chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.1
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Haematocrit decreased, Haemoglobin decreased, Intestinal anastomosis, Intestinal resection, Intussusception
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 weeks old female patient with no medical history, no previous illnesses and no known drug allergies was vaccinated on 17-NOV-2011 with the first dose of ROTATEQ (lot # 670010/0321AA), "by mouth", (dose not reported). Secondary suspect vaccine given on the same date included the second dose of RECOMBIVAX HB (lot # 669934/0571AA), I.M., in the right leg, (dose not reported). Concomitant vaccines given on the same date included the first dose of PREVNAR !# (batch # C3732AB), I.M., in the right leg and the first dose of PENTACEL, (batch # C3834AA), I.M., in the left leg. On 05-JAN-2012, the patient experienced intussusception 07-JAN-2012 reduced intraoperatively on 08-JAN-2012. The following information was obtained through follow-up and/or provided by the government. 31-JAN-2012. Hospital records date of service (DOS) 08-JAN-2012 to 12-JAN-2012. Diagnosis (DX): nonreducible intussusception. Chief complaint (CC): lethargy; vomiting; absence of bowel movements (BM). PE: masses palpable to right side of abdomen (abd). Intussusception unable to be reduced by air contrast enema; hence laparoscopy (E-Lap) done with ileocecal resection and primary re-anastomosis. Recovered well; the patient was discharged (DC) in stable condition to f/u with surgery primary care physician (PCP). Laboratory tests performed included serum calcium test 8.8 low, blood hemoglobin test 9.5 low and whole blood hematocrit 28. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room/doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447577. A priority lot check investigation for lot # 670010/0321AA has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 0.1
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5, DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Laparoscopic surgery, Lethargy, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 4 weeks old female patient with no medical history, no previous illnesses and no known drug allergies was vaccinated on 17-NOV-2011 with the first dose of ROTATEQ (lot # 670010/0321AA), "by mouth", (dose not reported). Secondary suspect vaccine given on the same date included the second dose of RECOMBIVAX HB (lot # 669934/0571AA), I.M., in the right leg, (dose not reported). Concomitant vaccines given on the same date included the first dose of PREVNAR !# (batch # C3732AB), I.M., in the right leg and the first dose of PENTACEL, (batch # C3834AA), I.M., in the left leg. On 05-JAN-2012, the patient experienced intussusception 07-JAN-2012 reduced intraoperatively on 08-JAN-2012. The following information was obtained through follow-up and/or provided by the government. 31-JAN-2012. Hospital records date of service (DOS) 08-JAN-2012 to 12-JAN-2012. Diagnosis (DX): nonreducible intussusception. Chief complaint (CC): lethargy; vomiting; absence of bowel movements (BM). PE: masses palpable to right side of abdomen (abd). Intussusception unable to be reduced by air contrast enema; hence laparoscopy (E-Lap) done with ileocecal resection and primary re-anastomosis. Recovered well; the patient was discharged (DC) in stable condition to f/u with surgery primary care physician (PCP). Laboratory tests performed included serum calcium test 8.8 low, blood hemoglobin test 9.5 low and whole blood hematocrit 28. This report was considered serious, immediately life threatening by the agency and required hospitalization for all adverse events. It required emergency room/doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 447577. A priority lot check investigation for lot # 670010/0321AA has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2cm X 2cm area of redness with local increase in temp at RUA Adacel IM site.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Decreased appetite, Dyskinesia, Fatigue, Heart rate increased
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Insomnia, Muscle spasms, Muscle tightness, Nausea
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Pyrexia, Thirst, Vomiting, Weight decreased
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Activities of daily living impaired, Alopecia, Antinuclear antibody negative, Blood urea decreased, Chest X-ray normal
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Constipation, Decreased appetite, Diarrhoea, Diplopia, Dizziness
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyskinesia, Fatigue, Feeling abnormal, Gait disturbance, HIV test negative
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Heart rate increased, Immediate post-injection reaction, Injection site pain, Insomnia
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphocyte percentage, Malaise, Mean platelet volume decreased, Mononucleosis heterophile test negative, Muscle spasms
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle tightness, Nausea, Nervous system disorder, Neurological examination normal, Neutrophil percentage decreased
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Platelet count increased, Pregnancy test negative, Protein albumin ratio increased
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Red blood cells urine positive, Rheumatoid factor negative, Somnolence, Thirst
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Tremor, Urine leukocyte esterase positive, Vaccination complication, Vertigo, Vomiting
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight decreased, White blood cell count increased, White blood cells urine positive
Clinical narrative: Nerve jerks & insomnia for first six months. Muscle spasms, fever when active, extreme fatigue, muscle tension, loss of appetite, extreme thirst, weight loss still to date. Several visits to E.R. for saline IV's to re-hydrate and lower high pulse. Treatment has been lots of water, rest, low cholesterol, low sodium, low sugar diet with lots of rest.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Gait disturbance, Pain, Pruritus, Rash erythematous, Swelling
Clinical narrative: Swelling, red bump, pain and itching, child also limping.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Fever after vaccination. 2 days later. Swelling started. On 5/9/12 at 12:20 PM severe swelling (warm) at the injection site and upper left arm.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain, Paraesthesia
Clinical narrative: Received vaccine in left arm 05/22/2012. Returned to pharmacy 5-24-12 redness amongst 80% of upper arm. Center (vaccination site) begin to blister. Warm to touch. Pt. reported tingling day before and now pain. Redness continued to spread. Referred to physician. Determined as "shingles outbreak" treated with antiviral.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Received vaccine in left arm 05/22/2012. Returned to pharmacy 5-24-12 redness amongst 80% of upper arm. Center (vaccination site) begin to blister. Warm to touch. Pt. reported tingling day before and now pain. Redness continued to spread. Referred to physician. Determined as "shingles outbreak" treated with antiviral.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash vesicular, Sensory disturbance
Clinical narrative: Has shingle-like rash on left side of neck. Has nerve sensation/tingling on left side of scalp.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Induration, Nodule
Clinical narrative: 2 days after shot had 4-5 inch area of redness & warmth & hard knot developed. Now 10 days later redness is gone but 1/2 inch hard knot under the skin remains.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Activities of daily living impaired, Erythema, Oedema peripheral, Skin warm
Clinical narrative: Left arm swollen, red, warm to touch. Mother gave MOTRIN po to child. Given 5/22/12 pm - Went to school 5/23/12 but sent home by school nurse.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Malaise
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient in her 70's who "2 weeks ago", on approximately 03-MAY-2012 was vaccinated subcutaneously with a dose of standard dose of ZOSTAVAX (Merck) (Lot #:670818/0662AA, exp 08/04/2012). It was reported to the pharmacist by a nurse who administered the vaccine that the patient did not feel well immediately after vaccination and about a week later, patient was hospitalized for "full blown shingles" (symptoms unspecified) and was treated with intravenous acyclovir. The patient was recovered on an unspecified date. Nurse told pharmacist that she called VAERS on 16-MAY-2012 to report this AE and was told by VAERS that there had 15 reported cases of adverse event with this particular lot #:670818/0662AA for ZOSTAVAX (Merck). This was captured on WAES# 1205USA04288. The patient's not feeling well and "full blown shingles" were considered to be disabling due to "extended hospital stay". A lot check has been initiated. This is one of several reports received from the same source. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Rubella antibody negative, Systemic lupus erythematosus
Clinical narrative: Information has been received from a registered nurse concerning an approximately 22 (at the time of the report 25) year old male patient who on an unknown date (when the patient was a child) was vaccinated with MMR II, (dose, route and Lot# not reported). In approximately 2009 (reported as about 3 years ago) the patient experienced lupus and was hospitalized. Currently the patient was recovered. On 03-MAY-2012 the patient underwent lab diagnostic test: the patient had low antibody titer to Rubella and Measles. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Oedema peripheral, Rash, Swelling face
Clinical narrative: Swelling to hand and cheeks. Rash to cheeks. Rash to neck.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Red, swollen, hard, warm to touch.
Age: 10.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Accommodation disorder, Neurological examination normal, Nuclear magnetic resonance imaging normal, Scan with contrast normal, Visual acuity reduced
Clinical narrative: Initial report was received from a health care professional on 16 May 2012. A 10-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4068 (corresponding sanofi pasteur Inc. lot number U4304BA) and an intramuscular injection of meningococcal vaccine, other manufacturer (lot number X10135B) on 21 February 2012. Two days after receiving the vaccinations, the patient began having vision disturbances and was unable to read clearly. The patient was seen by an ophthalmologist; vision was previously 20/20 but now was reported as 2200. The patient was seen by her primary care provider (PCP) and after testing was found not to have any neurological deficits. The diagnosis was accommodative paresis. The contrast MRI was negative. The patient had no illness at the time of vaccination and an allergy to amoxicillin. The patient's outcome was not recovered. Documents held by sender: None.
Age: 10.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Visual impairment
Clinical narrative: Initial report was received from a health care professional on 16 May 2012. A 10-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4068 (corresponding sanofi pasteur Inc. lot number U4304BA) and an intramuscular injection of meningococcal vaccine, other manufacturer (lot number X10135B) on 21 February 2012. Two days after receiving the vaccinations, the patient began having vision disturbances and was unable to read clearly. The patient was seen by an ophthalmologist; vision was previously 20/20 but now was reported as 2200. The patient was seen by her primary care provider (PCP) and after testing was found not to have any neurological deficits. The diagnosis was accommodative paresis. The contrast MRI was negative. The patient had no illness at the time of vaccination and an allergy to amoxicillin. The patient's outcome was not recovered. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Quarter size red, warm induration at vaccine site.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Emotional distress, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Unconsolable screaming for almost an hour, fever of 100.1, redness, swelling, and pain on right leg at injection site.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Pyrexia, Screaming
Clinical narrative: Unconsolable screaming for almost an hour, fever of 100.1, redness, swelling, and pain on right leg at injection site.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Right upper arm became swollen, hard to touch, and painful from elbow to shoulder. No redness, bruising or feeling of heat. No fever or other systemic symptoms.
Age: 1.51
Sex: M
Vaccine: DTAP
Symptoms: Bordetella test positive, Pertussis, Polymerase chain reaction
Clinical narrative: CHILD POSITIVE FOR PERTUSSIS.
Age: 55.0
Sex: F
Vaccine: DT
Symptoms: Aphasia, Burning sensation, Hyperacusis, Hypoaesthesia, Personality change
Clinical narrative: Development of numbness in face within hours of vaccination.  Symptoms progressed within 24 hours to include burning feeling in the body, ear ringing, change in personality, sensitive to bright lights and loud noises, difficulty understanding conversations.
Age: 55.0
Sex: F
Vaccine: DT
Symptoms: Photophobia, Tinnitus
Clinical narrative: Development of numbness in face within hours of vaccination.  Symptoms progressed within 24 hours to include burning feeling in the body, ear ringing, change in personality, sensitive to bright lights and loud noises, difficulty understanding conversations.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Noticeable area L posterior upper arm measuring 14cm X 15cm of erythema with induration of 5cm X 4cm. Pt c/o itching & discomfort to site but denies any numbness or tingling. Pt also received a TB skin test in L forearm same day.
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Asthenia, Blood culture, Cellulitis, Chest X-ray, Chills
Clinical narrative: 5/16 1230 Vaginal delivery 5/17 1349, 1350 received TDaP and Pneumovax 5/18 0050 fever 100.5 with shivering, sore throat 5/18 0745 whole body ache, site from pneumococcal vaccine reddened and size of quarter 1400 temp 101.8, site red and indurated 3cm x 2cm with pain 12 cm x 15 cm between shoulder and elbow, ice to site, CBC, UA ordered 2030 temp 102.3, blood cultures, chest xray ordered, started on clindamycin and Levaquin 5/19 feels weak, are sore, erythema 5 cm, dx cellulitis 5/20 10 cm erythema, fells better, dc home
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Full blood count, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 5/16 1230 Vaginal delivery 5/17 1349, 1350 received TDaP and Pneumovax 5/18 0050 fever 100.5 with shivering, sore throat 5/18 0745 whole body ache, site from pneumococcal vaccine reddened and size of quarter 1400 temp 101.8, site red and indurated 3cm x 2cm with pain 12 cm x 15 cm between shoulder and elbow, ice to site, CBC, UA ordered 2030 temp 102.3, blood cultures, chest xray ordered, started on clindamycin and Levaquin 5/19 feels weak, are sore, erythema 5 cm, dx cellulitis 5/20 10 cm erythema, fells better, dc home
Age: 30.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Urine analysis
Clinical narrative: 5/16 1230 Vaginal delivery 5/17 1349, 1350 received TDaP and Pneumovax 5/18 0050 fever 100.5 with shivering, sore throat 5/18 0745 whole body ache, site from pneumococcal vaccine reddened and size of quarter 1400 temp 101.8, site red and indurated 3cm x 2cm with pain 12 cm x 15 cm between shoulder and elbow, ice to site, CBC, UA ordered 2030 temp 102.3, blood cultures, chest xray ordered, started on clindamycin and Levaquin 5/19 feels weak, are sore, erythema 5 cm, dx cellulitis 5/20 10 cm erythema, fells better, dc home
Age: 24.0
Sex: F
Vaccine: MMRV
Symptoms: Back pain, Chest pain, Electrocardiogram, Headache, Lymphadenopathy
Clinical narrative: Headache for 6 days now-varying from constant pain to sharp weakening pain. Chest Pain on right side to include pain all the way down to my lower back. Bodyaches. Swelling of glands in armpit area on Right Side.
Age: 24.0
Sex: F
Vaccine: MMRV
Symptoms: Pain
Clinical narrative: Headache for 6 days now-varying from constant pain to sharp weakening pain. Chest Pain on right side to include pain all the way down to my lower back. Bodyaches. Swelling of glands in armpit area on Right Side.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Redness, swelling, hard lump at injection site, warmth around injection site, soreness, itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hard lump at injection site, warmth around injection site, soreness, itching.
Age: 1.51
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Febrile convulsion, Lethargy, Unresponsive to stimuli
Clinical narrative: Patient was taking a nap and started having a febrile seizure after sleeping for 3 hours. It lasted approximately 5 minutes. He was extremely lethargic/non-responsive for an hour afterwards.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives- pt. was taken to the ER.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever and vomiting.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Bite, Herpes zoster, Rash
Clinical narrative: Single bump/bite noted on back, which subsequently spread as a rash isolated to same site.  Not apparently itchy or painful. Appears to be shingles to the examiner.
Age: 51.0
Sex: M
Vaccine: MMR
Symptoms: Hypoaesthesia, Injection site anaesthesia, Injection site reaction, Pain in extremity, Paraesthesia
Clinical narrative: 51 year old male client with previous negative lab titer for Mumps advised by PCP to get MMR vaccine. On 5-21-12 client seen in IZ clinic and given MMR vaccine in left arm subcutaneous. Client called IZ clinic on 5-29-12 and stated he has experienced "minor tingling and numbness in his left shoulder, arm and hand that started on 5-23-12". As of today 5-29-12 client states "feel constant pins and needles in left shoulder, arm and hand, with pain level of 4/10 with the use of the left arm to pick up objects". Client states he called PCP 5-29-12 prior to notifying IZ clinic and spoke to someone in the office who told him "it sounds like a nerve thing". He states he was not seen or offered to come to be seen by PCP. Advised client if condition worsens or doesn't improve to call PCP again.
Age: 0.38
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: Mother states child had fever 101 degrees, hard to breathe at night, baby taken to Hospital, admitted for "early onset of pneumonia", treated stream tent, Pedialyte and Tylenol and discharged 2 days later.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Aggression, Agitation, Asthenia, Crying, Pyrexia
Clinical narrative: The day after vaccine he had low energy and a low grade fever, increased sleeping.  This persisted Through 5/24/2012.  Early evening of 5/24 he became violent kicking hitting, biting and unconsolable and would not let us touch him.  Screaming, crying, throwing himself on the ground, arching his back on the ground. This level of agitation and violence has never been previously exhibited by our child.  This episode lasted approximately 1 hour in which he finally cried himself to sleep.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Screaming, Somnolence
Clinical narrative: The day after vaccine he had low energy and a low grade fever, increased sleeping.  This persisted Through 5/24/2012.  Early evening of 5/24 he became violent kicking hitting, biting and unconsolable and would not let us touch him.  Screaming, crying, throwing himself on the ground, arching his back on the ground. This level of agitation and violence has never been previously exhibited by our child.  This episode lasted approximately 1 hour in which he finally cried himself to sleep.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a physician, via a sales representative, and described the occurrence of Guillain-Barre in a patient who received EPZICOM tablet for human immunodeficiency virus and INFLUENZA. Concurrent medical conditions included human immunodeficiency virus. Co-suspect medication included INFLUENZA. Concurrent medications included REYATAZ and NORVIR. On an unknown date, the patient started Abacavir sulfate & lamivudine (oral) at 1 capsule daily. In 2012, the patient received a dose of INFLUENZA (intramuscular injection). In 2012, approximately 1 month after receiving the INFLUENZA, the patient experienced Guillain-Barre. This case was assessed as medically serious by GSK. Treatment with Abacavir sulfate & lamivudine was discontinued. At the time of reporting, the outcome of the event was unknown. The reporting physician considered the event was possibly related to treatment with INFLUENZA and unlikely related to the treatment with Abacavir sulfate & lamivudine. The physician stated the patient was a long established user of Abacavir sulfate & lamivudine. The physician thought that the Guillain-Barre diagnosis may have been a result of the patient receiving the flu shot approximately one month prior, but the patient was sent to the neurologist and discontinued EPZICOM and REYATAZ.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Asocial behaviour, Decreased appetite, Drug administered at inappropriate site, Fatigue, Personality change
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of personality change in a 24-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medications included Tuberculin (TB skin test). On 23 April 2012 the subject received 2nd dose of HAVRIX (unknown, right arm) and experienced vaccine administered at inappropriate site. On 24 April 2012, the morning day after vaccination with HAVRIX, the subject experienced side effects. She was told the subject was tired, had a decrease in his appetite, he was not social (decreased social interest) and his mother noticed a change in his personality. The subject continues to experience the side effects until the afternoon of 30 April 2012 and the subject seemed to be back to normal. On 30 April 2012, the personality change, tiredness, decreased appetite, and decreased social interest were resolved. The physician via sales representative reported that the events were possibly related to vaccination with HAVRIX. Follow-up information was received on 25 May 2012 via physician who reported the subject had a mild runny nose and cough that started a few days prior to 23 April 2012 (previously 24 April 2012) and thought it was possibly allergies. The TB skin test (0.1ml) was administered intradermally. The HAVRIX vaccine was administered in the upper right arm. The physician noted regarding the administered at inappropriate site on the subject was adequate subcutaneous tissue or muscle. The physician reported the events started 23 April 2012 and resolved on 30 April 2012. The physician considered the events "serious because it occurred and frightened the parents" [clinically significant]. The physician reported "we found other reports of effect on personality (or seemed to be such)".
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Barium enema, Gastrointestinal surgery, Haematochezia, Hypophagia, Intussusception
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Otitis media, Ultrasound abdomen, Vomiting
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Alanine aminotransferase increased, Alanine aminotransferase normal, Barium enema, Blood albumin decreased, Blood calcium increased
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: C-reactive protein increased, Diarrhoea, Diarrhoea haemorrhagic, Haematochezia, Haematocrit decreased
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Haemoglobin decreased, Head lag, Hypophagia, Intensive care, Intestinal operation
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Intussusception, Irritability, Laparoscopic surgery, Lethargy, Lipase normal
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Lymphocyte percentage increased, Nasal congestion, Neutrophil percentage decreased, Otitis media, Platelet count increased
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Posture abnormal, Procedural pain, Pyrexia, Small intestinal intussusception reduction, Soft tissue disorder
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Ultrasound abdomen abnormal, Urinary system x-ray abnormal, Urine analysis abnormal, Viral infection, Vomiting
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC, RV5, DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: White blood cell count increased
Clinical narrative: Intussusception: 5/7/12 vomited. Bloody stools on 5/10/12; 5/14 left otitis media; 5/16/12 bloody stools, poor po intake. Open reduction of intussusception after failed BE.
Age: 35.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Pruritus, Skin irritation, Swelling face
Clinical narrative: Saw Dr 5/21/12 Pt states local irritation then 2-3 days itching % swelling face saw occ health 5/18/12.
Age: 78.0
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.11
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Body temperature increased, Rash maculo-papular
Clinical narrative: 3 weeks after first varicella vaccine; the child developed 102 degrees axillary and about 100 macular-papular vesicles on arms, chest, back, legs diaper area and in the mouth. No known contact with chicken pox or shingles cases.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & erythema of 1 cm at (R) upper arm.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Upper extremity mass
Clinical narrative: Lump size of a lemon on right arm. Red - warm area, itchy.
Age: 48.0
Sex: F
Vaccine: DTAP, HEPAB, MMR
Symptoms: Rash
Clinical narrative: Rash all over arms, legs, feet, stomach lasting about 2 1/2-3weeks started on 4-20-12 went to urgent care.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Pt returned next day with localized redness, swelling, stiff, hot injection site. Pt does not complain of other allergic sx or fever not involvement with tongue or ability to swallow.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rash maculo-papular
Clinical narrative: Fevers 103 degrees with macular-papular rash to chest and LUE - forearm.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm deltoid red and swollen. Hot to touch. MM 1" x 2" area of redness in deltoid region of (L) arm. No induration, no tenderness, using arm well.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Patient acquired a fever. Instructions from doctor was to take MOTRIN. Patient also had body aches.
Age: 33.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Culture urine, Full blood count, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Fever, swelling, redness, hardening of site (R) arm.
Age: 33.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pyrexia, Urine analysis
Clinical narrative: Fever, swelling, redness, hardening of site (R) arm.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Dependent rubor, Injection site erythema, Injection site warmth
Clinical narrative: (L) shoulder erythema. Calor, rubor.
Age: 1.11
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Rash, Urticaria
Clinical narrative: Pt's left arm red, swollen, with rash. Pt's (R) arm red, swollen and had half dollar size whelp per pt's mom. Mom reports symptoms started 5/19/12. Mom took pt to ER 5/20/12.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Local swelling, Mobility decreased, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Unable to turn neck due to swelling.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Fall, Loss of consciousness, Syncope
Clinical narrative: Received GARDASIL #2 5/21/12. Client was asked to sit for 20 min. Before 20 min. she fainted & fell off her chair. Regained consciousness after few seconds.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Fall, Laboratory test, Loss of consciousness, Syncope
Clinical narrative: Received GARDASIL #2 5/21/12. Client was asked to sit for 20 min. Before 20 min. she fainted & fell off her chair. Regained consciousness after few seconds.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram abnormal, Dizziness, Epistaxis, Facial bones fracture, Fall
Clinical narrative: Received GARDASIL #3 5/21/12 Mom in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, client felt dizzy & she fell on the floor. Sustained a rugged laceration on nasal bridge & nose bleed. EMS took her to hospital.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laceration
Clinical narrative: Received GARDASIL #3 5/21/12 Mom in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, client felt dizzy & she fell on the floor. Sustained a rugged laceration on nasal bridge & nose bleed. EMS took her to hospital.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram abnormal, Dizziness, Endoscopic retrograde cholangiopancreatography, Epistaxis, Facial bones fracture
Clinical narrative: Received GARDASIL #3 5/21/12 Mom in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, client felt dizzy & she fell on the floor. Sustained a rugged laceration on nasal bridge & nose bleed. EMS took her to hospital.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fall, Laceration
Clinical narrative: Received GARDASIL #3 5/21/12 Mom in a hurry to leave for work, so they left right after the shot was given. On the way out of the elevator, client felt dizzy & she fell on the floor. Sustained a rugged laceration on nasal bridge & nose bleed. EMS took her to hospital.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site swelling, Injection site vesicles, Pyrexia, Rash, Urticaria
Clinical narrative: Swelling on left leg, rash on head and face hive all over the body, and fever, and blisters around injection sight.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site discomfort, Injection site swelling
Clinical narrative: Patient called because having some discomfort at site of injection & some swelling during conversation realized she may have received IM instead of SQ (at 45 degrees pinched but upper arm instead of back).
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site streaking, Injection site warmth, Pyrexia
Clinical narrative: Patient received a tdap on 5/23/2012 left deltoid. Patient seen on 5/25/2012 for c/o warmth, redness to left deltoid with fever. 5cm red swelling with streaking toward axilla. Cold compress to arm. F/U if.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Anaphylactic reaction, Dyspnoea, Lip oedema, Rash, Tongue oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with a history of allergic rhinitis, wheezing and no known allergies, was vaccinated on 16-JAN-2012 with the second dose of GARDASIL, (lot # 671006/1291AA), I.M, in the left arm. The patient received GARDASIL #2. 3 hours later, the patient started to have difficulty breathing, rash; lip and tongue edema. The patient was seen at emergency room (ER) for anaphylaxis. Submucosal Injection Polypectomy (SIP) epinephrine, methylprednisolone, and diphenhydramine. The patient was discharged (D/C) home on oral prednisone and EPIPEN. The following information was obtained through follow-up and/or provided by the government. 20-JAN-2012. ER records date of service (DOS) 16-JAN-2012. Diagnosis (DX): anaphylaxis. Chief complaint (CC): difficulty breathing; skin rash with pruritus; tongue swelling; sensation of lump in throat; voice changes. Physical examination (PE): anxious; swollen lips/tongue; urticarial rash. X rays were taken (Rxed), epinephrine; steroid and antihistamine were administered. Patient's condition improved. Released in stable condition to f/u primary care physician (PCP). This report was considered serious and immediately life threatening. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # 447576. A priority lot check investigation has been finalized. All in-process quality checks for the lot number 671006/1291AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Anaphylactic reaction, Anxiety, Dysphonia, Dyspnoea, Lip oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with a history of allergic rhinitis, wheezing and no known allergies, was vaccinated on 16-JAN-2012 with the second dose of GARDASIL, (lot # 671006/1291AA), I.M, in the left arm. The patient received GARDASIL #2. 3 hours later, the patient started to have difficulty breathing, rash; lip and tongue edema. The patient was seen at emergency room (ER) for anaphylaxis. Submucosal Injection Polypectomy (SIP) epinephrine, methylprednisolone, and diphenhydramine. The patient was discharged (D/C) home on oral prednisone and EPIPEN. The following information was obtained through follow-up and/or provided by the government. 20-JAN-2012. ER records date of service (DOS) 16-JAN-2012. Diagnosis (DX): anaphylaxis. Chief complaint (CC): difficulty breathing; skin rash with pruritus; tongue swelling; sensation of lump in throat; voice changes. Physical examination (PE): anxious; swollen lips/tongue; urticarial rash. X rays were taken (Rxed), epinephrine; steroid and antihistamine were administered. Patient's condition improved. Released in stable condition to f/u primary care physician (PCP). This report was considered serious and immediately life threatening. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # 447576. A priority lot check investigation has been finalized. All in-process quality checks for the lot number 671006/1291AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Lip swelling, Pruritus, Rash, Sensation of foreign body, Swollen tongue
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with a history of allergic rhinitis, wheezing and no known allergies, was vaccinated on 16-JAN-2012 with the second dose of GARDASIL, (lot # 671006/1291AA), I.M, in the left arm. The patient received GARDASIL #2. 3 hours later, the patient started to have difficulty breathing, rash; lip and tongue edema. The patient was seen at emergency room (ER) for anaphylaxis. Submucosal Injection Polypectomy (SIP) epinephrine, methylprednisolone, and diphenhydramine. The patient was discharged (D/C) home on oral prednisone and EPIPEN. The following information was obtained through follow-up and/or provided by the government. 20-JAN-2012. ER records date of service (DOS) 16-JAN-2012. Diagnosis (DX): anaphylaxis. Chief complaint (CC): difficulty breathing; skin rash with pruritus; tongue swelling; sensation of lump in throat; voice changes. Physical examination (PE): anxious; swollen lips/tongue; urticarial rash. X rays were taken (Rxed), epinephrine; steroid and antihistamine were administered. Patient's condition improved. Released in stable condition to f/u primary care physician (PCP). This report was considered serious and immediately life threatening. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # 447576. A priority lot check investigation has been finalized. All in-process quality checks for the lot number 671006/1291AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Tongue oedema, Urticaria, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 year old female patient with a history of allergic rhinitis, wheezing and no known allergies, was vaccinated on 16-JAN-2012 with the second dose of GARDASIL, (lot # 671006/1291AA), I.M, in the left arm. The patient received GARDASIL #2. 3 hours later, the patient started to have difficulty breathing, rash; lip and tongue edema. The patient was seen at emergency room (ER) for anaphylaxis. Submucosal Injection Polypectomy (SIP) epinephrine, methylprednisolone, and diphenhydramine. The patient was discharged (D/C) home on oral prednisone and EPIPEN. The following information was obtained through follow-up and/or provided by the government. 20-JAN-2012. ER records date of service (DOS) 16-JAN-2012. Diagnosis (DX): anaphylaxis. Chief complaint (CC): difficulty breathing; skin rash with pruritus; tongue swelling; sensation of lump in throat; voice changes. Physical examination (PE): anxious; swollen lips/tongue; urticarial rash. X rays were taken (Rxed), epinephrine; steroid and antihistamine were administered. Patient's condition improved. Released in stable condition to f/u primary care physician (PCP). This report was considered serious and immediately life threatening. It required emergency room / doctor visit. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # 447576. A priority lot check investigation has been finalized. All in-process quality checks for the lot number 671006/1291AA were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.