chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site rash, Injection site erythema, Local reaction
Clinical narrative: Patient had localized reaction. Raised bumpy center with redness surrounding entire administration area. Instructed patient to contact physician for follow up and that this may occur due to her own tolerability.
Age: 1.02
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Injection site reaction, Pyrexia, Rash, Rash erythematous, Urticaria
Clinical narrative: Child received vaccines at 1040am on 3/7/12. Call from mom same day at 250pm to report rash right side of face, buttocks, back & legs. Rash red with puffy white spots in center. Spots are oval & oblong. Ran fever 100 that night. Hives spread both sides of body by evening.
Age: 1.04
Sex: F
Vaccine: HEPA, MMR
Symptoms: Injection site erosion, Injection site erythema, Injection site infection
Clinical narrative: 2 shots given 3/13/12 (L) thigh. Redness noted next day on both sites. Infant started scratching the area. One site became excoriated with secondary infection. Came follow up 3/20/12.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt was due for DTaP/DT/Td vaccination but was given DTaP/Hep B/IPV instead.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Blisters to upper torso.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Amnesia, Autoimmune disorder, Biopsy muscle, Blindness, Cardiac disorder
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Choking, Cognitive disorder, Deafness, Dizziness, Dysphagia
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Dyspnoea, Erythema, Exercise tolerance decreased, Eye pain, Fall
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Fatigue, Gait disturbance, Gastric disorder, Gastrointestinal motility disorder, Gastrooesophageal reflux disease
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Loss of consciousness, Lung disorder, Migraine, Movement disorder
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Muscular weakness, Nerve injury, Neuralgia, Pain, Pallor
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Paralysis, Pyrexia, Respiratory disorder, Swelling, Temperature regulation disorder
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Tremor, Urticaria, VIIth nerve paralysis
Clinical narrative: Fever, Redness, Swelling, severe pain, hives. Eye pain, loss of vision, loss of hearing, cognitive issues, severe chronic fatigue, dizziness, tremors, paralysis, difficulty breathing, passing out spells, difficulty walking, nerve pain, numbness in all extremities, heart issues, lung and respiratory issues, migraines, excercise and movement problems and intolerance, pale, trouble regulating my temperature in cold or heat, trouble swallowing, choking, facial drooping, falls, auto-immune type reaction, severe muscle weakness, loss of memory, cognitive issues, stomach and stomach motility issues, reflux, nerve damage.
Age: 1.68
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC
Symptoms: Incorrect dose administered, Injection site pain, Irritability
Clinical narrative: Patient was given 2 HIB vaccines. One in the Pentacel vaccine and one separate HIB vaccine. Pt. was also given routine Prevnar vaccine.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Entire body covered in hives.  Took one dose of Benadryl and the hives went away that same day.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Anaphylactic reaction, Food allergy, Intussusception
Clinical narrative: Hospitalized for dx intussusception.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Large area of warmth, induration, erythema around site of Menactra administration (right deltoid).
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm very swollen, red, warm to touch.  Pt taking Tylenol and applying ice.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Pt c/o 3-21-12 of "bubble" on bus to school at site of injection. Reaction appears bigger on 3-22-12 and seems red and slightly swollen at site of injection. Pt seen & assessed & monitored by nurse practitioner and prescribed AUGMENTIN 875 mg PO Q12 hours & BENADRYL 25 mg PO q 6 hours prn on 3-22-12 & ice/warm compresses. F/U 3-26-12 sx resolved.
Age: 1.64
Sex: M
Vaccine: HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Fever to 102.4 at 11 pm febrile seizure.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain, Tendonitis
Clinical narrative: Have been receiving treatment for tendonitis developed after flu shot. Receiving iontophoresis w/dexamethasone for shoulder pain and limitation of movements as well as physical therapy.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Warmth, redness, mild induration around vaccine administration site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever, fatigue.
Age: 14.0
Sex: F
Vaccine: MEN, TDAP, VARCEL
Symptoms: Dizziness, Fatigue, Headache, Pyrexia, Visual impairment
Clinical narrative: Time 9:00am on 3-20-12 Dizzy, vision, headache, fever, tiredness, felt lightheaded. Just gave TYLENOL symptoms subside on 3-21-12.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth, induration and pain at site of MCV. 3cm x 5cm (L) deltoid.
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Hypersomnia, Pain, Paraesthesia, Pyrexia, Somnolence
Clinical narrative: Note by Dr. 03/28/12. Became drowsy, achy, felt feverish. Slept most of the day and until 1pm the next day. Did not have fever when examined 3/28 tingling on bottom of his feet the next day - very mild.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Allergy test positive, Food allergy, Milk allergy, Urticaria
Clinical narrative: Approx 20-25 minutes after receiving MMR, Varicella and Hep A vaccines, infant developed hives to neck, chest, upper back. Hives responded to BENADRYL.
Age: 1.16
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Oral herpes, Rash generalised, Skin discolouration
Clinical narrative: Body rash on arms and legs, especially upper thighs. Two weeks after small clear blisters on wrists and fingers (black dot in center) a couple on legs later and cold sore inside mouth.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Inflammation on left deltoid.
Age: 16.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain upper, Headache
Clinical narrative: Client complained of stomach pain and headache; mother gave Advil for headache and Pepto Bismol for upset stomach.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Infertility female, Infertility tests, Laboratory test, X-ray of pelvis and hip
Clinical narrative: I have been diagnosed with unexplained infertility after one year of trying and I have a previous child.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Infertility female, Infertility tests, X-ray
Clinical narrative: I have been diagnosed with unexplained infertility after one year of trying and I have a previous child.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Induration, Paraesthesia, Pruritus
Clinical narrative: Hard area on right cheek, tingling, itchy and noticed blisters in this area.  Tingling in and lesions in V2 distribution - presumed shingles.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Hard area on right cheek, tingling, itchy and noticed blisters in this area.  Tingling in and lesions in V2 distribution - presumed shingles.
Age: 54.0
Sex: F
Vaccine: TYP
Symptoms: Cough, Influenza like illness
Clinical narrative: Patient reported cough and "flu-like symptoms".
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Pt vomited w/ 3 min of getting the zoster vaccine.
Age: 0.13
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large localized reaction on R thigh; no fever.
Age: 27.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Contusion
Clinical narrative: Client presented for PPD read on 3/30/12 and casually asked if unusual bruising could be the result of vaccinations received on 3/13/12.  Sent client to Comm. Health Center for evaluation.  Client reported back that physician thought was due to the aspirin the client had been taking.
Age: 51.0
Sex: F
Vaccine: TDAP, FLUX, TDAP
Symptoms: Fatigue, Hypertension, Palpitations
Clinical narrative: Awoke with very high blood pressure, pounding heart rate.  At times, my blood pressure was 145/97.  This lasted for over 15 days.   I visited Clinic twice within 3 weeks of vaccination.  They denied it was connected to vaccine.  I do not agree.  Severity of symptoms has subsided 04/01/2012.  Prior to this vaccination, my blood pressure has been controlled and kept normal for 20 years.  I was fearful of stroke or heart attack.  I was exhausted from my heart pounding.  I will never take this vaccination again.  Please ask medical people to take this more seriously.
Age: 51.0
Sex: F
Vaccine: TDAP, FLUX, TDAP
Symptoms: Blood pressure increased, Blood test, Palpitations, Tinnitus, X-ray
Clinical narrative: Awoke with very high blood pressure, pounding heart rate.  At times, my blood pressure was 145/97.  This lasted for over 15 days.   I visited Clinic twice within 3 weeks of vaccination.  They denied it was connected to vaccine.  I do not agree.  Severity of symptoms has subsided 04/01/2012.  Prior to this vaccination, my blood pressure has been controlled and kept normal for 20 years.  I was fearful of stroke or heart attack.  I was exhausted from my heart pounding.  I will never take this vaccination again.  Please ask medical people to take this more seriously.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Severe swelling of the entire upper arm in and around injection site.
Age: 17.0
Sex: F
Vaccine: DTAPIPV, MNQ, VARCEL
Symptoms: Chest discomfort, Cough, Pyrexia
Clinical narrative: Fever (101)-Tightness in chest, cough.
Age: 65.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Hypersomnia
Clinical narrative: Red swollen welt from armpit to just pass elbow. Muscle & joint pain & chills, tired. Slept for 2 days. Welt lasted 1 week.
Age: 65.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Myalgia, Oedema peripheral, Urticaria
Clinical narrative: Red swollen welt from armpit to just pass elbow. Muscle & joint pain & chills, tired. Slept for 2 days. Welt lasted 1 week.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face, neck, 24 hrs after injection. Exanthem rash, possible reaction to MMR. Does not itch. On Amoxicillin for ear inf. as well.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Patient turned pale, then fainted. Patient then layed on table/monitored for 30 minutes after injection. B/P taking after, then before she left.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: (L) arm red and swollen, fever 99.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Screaming
Clinical narrative: Screaming nonstop for a 24 hour period.
Age: 6.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Outbreak of varicella lesions scattered on trunk on (Lt) side/flank dermatome (as shingles).
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Severe swelling of entire arm. (per RN on 11/1/11). Went to ER. Diagnosed as cellulitis. Given steroid & antibiotics.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Malaise, Myalgia
Clinical narrative: Within 24h after IM injection of vaccine pt c/o malaise, myalgias, pain at injection site.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: Urticaria 6 hrs after vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Culture, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site papule
Clinical narrative: Localized rxn at site of injection - red, firm cellulitis 3 inch diameter - 1 small papulovesicle at inj site.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site vesicles, Local reaction
Clinical narrative: Localized rxn at site of injection - red, firm cellulitis 3 inch diameter - 1 small papulovesicle at inj site.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: L arm pain with intermittent numbness and tingling for at least 1 week after inj. Ibuprofen 600mg TID with food x 2 weeks, ice.
Age: 1.07
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Pruritus, Rash, Rash erythematous
Clinical narrative: Rash developed 10 days after vaccine and was a possible amoxicillin allergy. Then 14 days after the vaccine a bright red confluent rash developed only on the arms & legs with some spots distally on hands & ankles (+) itch. BENADRYL prn.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Pain
Clinical narrative: 3 cm raised red area on right thigh, soreness with walking.
Age: 47.0
Sex: F
Vaccine: YF
Symptoms: Electrocardiogram normal, Palpitations
Clinical narrative: After receiving the Yellow Fever vaccine 7-10 min later the patient started feeling heart palpitations, her heart rate was 142, after sitting down and drinking a glass of water her heart rate was 64, 15 min later her heart rate was 59.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Patient fainted after injection. Patient was pale and sweaty. Patient revived in 15 minutes with feet elevated, ice applied to back of neck  and 7-Up given.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site haematoma, Injection site joint pain, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: Vacc given 3/21. Site became achy next day, tender to touch, 3/22. Requiring ibuprofen for pain q 6 hours 3/23, radiated to shoulder & scapula (L). Cont to med ibuprofen Q 6 hours for pain until 3/25. Noted bruise at site 3/28. Site has been swollen since 3/22, but now decreased significantly 3/30. Seen by MD 3/28.
Age: 20.0
Sex: M
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: C/O fever, chills, body aches, nausea, (-) emesis, (-) diarrhea, (-) sore throat - started 3/26.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Loss of consciousness
Clinical narrative: Pt. lost consciousness and fell in the waiting room. She immediately regained consciousness and is doing fine.
Age: 19.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Hepatitis B surface antibody negative, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Student reports positive erythema, positive warmth, positive tenderness, increased edema at site of MMR injection - (R) deltoid that started 3-24-12 at 10:30-11:00 while trying to sleep. Tried Ibuprofen 400mg. Seen at Health Services on 3-26-12 at 3:15 p.m. T: 99.3. (R) deltoid positive edema, positive erythema, positive tender, positive warmth. Student reports improvement since 3-25-12. 3-29-12 11A re-examined. Eryth & edema almost resolved. No c/o pruritus or pain.
Age: 19.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Measles antibody, Mumps antibody test, Rubella antibody negative
Clinical narrative: Student reports positive erythema, positive warmth, positive tenderness, increased edema at site of MMR injection - (R) deltoid that started 3-24-12 at 10:30-11:00 while trying to sleep. Tried Ibuprofen 400mg. Seen at Health Services on 3-26-12 at 3:15 p.m. T: 99.3. (R) deltoid positive edema, positive erythema, positive tender, positive warmth. Student reports improvement since 3-25-12. 3-29-12 11A re-examined. Eryth & edema almost resolved. No c/o pruritus or pain.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Cold sweat, Dizziness, Flushing
Clinical narrative: Prior to administration, I asked the pt. if she had any signs or symptoms with previous vaccine given and if she had eaten. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines, the pt. complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the pt. to remain in the office for 15-20 minutes longer (it had been 40 minutes at this point). Pt. did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the pt. to grandfather's are with mother's knowledge. He was advised to have mom call us with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Nausea
Clinical narrative: Prior to administration, I asked the pt. if she had any signs or symptoms with previous vaccine given and if she had eaten. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines, the pt. complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the pt. to remain in the office for 15-20 minutes longer (it had been 40 minutes at this point). Pt. did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the pt. to grandfather's are with mother's knowledge. He was advised to have mom call us with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Chest pain, Cold sweat, Condition aggravated, Dizziness
Clinical narrative: Prior to administration, I asked the pt. if she had any signs or symptoms with previous vaccine given and if she had eaten. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines, the pt. complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the pt. to remain in the office for 15-20 minutes longer (it had been 40 minutes at this point). Pt. did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the pt. to grandfather's are with mother's knowledge. He was advised to have mom call us with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Flushing, Headache, Nausea
Clinical narrative: Prior to administration, I asked the pt. if she had any signs or symptoms with previous vaccine given and if she had eaten. Patient stated she had eaten and had no prior signs or symptoms. Approximately 5 minutes after vaccination of vaccines, the pt. complained of severe headache. Ten minutes later, she complained of nausea, lightheadedness, chest pain and abdominal pain. She appeared flushed and clammy. Vital signs (pulse, temp and blood pressure) were taken and were all normal. Dr. evaluated the patient and asked the pt. to remain in the office for 15-20 minutes longer (it had been 40 minutes at this point). Pt. did state to Dr. that she had chest pain and abdominal pain with the first 2 injections lasting 24 hours. Dr. released the pt. to grandfather's are with mother's knowledge. He was advised to have mom call us with an update. Total time spent in the office, after vaccine was given, was approximately 60 minutes.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Pt. received injection et that pm started to develop redness & swelling. States had 1/2 baseball size lump at site. Red, warm to touch et painful. Was told to do PO BENADRYL et ibuprofen et apply ice to site.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Pt. received injection et that pm started to develop redness & swelling. States had 1/2 baseball size lump at site. Red, warm to touch et painful. Was told to do PO BENADRYL et ibuprofen et apply ice to site.
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13
Symptoms: Dyskinesia, Lethargy, Mobility decreased, Oedema peripheral, Pyrexia
Clinical narrative: The evening after receiving 12 month immunizations pt. developed 102.5 fever, unable to roll over, swollen face & extremities, jerking of extremities, gagging, lethargic.
Age: 1.07
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PNC13
Symptoms: Retching, Swelling face
Clinical narrative: The evening after receiving 12 month immunizations pt. developed 102.5 fever, unable to roll over, swollen face & extremities, jerking of extremities, gagging, lethargic.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Hypersensitivity, Pain, Pruritus
Clinical narrative: Red, spreading, bruised, white marks, itching, sore, still some signs after 1 week - went to Dr on 19th for CELESTONE shot & 2 days of 50 mg x2day for 2 days.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: Red, spreading, bruised, white marks, itching, sore, still some signs after 1 week - went to Dr on 19th for CELESTONE shot & 2 days of 50 mg x2day for 2 days.
Age: 73.0
Sex: M
Vaccine: UNK
Symptoms: Pruritus generalised, Rash
Clinical narrative: Pt stated he got a rash located on his calves, forearms and back and feels itchy all over. No other symptoms. Spoke to his physician and he told him to take an antihistamine.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt. reports continuing pain at (L) deltoid after getting flu shot.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain lower, Arthralgia, Back pain, Computerised tomogram, Gynaecological examination
Clinical narrative: Pain in right shoulder injection site, joint & muscle pain including lower abdomen/pelvic area, buttocks, down back & front/sides of legs - from about 11/10/11 thru today 3/24/12 - filled out by patient. Acupuncture treatments pain clinic appointment.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site joint pain, Musculoskeletal pain, Myalgia, Pain in extremity, Pelvic pain
Clinical narrative: Pain in right shoulder injection site, joint & muscle pain including lower abdomen/pelvic area, buttocks, down back & front/sides of legs - from about 11/10/11 thru today 3/24/12 - filled out by patient. Acupuncture treatments pain clinic appointment.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Rectal examination, Ultrasound pelvis
Clinical narrative: Pain in right shoulder injection site, joint & muscle pain including lower abdomen/pelvic area, buttocks, down back & front/sides of legs - from about 11/10/11 thru today 3/24/12 - filled out by patient. Acupuncture treatments pain clinic appointment.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Antinuclear antibody, Blood creatine phosphokinase normal, Blood culture, C-reactive protein normal, Full blood count normal
Clinical narrative: The patient received varicella & Tdap in left shoulder. Since that day and over the past month she has had increasing pain and tenderness of her entire left upper extremity and intermittent pain and tenderness of her right arm, lumbar spine and left leg. No fever. Edema noted superior to left scapula. Normal studies: CBC, ESR, CRP, CMP, CPK, RF, 2 view xray left shoulder, urinalysis.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Metabolic function test normal, Oedema, Pain in extremity, Red blood cell sedimentation rate normal, Rheumatoid factor negative
Clinical narrative: The patient received varicella & Tdap in left shoulder. Since that day and over the past month she has had increasing pain and tenderness of her entire left upper extremity and intermittent pain and tenderness of her right arm, lumbar spine and left leg. No fever. Edema noted superior to left scapula. Normal studies: CBC, ESR, CRP, CMP, CPK, RF, 2 view xray left shoulder, urinalysis.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Spinal pain, Tenderness, Urine analysis normal, X-ray limb normal
Clinical narrative: The patient received varicella & Tdap in left shoulder. Since that day and over the past month she has had increasing pain and tenderness of her entire left upper extremity and intermittent pain and tenderness of her right arm, lumbar spine and left leg. No fever. Edema noted superior to left scapula. Normal studies: CBC, ESR, CRP, CMP, CPK, RF, 2 view xray left shoulder, urinalysis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash
Clinical narrative: Rash on chest & abd. x 3/25/12.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Irritability
Clinical narrative: Received 2 mo vaccines on 4/3 - 2-3 hours later crying inconsolable x 3 hrs. Mom ? if immune sides red. Seen in office fussy but consolable. Fed well. No redness noted at sites, tyl given.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Rash vesicular, Scab
Clinical narrative: Varicella-like rash from varicella vaccine. Vesicles (fluid-filled) which crust over in a few days.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelling, erythema, bruising & itching at left shoulder. Vaccine given 1-4-12 & symptoms still present at discharge 1-6-12.
Age: 1.68
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vaccination site rash
Clinical narrative: 1/31/12 large rash (R) ant thigh where vaccines give - refused to allergist.
Age: 7.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Feeling abnormal, Pruritus, Urticaria
Clinical narrative: Pt received vaccines around 3:30pm. 10:30p-11:00p developed hives to face, arm, back and one at panty line no s/s reaction at inj site. ER advised BENADRYL PO at 11:00p (approx). Mom gave dose this am. Hives very itchy no s/s of swelling lips, mouth, tongue, throat. Pt felt bad after inj. had been playing outside earlier day. BENADRYL po q 6-8 hours x 48. ER with further problems. Mom to let us know 4-2-12 how she is.
Age: 0.22
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Blood culture, Culture urine, Insomnia, Irritability, Pyrexia
Clinical narrative: Fussy, fever, not sleeping. Fever 100.3 (oto) at 0530 am. Temp in office 98.9 (tem oral) at approximately 1045.
Age: 0.22
Sex: F
Vaccine: HIBV, PNC13
Symptoms: White blood cell count increased
Clinical narrative: Fussy, fever, not sleeping. Fever 100.3 (oto) at 0530 am. Temp in office 98.9 (tem oral) at approximately 1045.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hypotonia, Immunisation reaction, Pallor, Somnolence
Clinical narrative: On 3-27-12 at 1830 patient became limp, pale and somnolent for about 5 minutes, which spontaneously resolved. Then the episode reoccurred an hour later. Patient was taken to the ER. By the time of arrival skin color is back to normal. Patient was back to normal Dx: Reaction to immunization resolved. Sent home stable.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Hypoaesthesia, Presyncope
Clinical narrative: Pre-syncope - numbness of arm.
Age: 19.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Orthopoxvirus test positive, Polymerase chain reaction, Scab, Secondary transmission, Skin lesion
Clinical narrative: 19 yo health female who had intimate contact with friend, primary vaccinee (vaccination date of 3/2/12) on 3/9/12. Friend's vaccination site was not covered and he was wearing short sleeve during intimate contact. On 3/13/12 she noted 5 facial lesions (left and right cheek and chin) which were originally treated with KEFLEX and then BACTRIM. Lesions tested positive for non-variola orthopox (per LRN) 3/22/12. As of 4/2/12 lesions are scabbed.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Red, swollen, hot indurated 65 x 90 cm.
Age: 1.25
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Lethargy, Pyrexia
Clinical narrative: On the morning following the vaccine administration the mother reported that patient was experiencing a fever of 103.2 and "lethargic". Patient was given TYLENOL and brought to the office where the temperature registered 98.7. Condition is improved.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Nausea, Pain
Clinical narrative: For approx. 3 days post-vaccination, pt. experienced fever, nausea, vomiting, body aches. Site of vaccination became sore, swollen, red, and redness spread down arm (not past elbow). A hard nodule developed. Pt. states these are resolving.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: For approx. 3 days post-vaccination, pt. experienced fever, nausea, vomiting, body aches. Site of vaccination became sore, swollen, red, and redness spread down arm (not past elbow). A hard nodule developed. Pt. states these are resolving.
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Hallucination, visual, Pain in extremity
Clinical narrative: Within 2-3 hr. developed pain in arm that vaccine was given; pain radiated down mid chest, pain midline, stay froze; visual hallucination "seeing spiders in the room".
Age: 15.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chest pain, Hallucination, visual, Injection site pain
Clinical narrative: Within 2-3 hr. developed pain in arm that vaccine was given; pain radiated down mid chest, pain midline, stay froze; visual hallucination "seeing spiders in the room".
Age: 30.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Lymphadenopathy, Malaise, Pain, Rash pruritic, Swelling face
Clinical narrative: March 29: Right side of face swelling next day both sides of face and lymph nodes. Face, arm, chest, lower back; raised itchy rash. General malaise, aches, pain. Resolved 4/2/12. Residual rash, swelling. Rx: Cephalexin 500mg 3xday 7 days, Loratadine 10mg qd x 30 days, Triamcinolone 0.1% cream affected area 2x day.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Syncope
Clinical narrative: Within 10 seconds of vaccine pt turned white & fainted. She came to in about 10-15 seconds. Sitting at time of syncope so no injury. 1st BP 105/55 - wait 15 mins 2nd BP 117/96 -> went home with father.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: Case number PHHY2011US115318 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 411731) website on 01 Feb 2011 with a follow up received from the quality assurance department (reference number: 148807) on 02 Mar 2012 and a follow up received on 26 Mar 2012. This report refers to a 56-year-old male patient. His medical history included pneumonia and concomitant medications were not reported. He was vaccinated with FLUVIRIN 2010/2011 vaccine (batch number: 11162403) intramuscularly on to left arm and pneumococcal polysaccharide vaccine (other manufacturer, batch number: 0930Z) intramuscularly on to right arm on 04 Oct 2010. On 05 Oct 2010, he developed fever of 102, redness and swelling rash at injection site. On 07 Oct 2010, he went to doctor and had ibuprofen. He was diagnosed with cellulitis localized to arm and was given antibiotic. The final outcome was reported as complete recovery as of an unspecified date. The quality assurance department opened a complaint for this case with reference number 148807. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 11162403 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148807) 02 Mar 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 148807) on 26 Mar 2012. Batch review report updated.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Axillary pain, Back pain, Breast pain, Cellulitis, Erythema
Clinical narrative: Case number PHHY2011US115387 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 412773) on 01 Feb 2011 and a follow up received from the quality assurance department on 01 Mar 2012, with a follow up batch review report received from quality assurance department on 26 Mar 2012. This case refers to a 35-year-old female patient. Her medical history included of type II diabetes and hypertension. She was vaccinated with FLUVIRIN (batch number: 1116933P) intramuscularly into her right arm on 09 Dec 2010. On the same day she was also vaccinated with Tdap (other manufacturer, batch number: C3539AA) intramuscularly into her left arm. On 10 Dec 2010 she had extreme back and arm pain. Eventually pain in arm was spread to breast and armpit region. She experienced flu-like symptoms and had a red, hard induration in arm which spread down. Over next few days, redness and hardness spread down arm. On 12 Dec 2010, she went to Emergency room and was advised to come back if pain and redness was spreading. She was believed to have cellulitis. The outcome was reported as condition unchanged as of 14 Dec 2010. A quality assurance investigation had been registered with reference number 148852. The quality assurance department reported that based on the document review, it was stated that the FLUVIRIN (batch number: 1116933P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 02 Mar 2012: Updated only the quality reference number. Follow up batch review report received from quality assurance department on 26 Mar 2012: Updated batch review report.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Induration, Influenza like illness, Pain in extremity
Clinical narrative: Case number PHHY2011US115387 is an initial spontaneous report received from vaccine adverse event reporting system website (VAERS reference number: 412773) on 01 Feb 2011 and a follow up received from the quality assurance department on 01 Mar 2012, with a follow up batch review report received from quality assurance department on 26 Mar 2012. This case refers to a 35-year-old female patient. Her medical history included of type II diabetes and hypertension. She was vaccinated with FLUVIRIN (batch number: 1116933P) intramuscularly into her right arm on 09 Dec 2010. On the same day she was also vaccinated with Tdap (other manufacturer, batch number: C3539AA) intramuscularly into her left arm. On 10 Dec 2010 she had extreme back and arm pain. Eventually pain in arm was spread to breast and armpit region. She experienced flu-like symptoms and had a red, hard induration in arm which spread down. Over next few days, redness and hardness spread down arm. On 12 Dec 2010, she went to Emergency room and was advised to come back if pain and redness was spreading. She was believed to have cellulitis. The outcome was reported as condition unchanged as of 14 Dec 2010. A quality assurance investigation had been registered with reference number 148852. The quality assurance department reported that based on the document review, it was stated that the FLUVIRIN (batch number: 1116933P) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department on 02 Mar 2012: Updated only the quality reference number. Follow up batch review report received from quality assurance department on 26 Mar 2012: Updated batch review report.
Age: 48.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood creatinine normal, Blood culture, Blood urea normal, Injection site cellulitis, White blood cell count increased
Clinical narrative: Case number PHHY2011US114891 is an initial spontaneous report derived from vaccine adverse event reporting system website (VAERS reference number: 416596) on 01 Apr 2011 with a follow up received from the quality assurance department (reference number: 148829) on 02 Mar 2012 and a follow up information received on 26 Mar 2012. This case refers to a 48-year-old male patient. His medical history included of myocardial infarction, hypertension and hyperlipidemia. He was vaccinated with FLUVIRIN (batch number: 11162602) intramuscularly into his right arm on 06 Feb 2011. On the same day he was also vaccinated with PPV (other manufacturer, batch number: 1294Z) intramuscularly into his right arm. On 08 Feb 2011, he developed cellulitis at the site of injection. Laboratory data revealed white blood cell count at 15.3, blood urea nitrogen at 13 and creatinine at 1.08. Blood cultures were also done but the results were not reported. He had recovered completely on an unspecified date. The quality assurance department opened a complaint for this case with reference number 148829. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 11162602 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from the quality assurance department (reference number: 148829) 02 Mar 2012: Updated reference number. Follow up received from the quality assurance department (reference number: 148829) on 26 Mar 2012. Batch review report updated.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Movement disorder
Clinical narrative: Case number PHHY2011US95062 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 431680) website on 27 Oct 2011 with a follow-up received from quality assurance department (reference number: 133136) on 10 Nov 2011 and 26 Mar 2011. This report refers to a 36-year old female patient. She was vaccinated with FLUVIRIN (batch number: 1100401) intramuscularly on 27 Aug 2011. On the same day, she had some loss of motor control of face and increased back pain 20 minutes after injection which lasted till 5:00 am. She recovered on 28 Aug 2011 approximately by 2:45 p.m. Based on the batch review report, it was stated that the concerned FLUVIRIN batch number 1100401 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up received from the quality assurance department (reference number: 133136) on 10 Nov 2011: Updated only the quality complaint number, Follow up information received from the quality assurance department on 26 Mar 2012: Updated batch review report.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Aphagia, Headache, Injection site induration, Musculoskeletal stiffness, Nausea
Clinical narrative: Case number PHHY2011US94992 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 433150) website on 27 Oct 2011 with a follow-up received from the product technical complaint department (PTC reference number: 133118) on 10 Nov 2011 and a follow up received on 26 Mar 2012. This report refers to a 74-year-old female patient. Her medical history included asthma and hepatitis C and emphysema and concomitant medication included TYLENOL, SYNTHROID, ALLEGRA, NEXIUM and albuterol inhaler. She was vaccinated with FLUVIRIN (batch number: 1101201) into left arm on 26 Aug 2011. After vaccination, she experienced sore in arm. Next day hard injection sites, aches and pain, severe headache, sinus clogged up. On 30 Aug 2011, she experienced stiff neck, sick of stomach and she could not eat. Headache was getting better as she was taking more TYLENOL with codeine than usual to help. She used neti-pot and ALLEGRA for congestion. She felt cross-eyed. The final outcome was reported as condition unchanged. The PTC department opened a complaint for this case with the reference number 133118. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1101201 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from the product technical complaint department (PTC reference number: 133118) on 10 Nov 2011: Reference number was updated. Follow up received from the quality assurance department (reference number: 133118) on 26 Mar 2012. Batch review report updated.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sinus congestion, Strabismus
Clinical narrative: Case number PHHY2011US94992 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 433150) website on 27 Oct 2011 with a follow-up received from the product technical complaint department (PTC reference number: 133118) on 10 Nov 2011 and a follow up received on 26 Mar 2012. This report refers to a 74-year-old female patient. Her medical history included asthma and hepatitis C and emphysema and concomitant medication included TYLENOL, SYNTHROID, ALLEGRA, NEXIUM and albuterol inhaler. She was vaccinated with FLUVIRIN (batch number: 1101201) into left arm on 26 Aug 2011. After vaccination, she experienced sore in arm. Next day hard injection sites, aches and pain, severe headache, sinus clogged up. On 30 Aug 2011, she experienced stiff neck, sick of stomach and she could not eat. Headache was getting better as she was taking more TYLENOL with codeine than usual to help. She used neti-pot and ALLEGRA for congestion. She felt cross-eyed. The final outcome was reported as condition unchanged. The PTC department opened a complaint for this case with the reference number 133118. Based on the documents review, it was stated that the concerned FLUVIRIN batch number 1101201 was manufactured in accordance with the approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from the product technical complaint department (PTC reference number: 133118) on 10 Nov 2011: Reference number was updated. Follow up received from the quality assurance department (reference number: 133118) on 26 Mar 2012. Batch review report updated.