chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient states small amount redness and itching on right upper arm injection site. Upon examination seen red area 2 in x 1 in indurate at injection site.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: Child received Dtap #4 at about 10AM 1-9-07. Mother noted "dime" sized reddened area at injection site later that day. Reddened area has increased in size since that time. 1-11-07 steadily until now has a "cherry red" area from his groin to his knee with a hard muscle on the back of the affected leg. No fever or other symptoms, but mother has been giving Tylenol as advised according to our fever control prolocal. Mother advised to take child to primary care physician and report back to nurse recommendations of physician. Phone call to mothers cell phone-mesage left to call health department. 1-16-07 No call from mother so another phone call placed to mother. Child almost totally improved now; just a small amount of redness on inner leg. Child was taken to doctor.  Doctor said that child had moderate local reaction. Advised Children's Motrin and warm compresses gradually improved. Child not complained of any pain today and participating in normal activities.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Arthralgia, Cold sweat, Muscle spasms, Myalgia, Nausea
Clinical narrative: Initial report received from a health care professional on 03/May/2006. A 19-year-old male patient with a medical history of seasonal allergies had received an injection on Menomune A./C/Y/W-135, lot number UE483AA, administered intra-muscularly in the right deltoid on 01/May/2006. One day later, the patient developed nausea and vomited once. He had cold sweats, joint and muscle aches. He also experienced a single cramp in his left leg. The patient did not have a fever. As per the reporter, the patient was to be evaluated by a physician on 03/May/2006. At the time of this report the patient's recovery status was unknown. Follow-up information received on 22/May/2006. Per the reporter, the patient had received allergy shots on the date of vaccination, and his age was 18-year-old. He was not examined by a physician for the event. Per the reporter, the patient had received the immunization late in the afternoon, and the symptoms began in the "middle of the night". On 04/May/2006, the parent indicated that he had fully recovered.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Vomiting
Clinical narrative: Initial report received from a health care professional on 03/May/2006. A 19-year-old male patient with a medical history of seasonal allergies had received an injection on Menomune A./C/Y/W-135, lot number UE483AA, administered intra-muscularly in the right deltoid on 01/May/2006. One day later, the patient developed nausea and vomited once. He had cold sweats, joint and muscle aches. He also experienced a single cramp in his left leg. The patient did not have a fever. As per the reporter, the patient was to be evaluated by a physician on 03/May/2006. At the time of this report the patient's recovery status was unknown. Follow-up information received on 22/May/2006. Per the reporter, the patient had received allergy shots on the date of vaccination, and his age was 18-year-old. He was not examined by a physician for the event. Per the reporter, the patient had received the immunization late in the afternoon, and the symptoms began in the "middle of the night". On 04/May/2006, the parent indicated that he had fully recovered.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Adacel given 12/18/06, onset of severe pruritis the following day (localized to palms and soles) and was seen 1-4-07 and 1-15-07 for persistent itching. No other new meds or significant illnesses. On Keflex.
Age: 1.42
Sex: F
Vaccine: UNK
Symptoms: Varicella
Clinical narrative: Mild form of Varicella
Age: 74.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site pain
Clinical narrative: On 10/30/6 pt rcv'd flu vaccine in L arm and Tdap vaccine in Rarm.  R arm near injection site sore the next day and still sore today near injection site and with certain arm movements--ie. adducting arm.
Age: 0.7
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, PPV
Symptoms: Unevaluable event
Clinical narrative: Gave the child an expired Hep A vaccine. There where no reactions
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site induration, Injection site nodule, Injection site oedema, Injection site pain
Clinical narrative: States her right arm was "knotted," swollen, bruised, sore and tender to touch within 24 hours of getting last dose of hepatitis B vaccine. States that dose "stung" more than others she's received. Firm, indurated, bruised area approximately 2.5 cm x 3 cm noted right deltoid area at/near injection site. Smaller firm, indurated, bruised area approximately 1.5 cm x 1.5 cm noted proximally and medially on right upper arm. States she felt like "vaccination drained to that area." No increased temperature or redness noted. Denies fever/chillls. States she takes a daily baby ASA. States she has never had a similar reaction to any vaccination. States she does not need medical evaluation or treatment at this time.
Age: 0.82
Sex: M
Vaccine: FLU3
Symptoms: Blood electrolytes normal, Chest X-ray normal, Electrocardiogram, Electroencephalogram, Febrile convulsion
Clinical narrative: Febrile Seizure approximately 10.5 hours after vaccination.  1/22/07 Received medical records from reporter which reveal patient seen 1/18 for flu shot & was well at that time.  Seen again on 1/19 s/p ER visit for febrile seizure.  Exam at that time found bulging red bilateral TMs.  Treated w/antibiotics. 1/26/07 Received medical records from hospital which reveal patient experienced an apneic spell with cyanosis, congestion & seizure activity at home.  On exam, right ear TM reddened. Given 1 dose of antibiotic.  No further seizure activity in ER & was d/c to f/u w/PCP next day.   FINAL DX: Febrile seizure.
Age: 0.82
Sex: M
Vaccine: FLU3
Symptoms: Full blood count normal
Clinical narrative: Febrile Seizure approximately 10.5 hours after vaccination.  1/22/07 Received medical records from reporter which reveal patient seen 1/18 for flu shot & was well at that time.  Seen again on 1/19 s/p ER visit for febrile seizure.  Exam at that time found bulging red bilateral TMs.  Treated w/antibiotics. 1/26/07 Received medical records from hospital which reveal patient experienced an apneic spell with cyanosis, congestion & seizure activity at home.  On exam, right ear TM reddened. Given 1 dose of antibiotic.  No further seizure activity in ER & was d/c to f/u w/PCP next day.   FINAL DX: Febrile seizure.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Patient returned to clinic on the day following flu shot with complaint of facial swelling (area around eyes & cheeks) which she noticed upon awakening on the day after the shot. No itching, rash or other swelling. No hx. of egg allergy. Takes no meds. Only known drug allergy is penicillin.  Exam revealed no significant swelling of face or elsewhere, no rash and no respiratory distress. B/P: 130/84, P 64. Lungs clear. No swelling of pharyngeal mucosa. Prescribed Benadryl 25-50 mg. q6h prn (#12)and patient advised to go to ED or return here prn return of swelling or other symptoms.
Age: 11.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Injection site rash, Injection site vesicles, Urticaria
Clinical narrative: Per phone call received from pt's mother on 1/18/2007: Taken to the ER 1 or 2 days after receiving the Pneumovax vaccine with a red raised area on her right deltoid with a surrounding rash, welts and blisters.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV, PNC
Symptoms: Agitation, Muscle twitching, Pyrexia
Clinical narrative: telephone call from mother approximately 24h after dtap,ipv,hib,pcv-7, and influenza izs. mo stated that 1h after izs given baby began "twitching all over, not actually convulsing, but continuous twitching in all limbs" baby remained alert, fussy with fever to 103 degrees. no prior reaction to previous izs. parents called paramedics, pulse ox, and vital signs all stable. as of 1/18/07 late in afternoon rare twitch, with fever to 101, less fussy.
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Injection site erythema, Malaise, Nasal congestion, Pyrexia
Clinical narrative: 5 days post-vaccination patient experienced mild malaise, stuffy nose and low grade fever (not recorded). The same day she noted redness on injection site.  P.E. 1 week post-vaccination-erythematous band 1x4 cm on back left arm, superficial, with no underlying induration.  No associated lymph nodes and remainder P.E. negative. Gradual improvement.  1 week later patient developed a mild (her words) "allergy rash," which improved after a few days.  Patient indicated a history of "egg allergy" (hives).
Age: 62.0
Sex: F
Vaccine: YF
Symptoms: Rash
Clinical narrative: 5 days post-vaccination patient experienced mild malaise, stuffy nose and low grade fever (not recorded). The same day she noted redness on injection site.  P.E. 1 week post-vaccination-erythematous band 1x4 cm on back left arm, superficial, with no underlying induration.  No associated lymph nodes and remainder P.E. negative. Gradual improvement.  1 week later patient developed a mild (her words) "allergy rash," which improved after a few days.  Patient indicated a history of "egg allergy" (hives).
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMRV
Symptoms: Herpes virus infection
Clinical narrative: Herpetiform Lesions on anus found 8 days after immunization
Age: 0.3
Sex: F
Vaccine: RV5
Symptoms: Dermatitis diaper, Haematochezia
Clinical narrative: baby developed severe diaper rash that lasted for 2 weeks and experienced some blood in stool intermittently during the 2 week period.  No treatment was administered other than topicals for rash.
Age: 1.07
Sex: F
Vaccine: FLU3, MMRV, PNC
Symptoms: Febrile convulsion
Clinical narrative: Patient had a febrile seizure three days after receiving immunizations.
Age: 0.82
Sex: M
Vaccine: FLU3, HEP
Symptoms: Blood immunoglobulin E normal, Skin test negative, Urticaria
Clinical narrative: On 1/12/07 Patient had 9 month checkup and received 3rd Hep B shot and 1st 0.25ml (thierosal-free) fluzone (prefilled syringe) injection. Within 15 minutes patient developed hives on cheek, torso and legs. Resolved after receiving Benadryl 3/4 tsp by mouth.  Follow-up: Developed hives on cheek, shoulder, torso within 20" after adm. of FLUZONE and hep B #3. No swelling or respiratory distress. Resolved with BENADRYL. Referred to allergist for follow up. Since then tolerated FLUZONE #2 and MMR-V without incident.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site pruritus, Injection site reaction
Clinical narrative: Local reaction left thigh 5x3.8 cm raised area, slightly itchy
Sex: F
Vaccine: DTAP
Symptoms: Induration, Inflammation
Clinical narrative: 4 cm induration and inflammation on Right thigh 24 hours after given. Prescribed Cephalexin 125 mg every 10 hours for 7 days.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Chills, Dizziness, Headache, Injection site reaction, Photophobia
Clinical narrative: About two hours after I received the Yellow Fever Vaccine, I got dizzy, got a severe headache, became light sensative, and started seeing incorrectly (I was seeing things that were to the side as if they were in the front). My sister and I were traveling and had to get a hotel room so I could lay down in the dark. I got chills and had to stay wrapped up in blankets to stay warm. The severe symptoms passed after about 8 hours but the headache lingered for several days. I did not receive any treatment. We just waited it out in the hotel room.
Age: 25.0
Sex: M
Vaccine: YF
Symptoms: Visual disturbance
Clinical narrative: About two hours after I received the Yellow Fever Vaccine, I got dizzy, got a severe headache, became light sensative, and started seeing incorrectly (I was seeing things that were to the side as if they were in the front). My sister and I were traveling and had to get a hotel room so I could lay down in the dark. I got chills and had to stay wrapped up in blankets to stay warm. The severe symptoms passed after about 8 hours but the headache lingered for several days. I did not receive any treatment. We just waited it out in the hotel room.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Severe headache, tiredness, nausea, weakness, fever of about 103, weakness and paleness, dizziness, and trouble breathing/shortness of breath.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pallor, Pyrexia
Clinical narrative: Severe headache, tiredness, nausea, weakness, fever of about 103, weakness and paleness, dizziness, and trouble breathing/shortness of breath.
Age: 0.38
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Grand mal convulsion, Pyrexia
Clinical narrative: Child developed fever 100.x when mom called in on 18th after vaccinations given.At this time child was almost recovered from an episode of bronchiolitis with otitis media and pharyngitis diagnosed on 01/03/2007. Still taking albuterol and pulmicort nebs, tylenol and dimetapp as he had developed a new cold. Upon exam it was noted that the ear infection was not completely resolved and child had a cough. Did not appear ill and was in good spirits. Received a call from mom on 01/19/2007 that the child had had a tonic clonic seizure and had been transported to ER where a full sepsis workup was performed. Child was being referred to hospital for admission and observation. Current status is not exactly known yet.  2/5/07 Received medical records from 2nd hospital which reveal patient experienced apparent life threatening event & possible onset seizure disorder vs GERD.  Neuro & GI consults obtained.  Temp in ER was 101.5.  Neuro felt was febrile seizure vx s/p vax provoked seizure. FINAL DX: Apparent life threatening evelt; febrile seizure vs s/p vax provoked seizure.
Age: 0.38
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, Grand mal convulsion, Laboratory test, Nasopharyngitis, Pyrexia
Clinical narrative: Child developed fever 100.x when mom called in on 18th after vaccinations given.At this time child was almost recovered from an episode of bronchiolitis with otitis media and pharyngitis diagnosed on 01/03/2007. Still taking albuterol and pulmicort nebs, tylenol and dimetapp as he had developed a new cold. Upon exam it was noted that the ear infection was not completely resolved and child had a cough. Did not appear ill and was in good spirits. Received a call from mom on 01/19/2007 that the child had had a tonic clonic seizure and had been transported to ER where a full sepsis workup was performed. Child was being referred to hospital for admission and observation. Current status is not exactly known yet.  2/5/07 Received medical records from 2nd hospital which reveal patient experienced apparent life threatening event & possible onset seizure disorder vs GERD.  Neuro & GI consults obtained.  Temp in ER was 101.5.  Neuro felt was febrile seizure vx s/p vax provoked seizure. FINAL DX: Apparent life threatening evelt; febrile seizure vs s/p vax provoked seizure.
Age: 0.38
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Sepsis
Clinical narrative: Child developed fever 100.x when mom called in on 18th after vaccinations given.At this time child was almost recovered from an episode of bronchiolitis with otitis media and pharyngitis diagnosed on 01/03/2007. Still taking albuterol and pulmicort nebs, tylenol and dimetapp as he had developed a new cold. Upon exam it was noted that the ear infection was not completely resolved and child had a cough. Did not appear ill and was in good spirits. Received a call from mom on 01/19/2007 that the child had had a tonic clonic seizure and had been transported to ER where a full sepsis workup was performed. Child was being referred to hospital for admission and observation. Current status is not exactly known yet.  2/5/07 Received medical records from 2nd hospital which reveal patient experienced apparent life threatening event & possible onset seizure disorder vs GERD.  Neuro & GI consults obtained.  Temp in ER was 101.5.  Neuro felt was febrile seizure vx s/p vax provoked seizure. FINAL DX: Apparent life threatening evelt; febrile seizure vs s/p vax provoked seizure.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling cold, Feeling hot, Hyperhidrosis, Listless, Nausea
Clinical narrative: Woke up after feeling very hot, entire body broke out into a sweat then got freezing cold (all within a 10 minute period), felt incredibly nauseous, blurry and darkened vision, hands were extremely shaky, then collapsed back asleep because I felt zapped of energy. Woke up three hours later and felt completely normal.
Age: 21.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, Vision blurred, Visual disturbance
Clinical narrative: Woke up after feeling very hot, entire body broke out into a sweat then got freezing cold (all within a 10 minute period), felt incredibly nauseous, blurry and darkened vision, hands were extremely shaky, then collapsed back asleep because I felt zapped of energy. Woke up three hours later and felt completely normal.
Age: 0.18
Sex: M
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 9 week old male who on 29 Sep 2006 was vaccinated PO with the first dose of Rotateq (human-bovine) (Lot # 654248/0577F). The RN reported that on 29 Sep 2006, immediately after the administration Rotateq, the patient developed a mild case of hives. Unspecified medical attention was sought. After about 10 minutes, the patient's hives subsided. It was noted that the series of Rotateq was discontinued after the first dose. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Insomnia, Pain, Pain in jaw, Rash
Clinical narrative: Information has been received from a physician and a 66 year old female consumer with a history of childhood varicella, irritable bowel syndrome, Raynaud's and dyslipidemia who on 01 Dec 2006 was vaccinated in the left upper extremity with a first dose of Zostavax (lot #652925/0621F). There was no concomitant medication. The consumer reported that by 04 Dec 2006 she developed a pain from the base of her neck to her jaw on the right side of her body. A rash also began on her right upper back. On 05 Dec 2006 the rash became more severe and spread to her right shoulder and the right side of her chest. The lymph nodes on the right side of her neck became very pronounced. The patient reported that she was in much discomfort. On 06 Dec 2006 the patient was seen by the physician who diagnosed her with shingles on the right C6-C7 dermatone. Her pain was rated 2-3 on a scale of 0-10 (0 least and 10 most). The physician reported that the patients rash occurred 72 hours after vaccination on 03 Dec 2006. No rash occurred at the site of injection. The patient was treated with Valtrex 1000 mg TID. At the time of the report, the patient had not recovered. There was no recent exposure to chickenpox or herpes zoster. Additional information has been requested. 6/17/10 Additional information from the consumer on 25-JAN-2007 indicated that her pain was gone, but scarring on her neck, back and chest was quite visible.  No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Lymphadenopathy, Neck pain, Pain in jaw
Clinical narrative: Information has been received from a physician and a 66 year old female consumer with a history of childhood varicella, irritable bowel syndrome, Raynaud's and dyslipidemia who on 01 Dec 2006 was vaccinated in the left upper extremity with a first dose of Zostavax (lot #652925/0621F). There was no concomitant medication. The consumer reported that by 04 Dec 2006 she developed a pain from the base of her neck to her jaw on the right side of her body. A rash also began on her right upper back. On 05 Dec 2006 the rash became more severe and spread to her right shoulder and the right side of her chest. The lymph nodes on the right side of her neck became very pronounced. The patient reported that she was in much discomfort. On 06 Dec 2006 the patient was seen by the physician who diagnosed her with shingles on the right C6-C7 dermatone. Her pain was rated 2-3 on a scale of 0-10 (0 least and 10 most). The physician reported that the patients rash occurred 72 hours after vaccination on 03 Dec 2006. No rash occurred at the site of injection. The patient was treated with Valtrex 1000 mg TID. At the time of the report, the patient had not recovered. There was no recent exposure to chickenpox or herpes zoster. Additional information has been requested. 6/17/10 Additional information from the consumer on 25-JAN-2007 indicated that her pain was gone, but scarring on her neck, back and chest was quite visible.  No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician and a 66 year old female consumer with a history of childhood varicella, irritable bowel syndrome, Raynaud's and dyslipidemia who on 01 Dec 2006 was vaccinated in the left upper extremity with a first dose of Zostavax (lot #652925/0621F). There was no concomitant medication. The consumer reported that by 04 Dec 2006 she developed a pain from the base of her neck to her jaw on the right side of her body. A rash also began on her right upper back. On 05 Dec 2006 the rash became more severe and spread to her right shoulder and the right side of her chest. The lymph nodes on the right side of her neck became very pronounced. The patient reported that she was in much discomfort. On 06 Dec 2006 the patient was seen by the physician who diagnosed her with shingles on the right C6-C7 dermatone. Her pain was rated 2-3 on a scale of 0-10 (0 least and 10 most). The physician reported that the patients rash occurred 72 hours after vaccination on 03 Dec 2006. No rash occurred at the site of injection. The patient was treated with Valtrex 1000 mg TID. At the time of the report, the patient had not recovered. There was no recent exposure to chickenpox or herpes zoster. Additional information has been requested. 6/17/10 Additional information from the consumer on 25-JAN-2007 indicated that her pain was gone, but scarring on her neck, back and chest was quite visible.  No further information is available.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Hypotension, Nausea
Clinical narrative: Information has been received from a health professional concerning a female who on 12-Dec-2006 was vaccinated with what was thought to be the first dose of Gardasil vaccine (yeast). On 12-Dec-2006, following vaccination, the patient felt dizzy, weak, and nauseous and was noted to have a low blood pressure with a systolic of 100. The patient did not faint. The patient did not recover in the office and was therefore sent to the emergency room. She was not admitted. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Chills, Lymphoblast count, Lymphocyte count abnormal, Pain in extremity
Clinical narrative: Information has been received from a nurse concerning an 18 year old  female non-smoker who abstains from alcohol and has no known drug allergies. On 22-Nov-2006, the patient was vaccinated with the first dose of Gardasil vaccine (yeast) (lot number 653937/0637F). On 22-Nov-2006 (also reported as 26-Nov-2006) the patient experienced maculopapular rash to bilateral lower extremities which started on her thighs and moved down to her feet, swelling to bilateral lower extremities with the right leg larger than the left, deep pain of bilateral lower extremity leg muscles particularly below the knee, and chills. The patient was seen in the Emergency Department on 27-Nov-2006. White blood cell count was 14.1 thou/cc/mm (range 4.0-10.0), platelet count was 361 thou/cc/mm (range 150-450), and lymphocyte count was 12.3% (range 20.0-45.0). The deep pain of bilateral lower extremity leg muscles particularly below the knee was so severe the patient could not walk, and it was considered an "emergency medical condition due to the impairment of bodily function". The patient was discharged to home on Percocet and Prednisone. Subsequently the patient recovered from maculopapular rash to bilateral lower extremities, swelling to bilateral lower extremities, deep pain of bilateral lower extremity leg muscles and chills. Deep pain of bilateral leg muscles particularly below the knee of bilateral lower extremities was considered to be disabling. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Platelet count normal, Rash maculo-papular, Swelling, White blood cell count increased
Clinical narrative: Information has been received from a nurse concerning an 18 year old  female non-smoker who abstains from alcohol and has no known drug allergies. On 22-Nov-2006, the patient was vaccinated with the first dose of Gardasil vaccine (yeast) (lot number 653937/0637F). On 22-Nov-2006 (also reported as 26-Nov-2006) the patient experienced maculopapular rash to bilateral lower extremities which started on her thighs and moved down to her feet, swelling to bilateral lower extremities with the right leg larger than the left, deep pain of bilateral lower extremity leg muscles particularly below the knee, and chills. The patient was seen in the Emergency Department on 27-Nov-2006. White blood cell count was 14.1 thou/cc/mm (range 4.0-10.0), platelet count was 361 thou/cc/mm (range 150-450), and lymphocyte count was 12.3% (range 20.0-45.0). The deep pain of bilateral lower extremity leg muscles particularly below the knee was so severe the patient could not walk, and it was considered an "emergency medical condition due to the impairment of bodily function". The patient was discharged to home on Percocet and Prednisone. Subsequently the patient recovered from maculopapular rash to bilateral lower extremities, swelling to bilateral lower extremities, deep pain of bilateral lower extremity leg muscles and chills. Deep pain of bilateral leg muscles particularly below the knee of bilateral lower extremities was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Induration, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a adult female post-menopausal smoker with hypertension and on estrogen replacement therapy who on 15-Nov-2006 at 11:00 AM was vaccinated SC in the left arm with a 0.65 ml first dose of Zostavax vaccine (lot#652946/1012F). There was no illness at the time of vaccination. Concomitant therapy included aspirin, verapamil, Benicar and estradiol. Subsequently the patient  developed a rash (non-varicella) at the injection site. Her arm swelled up, a bruise developed and was itchy. Unspecified quality complaint was not involved. Additional information has been received from the physician who reported that on an unknown date the patient developed marked local swelling and erythema. Subsequently, per the patient, she developed vesicles with parenthesis down the arm. At month month follow-up, the patient had persistent induration of approximately three centimeters. The date of recovery was anticipated to be in six months. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a adult female post-menopausal smoker with hypertension and on estrogen replacement therapy who on 15-Nov-2006 at 11:00 AM was vaccinated SC in the left arm with a 0.65 ml first dose of Zostavax vaccine (lot#652946/1012F). There was no illness at the time of vaccination. Concomitant therapy included aspirin, verapamil, Benicar and estradiol. Subsequently the patient  developed a rash (non-varicella) at the injection site. Her arm swelled up, a bruise developed and was itchy. Unspecified quality complaint was not involved. Additional information has been received from the physician who reported that on an unknown date the patient developed marked local swelling and erythema. Subsequently, per the patient, she developed vesicles with parenthesis down the arm. At month month follow-up, the patient had persistent induration of approximately three centimeters. The date of recovery was anticipated to be in six months. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old female with drug allergies to Depakote, Lortab, Neurotin, Valium and Fioricet. On 18-Dec-2006 (also reported as 18-Dec-1976) the patient was vaccinated with her first dose of Gardasil vaccine (yeast) (lot number 654540/1161F), intramuscularly in the left deltoid. On 18-Dec-2006 in the evening, the patient experienced generalized itching, and hives. The patient was instructed to take Benadryl 25 mg every 6-8 hours until the itching subsided. The patient was informed that she will not be receiving the additional 2 vaccinations. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 31 year old female with drug allergies to Depakote, Lortab, Neurotin, Valium and Fioricet. On 18-Dec-2006 (also reported as 18-Dec-1976) the patient was vaccinated with her first dose of Gardasil vaccine (yeast) (lot number 654540/1161F), intramuscularly in the left deltoid. On 18-Dec-2006 in the evening, the patient experienced generalized itching, and hives. The patient was instructed to take Benadryl 25 mg every 6-8 hours until the itching subsided. The patient was informed that she will not be receiving the additional 2 vaccinations. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated with a single 2ml oral first dose of Rotateq vaccine (human-bovine). Concomitant vaccinations included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (IPOL), a dose of Hib conj vaccine (tetanus toxoid (ACTHIB) and a dose of Prevnar. "Within hours after vaccination with Rotateq vaccine (human-bovine)" the patient developed a fever of 101-102 degrees. It was reported that the "patient was doing fine". Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to reports previously submitted on 1/16/2007. Information has been received from a physician concerning a 10 week old female, with a history of apnea episodes with the first at 13 days of life, who on 30-NOV-2006, at 10:00 a.m., was vaccinated with the first dose of ROTATEQ (lot# 655863/1034F). Concomitant vaccinations administered at the same time included a first intramuscular dose in the right leg of TRIPEDIA (Lot# C2521AA), a first subcutaneous dose in the left leg of VERO IPOL (Lot # Z0306) a first intramuscular dose in the right leg of ACTHIB (Lot# UF054AA) and a first intramuscular dose in the left leg of PREVNAR (Lot# BQ8683K). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 01-DEC-2006, at 12:00pm (previously reported as within hours after the vaccination) the patient developed a fever of 1001-102 degrees for 24 hours. It was reported that the "patient was doing fine" and had recovered on 02-DEC-2006. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Body temperature increased, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 2 month old patient who was vaccinated with a single 2ml oral first dose of Rotateq vaccine (human-bovine). Concomitant vaccinations included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (IPOL), a dose of Hib conj vaccine (tetanus toxoid (ACTHIB) and a dose of Prevnar. "Within hours after vaccination with Rotateq vaccine (human-bovine)" the patient developed a fever of 101-102 degrees. It was reported that the "patient was doing fine". Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to reports previously submitted on 1/16/2007. Information has been received from a physician concerning a 10 week old female, with a history of apnea episodes with the first at 13 days of life, who on 30-NOV-2006, at 10:00 a.m., was vaccinated with the first dose of ROTATEQ (lot# 655863/1034F). Concomitant vaccinations administered at the same time included a first intramuscular dose in the right leg of TRIPEDIA (Lot# C2521AA), a first subcutaneous dose in the left leg of VERO IPOL (Lot # Z0306) a first intramuscular dose in the right leg of ACTHIB (Lot# UF054AA) and a first intramuscular dose in the left leg of PREVNAR (Lot# BQ8683K). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 01-DEC-2006, at 12:00pm (previously reported as within hours after the vaccination) the patient developed a fever of 1001-102 degrees for 24 hours. It was reported that the "patient was doing fine" and had recovered on 02-DEC-2006. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse and a physician via a company representative concerning a 19 year old female with a latex allergy, who on 28 Dec 2006 was vaccinated with a 0.5 mL dose of Gardasil. The nurse reported that on 28 Dec 2006, the patient experienced "a near anaphylactic reaction". The patient's status was not reported. The patient sought unspecified medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a registered nurse and a physician concerning a 19 year old female with a latex allergy, gonorrhoea, cervical pain, chlamydial cervicitis and cervical dysplasia, who on 28-DEC-2006, at 11:20AM, was vaccinated IM in the right deltoid with a first 0.5 mL dose of GARDASIL vaccine (Lot#653937/0637F). Concomitant therapy included DEPR-PROVERA and OS-CAL. Information from medical records date 28-DEC-2006, indicated that the patient developed a "localized rash on the right side of the neck" after her vaccination with GARDASIL vaccine. There was no illness at the time of vaccination. Medical records also noted that she developed a rash and itching, "20 minutes" after the vaccination (onset also reported as 11:45 AM), located on right shoulder and upper chest (the nurse previously reported that the patient experienced "a near anaphylactic reaction). Follow up information from the nurse indicated that 15 minutes after vaccination, the patient developed hives on her neck (right side) and hives continued to move up on her face. She also reported that 20 minutes post-injection, the hives became itchy over neck, face and back. The patient was treated with BENADRYL, 50 mg IM, given in right hip at 1150. At 1215, the patient's itching/rash was fadding and at 1220, she stated she was feeling better. She had no shortness of breath. Her physical exam was normal. The patient was also given fluocinonide 0.05% cream. An epinephrine 0.3 mg syringe was also given to the patient and use was discussed. She was also given additional BENADRYL, 25mg tablets for use as necessary. The patient was considered recovered the same day, 28-DEC-2006. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactoid reaction, Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from a registered nurse and a physician via a company representative concerning a 19 year old female with a latex allergy, who on 28 Dec 2006 was vaccinated with a 0.5 mL dose of Gardasil. The nurse reported that on 28 Dec 2006, the patient experienced "a near anaphylactic reaction". The patient's status was not reported. The patient sought unspecified medical attention. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 1/16/2007. Information has been received from a registered nurse and a physician concerning a 19 year old female with a latex allergy, gonorrhoea, cervical pain, chlamydial cervicitis and cervical dysplasia, who on 28-DEC-2006, at 11:20AM, was vaccinated IM in the right deltoid with a first 0.5 mL dose of GARDASIL vaccine (Lot#653937/0637F). Concomitant therapy included DEPR-PROVERA and OS-CAL. Information from medical records date 28-DEC-2006, indicated that the patient developed a "localized rash on the right side of the neck" after her vaccination with GARDASIL vaccine. There was no illness at the time of vaccination. Medical records also noted that she developed a rash and itching, "20 minutes" after the vaccination (onset also reported as 11:45 AM), located on right shoulder and upper chest (the nurse previously reported that the patient experienced "a near anaphylactic reaction). Follow up information from the nurse indicated that 15 minutes after vaccination, the patient developed hives on her neck (right side) and hives continued to move up on her face. She also reported that 20 minutes post-injection, the hives became itchy over neck, face and back. The patient was treated with BENADRYL, 50 mg IM, given in right hip at 1150. At 1215, the patient's itching/rash was fadding and at 1220, she stated she was feeling better. She had no shortness of breath. Her physical exam was normal. The patient was also given fluocinonide 0.05% cream. An epinephrine 0.3 mg syringe was also given to the patient and use was discussed. She was also given additional BENADRYL, 25mg tablets for use as necessary. The patient was considered recovered the same day, 28-DEC-2006. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Angiogram pulmonary abnormal, Atrial tachycardia, Blood culture negative, Blood sodium decreased, Chest X-ray abnormal
Clinical narrative: No energy 1 week after, failing to thrive after that, slept alot, mild throat couth, HA, earaches, then developed into severe low back pain prompted MD Visit. Sent to ERD with bilateral pneumonia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Chronic obstructive pulmonary disease, Electrocardiogram abnormal, Fatigue, Hyponatraemia, Lethargy
Clinical narrative: No energy 1 week after, failing to thrive after that, slept alot, mild throat couth, HA, earaches, then developed into severe low back pain prompted MD Visit. Sent to ERD with bilateral pneumonia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: No reaction on previous exposure to drug, Pneumonia, Supraventricular tachycardia, Tobacco user, White blood cell count increased
Clinical narrative: No energy 1 week after, failing to thrive after that, slept alot, mild throat couth, HA, earaches, then developed into severe low back pain prompted MD Visit. Sent to ERD with bilateral pneumonia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Asthenia, Back pain, Chest X-ray abnormal, Cough, Ear pain
Clinical narrative: No energy 1 week after, failing to thrive after that, slept alot, mild throat couth, HA, earaches, then developed into severe low back pain prompted MD Visit. Sent to ERD with bilateral pneumonia.
Age: 71.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Failure to thrive, Headache, Hypersomnia, Pneumonia
Clinical narrative: No energy 1 week after, failing to thrive after that, slept alot, mild throat couth, HA, earaches, then developed into severe low back pain prompted MD Visit. Sent to ERD with bilateral pneumonia.
Age: 26.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Back pain, Heart rate increased, Hypersensitivity, Muscle spasms, Pain in extremity
Clinical narrative: Patient stated that on about 12/20/06 she had fever for 2 days then began to have neck and shoulder pain on 12/23/06. On about 12/23/06 pain was then in her back and she went to her Doctor on 12/26/06. Returned to doctor on 1/2/07.  Doctor sent her to the ER. The ER doctor told her it was a reaction to the MMR vaccine.
Age: 26.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Pyrexia, Torticollis
Clinical narrative: Patient stated that on about 12/20/06 she had fever for 2 days then began to have neck and shoulder pain on 12/23/06. On about 12/23/06 pain was then in her back and she went to her Doctor on 12/26/06. Returned to doctor on 1/2/07.  Doctor sent her to the ER. The ER doctor told her it was a reaction to the MMR vaccine.
Age: 26.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Injection site reaction, Musculoskeletal pain, Neck pain, Pyrexia
Clinical narrative: Patient stated that on about 12/20/06 she had fever for 2 days then began to have neck and shoulder pain on 12/23/06. On about 12/23/06 pain was then in her back and she went to her Doctor on 12/26/06. Returned to doctor on 1/2/07.  Doctor sent her to the ER. The ER doctor told her it was a reaction to the MMR vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Ecchymosis, Erythema, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Patient had immunizations Wed 1/3/07, by Friday after school mom noticed band aid, itching on left deltoid. Got ecchymosis below the puncture site. Bright red and swollen. Mother gave child Benadryl Saturday and Sunday. Itching a lot at left forearm. Today slight redness and warmth below puncture site.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, IPV
Symptoms: Swelling
Clinical narrative: Patient had immunizations Wed 1/3/07, by Friday after school mom noticed band aid, itching on left deltoid. Got ecchymosis below the puncture site. Bright red and swollen. Mother gave child Benadryl Saturday and Sunday. Itching a lot at left forearm. Today slight redness and warmth below puncture site.
Age: 26.0
Sex: M
Vaccine: ANTH, HEP, SMALL, YF
Symptoms: Pruritus, Rash, Skin infection
Clinical narrative: Skin infection with rash, itching
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Respiratory arrest
Clinical narrative: Sleeping with caregiver. Found not breathing. Vaccines administered within 28 days.
Age: 0.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Lethargy, Leukocytosis, Vomiting
Clinical narrative: Bilious emesis, diarrhea, lethargy, leukocytosis, dehydration requiring hospitalization and IVF. 1/23/07 Medical records received with report & considered complete as is.  Admitted 1/10-1/11/07 for bilious emesis, diarrhea, dehydration, lethargy & leukocytosis.  Received IVF.  No further emesis & afebrile. FINAL DX: bilious emesis.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Blood culture positive, Body temperature increased, Bronchiolitis, Pneumonia streptococcal, Virus serology test
Clinical narrative: Pt with RSV + bronchiolitis, admitted to hospital 01/02/2007-01/04/2007. Readmitted 01/05/007 2 hours worsening SX's. Increase temp 01/08/07. Bld culture done + strep pneumonia. Now treated adequately and improving.  01/29/07-records received and reviewed DC Summary for DOS 01/05-01/12/2007 DC DX: History of RSV positive bronchiolitis and strep pneumo bacteremia most likely secondary to Strep. pneumonitis.  Hospital Course :presented with respiratory distress and fevers, treated with IV antibiotics and fluids.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Pruritus, Rash, Skin burning sensation
Clinical narrative: After patient completed clinical exam at approximately 3:50pm. Patient given flu vaccine. After taking a few steps down hallway to leave at approximately 4pm patient complained of burning, itching and feeling broken out on face. Patient noted to have red, flushed cheeks. Right cheek appeared to have a circular area about dime size with red outer area and white inner area, over Right outer eyebrow noted to be red with a few small bumps. Doctor saw patient and advised to give patient Benadryl. Approximately 4:03pm patient given Benadryl elixir 50 mg (4tsp). 4:25pm cheeks appear more normal with just a few pinkened areas, circular area on Right cheek barely visible. Area over Right eyebrow normal in appearance with only a small bump noted. Patient reported face didn't feel like it was burning or itching anymore. Patient left with mom.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Skin discolouration
Clinical narrative: After patient completed clinical exam at approximately 3:50pm. Patient given flu vaccine. After taking a few steps down hallway to leave at approximately 4pm patient complained of burning, itching and feeling broken out on face. Patient noted to have red, flushed cheeks. Right cheek appeared to have a circular area about dime size with red outer area and white inner area, over Right outer eyebrow noted to be red with a few small bumps. Doctor saw patient and advised to give patient Benadryl. Approximately 4:03pm patient given Benadryl elixir 50 mg (4tsp). 4:25pm cheeks appear more normal with just a few pinkened areas, circular area on Right cheek barely visible. Area over Right eyebrow normal in appearance with only a small bump noted. Patient reported face didn't feel like it was burning or itching anymore. Patient left with mom.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Erythema, Injection site induration, Nausea, Pain
Clinical narrative: Redness, induration of injection site 45 mm-tightness of throat, fever 101F, chills, localized pain, nausea, vomiting, diarrhea.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Throat tightness, Vomiting
Clinical narrative: Redness, induration of injection site 45 mm-tightness of throat, fever 101F, chills, localized pain, nausea, vomiting, diarrhea.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Convulsion
Clinical narrative: Received present complaint from Emergency Room Doctor requesting name of vaccines child received 2 hours in ER. Seizure this AM in school for 2 minutes. 01/24/07- received ER report supports seizure with recommendation to see a neurologist. Seizure at school. Seen in ER lethargic . PE: WNL.
Age: 12.0
Sex: M
Vaccine: FLUN3, TDAP
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Fever, rash, redness, started on Friday 01/12/07.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Haematoma, Hypokinesia, Injection site pain, Injection site swelling
Clinical narrative: Slight swelling at site of injection within a few days after shot, never went down. No pain. As months went by, arm still seemed slightly swollen and pain began at site extending to shoulder and restricting motion.  Doctor said a hematoma had developed and sent me to PT