chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: Red, hot, swelling (right arm Pneumonia shot), fever 102F and 99.8F, Treatment Tylenol 500 mg, clindamycin 150 mg.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pruritus, Rash macular, Skin burning sensation
Clinical narrative: Itchy hands, blotches spreading from hands to trunk. Hands burning, developed slight tightness in chest.
Age: 1.04
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 23Sep05 was vaccinated with a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) In the evening of 23Sep05, the pt presented to an ER with a drug reaction. The reaction was described as a rash all over his body. It was noted that he had no respiratory distress and no fever. The pt was treated with oral diphenhydramine hydrochloride (Benadryl) and was not hospitalized. On an unspecified date the pt recovered. A product quality complaint was not involved. Rash all over his body was considered to be an other important medical event (OMIC) by the physician. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a physician concerning a 4 yr old male with asthma and respiratory allergies who on 30Aug04 at 15:00 was vaccinated SC with a first 0.5 dose of varicella virus vaccine live (lot647528/1242N). There was no illness at the time of vaccination. On 30Aug04, one hr post vaccination, the pt developed hives and an itchy throat (also reported as one half post vaccination). Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The pt took diphenhydramine hydrochloride (Benadryl) and albuterol inhaler and improved.  Later that same day, the pt recovered from hives and itchy throat. No product quality complaint was involved. The physician considered the hives and itchy throat to be other important medical events (OMIC). It was also reported that the pt had an adverse event following vaccination with  measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (WAES0509USA03077). Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 66 yr old female with allergies to cephalexin, lidocaine, and clenodomycin who on 28Sep05 was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P). Concomitant therapy included risedronate sodium (Actonel), beta carotene, vitamin B (unspecified), vitamin E, calcium (unspecified), ascorbic acid, lorazepam, and diphenhydramine HC1 (Benadryl). Two days after vaccination, on 30Sep05, the pt presented to the physician's office with erythema at the injection site and a fever of 102. The pt was treated with diphenhydramine HC1 (Benadryl) and acetaminophen (Tylenol) as needed. No diagnostic laboratory tests were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Erythema at the injection site and a fever of 102 were considered to be other important medical events (OMIC) by the nurse. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: Information has been received from a RN concerning a 67 year old female with type II diabetes mellitus and an allergy to pain medications (not further specified) who on 24Aug05 was vaccinated IM in the left deltoid with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649979/0531P). Concomitant therapy included fosinopril sodium (Monopril), amlodipine besylate (Norvasc), potassium chloride, insulin glargine (Lantus), insulin lispro (Humalog), ascorbic acid, cyanocobalamin, calcium (unspecified) (+) magnesium (unspecified) (+) zinc (unspecified), quinlin sulfate, and HCTZ/triamterene. Two days after vaccination, on 26Aug05, the pt presented to the physician's office with erythema, her whole upper left arm was swollen, and her left arm movement was restricted. She was noted to be afebrile. She was treated with cephalexin (500mg) and recovered on an unspecified date. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Erythema, whole upper left arm swollen, and left arm movement restricted were considered to be disabling and other important medical events (OMIC) by the nurse. Additional information has been requested.
Age: 0.75
Sex: F
Vaccine: HIBV, PNC
Symptoms: Abnormal behaviour, Mental retardation severity unspecified, Speech disorder
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from the mother regarding a 9 month old female patient who use to say words but now is simply making sounds, sporadically turns head when mother calls her name and tries to bite when nuzzling with mom, and a steady decline in development since receiving the first dose of the vaccine on Sept 19 2005. The patient also received the third dose of Act Hib (haemophilus B conjugate vaccine) (tetanus) on Sept 19 2005. Relevant medical history was not provided. Indication for Prevnar was immunization. product was administered on Sept 19 2005. Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included Recombivax Hb (hep B vaccine), Tripedia (DPaT) and poliomyelitis vaccine inactivated. Concomitant therapy was not provided. Since receiving the Prevnar vaccine on Sept 19 2005, the mother noticed that her child is now simply making sounds (speech disorder) where before she would say words. the mother also noticed that the child sporadically turns head when she calls her name (abnormal behavior) where before she would turn her head every time her mother called her name. The child also tries to bite mom when nuzzling with her. Mother considers her child's development a steady decline (developmental delay). Events were persisting at time of report. No additional information was available at the time of this report.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Blood glucose increased, Hypoxia, Muscle disorder, Respiratory rate increased
Clinical narrative: A 52 year old female patient with medical history of myocardial infarction, congestive heart failure, insulin dependant diabetes mellitus, chronic obstructive pulmonary disease and respiratory failure admitted in a hospital on Oct 03 2005 for the treatment of mental changes and also for all the above mentioned diseases. According to the hospital standing orders patient was given influenza vaccine (Fluzone SV 2005 2006) on Oct 5 2005 and the next day, patient developed decreased muscle reflexes in both lower extremities and increased respiration on ventilator. Neurological consultation was pending to rule out Reyes syndrome at the time of the report. CAT scan and LST performed at an unspecified time was normal but LST ap showed no bacteria but positive glucose. As concomitant treatment she was receiving aspirin and she refused to take insulin for diabetes. Outcome was not reported.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Hyporeflexia, Nervous system disorder, Neuralgia
Clinical narrative: On 04 year old male child pt with no reported medical history and was in good condition at the time of the vaccination experienced bilateral leg pain in entire limbs with subsequent loss of reflexes on 02Oct05, i.e 5 days following influenza vaccine (Fluzone SV 20052006), lot no: U1804AA, administration. The pt was admitted overnight at an unspecified time in an hospital for observation. Neurological diagnosis was neuralgia. Reflexes returned to normal, pt was recovering but the outcome was unk at the time of the report.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling hot, Headache, Injection site hypersensitivity, Musculoskeletal stiffness, Petechiae
Clinical narrative: Stiff neck, headache, photophobia phonophobia, petechial rash local 2 cm red, warm area at injection site.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Photophobia
Clinical narrative: Stiff neck, headache, photophobia phonophobia, petechial rash local 2 cm red, warm area at injection site.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Chest discomfort, Chest pain, Headache, Hypoaesthesia, Pain
Clinical narrative: Patient had headache, fever, and upset stomach. Took Tylenol which helped with the fever but came back shortly but medicine helped with soreness and aches. Symptoms continued into next morning and then resolved. On follow days, patient started complaining of chest pain, especially tightness when going up and down stairs in dorm. Also had more stiffness, tightness in chest in the morning when wake up. By first days of September 9/1 or 9/2 for sure by 9/6 she started to complain of tingling and numbness on legs, sometimes while sitting down, didn't feel the legs at all. On 9/17 had a doctor visit and given Advair inhaler which was used for 2 days. A pulmonary test on 9/24 was normal. Patient will be seen by a ENT specialist on 10/27.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Paraesthesia, Pyrexia, Stomach discomfort
Clinical narrative: Patient had headache, fever, and upset stomach. Took Tylenol which helped with the fever but came back shortly but medicine helped with soreness and aches. Symptoms continued into next morning and then resolved. On follow days, patient started complaining of chest pain, especially tightness when going up and down stairs in dorm. Also had more stiffness, tightness in chest in the morning when wake up. By first days of September 9/1 or 9/2 for sure by 9/6 she started to complain of tingling and numbness on legs, sometimes while sitting down, didn't feel the legs at all. On 9/17 had a doctor visit and given Advair inhaler which was used for 2 days. A pulmonary test on 9/24 was normal. Patient will be seen by a ENT specialist on 10/27.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Chills, Cough, Fluid retention, Headache
Clinical narrative: Pt would like to remain anonymous as the reporter so that the doctor doesn't know she filed the complaint. Pt complains of soreness at injection sites however had serious pain on left arm, it was also hot, discomfort such that couldn't sleep at night or move left arm at all by next day. Blisters at injection site also appeared and extended through the back of the neck. Had a horrendous case of flu next day with headache, nausea, chills, coughing. No medication taken. Evening of 2nd day bad case of flu starting to recover, symptoms subsiding. Left arm muscles are paralyzed and right arm just sore. Monday hand and arm numb, unable to close fingers. The blisters are now on abdomen, upper breast, shoulder neck and more are appearing. Blisters ooze liquid.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Hypokinesia, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Pt would like to remain anonymous as the reporter so that the doctor doesn't know she filed the complaint. Pt complains of soreness at injection sites however had serious pain on left arm, it was also hot, discomfort such that couldn't sleep at night or move left arm at all by next day. Blisters at injection site also appeared and extended through the back of the neck. Had a horrendous case of flu next day with headache, nausea, chills, coughing. No medication taken. Evening of 2nd day bad case of flu starting to recover, symptoms subsiding. Left arm muscles are paralyzed and right arm just sore. Monday hand and arm numb, unable to close fingers. The blisters are now on abdomen, upper breast, shoulder neck and more are appearing. Blisters ooze liquid.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Paralysis, Sleep disorder
Clinical narrative: Pt would like to remain anonymous as the reporter so that the doctor doesn't know she filed the complaint. Pt complains of soreness at injection sites however had serious pain on left arm, it was also hot, discomfort such that couldn't sleep at night or move left arm at all by next day. Blisters at injection site also appeared and extended through the back of the neck. Had a horrendous case of flu next day with headache, nausea, chills, coughing. No medication taken. Evening of 2nd day bad case of flu starting to recover, symptoms subsiding. Left arm muscles are paralyzed and right arm just sore. Monday hand and arm numb, unable to close fingers. The blisters are now on abdomen, upper breast, shoulder neck and more are appearing. Blisters ooze liquid.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Vomiting
Clinical narrative: Headache about 1 hr at shot, stomach ache around 5PM. Vomit and diarrhea started at 2:00AM still present at time chills.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Erythema, Feeling hot, Injection site erythema
Clinical narrative: Redness and soreness at the site, upper respiratory symptoms like diff breathing, sore throat, running nose and sneezing non stop, aches, dizziness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Pain, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Redness and soreness at the site, upper respiratory symptoms like diff breathing, sore throat, running nose and sneezing non stop, aches, dizziness.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder, Rhinorrhoea, Sneezing
Clinical narrative: Redness and soreness at the site, upper respiratory symptoms like diff breathing, sore throat, running nose and sneezing non stop, aches, dizziness.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Oedema
Clinical narrative: PVP 0.5ml administered Mon. 10/10/05 right arm. Approx 7 hrs post injection arm felt warm and next morning c/o arm stiffness and soreness of arm. Denies fever c/o chills. No redness or tenderness noted at injection site. Instructed to put ice to area and call Dr. 2 lg red raised areas noted firm to touch on front and back of upper arm (no redness, tenderness or edema noted at site of injection). Appt made with family physician for 10/13/05. Instr by Dr to cont with ice and use Motrin or Tylenol until seen.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Same evening as injection was given Pt noticed inj site became red. By the next day the site was also hot and sore, and more red. Pt did not treat.
Age: 1.21
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Gaze palsy, Pneumonia, Pyrexia, Urticaria
Clinical narrative: Pt developed hive fever and eyes rolled back per mother. pt taken to ER who diagnosed pneumonia. Pt was previously well. Normal exam when vaccines were given.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Agitation, Crying, Irritability, Pyrexia, Rash
Clinical narrative: 9/26/05 Fever, irritability started, 9/27/05 inconsolable crying, rash erythematous maculopapular exanthem with papules/plaques on face, trunk, shoulders and buttocks.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular, Rash papular, Screaming
Clinical narrative: 9/26/05 Fever, irritability started, 9/27/05 inconsolable crying, rash erythematous maculopapular exanthem with papules/plaques on face, trunk, shoulders and buttocks.
Age: 1.2
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Diffuse rash, itching and fever
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Spot swelling, redness on same arm but opposite to site of injection. No temp. By Sun. signs of sx had disappeared.
Sex: U
Vaccine: SMALL, TYP
Symptoms: Unintended pregnancy
Clinical narrative: Pt expressed concern about pregnancy at screening visit, pregnancy test was done on day of vaccination. Pregnancy diagnosed 06Oct05 (LMP:12Aug05). No previous pregnancies. Other vaccines administered during pregnancy: Typhoid.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Had tingling in fingers and toes on right side 12 days after first shot.  Tingling & numbness in both sides in all extremities.  Headaches, vision problems, aching and pain in right side, stomach cramps, diarrhea, nausea, fatigue, pain down right arm when vaccine was being administered, sweating & chills, dizziness, tremors
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Nausea, Pain
Clinical narrative: Had tingling in fingers and toes on right side 12 days after first shot.  Tingling & numbness in both sides in all extremities.  Headaches, vision problems, aching and pain in right side, stomach cramps, diarrhea, nausea, fatigue, pain down right arm when vaccine was being administered, sweating & chills, dizziness, tremors
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Paraesthesia, Tremor, Visual disturbance
Clinical narrative: Had tingling in fingers and toes on right side 12 days after first shot.  Tingling & numbness in both sides in all extremities.  Headaches, vision problems, aching and pain in right side, stomach cramps, diarrhea, nausea, fatigue, pain down right arm when vaccine was being administered, sweating & chills, dizziness, tremors
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Erythema, Musculoskeletal stiffness, Pain
Clinical narrative: Vaccine administered 10/13/05 at 9:30 AM.  Pt. subsequently worked in warehouse, experienced an asthma attack, vs. MD and was treated with a nebulizer and recovered. Evening of 10/13/05 pt. experienced severe pain and stiffness in entire R. arm which continued through 10/14/05.  On 10/14 at 5:00 PM pt. noticed confluent red,raised quarter sized areas (no itching)extending to elbow directly below where vaccine was given on R arm. 10/15/05 erythematous area spread to back of R arm. Pt consulted MD and advised to use warm compresses on affected arm. 10/16/05 eryythema and pain and stiffness resolved.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous
Clinical narrative: Vaccine administered 10/13/05 at 9:30 AM.  Pt. subsequently worked in warehouse, experienced an asthma attack, vs. MD and was treated with a nebulizer and recovered. Evening of 10/13/05 pt. experienced severe pain and stiffness in entire R. arm which continued through 10/14/05.  On 10/14 at 5:00 PM pt. noticed confluent red,raised quarter sized areas (no itching)extending to elbow directly below where vaccine was given on R arm. 10/15/05 erythematous area spread to back of R arm. Pt consulted MD and advised to use warm compresses on affected arm. 10/16/05 eryythema and pain and stiffness resolved.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Received flu and pneumonia vaccine on 10-14-05. Both vaccines given in same arm due to pt preference. Pt noticed Left upper arm was red on 10-17-05. Area is approximately 3 inches by 2 inches on lower portion of upper arm. Is below where shots would have been given. Area red and warm to touch. No swelling noted.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Urticaria
Clinical narrative: Within 10 minutes I had inflammation surrounding the shot site and had hives all over. The nurses who were administering the shots told me to place a cold compress on the site and take Benedryl. Once I did that the hives went away. Then, again the next afternoon I got another case of hives on the arm where I got the shot.  I have no known allergies, so this was quite unexpected for me. I've also gotten flu shots over the years with no reaction.
Age: 72.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Pain, Vaccine positive rechallenge
Clinical narrative: Seen in our ER 2 days after vaccination with Pneumovax (not sure where she received it) c/o pain, edema and erythema at vaccine injection site (left arm). Erythema and edema initially extended from shoulder to elbow. When patient presented to ER, erythema and edema still persisted lower half of upper arm. Afebrile in ER (temp of 98.1). Rated her pain as 3/10 and described pain as burning. MD diagnosis states Acute Cellulitis after Pneumovax. Treatmentin ER included Zithromax 500 mg PO and Decadron 8 mg PO. Also given prescriptions for Zithromax Z-Pak & Decadron.
Age: 76.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Swelling
Clinical narrative: Patient c/o pain and swelling right mid to upper arm following pneumovax vaccination. Described pain as constant, throbbing, rated pain as 6/10.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea
Clinical narrative: EMPLOYEE RECEIVED FLUZONE 0.5ML IM AT APPROX 8AM 10/14/05. aT APPROX 1 PM DEVELOPED COUGH, FEELING OF SHORTNESS OF BREATH. SEEN IN EMERGENCY DEPARTMENT, HAD NEBULIZER TREATMENT AND RETURNED TO WORK.
Age: 74.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient c/o redness, pain and swelling in left arm persisting 3 days after Pneumovax & influenza vaccines (unknown if one/both vaccinations were  given in left arm).
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient received flu vaccination on afternoon of 10/14/05.  She stated the rash started a couple of hours after the shot was given.  The rash consists of welts on various parts of her body that she says itches.  She denied having difficulty breathing or other signs or symptoms.  She showed the rash to me, her school nurse, on Monday morning around 10:00 AM.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate pain at site. Within 12 hours swelling, redness and pain at site with numbness and tingling down left arm/hand and that evening, wheezing and SOB. Within 24 hours of injection, wheezing and SOB better but left arm with numbness,and underarm pain and SEVERE swelling of lymph nodes affecting whole underarm, breast area. Now Monday, 10/17 not quite 36 hours with decreased swelling but still underarm sensitivity, pain and swelling.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Paraesthesia, Wheezing
Clinical narrative: Immediate pain at site. Within 12 hours swelling, redness and pain at site with numbness and tingling down left arm/hand and that evening, wheezing and SOB. Within 24 hours of injection, wheezing and SOB better but left arm with numbness,and underarm pain and SEVERE swelling of lymph nodes affecting whole underarm, breast area. Now Monday, 10/17 not quite 36 hours with decreased swelling but still underarm sensitivity, pain and swelling.
Age: 1.95
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event, Upper respiratory tract infection
Clinical narrative: Received flu vaccine in his doctor's office on 10/14/2005. No adverse effects described that evening. Found dead in bed the following morning. Autopsy was performed; results are pending. 3/30/06 Autopsy Report received which stated COD as undetermined.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling @ site.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, MMR, TD
Symptoms: Demyelination, Hypoaesthesia
Clinical narrative: The reporter is the parent and is a practicing D.O. who states that this report was also given by telephone to manufacturer sometime during the week of 10-10-05. The reporter called this report to CDC, who is entering this info on behalf of the reporter.  Child began to experience right hand numbness on 8-21-05.  This progressed to left hand within 2 weeks.  MRI done 9-8-05, showed demyelination at C2-C3.  Neuro consult on 9-9-05, LP and blood work done.  On 9-20-05, upper body symptoms seems to peak.  Repeat MRI on 9-22-05 showed increase in c2-C3 lesion, but a decrease in the update of contrast dye seemed to indicate that the lesion was improving.  Then on 9-30-05, lower leg numbness presented bilaterally, and a third MRI on 10-5-05 showed a second demyelination at C3-C4.  A five day Steroid taper was initiated on 10-6-05 and improvement was noted on about 10-8-05.  As of this report, child is slowly improving, and the reporter has received neuro consult with neurologist to consider beta-interferon tx.  Medical records were requested to be sent and reporter states that he will send the records on 10-18-05.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, MMR, TD
Symptoms: CSF test abnormal, Hypoaesthesia, Myelitis transverse, Skin ulcer
Clinical narrative: The reporter is the parent and is a practicing D.O. who states that this report was also given by telephone to manufacturer sometime during the week of 10-10-05. The reporter called this report to CDC, who is entering this info on behalf of the reporter.  Child began to experience right hand numbness on 8-21-05.  This progressed to left hand within 2 weeks.  MRI done 9-8-05, showed demyelination at C2-C3.  Neuro consult on 9-9-05, LP and blood work done.  On 9-20-05, upper body symptoms seems to peak.  Repeat MRI on 9-22-05 showed increase in c2-C3 lesion, but a decrease in the update of contrast dye seemed to indicate that the lesion was improving.  Then on 9-30-05, lower leg numbness presented bilaterally, and a third MRI on 10-5-05 showed a second demyelination at C3-C4.  A five day Steroid taper was initiated on 10-6-05 and improvement was noted on about 10-8-05.  As of this report, child is slowly improving, and the reporter has received neuro consult with neurologist to consider beta-interferon tx.  Medical records were requested to be sent and reporter states that he will send the records on 10-18-05.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Rash, Sleep disorder
Clinical narrative: Immunization: Smallpox Vaccine Date: 07 Sept 2005, right arm Onset Date: 16-17 Sept 2005 Symptoms:  This 28 year old received his primary smallpox vaccination on 07 Sept 2005.  Approximately 16-17 Sept 2005 he complained of a sudden onset of "moderate midsternal chest pain/pressure" of variable intensity that was eased by sitting up and forward.  This discomfort disturbed his sleep and would wax and wane. He described the pain as feeling "like someone was standing on my chest  worse when lying flat or taking a deep breath". He denies nausea, vomiting, fevers, shortness of breath, or any radiating pain. He stated use of Ibuprofen had "minimal" effects.   He presented to medical clinic on 20 Sept 2005 with above complaints and complained of a rash from his thighs into his groin.  The rash was described as a papular design of the upper thigh in the area covered by his underwear that was diagnosed as "heat rash." His EKG showed NSR rate 73 with inverted T wave, unchanged from December 2004.   He was transferred to a hospital via ambulance for chest pain/pressure rule out myocarditis-pericarditis. Paramedics administered one 325 mg ASA enroute with cardiac monitoring. He described a mild squeezing midsternal type chest pain that began gradually one month ago while at rest with nausea to the nursing staff; however he denied any complaint of chest pain in the ER or while there to the physician.  He completed a cardiac evaluation to include a CBC, BMP, Cardiac panel (184/1.5/<0.04), PT, PTT  all normal; normal CXR and CT chest; and a normal EKG (NSR 66, T wave inversion, early repolarization). Cardiologist consulted and an echocardiogram was done.  He was released with a diagnosis of "non-specific chest pain" with prescriptions for Motrin 800mg and Albuterol inhaler as needed.  Attempts to contact this patient utilizing his cell and with above physician have been unsuccessful between 20 Sept 2005 and 17 Oct 2005. He is no longer in this town and his location is unknown. His cell phone is temporarily out of service.  CHCS II has no updated contact information.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Lymphadenopathy, Pain in jaw
Clinical narrative: 10 cm area of erythema, warmth at injection site on left arm with pain in left jaw, decreased range of motion in jaw, swollen cervical glands.  Treated with NSAID and Bactrim DS. Jaw pain persisted for 6 weeks. Skelaxin was prescribed after 6 weeks.
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaemia, Aspartate aminotransferase increased, Cardiomegaly, Ecchymosis, Eye haemorrhage
Clinical narrative: AS PER MOTHER'S INFORMATION, PATIENT BEGAN HAVING  HEADACHES AND FLU LIKE SYMPTOMS WITH THE INFLUENZA VIRUS VACCINE SHE RECEIVED 10/13/05 AT HER PLACE OF WORK.  THE HEADACHES BECAME WORSE AND THE PATIENT BEGAN EXERIENCING NAUSEA AND VOMITING WHICH PROMPTED HER TO GET MEDICAL HELP 10/17/05 AT OUR FACILITY.  AS PER THE PATIENTS MOTHER'S STATEMENT, THE PATIENT RECEIVE THE INFLUENZA VIRUS VACCINE LAST YEAR WITHOUT A PROBLEM.  THE VACCINE SHE RECEIVED 10/13/05 DID CAUSE A REACTION. SHE BEGAN EXPERIENCING A  RASH TO HER NECK AND THE SITE AS PER HER SUPERVISOR AT HER PLACE OF WORK. AS PER THE ADMITTING RN AT OUR FACILITY,  THE PATIENT IS NOT ALLERGIC TO EGG OR EGG CONTAINING PRODUCTS. SHE HAS NO HISTORY OF GUILLIAN BARRE. SHE HAS NO HISTORY OF OTHER DISEASES. Infroation received from medical records states malaise, blood short eyes, ecchymosis. msv Information from discharge summary states thrombocytopenoia, hemoptosis, hematemesis, hematuria, impaired thinking. msv Medical records states cardiomegely, cholelithiasis, pulmonary edema, perepherial edema, vascular anomaly. msv
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Haematemesis, Haematuria, Haemoptysis, Headache, Influenza like illness
Clinical narrative: AS PER MOTHER'S INFORMATION, PATIENT BEGAN HAVING  HEADACHES AND FLU LIKE SYMPTOMS WITH THE INFLUENZA VIRUS VACCINE SHE RECEIVED 10/13/05 AT HER PLACE OF WORK.  THE HEADACHES BECAME WORSE AND THE PATIENT BEGAN EXERIENCING NAUSEA AND VOMITING WHICH PROMPTED HER TO GET MEDICAL HELP 10/17/05 AT OUR FACILITY.  AS PER THE PATIENTS MOTHER'S STATEMENT, THE PATIENT RECEIVE THE INFLUENZA VIRUS VACCINE LAST YEAR WITHOUT A PROBLEM.  THE VACCINE SHE RECEIVED 10/13/05 DID CAUSE A REACTION. SHE BEGAN EXPERIENCING A  RASH TO HER NECK AND THE SITE AS PER HER SUPERVISOR AT HER PLACE OF WORK. AS PER THE ADMITTING RN AT OUR FACILITY,  THE PATIENT IS NOT ALLERGIC TO EGG OR EGG CONTAINING PRODUCTS. SHE HAS NO HISTORY OF GUILLIAN BARRE. SHE HAS NO HISTORY OF OTHER DISEASES. Infroation received from medical records states malaise, blood short eyes, ecchymosis. msv Information from discharge summary states thrombocytopenoia, hemoptosis, hematemesis, hematuria, impaired thinking. msv Medical records states cardiomegely, cholelithiasis, pulmonary edema, perepherial edema, vascular anomaly. msv
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site rash, Laboratory test abnormal, Malaise, Mental impairment, Nausea
Clinical narrative: AS PER MOTHER'S INFORMATION, PATIENT BEGAN HAVING  HEADACHES AND FLU LIKE SYMPTOMS WITH THE INFLUENZA VIRUS VACCINE SHE RECEIVED 10/13/05 AT HER PLACE OF WORK.  THE HEADACHES BECAME WORSE AND THE PATIENT BEGAN EXERIENCING NAUSEA AND VOMITING WHICH PROMPTED HER TO GET MEDICAL HELP 10/17/05 AT OUR FACILITY.  AS PER THE PATIENTS MOTHER'S STATEMENT, THE PATIENT RECEIVE THE INFLUENZA VIRUS VACCINE LAST YEAR WITHOUT A PROBLEM.  THE VACCINE SHE RECEIVED 10/13/05 DID CAUSE A REACTION. SHE BEGAN EXPERIENCING A  RASH TO HER NECK AND THE SITE AS PER HER SUPERVISOR AT HER PLACE OF WORK. AS PER THE ADMITTING RN AT OUR FACILITY,  THE PATIENT IS NOT ALLERGIC TO EGG OR EGG CONTAINING PRODUCTS. SHE HAS NO HISTORY OF GUILLIAN BARRE. SHE HAS NO HISTORY OF OTHER DISEASES. Infroation received from medical records states malaise, blood short eyes, ecchymosis. msv Information from discharge summary states thrombocytopenoia, hemoptosis, hematemesis, hematuria, impaired thinking. msv Medical records states cardiomegely, cholelithiasis, pulmonary edema, perepherial edema, vascular anomaly. msv
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Oedema peripheral, Pulmonary oedema, Rash, Thrombocytopenia, Vascular anomaly
Clinical narrative: AS PER MOTHER'S INFORMATION, PATIENT BEGAN HAVING  HEADACHES AND FLU LIKE SYMPTOMS WITH THE INFLUENZA VIRUS VACCINE SHE RECEIVED 10/13/05 AT HER PLACE OF WORK.  THE HEADACHES BECAME WORSE AND THE PATIENT BEGAN EXERIENCING NAUSEA AND VOMITING WHICH PROMPTED HER TO GET MEDICAL HELP 10/17/05 AT OUR FACILITY.  AS PER THE PATIENTS MOTHER'S STATEMENT, THE PATIENT RECEIVE THE INFLUENZA VIRUS VACCINE LAST YEAR WITHOUT A PROBLEM.  THE VACCINE SHE RECEIVED 10/13/05 DID CAUSE A REACTION. SHE BEGAN EXPERIENCING A  RASH TO HER NECK AND THE SITE AS PER HER SUPERVISOR AT HER PLACE OF WORK. AS PER THE ADMITTING RN AT OUR FACILITY,  THE PATIENT IS NOT ALLERGIC TO EGG OR EGG CONTAINING PRODUCTS. SHE HAS NO HISTORY OF GUILLIAN BARRE. SHE HAS NO HISTORY OF OTHER DISEASES. Infroation received from medical records states malaise, blood short eyes, ecchymosis. msv Information from discharge summary states thrombocytopenoia, hemoptosis, hematemesis, hematuria, impaired thinking. msv Medical records states cardiomegely, cholelithiasis, pulmonary edema, perepherial edema, vascular anomaly. msv
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: AS PER MOTHER'S INFORMATION, PATIENT BEGAN HAVING  HEADACHES AND FLU LIKE SYMPTOMS WITH THE INFLUENZA VIRUS VACCINE SHE RECEIVED 10/13/05 AT HER PLACE OF WORK.  THE HEADACHES BECAME WORSE AND THE PATIENT BEGAN EXERIENCING NAUSEA AND VOMITING WHICH PROMPTED HER TO GET MEDICAL HELP 10/17/05 AT OUR FACILITY.  AS PER THE PATIENTS MOTHER'S STATEMENT, THE PATIENT RECEIVE THE INFLUENZA VIRUS VACCINE LAST YEAR WITHOUT A PROBLEM.  THE VACCINE SHE RECEIVED 10/13/05 DID CAUSE A REACTION. SHE BEGAN EXPERIENCING A  RASH TO HER NECK AND THE SITE AS PER HER SUPERVISOR AT HER PLACE OF WORK. AS PER THE ADMITTING RN AT OUR FACILITY,  THE PATIENT IS NOT ALLERGIC TO EGG OR EGG CONTAINING PRODUCTS. SHE HAS NO HISTORY OF GUILLIAN BARRE. SHE HAS NO HISTORY OF OTHER DISEASES. Infroation received from medical records states malaise, blood short eyes, ecchymosis. msv Information from discharge summary states thrombocytopenoia, hemoptosis, hematemesis, hematuria, impaired thinking. msv Medical records states cardiomegely, cholelithiasis, pulmonary edema, perepherial edema, vascular anomaly. msv
Age: 24.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site rash, Rash, Thrombocytopenic purpura
Clinical narrative: AS PER MOTHER'S INFORMATION, PATIENT BEGAN HAVING  HEADACHES AND FLU LIKE SYMPTOMS WITH THE INFLUENZA VIRUS VACCINE SHE RECEIVED 10/13/05 AT HER PLACE OF WORK.  THE HEADACHES BECAME WORSE AND THE PATIENT BEGAN EXERIENCING NAUSEA AND VOMITING WHICH PROMPTED HER TO GET MEDICAL HELP 10/17/05 AT OUR FACILITY.  AS PER THE PATIENTS MOTHER'S STATEMENT, THE PATIENT RECEIVE THE INFLUENZA VIRUS VACCINE LAST YEAR WITHOUT A PROBLEM.  THE VACCINE SHE RECEIVED 10/13/05 DID CAUSE A REACTION. SHE BEGAN EXPERIENCING A  RASH TO HER NECK AND THE SITE AS PER HER SUPERVISOR AT HER PLACE OF WORK. AS PER THE ADMITTING RN AT OUR FACILITY,  THE PATIENT IS NOT ALLERGIC TO EGG OR EGG CONTAINING PRODUCTS. SHE HAS NO HISTORY OF GUILLIAN BARRE. SHE HAS NO HISTORY OF OTHER DISEASES. Infroation received from medical records states malaise, blood short eyes, ecchymosis. msv Information from discharge summary states thrombocytopenoia, hemoptosis, hematemesis, hematuria, impaired thinking. msv Medical records states cardiomegely, cholelithiasis, pulmonary edema, perepherial edema, vascular anomaly. msv
Age: 9.0
Sex: M
Vaccine: FLUN3
Symptoms: Urticaria
Clinical narrative: Hives 8 hours after FluMist administered intranasally.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Received pneumonia vaccine at about 1:45 PM in left deltoid on 10/15/05. Site red and swollen by evening. Monday, progressed down to left forearm, red, swollen, painful. Going to urgent care after phone call. I asked for follow up call.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEP, HIBV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Right leg 5cmx6cm red, firm, edematous.
Age: 1.52
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site rash
Clinical narrative: Contact-like rash 11cmx5cm surrounding vaccine injection site - erythematous papules, no tenderness, slight edema.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: From initial information received on Sept 15 2004 from a physician regarding an adverse event, it was reported that a four year old male patient received a fourth dose of IPOL, lot number X1040, administered subcutaneously in the right arm, a fifth dose of Tripedia, lot number U1307CA, administered in the right deltoid, and a second dose of MMR, lot number 1306N, administered subcutaneously in the left arm on Aug 23 2004 at 4:00pm. two days later, on Aug 25 2004 at 8:00am, the patient developed a 2cm x 2cm non tender, warm, erythematous area on his right upper arm surrounding the injection site. It was not specified whether the reaction occurred at the site of the IPOL or Tripedia vaccines. The patient recovered from these events. From additional information received on Nov 18 2004 from the responsible physician, it is unclear whether the reaction originated around the IPOL or Tripedia site. the only treatment was cool compresses. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter as cases 200403035, 200403036, 200403037, 200403039 and 200403040.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity
Clinical narrative: From initial information received on Sept 15 2004 from a physician regarding an adverse event, it was reported that a five year old female patient received a fourth dose of IPOL, lot number W0363, administered subcutaneously in the right thigh, a fifth dose of Tripedia, lot # U1301DA, administered in the right thigh, and a second dose of MMR , lot number 0961N, administered subcutaneously in the left leg on Jun 11 2004 at 9:30am. The next day on Jun 12 2004 at 3:00pm, the patient developed a large red area at the injection site on the right lower extremity. No treatment was given and the event resolved on the fourth day. The patient recovered from this event. From additional information received on Nov 18 2004 from the responsible physician, it was reported that it cannot be determined whether the reaction occurred at the IPOL or the Tripedia injection site. No further information is anticipated, this case is considered closed. The reporter of this case is the same as for cases 200403035, 200403036, 200403037, 200403038 and 200403040.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: From  initial information received on Sept 15 2004 from a physician regarding an adverse event, it was reported that a four year old female patient received a fourth dose of IPOL, lot number X1040, administered subcutaneously in the right leg, a fifth dose of Tripedia, lot number U1307DA, administered intra muscularly in the right leg, and a second dose of MMR, lot number 1306N, administered subcutaneously in the left leg on Aug 31 2004 at 4:00pm. The following day, on Sept 1 2004 at 8:00am, the patient developed a large non tender area of warmth and erythema measuring 6-7 cm at an unspecified injection site. She was treated with cool compresses. The symptoms lasted for four days and the patient recovered. From additional information received on Nov 18 2004from the responsible physician, it was reported that the patient developed the reaction on her right leg. The physician was unable to state whether the reaction occurred around the IPOL or Tripedia injection site. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter as cases 200403035, 200403036, 200403037, 20403308 and 200403039.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site inflammation, Injection site oedema, Tenderness
Clinical narrative: From initial information received on Sept 15 2004 from a physician regarding an adverse event occurring, it was reported that a five year old patient received a fourth dose of IPOL, lot number U1307CA, administered in the right thigh, and a second dose of MMR vaccine, lot number 1306N, administered subcutaneously in the left leg on Aug 23 2004 at 3:30pm. Four and a half hours later, at 8:00pm, the patient developed tenderness and swelling at the site of injection on the right leg. It was not specified whether the reaction occurred at the site of the IPOL or Tripedia injection. The swelling progressed and redness developed over the following two days. The patient was seen by his physician on Aug 28 2004 and had a 4.5 cm x 6 cm area of warmth and erythema at the injection site. The area was non tender. The patient was treated with Duricef 250mg. twice daily for five days and recovered from these events. From additional information received on Nov 18 2004 from a physician, it was reported that the patient recovered from these events on Aug 26 2004. The reporter stated that she was unclear whether the reaction occurred at the IPOL site or the Tripedia site. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter as cases 200403035, 200403036, 200403038, 200403039 and 200403040.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: from initial information received on Nov 18 2004 from a physician regarding an adverse event, it was reported that a five year old female patient received her fifth dose of Tripedia, lot number U1307CA, administered in the right vastus lateralis (route of administration nor reported) a fourth dose of IPOL, lot number X0800, administered subcutaneously in the right thigh and a second dose of MMR vaccine lot number 1306N, administered sub cutaneously in the left thigh on Aug 13 2004 at 3:00 pm. The following day, ON Aug 14 2004, the patient developed redness and swelling of thee entire side of her right thigh, which lasted for two to three days. Per the reporter, the patients mother did not call the physicians office because the child remained playful and did not have any tenderness or fever. The patients mother mentioned the events to the physician during an office visit on Nov 1 2004. Reportedly, the patient recovered from these events. The reporter of this case is the same as for case 200403035, 200403036, 200403037, 200403038, 200403039 and 200403040.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, DTAP, HEPA, MMR
Symptoms: Bacterial infection, Injection site erythema, Injection site swelling
Clinical narrative: Injection site inflammation, injection site redness, injection site swelling.  From initial information received on 9/1/04 from health care professional regarding an adverse event occurring in the U.S.A., it was reported that a four-year- old male patient received a Tripedia vaccination, lot # U1028CA, administered in the right arm, a Hepatitis A vaccination, lot # 0123P, manufactured by Merck, administered in the right arm, and a M-M-R/Measles, Mumps ad Rubella vaccination, lot #0268P. Manufactured by Merck and administered subcutaneously (site not reported) on 8/13/04 at 4:pm. The next day at 12:30pm, the patient developed redness and swelling around the injection site from the right shoulder to the right elbow. The patient recovered from these events, The reporter of this case is the same reporter as case 2004-02928.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMR, DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling, Laboratory test abnormal
Clinical narrative: Injection site inflammation, injection site redness, injection site swelling.  From initial information received on 9/1/04 from health care professional regarding an adverse event occurring in the U.S.A., it was reported that a four-year- old male patient received a Tripedia vaccination, lot # U1028CA, administered in the right arm, a Hepatitis A vaccination, lot # 0123P, manufactured by Merck, administered in the right arm, and a M-M-R/Measles, Mumps ad Rubella vaccination, lot #0268P. Manufactured by Merck and administered subcutaneously (site not reported) on 8/13/04 at 4:pm. The next day at 12:30pm, the patient developed redness and swelling around the injection site from the right shoulder to the right elbow. The patient recovered from these events, The reporter of this case is the same reporter as case 2004-02928.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV
Symptoms: Medication error, Urticaria
Clinical narrative: From initial information received on Jan 21 2005 from another manufacturer (reference number HQWYE984115DEC04), regarding an adverse event, it was initially reported b a physician that a four month old female patient received a dose of IPOL. lot number X1240, as well as a dose of Tripedia, lot number U1316CA, administered on Dec 16 2004. the routes and sites of administration were not reported. Three days later on Dec 9 2004, the patient developed hives all over her body. IT is unknown whether the patient recovered from this event. From additional information received on Apr 15 2005 from the responsible physician, it was reported that the patient had two previous dosed of IPOL and Tripedia with no reaction. The route of administration for IPOL was subcutaneous. She also received a second dose of Comvax, lot number 0129P, administered intra muscularly in the right thigh. Reportedly, there is no lab performed and name of responsible physician and vaccine administered were provided. Per the reporter, the patient was recovered from these events. From additional information received Apr 18 2005 from a health care professional, it was reported that the date of 12/06/2004 was listed next to date of death in error. A correction to patients first and last initial have been made. Per the reporter the IPOL and Tripedia vaccines listed were the second dose for this patient. No further information is anticipated, this case is considered closed.
Age: 0.38
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV
Symptoms: Urticaria
Clinical narrative: From initial information received on Jan 21 2005 from another manufacturer (reference number HQWYE984115DEC04), regarding an adverse event, it was initially reported b a physician that a four month old female patient received a dose of IPOL. lot number X1240, as well as a dose of Tripedia, lot number U1316CA, administered on Dec 16 2004. the routes and sites of administration were not reported. Three days later on Dec 9 2004, the patient developed hives all over her body. IT is unknown whether the patient recovered from this event. From additional information received on Apr 15 2005 from the responsible physician, it was reported that the patient had two previous dosed of IPOL and Tripedia with no reaction. The route of administration for IPOL was subcutaneous. She also received a second dose of Comvax, lot number 0129P, administered intra muscularly in the right thigh. Reportedly, there is no lab performed and name of responsible physician and vaccine administered were provided. Per the reporter, the patient was recovered from these events. From additional information received Apr 18 2005 from a health care professional, it was reported that the date of 12/06/2004 was listed next to date of death in error. A correction to patients first and last initial have been made. Per the reporter the IPOL and Tripedia vaccines listed were the second dose for this patient. No further information is anticipated, this case is considered closed.