chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Infantile spasms, Myoclonic epilepsy, Nuclear magnetic resonance imaging
Clinical narrative: 3 days after shot she began having eye rolling and weird jerking movements in arms and face. Called DR several times to report this and they were not concerned at 1st. finally got appt to be seen exactly 1 week after shots were recvd and they made appt for EEG. 4 EEG's later and she is develop behind to a 1 month old per Dr and PT/OT. She may not be able to see/hear. She suffers from Infantile spasms/static encephalopathy and progressive myclonic epilepsy.  02/19/2007 MR received from PCP for office visits beginning on 11/06/2006 (date of vax.) to 01/30/2007. HPI: 1 week following vax. infant presented to PCP with parental c/o increasing frequency of eye movements.  Infant also has startle-like movements associated with the episodes PE: WNL. Assessment: ? seizures.  EEG to be obtained. Several more office visits for increasing frequency of seizures.  Seizures are focal, motor manifestations. Diagnosed with infantile spasms.  Pt did have a very short episode of upper extremity jerking during 12/09/2006 office visit. Assessment: Seizures/Other convulsions, non-febrile.  Infantile Spasms without mention of intractable epilepsy.  Treated with Topamax and ACTH.  02/26/2007 MR received from evaluating hospital for an admission to further work up child's infantile spasms. Admission PE showed a very chubby irritable child with slightly low tone in the musculoskeletal area.  Inconsistant tracking.  Can hold head when pulled up but cannot sit unsupported.  Does not reach for objects.  Axial hypotonia.  No attempt to roll over.  Otherwise WNL. Assessment:  Child appears to have a progressive encephalopathy in association with the onset of infantile spasms. Genetics and Metabolism Consult: Loss of developmental milestones now with developmental delay and seizure-like activity.  03/26/2007 DC Summary received from hospital stay. DC DX: Infantile Spasms.  Developmental Regression of milestones/delay. Developmentally delayed to a 2 month old still has abnormal EEG with Sz.
Age: 1.1
Sex: F
Vaccine: DTAP, HIBV, MMRV, PNC
Symptoms: Pruritus, Rash
Clinical narrative: Rash beginning at diaper area and axilla area, spreads to trunk. Extremely itchy.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMRV, PNC
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Reported that patient's mom stated that he had redness, swelling, and moderate pain the day after the vaccines were given. He would not let his mother touch his leg; MOTRIN was given every 6 hrs and he soaked/played in a tub of warm water x 1; His temp was not taken; mom states was dancing this am. Instructed how to apply warm compresses and draw a line around the redness and swelling with a pen if it gets larger or has a red line going up the leg to come to the HD or take to her health provider.
Age: 3.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Both childs thighs were red and swollen within 24 hours of injection.  Treated with Keflex and Benadryl on 1/25/07 at PCC Wellness.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Autism, Developmental delay, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of high fever in a 4-month-old female subject was vaccinated with Pediarix vaccine for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject's medical history included sinus allergy. The subject experienced a low grade fever following receipt of prior unspecified immunizations. Concurrent medications included Paracetamol (Tylenol). On 12 July 2004, the subject received the 1st dose of Pediarix. On 23 August 2004 the subject received 2nd dose of Pediarix. On an unspecified date in August 2004, less than one week after receipt of the 2nd dose of Pediarix, the subject experienced a high fever and was seen in an emergency room. The subject was treated with unspecified "medication to reduce the fever" and the fever resolved on an unspecified date. The vaccination course with Pediarix was discontinued. At an unspecified time following receipt of the 2nd dose of Pediarix, on an unspecified date, the subject's "overall development slowed down". On 14 November 2006, the subject was diagnosed with autism. The consumer reported that the events were considered disabling. At the time of initial reporting, 05 February 2007, the development delay and autism were ongoing.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: erythema and swelling at injection site
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Hyperhidrosis, Presyncope
Clinical narrative: c/o lightheadedness/dizzy with diarphoresis and near syncope-noted head pain to occipital reg. Dull non-radiating 2/10 in severity w/o visual disturbances (onset) 1 hr after injection.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Convulsion, Dyskinesia, Electroencephalogram normal, Muscle spasms, Muscle twitching
Clinical narrative: Initial report received on 25 January 2007 from another manufacturer, report numbers WAES0610USA09135. The reporter to this manufacturer had been a health care provider. Verbatim from the report: information has been received from a physician concerning a 24 week old female, with no medical history and no allergies, who 2 months ago, on 14 Aug 2006, was vaccinated with a first oral 2 ml dose of Rotateq (lot #653755/0319F). Concomitant vaccines administered on the same day included a dose of Prevnar, a dose of Daptacel, a dose of Comvax and a dose of Ipol. There was no illness at the time of vaccination and no adverse events following prior vaccination. "Three weeks ago", on approximately 21 Sep 2006, the patient developed spasms, described as a jumping type movement. The patient was evaluated in the hospital and released. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a physician indicated that on 02 Oct 2006 the patient was seen in the office and was observed for 15 minutes and had four episodes of spasms and jumping type movements which looked seizure like. On that same day the patient was admitted to the hospital. While hospitalized, the patient underwent and MRI and a 24 hour EEG both of which were negative for any seizure activity. The patient was subsequently discharged from the hospital after two days. The patient was seen by the physician on 11 Oct 2006 and was noted to be recovered, as she had not had any additional episodes of spasms and jumping type movements. Follow up information from a health professional indication that beginning on 01 Oct 2006 the patient presented with twitching and was referred to a neurologist for a work up. The in office exam was unremarkable, and the neurologists impression was that the patient had benign infantile myoclonus or subtle reflux. The duration of the event was reported to be 2 weeks. On 11 Oct 2006, at 10:00 am, the patient was vaccinated with a second oral dose of Rotateq (lot 653755/0319F0, a third intramuscular dose in the right thigh of Prevnar (lot B08629H), a third intramuscular dose in the left thigh of Daptacel (Lot C2629AAA), a third intramuscular dose in the right thigh of Comvax (lot C2629AAA), a third intramuscular dose in the left thigh of Ipol (lot B08629H). Additional information is not expected. EEG dated 02 Oct 2006 was negative, and MRI dated 02 October 2006 was negative.
Age: 0.34
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: Initial report received on 25 January 2007 from another manufacturer, report numbers WAES0610USA09135. The reporter to this manufacturer had been a health care provider. Verbatim from the report: information has been received from a physician concerning a 24 week old female, with no medical history and no allergies, who 2 months ago, on 14 Aug 2006, was vaccinated with a first oral 2 ml dose of Rotateq (lot #653755/0319F). Concomitant vaccines administered on the same day included a dose of Prevnar, a dose of Daptacel, a dose of Comvax and a dose of Ipol. There was no illness at the time of vaccination and no adverse events following prior vaccination. "Three weeks ago", on approximately 21 Sep 2006, the patient developed spasms, described as a jumping type movement. The patient was evaluated in the hospital and released. It was reported that the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a physician indicated that on 02 Oct 2006 the patient was seen in the office and was observed for 15 minutes and had four episodes of spasms and jumping type movements which looked seizure like. On that same day the patient was admitted to the hospital. While hospitalized, the patient underwent and MRI and a 24 hour EEG both of which were negative for any seizure activity. The patient was subsequently discharged from the hospital after two days. The patient was seen by the physician on 11 Oct 2006 and was noted to be recovered, as she had not had any additional episodes of spasms and jumping type movements. Follow up information from a health professional indication that beginning on 01 Oct 2006 the patient presented with twitching and was referred to a neurologist for a work up. The in office exam was unremarkable, and the neurologists impression was that the patient had benign infantile myoclonus or subtle reflux. The duration of the event was reported to be 2 weeks. On 11 Oct 2006, at 10:00 am, the patient was vaccinated with a second oral dose of Rotateq (lot 653755/0319F0, a third intramuscular dose in the right thigh of Prevnar (lot B08629H), a third intramuscular dose in the left thigh of Daptacel (Lot C2629AAA), a third intramuscular dose in the right thigh of Comvax (lot C2629AAA), a third intramuscular dose in the left thigh of Ipol (lot B08629H). Additional information is not expected. EEG dated 02 Oct 2006 was negative, and MRI dated 02 October 2006 was negative.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature, Hypokinesia, Screaming, Unresponsive to stimuli
Clinical narrative: This case was considered medically important for event of unresponsive to stimuli. Information regarding Prevnar was received from a healthcare professional via manufacturer regarding a 4 month old male patient who screamed for about 20 minutes, experienced lack of movements and was unresponsive to external stimuli. The patient received the second dose on 14 Nov 2006. The patient also received the second dose of Hib Vaccine (manufacturer unknown) and the second dose of Pediarix on 14 Nov 2006. Immediately after receiving the second dose of Prevnar, Pediarix and Hib on 14 Nov 2006, the patient screamed for about 20 minutes. He then became unresponsive to external stimuli and exhibited lack of movements for approximately 45 minutes. The events resolved on 14 Nov 2006. The reporter considered the events to be possibly related to the administered vaccines. Body temperature (results no fever) was done on 14 Nov 2006. No additional information was available at the time of this report.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Agitation, Cough, Diarrhoea, Haematochezia, Pyrexia
Clinical narrative: Initial report received on 29 January 2007, from another manufacturer, under the reference number WAES0701USA02085. The other manufacturer received this report from a nurse practitioner. A 19 week old male patient received on 06 November 2007 the second dose of ActHib (lot number unknown). Concomitant vaccines included second oral dose of Rotateq (lot number 654247/0600F), Pediarix (lot number unknown) and Prevnar (lot number unknown). On 19 November 2006, 18 days post vaccination, the patient became fussy and vomited seven times. The patient was admitted to the hospital on night of 19 November 2007 with a one day history of vomiting, diarrhea, blood in the stool, fever and cough. The patient was diagnosed with rotavirus. The patient was discharged on 21 November 2006. The patient was seen in the office on 22 November 2006 and was considered to be recovered by the reporter through the patients mother noted that the patient had controlled diarrhea. The patient did not have a pre existing physician diagnosed allergies, birth defects or medical conditions. The patient received previously on 06 November 2006 and the first dose of Rotateq. No relevant diagnostic tests or laboratory date were provided. No other information was provided.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rotavirus test positive, Vomiting
Clinical narrative: Initial report received on 29 January 2007, from another manufacturer, under the reference number WAES0701USA02085. The other manufacturer received this report from a nurse practitioner. A 19 week old male patient received on 06 November 2007 the second dose of ActHib (lot number unknown). Concomitant vaccines included second oral dose of Rotateq (lot number 654247/0600F), Pediarix (lot number unknown) and Prevnar (lot number unknown). On 19 November 2006, 18 days post vaccination, the patient became fussy and vomited seven times. The patient was admitted to the hospital on night of 19 November 2007 with a one day history of vomiting, diarrhea, blood in the stool, fever and cough. The patient was diagnosed with rotavirus. The patient was discharged on 21 November 2006. The patient was seen in the office on 22 November 2006 and was considered to be recovered by the reporter through the patients mother noted that the patient had controlled diarrhea. The patient did not have a pre existing physician diagnosed allergies, birth defects or medical conditions. The patient received previously on 06 November 2006 and the first dose of Rotateq. No relevant diagnostic tests or laboratory date were provided. No other information was provided.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Cough, Diarrhoea, Gastroenteritis rotavirus, Haematochezia, Irritability
Clinical narrative: Initial report received on 29 January 2007, from another manufacturer, under the reference number WAES0701USA02085. The other manufacturer received this report from a nurse practitioner. A 19 week old male patient received on 06 November 2007 the second dose of ActHib (lot number unknown). Concomitant vaccines included second oral dose of Rotateq (lot number 654247/0600F), Pediarix (lot number unknown) and Prevnar (lot number unknown). On 19 November 2006, 18 days post vaccination, the patient became fussy and vomited seven times. The patient was admitted to the hospital on night of 19 November 2007 with a one day history of vomiting, diarrhea, blood in the stool, fever and cough. The patient was diagnosed with rotavirus. The patient was discharged on 21 November 2006. The patient was seen in the office on 22 November 2006 and was considered to be recovered by the reporter through the patients mother noted that the patient had controlled diarrhea. The patient did not have a pre existing physician diagnosed allergies, birth defects or medical conditions. The patient received previously on 06 November 2006 and the first dose of Rotateq. No relevant diagnostic tests or laboratory date were provided. No other information was provided.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial report received on 29 January 2007, from another manufacturer, under the reference number WAES0701USA02085. The other manufacturer received this report from a nurse practitioner. A 19 week old male patient received on 06 November 2007 the second dose of ActHib (lot number unknown). Concomitant vaccines included second oral dose of Rotateq (lot number 654247/0600F), Pediarix (lot number unknown) and Prevnar (lot number unknown). On 19 November 2006, 18 days post vaccination, the patient became fussy and vomited seven times. The patient was admitted to the hospital on night of 19 November 2007 with a one day history of vomiting, diarrhea, blood in the stool, fever and cough. The patient was diagnosed with rotavirus. The patient was discharged on 21 November 2006. The patient was seen in the office on 22 November 2006 and was considered to be recovered by the reporter through the patients mother noted that the patient had controlled diarrhea. The patient did not have a pre existing physician diagnosed allergies, birth defects or medical conditions. The patient received previously on 06 November 2006 and the first dose of Rotateq. No relevant diagnostic tests or laboratory date were provided. No other information was provided.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Abnormal loss of weight, Arthralgia, Blindness unilateral, Blood test
Clinical narrative: Initial report received from a daughter of a patient on 11 January 2007. An 89 year old female patient (with a history of arthritis and hypertension) developed generalized joint pain "about a week", after she received Fluzone (lot number U2213AA, route of administration not reported) in the left deltoid on 25 October 2006. She was evaluated by a physician and was treated with "PT" and Tylenol. The patient did not have any laboratory tests performed. The patient receives the "flu shot" yearly. She did not have any illness at the time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 29 January 2007, from a health care professional. The report was upgraded to serious. The patient was presented in November 2006 for signs and symptoms of bilateral upper thigh pain, clinically found to be osteoarthritis (OA). P.T. was ordered. The patient presented in January 2007 with diffuse muscle pain and stiffness. Labs showed elevated ESR (over 80), elevated CRP (2.4) with -L3, L4 and was diagnosed with PMR (Polymyalgia Rheumatica). No illness at vaccination time. Additional concomitant medications included: Diovan, Lipitor and Tensopril. The patient's recovery status was not reported.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Body temperature decreased, Hypokinesia, Injection site pain, Joint swelling, Muscle swelling
Clinical narrative: Initial report received from a daughter of a patient on 11 January 2007. An 89 year old female patient (with a history of arthritis and hypertension) developed generalized joint pain "about a week", after she received Fluzone (lot number U2213AA, route of administration not reported) in the left deltoid on 25 October 2006. She was evaluated by a physician and was treated with "PT" and Tylenol. The patient did not have any laboratory tests performed. The patient receives the "flu shot" yearly. She did not have any illness at the time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 29 January 2007, from a health care professional. The report was upgraded to serious. The patient was presented in November 2006 for signs and symptoms of bilateral upper thigh pain, clinically found to be osteoarthritis (OA). P.T. was ordered. The patient presented in January 2007 with diffuse muscle pain and stiffness. Labs showed elevated ESR (over 80), elevated CRP (2.4) with -L3, L4 and was diagnosed with PMR (Polymyalgia Rheumatica). No illness at vaccination time. Additional concomitant medications included: Diovan, Lipitor and Tensopril. The patient's recovery status was not reported.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Myalgia, Oedema peripheral, Pain in extremity, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Initial report received from a daughter of a patient on 11 January 2007. An 89 year old female patient (with a history of arthritis and hypertension) developed generalized joint pain "about a week", after she received Fluzone (lot number U2213AA, route of administration not reported) in the left deltoid on 25 October 2006. She was evaluated by a physician and was treated with "PT" and Tylenol. The patient did not have any laboratory tests performed. The patient receives the "flu shot" yearly. She did not have any illness at the time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 29 January 2007, from a health care professional. The report was upgraded to serious. The patient was presented in November 2006 for signs and symptoms of bilateral upper thigh pain, clinically found to be osteoarthritis (OA). P.T. was ordered. The patient presented in January 2007 with diffuse muscle pain and stiffness. Labs showed elevated ESR (over 80), elevated CRP (2.4) with -L3, L4 and was diagnosed with PMR (Polymyalgia Rheumatica). No illness at vaccination time. Additional concomitant medications included: Diovan, Lipitor and Tensopril. The patient's recovery status was not reported.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, C-reactive protein increased, Musculoskeletal stiffness, Myalgia, Osteoarthritis
Clinical narrative: Initial report received from a daughter of a patient on 11 January 2007. An 89 year old female patient (with a history of arthritis and hypertension) developed generalized joint pain "about a week", after she received Fluzone (lot number U2213AA, route of administration not reported) in the left deltoid on 25 October 2006. She was evaluated by a physician and was treated with "PT" and Tylenol. The patient did not have any laboratory tests performed. The patient receives the "flu shot" yearly. She did not have any illness at the time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 29 January 2007, from a health care professional. The report was upgraded to serious. The patient was presented in November 2006 for signs and symptoms of bilateral upper thigh pain, clinically found to be osteoarthritis (OA). P.T. was ordered. The patient presented in January 2007 with diffuse muscle pain and stiffness. Labs showed elevated ESR (over 80), elevated CRP (2.4) with -L3, L4 and was diagnosed with PMR (Polymyalgia Rheumatica). No illness at vaccination time. Additional concomitant medications included: Diovan, Lipitor and Tensopril. The patient's recovery status was not reported.
Age: 89.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Initial report received from a daughter of a patient on 11 January 2007. An 89 year old female patient (with a history of arthritis and hypertension) developed generalized joint pain "about a week", after she received Fluzone (lot number U2213AA, route of administration not reported) in the left deltoid on 25 October 2006. She was evaluated by a physician and was treated with "PT" and Tylenol. The patient did not have any laboratory tests performed. The patient receives the "flu shot" yearly. She did not have any illness at the time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 29 January 2007, from a health care professional. The report was upgraded to serious. The patient was presented in November 2006 for signs and symptoms of bilateral upper thigh pain, clinically found to be osteoarthritis (OA). P.T. was ordered. The patient presented in January 2007 with diffuse muscle pain and stiffness. Labs showed elevated ESR (over 80), elevated CRP (2.4) with -L3, L4 and was diagnosed with PMR (Polymyalgia Rheumatica). No illness at vaccination time. Additional concomitant medications included: Diovan, Lipitor and Tensopril. The patient's recovery status was not reported.
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV, HEPA, MMRV
Symptoms: Allergy test, Flushing, Hypersensitivity, Oxygen saturation decreased, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with an amoxicillin allergy and allergy and gelatin allergy and no other medical history who on 04-DEC-2006 was vaccinated with a 0.5 ml SC dose of ProQuad vaccine (lot#655142/0974F). Suspect vaccination administered that day included a dose of hepatitis A vaccine (inactive) (manufacturer unknown). On 04-DEC-2006 the patient developed a hypersensitivity reaction. After the vaccination he was itching, had difficulty breathing, and vomited. He lost consciousness and oxygen saturation level in his blood was decreased. Epinephrine and oxygen was given and an emergency medical service was notified. He was admitted to the hospital, a gelatin allergy test was performed and he was determined to have a gelatin allergy. The length of hospitalization was unknown. The patient recovered completely on an unspecified date. There was no product quality complaint involved. The patient's hypersensitivity reaction was considered to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV, HEPA, MMRV
Symptoms: Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with an amoxicillin allergy and allergy and gelatin allergy and no other medical history who on 04-DEC-2006 was vaccinated with a 0.5 ml SC dose of ProQuad vaccine (lot#655142/0974F). Suspect vaccination administered that day included a dose of hepatitis A vaccine (inactive) (manufacturer unknown). On 04-DEC-2006 the patient developed a hypersensitivity reaction. After the vaccination he was itching, had difficulty breathing, and vomited. He lost consciousness and oxygen saturation level in his blood was decreased. Epinephrine and oxygen was given and an emergency medical service was notified. He was admitted to the hospital, a gelatin allergy test was performed and he was determined to have a gelatin allergy. The length of hospitalization was unknown. The patient recovered completely on an unspecified date. There was no product quality complaint involved. The patient's hypersensitivity reaction was considered to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV, HEPA, MMRV
Symptoms: Allergy test, Dyspnoea, Hypersensitivity, Loss of consciousness, Oxygen saturation decreased
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with an amoxicillin allergy and allergy and gelatin allergy and no other medical history who on 04-DEC-2006 was vaccinated with a 0.5 ml SC dose of ProQuad vaccine (lot#655142/0974F). Suspect vaccination administered that day included a dose of hepatitis A vaccine (inactive) (manufacturer unknown). On 04-DEC-2006 the patient developed a hypersensitivity reaction. After the vaccination he was itching, had difficulty breathing, and vomited. He lost consciousness and oxygen saturation level in his blood was decreased. Epinephrine and oxygen was given and an emergency medical service was notified. He was admitted to the hospital, a gelatin allergy test was performed and he was determined to have a gelatin allergy. The length of hospitalization was unknown. The patient recovered completely on an unspecified date. There was no product quality complaint involved. The patient's hypersensitivity reaction was considered to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV, HEPA, MMRV
Symptoms: Pruritus, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with an amoxicillin allergy and allergy and gelatin allergy and no other medical history who on 04-DEC-2006 was vaccinated with a 0.5 ml SC dose of ProQuad vaccine (lot#655142/0974F). Suspect vaccination administered that day included a dose of hepatitis A vaccine (inactive) (manufacturer unknown). On 04-DEC-2006 the patient developed a hypersensitivity reaction. After the vaccination he was itching, had difficulty breathing, and vomited. He lost consciousness and oxygen saturation level in his blood was decreased. Epinephrine and oxygen was given and an emergency medical service was notified. He was admitted to the hospital, a gelatin allergy test was performed and he was determined to have a gelatin allergy. The length of hospitalization was unknown. The patient recovered completely on an unspecified date. There was no product quality complaint involved. The patient's hypersensitivity reaction was considered to be an other important medical event. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: Agitation, Barium double contrast, Decreased appetite, Screaming, X-ray
Clinical narrative: Patient woke up screaming at 1 am.  there was no consoling him, refused to eat.  he would scream, fall asleep for about 15 minutes, then scream again.  i took him to hospital.  they did a full work up.  the x-ray did not catch the intussuseption, but the doctors were confident that that was what had happened.  he had a 2 night stay in the hospital.  this occured 2 weeks after he received the rotavirus vaccine.  (this was not 100 percent diagnosed and was not reported for that reason by the hospital.  i thought the information should be shared however.  i am very concerned with giving the second dose.)  he received the air enema as diagnosis and treatment.  he had a upper gi with a small bowel series.  he had gi consult and surgery consult as well. 02/23/07-records received and reviewed for DOS:01/17-01/18/07 DC DX: abdomen pain  12/23/06-possible intussusception but not diagnosed, also with otitis media. Completed 10 day course of antibiotics. Presents with nasal congestion and cough, prior to admission mucous like stool and decreased feeding, grunting with loud shrieking noise.
Age: 0.21
Sex: M
Vaccine: RV5
Symptoms: X-ray with contrast upper gastrointestinal tract
Clinical narrative: Patient woke up screaming at 1 am.  there was no consoling him, refused to eat.  he would scream, fall asleep for about 15 minutes, then scream again.  i took him to hospital.  they did a full work up.  the x-ray did not catch the intussuseption, but the doctors were confident that that was what had happened.  he had a 2 night stay in the hospital.  this occured 2 weeks after he received the rotavirus vaccine.  (this was not 100 percent diagnosed and was not reported for that reason by the hospital.  i thought the information should be shared however.  i am very concerned with giving the second dose.)  he received the air enema as diagnosis and treatment.  he had a upper gi with a small bowel series.  he had gi consult and surgery consult as well. 02/23/07-records received and reviewed for DOS:01/17-01/18/07 DC DX: abdomen pain  12/23/06-possible intussusception but not diagnosed, also with otitis media. Completed 10 day course of antibiotics. Presents with nasal congestion and cough, prior to admission mucous like stool and decreased feeding, grunting with loud shrieking noise.
Age: 34.0
Sex: F
Vaccine: IPV, TD, TYP, YF
Symptoms: Injection site induration, Injection site pain
Clinical narrative: Client received yellow fever vaccine in right arm SQ and Td IM and IPV SQ in the left arm on 1/19/2007. Telephone call to us on 2/1/07 to state she developed a small, hard painful bump over last 2 days in right tricep, at area of yellow fever injection. No other problems stated.
Age: 0.04
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Pyrexia
Clinical narrative: 15 day old infant received 2 months immunization. Patient record with baby not baby record. Informed mom of immunization information side effects including giving Tylenol 0.4 after shots if baby develop fever. Baby kept at clinic for further monitoring after shots given. Examined by provider. Exam within normal. 2-6-07 talked to father of baby states baby has a little fever but did not know how high.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Fatigue, Feeling abnormal, Loss of consciousness, Vomiting
Clinical narrative: Pt was receiving Gardasil, Hep A and Then  Menactra. Right after administering the Menactra she said I feel funny and passed out. She was out for about 10 seconds. Then vomited 1x. Said she felt really tired.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Developed high fever 101-102 and then redness at site within 12 hours of vaccination. Redness has much warmth to palpation, non tender, no Fluctuance (site of Pedivax vaccination).
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Aphasia, Blood electrolytes normal, C-reactive protein normal, Chills, Computerised tomogram normal
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no history of drug reactions/allergies who on 26-JAN-2007 was vaccinated with Gardasil vaccine (yeast) (lot# not reported), IM. There was no concomitant medication. On 26-JAN-2007, the patient developed a sore throat, fever, and chills later that evening. She went to the emergency room on 30-JAN-2007 where she exhibited expressive aphasia. A computed tomography (CT) scan showed nothing. She was admitted to the hospital where she a neurology consult. All tests have come up negative (CT scan, magnetic resonance imaging, complete blood count, electrolytes, and C-reactive protein). The physician stated that the patient has 3 chinchilla pets and one of them has a fungal infection which is currently being treated with myconazole spray. The physician consulted the veterinarian as well as an infectious disease specialist. The physician saw the patient today and she was able to form some sentences. The physician is observing the patient and will order some additional tests. The physician reported the event will be a disability if this adverse event continues. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Full blood count normal, Nuclear magnetic resonance imaging normal, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no history of drug reactions/allergies who on 26-JAN-2007 was vaccinated with Gardasil vaccine (yeast) (lot# not reported), IM. There was no concomitant medication. On 26-JAN-2007, the patient developed a sore throat, fever, and chills later that evening. She went to the emergency room on 30-JAN-2007 where she exhibited expressive aphasia. A computed tomography (CT) scan showed nothing. She was admitted to the hospital where she a neurology consult. All tests have come up negative (CT scan, magnetic resonance imaging, complete blood count, electrolytes, and C-reactive protein). The physician stated that the patient has 3 chinchilla pets and one of them has a fungal infection which is currently being treated with myconazole spray. The physician consulted the veterinarian as well as an infectious disease specialist. The physician saw the patient today and she was able to form some sentences. The physician is observing the patient and will order some additional tests. The physician reported the event will be a disability if this adverse event continues. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest X-ray normal, Erythema multiforme, Genital pruritus female, Lip swelling, Pneumonia
Clinical narrative: Initial report received on 26 January 2007, from another manufacturer, under the reference number B0454855A, concerning a patient. A 12 year old female patient, was enrolled in the other manufacturers study and received on 04 January 2007 a dose of Menactra (lot number U2091AA) intramuscular intro the left upper deltoid and the first dose of study vaccine of Gardasil (lot number DHPVA017A). Since 16 January 2007, since 12 days post administration, the patient had been experiencing pneumonia and developed erythema multiforme and was hospitalized. The patient had been to th e(study) office two days prior to admission with fever, swollen lips and vaginal itch. Exam failed to reveal significant findings other than rales over left posterior lung fields (urine analysis and chest X ray were normal). A clinical diagnosis of rash fitting description of erythema multiform was made. The patient was discharged with symptomatic treatment. She was seen in emergency room the next day and admitted on 18 January 2007 for intravenous treatment (rochepin). The event was unresolved at the time of reporting. The other manufacturer's investigator considered that there was a reasonable possibility that th erythema multiforme may have been caused by Gardasil and Menactra and was due to pneumonia.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Pyrexia, Rales, Rash, Urine analysis normal
Clinical narrative: Initial report received on 26 January 2007, from another manufacturer, under the reference number B0454855A, concerning a patient. A 12 year old female patient, was enrolled in the other manufacturers study and received on 04 January 2007 a dose of Menactra (lot number U2091AA) intramuscular intro the left upper deltoid and the first dose of study vaccine of Gardasil (lot number DHPVA017A). Since 16 January 2007, since 12 days post administration, the patient had been experiencing pneumonia and developed erythema multiforme and was hospitalized. The patient had been to th e(study) office two days prior to admission with fever, swollen lips and vaginal itch. Exam failed to reveal significant findings other than rales over left posterior lung fields (urine analysis and chest X ray were normal). A clinical diagnosis of rash fitting description of erythema multiform was made. The patient was discharged with symptomatic treatment. She was seen in emergency room the next day and admitted on 18 January 2007 for intravenous treatment (rochepin). The event was unresolved at the time of reporting. The other manufacturer's investigator considered that there was a reasonable possibility that th erythema multiforme may have been caused by Gardasil and Menactra and was due to pneumonia.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Body temperature, Chills, Influenza like illness, Nausea, Rash generalised
Clinical narrative: Symptoms were flu like, with Sub normal temps, chills, nausea, itchy generalized rash,
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: Symptoms were flu like, with Sub normal temps, chills, nausea, itchy generalized rash,
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: Onset was about 7 days injection and on rising, felt ill, not well, as before only the symptoms were stringer.
Age: 54.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Arthritis, Blister, Blood glucose increased, Body temperature decreased, Chills
Clinical narrative: Symptoms of Measles, Mumps and Chicken Pox intermittently for over two months. Subnormal temps, chills, nausea, rash, arthritis, blisters, welts, shingle symptoms. Blood sugar elevation. Increasing trouble with my hands.     Vaccination record received, no additional information. Received  OV note of 10/21/2006 from above provider for PE which was WNL except for pharynx red, and rash (neck).  Medrol dose pak given.  Notation made that pt. did not require MMR given past disease history and age.  Office visit 2/12/2007 with c/o swelling  and pain in hands/forearms x 6 months which pt. believes is r/t her vaccine.  Patient also states that her hands feel cold.  DX: Neuropathy to hands.  Refered to neurologist.
Age: 54.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Herpes zoster, Nausea, Rash, Urticaria
Clinical narrative: Symptoms of Measles, Mumps and Chicken Pox intermittently for over two months. Subnormal temps, chills, nausea, rash, arthritis, blisters, welts, shingle symptoms. Blood sugar elevation. Increasing trouble with my hands.     Vaccination record received, no additional information. Received  OV note of 10/21/2006 from above provider for PE which was WNL except for pharynx red, and rash (neck).  Medrol dose pak given.  Notation made that pt. did not require MMR given past disease history and age.  Office visit 2/12/2007 with c/o swelling  and pain in hands/forearms x 6 months which pt. believes is r/t her vaccine.  Patient also states that her hands feel cold.  DX: Neuropathy to hands.  Refered to neurologist.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Influenza like illness, Poor quality sleep
Clinical narrative: Flu like syndrome could not tolerate being up out of bed for very long, about 3 hours. Low energy, strength, tired, poor sleep, GI Disturbances, symptoms lasted over 9 days.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Vaccine positive rechallenge, Vomiting
Clinical narrative: Patient experienced 1 month of intermittent diarrhea and vomiting after 1st rotavirus on 31 Oct 06.  After 2nd rotavirus on 23 Jan 07- patient started with vomiting and diarrhea.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: PT C/O ERYTHEMA, SWELLING, PAINFUL WITH MOVEMENT TENDER TO TOUCH. RIGHT ARM
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Paraesthesia, Visual disturbance
Clinical narrative: Approximately 5 minutes after receiving injection, client felt "faint", face was tingly, saw spots, but did not pass out.  BENADRYL 50 mg. given orally approximately 15 minutes post-injection, recovery from symptoms within 30 minutes.
Age: 0.2
Sex: F
Vaccine: HEP, IPV, PNC, RVX
Symptoms: Haematochezia
Clinical narrative: Blood in stool 8 days after first Rotavaccine
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Erythema
Clinical narrative: RIGHT DELTOID AREA SLIGHTLY BRUISE ERYTHEMIA 8-10 CENTIMETERS CIRCUMFERENCE
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Chest pain, Lip swelling, Respiratory distress, Urticaria, Wheezing
Clinical narrative: Child began wheezing, broke out in hives throughout trunk and extremities, with swelling of lips, and respiratory distress/chest pain. Pt given Albuterol nebulizer treatment and epinephrine IM.
Age: 1.3
Sex: F
Vaccine: DTAPH, HIBV, PPV
Symptoms: Body temperature increased, Injection site rash, Injection site swelling
Clinical narrative: Severe Rash and swelling at all injection sites, followed by elevated tempature
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: redness, swelling at inj site, fever 100.4
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Diarrhoea, Intussusception, Ultrasound scan, Vomiting
Clinical narrative: Patient developed explosive diarrhea and emesis shortly after vaccine given. On 2/6/07 he was admitted for worsening vomiting, and on the morning of 2/7/07 he was found to have intussusception.   3/1/07 Received medical records from hospital which reveal patient experienced dehydration, vomiting & diarrhea, tactile temp at home, cough & nasal congestion. Seen in ER x2 then admitted.  After admission, had large maroon stool & continued to have bile tinged emesis.  After confirmation of IS, patient transferred to higher level of care. 3/15/07 Received medical records from transfer hospital which reveal patient admitted 2/7/07-2/8/07 s/p 48 hour history of abdominal pain, diarrhea & 1 week history of flu like symptoms w/bloody stools developing 24 hours prior to admit.  IS successfully reduced w/air enema & kept overnight for observation.   FINAL DX: Intussusception, reduced by air contrast enema.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Intussusception, Ultrasound scan abnormal, Vomiting
Clinical narrative: Patient developed explosive diarrhea and emesis shortly after vaccine given. On 2/6/07 he was admitted for worsening vomiting, and on the morning of 2/7/07 he was found to have intussusception.   3/1/07 Received medical records from hospital which reveal patient experienced dehydration, vomiting & diarrhea, tactile temp at home, cough & nasal congestion. Seen in ER x2 then admitted.  After admission, had large maroon stool & continued to have bile tinged emesis.  After confirmation of IS, patient transferred to higher level of care. 3/15/07 Received medical records from transfer hospital which reveal patient admitted 2/7/07-2/8/07 s/p 48 hour history of abdominal pain, diarrhea & 1 week history of flu like symptoms w/bloody stools developing 24 hours prior to admit.  IS successfully reduced w/air enema & kept overnight for observation.   FINAL DX: Intussusception, reduced by air contrast enema.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Barium enema, Diarrhoea, Intussusception, Ultrasound scan, Ultrasound scan abnormal
Clinical narrative: Patient developed explosive diarrhea and emesis shortly after vaccine given. On 2/6/07 he was admitted for worsening vomiting, and on the morning of 2/7/07 he was found to have intussusception.   3/1/07 Received medical records from hospital which reveal patient experienced dehydration, vomiting & diarrhea, tactile temp at home, cough & nasal congestion. Seen in ER x2 then admitted.  After admission, had large maroon stool & continued to have bile tinged emesis.  After confirmation of IS, patient transferred to higher level of care. 3/15/07 Received medical records from transfer hospital which reveal patient admitted 2/7/07-2/8/07 s/p 48 hour history of abdominal pain, diarrhea & 1 week history of flu like symptoms w/bloody stools developing 24 hours prior to admit.  IS successfully reduced w/air enema & kept overnight for observation.   FINAL DX: Intussusception, reduced by air contrast enema.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5, DTAPHEPBIP, FLU3, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Patient developed explosive diarrhea and emesis shortly after vaccine given. On 2/6/07 he was admitted for worsening vomiting, and on the morning of 2/7/07 he was found to have intussusception.   3/1/07 Received medical records from hospital which reveal patient experienced dehydration, vomiting & diarrhea, tactile temp at home, cough & nasal congestion. Seen in ER x2 then admitted.  After admission, had large maroon stool & continued to have bile tinged emesis.  After confirmation of IS, patient transferred to higher level of care. 3/15/07 Received medical records from transfer hospital which reveal patient admitted 2/7/07-2/8/07 s/p 48 hour history of abdominal pain, diarrhea & 1 week history of flu like symptoms w/bloody stools developing 24 hours prior to admit.  IS successfully reduced w/air enema & kept overnight for observation.   FINAL DX: Intussusception, reduced by air contrast enema.
Age: 63.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt had Zostervax vaccination along w/Pneumovax vaccination in 11/06.  Pt presented yesterday w/outbreak of shingles on lower jaw.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Patient with history of roux-en Y gastric bypass, 35 year old, experienced symptoms of hypoglycemia necessitating surgical management of hr noninsulionoma pancreatogenous hypoglycemia with a distal panoreatectomy and splenectomy.  Post-operatively patient received influenza vaccine and pneumococcal vaccine in the right deltoid on 1/30/2007.  Patient reacted with a cellulitis like reactions. Cultures are currently pending and patient continued to have febrile spikes.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Has a hematoma on left arm at the injection site which is tender and is being treated.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Blood glucose, Blood glucose normal, Blood pressure normal, Convulsion, Electrocardiogram
Clinical narrative: Patient had a vasovagal syncopal episode with seizure seconds after receiving the vaccine. Checked blood sugar and BP and EKG and everything looked normal. Observed patient in clinic and no problems after.