke out in a rash. The pt was seen by a physician who reported that the pt was covered with very, very small papular lesions. The lesions were all over the child's body and she definitely has more than 50. Additionally the physician reported that the pt developed coryza. The physician expressed a concern about the lot number. Follow up information from a physician reported the rash became generalized and was small vesicular and pruritic is nature. The physician was unable to obtain fluid culture as the vesicles were reportedly too small. The pt was treated conservatively. The pt recovered without sequelae.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: One day post vax the pt experienced arthralgias of both hips, rib pain, b/l wrist pain, myalgias of both thighs, low grade fever and fatigue. Sedimentation rate was elevated at 30. It was reported that the symptoms waxed and waned and abruptly resolved on 09/12/1999.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Approximately 2-3 years post vax a pre-school pt developed chickenpox and was excluded from school. The pts brother also had a reaction following exposure to varicella virus live.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: 9-10 days post vax the pt developed generalized chickenpox outbreak and fever. 5 days post onset the pts lesions dried up. His fever lasted 2 days. The pt sought unspecified medical attention. No further information is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt broke out in chickenpox with marks covering her torso with more on her legs and face. She was seen by the school nurse. The pts sister also had a similar experience.  No further information is available.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt was exposed to varicella. 1-2 weeks post exposure she developed a moderate case of breakthrough chickenpox. The pt sought unspecified medical attention. She recovered from the experience. It was reported that 2 of the pts siblings had similar experiences. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt was exposed to varicella. Approximately 10 days post exposure the pt developed a moderate case of breakthrough varicella. The pt sought unspecified medical attention. Subsequently the pt recovered. It was reported that two of the pts siblings had similar experiences. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Subsequent to receiving vaccines the pt broke out in a moderate case of chickenpox with an unspecified number of lesions. The pt recovered. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, OPV, VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Approximately 5 days post vax the pt developed a rash described as red, round, raised areas, about 12 spots peppered on face and hands. The pt had itching but no fever. The pt did not have blisters, so no crusting occurred. Follow up information from a registered nurse reported that the pt subsequently recovered.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis contact, Herpes zoster, Infection, Pruritus, Rash
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt developed itchy rash on his thigh. He was presented to a physician who diagnosed shingle on his left inner thigh, groin and penis. A week prior he was a pediatrician and was diagnosed with contact dermatitis. He was given cortisone ointment. This did not help. The pt was then referred to a dermatologist who diagnosed shingles. The pts symptom resolved.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Approximately 9 days post vax the pt experienced an oblong red rash with 3 pin point sized bumps. The pt was afebrile The pt sought unspecified medical treatment. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Subsequent to receiving two doses of varicella virus vaccine live the pt failed to seroconvert. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox with greater than 300 lesions. The pt sought unspecified medical treatment. The pt was noted as covered with lesions but not in mouth. Additionally the physician noted course and recovery were uneventful. The pt recovered. No further information is available.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Face oedema, Pruritus
Clinical narrative: Subsequent to receiving vax pt experienced difficulty breathing, itching and a swollen face. The itching appeared 48 hours post vax with the breathing difficulties occurring 5 days post vax. On the 6th day post vax the pt woke up with a swollen face. The pt took homeopathic antihistamine during the 4th - 6th days post vax and Benadryl at night. By the 7th day the breathing difficulties had resolved and the itching and swelling were getting better. The pt has been advised not to have the influenza vaccine again.
Age: 39.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injection site hypersensitivity
Clinical narrative: p/vax pt w/"1/4" blister formation @ site of inj;otherwise asymptomatic;requested client to come to clinic for further eval; Per HCP follow up report- spoke with patient 11/18/99 at 6pm about prescence of blister formation-exact onset time not noted.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rash macular
Clinical narrative: Pt experienced a generalized macular confluent rash affecting his entire back with a fever of100.4 5 minutes post vax. Pt was diagnosed  with an allergy to influenza vaccine and treated with Benadryl. The pt was previously immunized 16 times for influenza with no adverse effects.
Age: 0.9
Sex: M
Vaccine: DTAP, DTAP
Symptoms: Cardiac arrest, Hypotonia
Clinical narrative: Pt found to be cold & limp by mother who checked on him during his nap. Arrived in ER in asystole, DOA. 07/06/2000 Call from reporter today to say she finally obtained autopsy report and will fax it to us.  07/07/2000 autopsy report received from coroner. COD acute pulmonary decompensation due to DAD. Case complete.
Age: 4.0
Sex: F
Vaccine: DTAP, OPV, VARCEL, DTAP, OPV, VARCEL
Symptoms: Injection site hypersensitivity, Injection site mass, Injection site pain
Clinical narrative: Pt was seen on 2/2/00 with local toxic reaction (6-7 cm) induration , redness & sight tenderness.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, RV, DTAP, HIBV, IPV, RV
Symptoms: Convulsion
Clinical narrative: Subsequent to vax admin 5/27/99, pt devel seizures and continues to exp these as of Dec 99.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Convulsion, Dysphagia, Gaze palsy, Nuchal rigidity, Stupor
Clinical narrative: One day post vax the pt was given Reglan to treat gastroesophageal reflux.  Later that day the pt experienced approximately 15 episodes of staring, shaking, stiffness and arching of the back which lasted a few seconds to a few minutes. Physician observed a staring state and arching of the back and considered these events to be a generalized seizure. The pt was hospitalized. Pt was discharged after one day, but had tongue thrusting for 1 week after the seizure.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, DTAP, HIBV, IPV
Symptoms: Convulsion, Musculoskeletal stiffness, Opisthotonus, Staring, Tremor
Clinical narrative: One day post vax the pt was given Reglan to treat gastroesophageal reflux.  Later that day the pt experienced approximately 15 episodes of staring, shaking, stiffness and arching of the back which lasted a few seconds to a few minutes. Physician observed a staring state and arching of the back and considered these events to be a generalized seizure. The pt was hospitalized. Pt was discharged after one day, but had tongue thrusting for 1 week after the seizure.
Age: 24.0
Sex: M
Vaccine: TD, TD
Symptoms: Injection site reaction, Malaise, Pyrexia
Clinical narrative: 2 hours, post vax, pt developed a fever as well as hot flashes, chills, nausea, malaise and painful joints. The pt also developed an injection site reaction characterized by redness and tenderness. He was prescribed Motrin, increased fluids and rest. As of 4/13/00, the injection site reaction persisted.
Age: 24.0
Sex: M
Vaccine: TD, TD
Symptoms: Arthralgia, Chills, Hot flush, Injection site erythema, Injection site pain
Clinical narrative: 2 hours, post vax, pt developed a fever as well as hot flashes, chills, nausea, malaise and painful joints. The pt also developed an injection site reaction characterized by redness and tenderness. He was prescribed Motrin, increased fluids and rest. As of 4/13/00, the injection site reaction persisted.
Age: 24.0
Sex: M
Vaccine: TD, TD
Symptoms: Malaise, Nausea, Pyrexia
Clinical narrative: 2 hours, post vax, pt developed a fever as well as hot flashes, chills, nausea, malaise and painful joints. The pt also developed an injection site reaction characterized by redness and tenderness. He was prescribed Motrin, increased fluids and rest. As of 4/13/00, the injection site reaction persisted.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Haemoglobin decreased, Hypotonia, Stupor
Clinical narrative: Subsequently post vax, the pt developed a hypotonic reaction. The pt was hospitalized and placed on a ventilator. Follow-up information received on 18-Jul-2000 indicated that a 1-month-old male received his first doses of Prevnar, Hib-Titer Acel-Imune and IPV vaccines on 17-May-2000. On 19-May-2000, he developed a hypotonic reaction. One day later, he became restless, "very" quiet and did not breathe well, he required assisted ventilation. A "septic work up", EEG and echocardiogram were negative. The reporter indicated that the patient recovered; however, the reported also indiated that there "may be problems later" and that permanent disability is "to be determined". A copy of this report has been forwarded to manufacturerer of IPV. Cancelled: Follow-up information received from the physician on 22-Aug-2000 indicated that this case is a duplicate of case HQ6794902JUN2000.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Dyspnoea, Hypotonia, Mental impairment, Restlessness
Clinical narrative: Subsequently post vax, the pt developed a hypotonic reaction. The pt was hospitalized and placed on a ventilator. Follow-up information received on 18-Jul-2000 indicated that a 1-month-old male received his first doses of Prevnar, Hib-Titer Acel-Imune and IPV vaccines on 17-May-2000. On 19-May-2000, he developed a hypotonic reaction. One day later, he became restless, "very" quiet and did not breathe well, he required assisted ventilation. A "septic work up", EEG and echocardiogram were negative. The reporter indicated that the patient recovered; however, the reported also indiated that there "may be problems later" and that permanent disability is "to be determined". A copy of this report has been forwarded to manufacturerer of IPV. Cancelled: Follow-up information received from the physician on 22-Aug-2000 indicated that this case is a duplicate of case HQ6794902JUN2000.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Depersonalisation, Dyspnoea, Hypotonia, Hypoxia, Restlessness
Clinical narrative: Subsequently post vax, the pt developed a hypotonic reaction. The pt was hospitalized and placed on a ventilator. Follow-up information received on 18-Jul-2000 indicated that a 1-month-old male received his first doses of Prevnar, Hib-Titer Acel-Imune and IPV vaccines on 17-May-2000. On 19-May-2000, he developed a hypotonic reaction. One day later, he became restless, "very" quiet and did not breathe well, he required assisted ventilation. A "septic work up", EEG and echocardiogram were negative. The reporter indicated that the patient recovered; however, the reported also indiated that there "may be problems later" and that permanent disability is "to be determined". A copy of this report has been forwarded to manufacturerer of IPV. Cancelled: Follow-up information received from the physician on 22-Aug-2000 indicated that this case is a duplicate of case HQ6794902JUN2000.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Coma, Convulsion, Dyspnoea, Flushing
Clinical narrative: Same day post vax, the pt developed bright erythema which extended from her lower abdomen to her legs. She became unresponsive and had a stiffness or posturing (believed to be seizure activity) which lasted 5 minutes. Her vital signs were monitored and was given an unspecified breathing medication. She was brought to the ER and admitted.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Coma, Erythema, Musculoskeletal stiffness
Clinical narrative: Same day post vax, the pt developed bright erythema which extended from her lower abdomen to her legs. She became unresponsive and had a stiffness or posturing (believed to be seizure activity) which lasted 5 minutes. Her vital signs were monitored and was given an unspecified breathing medication. She was brought to the ER and admitted.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTP, HBHEPB, IPV
Symptoms: Convulsion, Crying, Depressed level of consciousness, Erythema, Musculoskeletal stiffness
Clinical narrative: Same day post vax, the pt developed bright erythema which extended from her lower abdomen to her legs. She became unresponsive and had a stiffness or posturing (believed to be seizure activity) which lasted 5 minutes. Her vital signs were monitored and was given an unspecified breathing medication. She was brought to the ER and admitted.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Pt receiving one dose of varicella virus vaccine live 2.5 weeks post exposure. Approximately 3 days post vax the pt developed approximately half dozen pox. It was noted that the pt was afebrile. The pts sister had a similar experience following exposure to varicella virus vaccine live. Follow up was received which indicated the pt recovered after a few days.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Pt received one dose of varicella virus vaccine live 2.5 weeks post exposure. Several days post vax, the pt developed very few pox marks. It was noted that the pt was afebrile. The pts sister had a similar experience following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash
Clinical narrative: Subsequent to receiving vax, the pt experienced a rash around the neck, armpits, abdomen, and feet. There were also areas with blister like lesions. The pt recovered. No further information is available.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Conjunctivitis, Herpes zoster, Infection, Pyrexia, Rash vesicular
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live the pt developed herpes zoster with a positive DFA for VZV. His rash was described as vesicular with a distribution of many lesions along the trigeminal nerve and involving several dermatomes, including his left face. He also experienced conjunctivitis without corneal lesions and a subjective fever. The pt sought unspecified medical attention and was treated with acyclovir. Two swab specimens used to scrape the base of two vesicles on the child's left face were submitted for PCR analysis. It was reported that one PCR swab specimen was inadequate, while the other specimen was weakly positive for VZV. 5 days post onset the pt recovered from his experience. Follow up information receiving indicated that the second swab specimen was positive for the Oka/Kerck vaccine strain VZV. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Irritability, Rash vesicular
Clinical narrative: Approximately 2 weeks post vax the pt developed one fluid filled lesion on his nose and six fluid filled lesions on his back.  Based on the description the pts pediatrician diagnosed the pt with chickenpox over the phone. It was reported that the pt was also irritable and afebrile.  Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Hypersensitivity, Urticaria
Clinical narrative: Subsequent to receiving vax the pt developed about 20 wheals on her torso. She was treated with Benadryl and the wheals went away. A few days later she broke out with 30 wheals which left bruises when they went away. At one point the child had 50 wheals including some on her eyelids. The pt was seen by a physician and a dermatologist, both of whom felt her adverse reaction was related to therapy with varicella virus vaccine live. The pt was treated with Atarax. The pt currently has bruising on her back and abdomen with no lesions. Follow up information indicated that the pt has a history of pneumonia with one associated case of asthma at the age of six months. Pt was treated with albuterol at this time but never received steroid therapy. Pt never had a reoccurrence of asthma. The pt has had several colds and ear infections, but no other significant medical history. There was no other concurrent medication and no known exposure to varicella or a tan center. None of the lesions vesiculated or scabbed over. These first 20 lesions resolved after treatment with Benadryl, however bruising developed and remained at the site of the wheals. Several days later the pt again broke out with approximately 30 wheals, which also resolved and left bruises. At one point the pt has 50 wheals and each time they resolve she is left with bruising. There are no other signs or symptoms. The pt was seen by a physician who diagnosed the lesions as mosquito bites. She was seen by two other physicians who felt that they were a hypersensitivity reaction to varicella virus vaccine live. Pt began treatment with Atarax The pts experiences persisted. No further information is available.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Pyrexia, Rash
Clinical narrative: Five days post vax the pt developed generalized chickenpox with fever of 102.6F. It was indicated that the pt had approximately 50 lesions covering her entire body, but mostly on her head and torso. Subsequently the pt recovered from symptoms. The reporter expressed concern with the vaccine lot. No further information is available.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Rash, Skin disorder
Clinical narrative: Immediately following vax, the pt broke out in a rash on her butt. She then developed red, itchy bumps on her legs and arms. The pt was seen in the hospital and was said to have molluscum contagioscum. The hospital stated that she was contagious and that the rash would go away on its own. The pts condition persisted. No further information is available.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Aspartate aminotransferase increased, Haematocrit decreased, Haemoglobin decreased, Leukopenia, Pyrexia
Clinical narrative: Next day post vax, he developed a fever of 103.
Age: 0.75
Sex: M
Vaccine: HEP, PNC
Symptoms: Thrombocytopenia
Clinical narrative: Next day post vax, he developed a fever of 103.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Constipation
Clinical narrative: A few days post vax, the pt developed constipation. The constipation resolved after 1 day.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Erythema, Injection site erythema, Joint swelling, Rash papular, Skin ulcer
Clinical narrative: On 4/18/00, the pt developed a red, papular  rash with increased lesions noted around both vaccine sites. Additionally, the child experienced red and swollen ankles. The events were treated with Benadryl.
Age: 1.6
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dysphonia, Injection site erythema, Injection site warmth, Nasal congestion, Rhinorrhoea
Clinical narrative: A mother reported that he 18 month old son received his first injection of Prevnar, as well as Hib, DtaP and Polio on 4/18/00. Later that day, he developed an injection site reaction characterized by hardness, warmth and redness the size of a softball. The reporter also indicated that her son experienced hoarseness, congestion and a runny nose draining a thick green discharge. Additional information received on 5/18/00 from the physician indicated that the pt developed an injection site reaction at the site of the Acel-Imune administration. The reporter also indicated that the pt has an allergy to Omnicef.
Age: 2.25
Sex: F
Vaccine: PNC
Symptoms: Blister, Erythema multiforme, Pyrexia, Rash erythematous, Rash papular
Clinical narrative: On 4/24/00, she developed a "tremendous" papular rash, which was not pruritic on the top and bottom surfaces of her hands, feet, which blistered and turned black and blue; buttocks and thighs. She also developed an erythematous rash on her hard palate, lips and tongue, and described the rash as erythema multiforme. She also developed a fever of 100.6. She recovered.
Age: 2.25
Sex: F
Vaccine: PNC
Symptoms: Skin discolouration
Clinical narrative: On 4/24/00, she developed a "tremendous" papular rash, which was not pruritic on the top and bottom surfaces of her hands, feet, which blistered and turned black and blue; buttocks and thighs. She also developed an erythematous rash on her hard palate, lips and tongue, and described the rash as erythema multiforme. She also developed a fever of 100.6. She recovered.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Agitation, Condition aggravated, Infection, Pyrexia
Clinical narrative: The mother of an 18 month old female reported that her daughter received an injection of Prevnar on 4/21/00. Ten to 14 days prior to immunization, the child developed an ear infection. The infection was initially treated with amoxicillin, then amoxicillin/clavulanate. On 4/22/00, the symptoms of the child's ear infection worsened. The child became listless, her fever became higher and she cried and held her ear.
Sex: U
Vaccine: PNC
Symptoms: Erythema, Flushing, Irritability, Restlessness
Clinical narrative: A company representative reported that a child received an injection of Prevnar. That evening, the child developed irritability, restlessness and redness/flushing of his face. No further information was available at the date of this report.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Lethargy
Clinical narrative: A consumer reported that a 4 month old male received Prevnar, Hib-Titer, Tripedia, and IPV vaccines on 4/28/00. Immediately, the infant became quieter, and became less focal. (Talked less baby talk), and smiled less than usual. The reduction in vocalization and smiling persisted as of 5/4/00. A copy of this report has been forwarded to Aventis Pasteur.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth, Leukocytosis
Clinical narrative: A nurse reported that a 10 month old male received an injection of Prevnar on 5/2/00. One day post vax, the pt developed a fever of 103.6 and a red, warm, raised nodule at the injection site. He was seen by the physician. White blood cell count was 22700 cells. The physician prescribed ceftrixone and amoxicillin and clavulanate. As of 5/5/00, the fever was lower and the injection site nodule was beginning to resolve.
Age: 0.8
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: A nurse reported that a 10 month old male received an injection of Prevnar on 5/2/00. One day post vax, the pt developed a fever of 103.6 and a red, warm, raised nodule at the injection site. He was seen by the physician. White blood cell count was 22700 cells. The physician prescribed ceftrixone and amoxicillin and clavulanate. As of 5/5/00, the fever was lower and the injection site nodule was beginning to resolve.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Diarrhoea, Irritability, Pyrexia, Vomiting
Clinical narrative: A 10 month old female received a dose of Prevnar. On 5/1/00, the pt developed an "intermittent" tactile fever, and "severe" vomiting. Diarrhea and irritability also developed. These events continued over a 5 day period. The diarrhea, and irritability persist. This is one of two reports from this facility of an adverse experience following receipt of Prevnar.
Sex: U
Vaccine: PNC
Symptoms: Erythema, Flushing, Irritability, Restlessness
Clinical narrative: A company representative reported that a child received an injection of Prevnar. That evening, the child developed irritability, restlessness, and redness/flushing of the face. No further information was available at the date of this report.
Age: 1.1
Sex: F
Vaccine: PNC
Symptoms: Erythema, Rash, Swelling face
Clinical narrative: A nurse reported that a 13 month old female received an injection of Prevnar on 5/17/00. That evening her face became red and swollen. She recovered after several hours without treatment. Followup info received 8/14/00 indicated that the infant developed redness and swelling of the face and a fine rash on her abdomen within 30 to 45 minutes of immunization. She recovered by lunchtime the next day, without treatment. The reporter considered these events to be medically important (OMIC); therefore, this report has been reclassified as serious, unexpected.
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a female resident who was exposed to a pt who received varicella vaccine 14 days prior. Subsequently the pt was noted to be 3-5 weeks pregnant at the time of exposure and has not developed a rash. The pt sought unspecified medical treatment. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: PNC
Symptoms: Heart rate increased, Pyrexia, Vomiting
Clinical narrative: Two hours post vax, the pt developed a fever of 103, constant vomiting for 12 hours, and a heart rate of 180 beats per minute. The infant slept for 13 hours. He was taken to the ER where a urinary tract infection was reportedly ruled out. The infant was treated with ibuprofen. Follow up info received from the vaccine provider on 6/13/00 confirmed this event and provided the Prevnar lot number.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Pt received vax in 1997. On 9/2/99, the pt broke out in chickenpox with marks on her torso and many on her legs. She was seen by the school nurse.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, Balance disorder, Coordination abnormal, Electroencephalogram abnormal, Muscular weakness
Clinical narrative: Approximately two weeks post vax the pt developed CNS symptoms. The physician noted child's symptoms started as weakness in the legs. The weakness became worse and the child could no longer walk due to the loss of balance. Ataxia was diagnosed. The pts symptoms increased and the pt could no longer use his left arm. At the time of reporting the pt had regained the use of his arm, however, he still could not walk. An EEG was performed which was found to be normal. A pediatric neurologist was consulted and does not believe the pt has Guillain-Barre. Additional information has been requested. Follow up information from a physician reported that the pts EEG has changes and the pt has become progressively weaker. The pts pediatric neurologist feels that the pt may have some type of metabolic disorder. The physician has not completely ruled out the vaccinations as causative factors in the pt experience, however, it was looking less likely that the pts experience was in any way related to the vaccinations.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection, Pain, Pruritus
Clinical narrative: Subsequent to receiving vax the pt developed shingles, consisting of approximately 100 lesions. The distribution of the lesions was the C-5 region. His experience began as what appeared to be a bug bite between his shoulders, but developed in a perfect dermatomal pattern down his left arm. The pt complained of itching. The pt was afebrile. He reported his pain as a 2 on a sale of 1-10, 10 being the most pain. The pt was seen in the physician's office and treated symptomatically. The pt recovered. Follow up information reported that the preliminary PCR result was positive and further follow up indicated the the specimen was OKA/Merck vaccine strain.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Pt received first and second dose of varicella virus vaccine live. Subsequently, ELISA testing within 60 days post vax revealed negative seroconversion following second dose of the vaccine. Four other pts were reported with similar episode following vaccination with varicella virus vaccine live.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Two weeks post vax the pt developed 11 pustular vesicular erythematous skin lesions on the stomach and extremities. It was reported that the pt was afebrile. An ER or physician visit was required. Subsequently the pt recovered.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: One week post vax the pt developed 30 scabbed lesions located on the face, torso and extremities. It was noted that the pt was afebrile. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Subsequent to receiving vax the pt experienced what appears to be herpes zoster. The pt sought unspecified medical treatment. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Subsequent to receiving one dose of varicella virus vaccine live, testing results were negative for VZV antibodies. It was also noted that the pt did not respond to hepatitis B vaccine. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: FLUX
Symptoms: Eyelid oedema, Herpes simplex, Urticaria
Clinical narrative: 25 days post vax pt experienced lid edema and urticaria (upper arms, chest, shoulder). The duration of the symptoms are stated as 3 months. Treatment consisted of Lisino Apis D30 and Sulfur D30 but without lasting effect. After Influenza C30 was administered 01/21/1999 the symptoms increased then completely abated. It is also stated that 2 weeks post vax severe herpes labialis occurred along with lid edema and nettles which increased with cold and sleep, with intense.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Pt experienced generalized muscle aches after receiving vax. Pt still has complaints in both shoulders. He is concerned about taking vaccine.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Arthritis, Pain
Clinical narrative: 2 weeks post vax the pt experienced arthritis pain in his elbow, hip, ankle and knees for a duration of 4 months. Pt is now feeling better, however, his elbow still hurts. The pt has questioned the use of sequaline in flu.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion
Clinical narrative: Pt experienced phlegm build up in the laryngeal area after receiving Fluvirin and Pneumovax vax. The pt is currently seeing a speech therapist due to the phlegm build up. The pt has told her GP that the problem dated from 10/1997, when she received the vax.
Age: 78.0
Sex: F
Vaccine: FLUX
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: After receiving vax pt experienced polymyalgia rheumatica. Pt is recovering after treatment. The reaction has been described as progressive myalgia which became localized to peMC and shoulder girdles. Pt was treated with prednisone.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Haemorrhoids
Clinical narrative: Pt 055 in clinical study MPL318-01 with a history of hemorrhoids had a preplanned hemorrhoidectomy 1week and 4 days post vax. The pt was being treated with Tri-Adcortyl until the day of surgery. The vaccinee was hospitalized for 1 day. The procedure was performed under anesthesia and the pt was prescribed unspecified pain killers for post operative pain relief. In addition he was given Lactulose and Fybogel. The event is now considered to be resolved. The investigator considered the event to be moderate and unrelated to study medication. The Medical Reviewer also considered the event to be unrelated.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Nasal congestion, Productive cough, Pyrexia
Clinical narrative: Pt received Pnu-Imune 23 and Fluvirin on the same day into the right deltoid. Within 24 hours post vax the pt developed a fever of 104F which persisted for several days then decreased to 102F. She was afebrile as of 10/01/1998, but had a cough productive for white sputum and had chest congestion. It is recommended that these two vaccines be injected into separate sites when they are administered concomitantly. Follow up information information indicated that the vaccinee had a history of small cell lung adenocarcinoma which was treated with Taxol and carboplatin. Pt was treated with Tylenol which relieved her symptoms of fever, chest congestion and productive cough. The fever resolved after 48 hours and all symptoms are stated as having resolved 4 days post onset. Reporting physician strongly believes that the pts reaction may be related to injection of influenza and pneumo vax simultaneously.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: A few hours post vax the pt developed hives mostly on the arms, and was itching all over. Pt was seen by a physician and Benadryl tablets were prescribed. The outcome of the event was not reported. Additional detail indicated that the pt had hives; red, raised on wrists, forearm and one side of neck. The pt denied shortness of breath or difficulty breathing. Symptoms resolved after two days.