chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Injection site urticaria, Paraesthesia oral, Pruritus, Throat irritation
Clinical narrative: 2:50 pm Lips tingling, itchy throat - given 25 BENADRYL. 7:00 pm hives on left arm (area where flu shot was given) hives on stomach, itchy eyes, face, neck - BENADRYL and OTC anti itch cream.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Flushing, Pain in extremity
Clinical narrative: Flushing, lightheaded, chills within 10 min of vaccine. Did not return to report symptoms until 2:20 pm. Returned to work. 10-6 Follow up - Pt at work - c/o sore arm. Said she called her Dr last pm - he felt that this was a possible reaction to N1H1.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pain, Swelling
Clinical narrative: Pain, swelling & redness between injection sites on arm (Flu & Pneumo). Day 1 - no reaction. Day 2 - Rxn - treated with APAP & cold compress. Day 3 - Rxn continued - referred to PCP.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Initial report received from a health care professional on 07 Oct 2010: This patient was vaccinated with FLUVIRIN 2010/2011 (batch number: 111625A01) on an unspecified date. At the time of vaccination, the patient was pregnant. No adverse events were reported. Follow up report health care professional on 19 Oct 2010: The patient had history of one previous healthy birth. The patient received FLUVIRIN 0.5 ml intramuscularly on 06 Oct 2010. The estimated date of delivery was reported as Jun 2011. No prenatal tests were performed. The patient had spontaneous abortion in first trimester after 5 days of vaccination. The case was reported as non serious. No other information was reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Lethargy, Scab, Tenderness
Clinical narrative: Vaccinated on 10/22/10 4:30pm, on 10/27/10 patient returned. Displayed quarter size yellowish bruise on R shoulder with 18 pin sized scabs running linearly thru bruised area in a vertical line. Patient had no apparent redness or swelling at site. Patient states area is tender. Has felt lethargic for several days.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever of 101.4 degrees started 10/21/10 approx 3AM, left arm at sight of shot was extremely sore for 9 days. Fever continued & on 10/25/10, went to doctor. Arm was examined & doctor determined I was possibly injected with a contaminated needle. 10-day antibiotic prescribed. Fever continued until 10/29/10. Cost $75 - dr. antibiotic - $8.42 = $83.42.  I should be reimbursed for doctors & drugs.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Fever to 101 degrees F - Night of flu shot is afebrile the morning after with malaise and body aches.
Age: 2.0
Sex: F
Vaccine: FLU3, HEPA, PNC13
Symptoms: Dyspnoea, Gaze palsy
Clinical narrative: Patient was gasping for air. Short of breath and rolling her eyes. I called 911, and she was taken to the emergency room.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Redness at site of injection. Rash, minor swelling. Normal pain associated with local site injection. No major pain otherwise stated. Since both the pneumonia/flu vaccines were administered in the same arm, it is difficult to determine which product caused the reaction.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Blood thyroid stimulating hormone decreased, C-reactive protein increased, Goitre, Hyperthyroidism
Clinical narrative: Initial literature report received on 19 Oct 2010: This patient with no prior history of thyroid disease or symptoms to suggest a recent viral infection had received H1N1 (manufacturer unknown, batch number: unknown) on unspecified date. 1 month after vaccination the patient presented with acute onset of palpitations, anxiety, and anterior neck pain. She had clinical features of thyrotoxicosis, including sinus tachycardia and a fine tremor of both hands in addition to an exquisitely tender and enlarged thyroid gland. Serum thyroid function tests confirmed severe thyrotoxicosis with thyroid stimulating hormone (TSH)<0.02 mlU/l (reference range: 0.3-4.5 mlU/l), T4 100 pmol/l (reference 1-21 pmol/l), and T3 20.6 pmol/l (reference range 2.8-6.1 pmol/l). In the context of no recent iodine exposure, 99m Tc-pertechnetate thyroid scintigraphy was performed which demonstrated marker diffuse reduction in tracer uptake. This appearance was typical of thyroiditis. The inflammatory markers, erythrocyte sedimentation rate and C-reactive protein (CRP), were significantly elevated at 104mm/h (reference range 0-12 mm/h) and 101 mg/l (reference range<5 mg/l), respectively. Consequently the diagnosis of subacute thyroiditis, also known as De Quervain's thyroiditis, was made. 5 weeks prior to this diagnosis the patient was euthyroid with TSH of 0.55 mlU/l (reference range 0.3-4.5 mlU/l). The patient was treated with propanolol and a prolonged course of prednisone, initially at a daily dosage of 40 mg. This was weaned over several weeks and there was a gradual improvement in serial thyroid function tests after commencement of prednisone, there was a remission of her thyroiditis with following results (TSH 2.79 mlU/l, T4 12.3 pmol/l, T3 3.2 pmol/l, CRP 2 mg/l). At the time of reporting there was no evidence of the development of hypothyroidism. Seeing the temporal sequence of events, a causal link between the H1N1 vaccine and the development of patient's subacute thyroiditis was suspected.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Palpitations, Red blood cell sedimentation rate increased, Scan thyroid gland, Sinus tachycardia
Clinical narrative: Initial literature report received on 19 Oct 2010: This patient with no prior history of thyroid disease or symptoms to suggest a recent viral infection had received H1N1 (manufacturer unknown, batch number: unknown) on unspecified date. 1 month after vaccination the patient presented with acute onset of palpitations, anxiety, and anterior neck pain. She had clinical features of thyrotoxicosis, including sinus tachycardia and a fine tremor of both hands in addition to an exquisitely tender and enlarged thyroid gland. Serum thyroid function tests confirmed severe thyrotoxicosis with thyroid stimulating hormone (TSH)<0.02 mlU/l (reference range: 0.3-4.5 mlU/l), T4 100 pmol/l (reference 1-21 pmol/l), and T3 20.6 pmol/l (reference range 2.8-6.1 pmol/l). In the context of no recent iodine exposure, 99m Tc-pertechnetate thyroid scintigraphy was performed which demonstrated marker diffuse reduction in tracer uptake. This appearance was typical of thyroiditis. The inflammatory markers, erythrocyte sedimentation rate and C-reactive protein (CRP), were significantly elevated at 104mm/h (reference range 0-12 mm/h) and 101 mg/l (reference range<5 mg/l), respectively. Consequently the diagnosis of subacute thyroiditis, also known as De Quervain's thyroiditis, was made. 5 weeks prior to this diagnosis the patient was euthyroid with TSH of 0.55 mlU/l (reference range 0.3-4.5 mlU/l). The patient was treated with propanolol and a prolonged course of prednisone, initially at a daily dosage of 40 mg. This was weaned over several weeks and there was a gradual improvement in serial thyroid function tests after commencement of prednisone, there was a remission of her thyroiditis with following results (TSH 2.79 mlU/l, T4 12.3 pmol/l, T3 3.2 pmol/l, CRP 2 mg/l). At the time of reporting there was no evidence of the development of hypothyroidism. Seeing the temporal sequence of events, a causal link between the H1N1 vaccine and the development of patient's subacute thyroiditis was suspected.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Thyroiditis subacute, Thyroxine increased, Tremor, Tri-iodothyronine increased
Clinical narrative: Initial literature report received on 19 Oct 2010: This patient with no prior history of thyroid disease or symptoms to suggest a recent viral infection had received H1N1 (manufacturer unknown, batch number: unknown) on unspecified date. 1 month after vaccination the patient presented with acute onset of palpitations, anxiety, and anterior neck pain. She had clinical features of thyrotoxicosis, including sinus tachycardia and a fine tremor of both hands in addition to an exquisitely tender and enlarged thyroid gland. Serum thyroid function tests confirmed severe thyrotoxicosis with thyroid stimulating hormone (TSH)<0.02 mlU/l (reference range: 0.3-4.5 mlU/l), T4 100 pmol/l (reference 1-21 pmol/l), and T3 20.6 pmol/l (reference range 2.8-6.1 pmol/l). In the context of no recent iodine exposure, 99m Tc-pertechnetate thyroid scintigraphy was performed which demonstrated marker diffuse reduction in tracer uptake. This appearance was typical of thyroiditis. The inflammatory markers, erythrocyte sedimentation rate and C-reactive protein (CRP), were significantly elevated at 104mm/h (reference range 0-12 mm/h) and 101 mg/l (reference range<5 mg/l), respectively. Consequently the diagnosis of subacute thyroiditis, also known as De Quervain's thyroiditis, was made. 5 weeks prior to this diagnosis the patient was euthyroid with TSH of 0.55 mlU/l (reference range 0.3-4.5 mlU/l). The patient was treated with propanolol and a prolonged course of prednisone, initially at a daily dosage of 40 mg. This was weaned over several weeks and there was a gradual improvement in serial thyroid function tests after commencement of prednisone, there was a remission of her thyroiditis with following results (TSH 2.79 mlU/l, T4 12.3 pmol/l, T3 3.2 pmol/l, CRP 2 mg/l). At the time of reporting there was no evidence of the development of hypothyroidism. Seeing the temporal sequence of events, a causal link between the H1N1 vaccine and the development of patient's subacute thyroiditis was suspected.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling in fingers of arm that received shot after approximately 1hr.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Death, Dysphagia, Gastrointestinal tube insertion, Laboratory test, Paraesthesia
Clinical narrative: Approximately 3-4 weeks after flu shot began to have tingling of face and arm. Symptoms progressed to lower extremities Experienced sensory problems - unable to swallow/had feeding tube. 1) Hospitalized - family states multiple tests were done. 2) Released and went to neurology clinic in another state for second opinion. 3) Admitted to another hospital and then transferred to a rehab facility in another state. 4) Family had him brought back to original hospital.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Sensory disturbance
Clinical narrative: Approximately 3-4 weeks after flu shot began to have tingling of face and arm. Symptoms progressed to lower extremities Experienced sensory problems - unable to swallow/had feeding tube. 1) Hospitalized - family states multiple tests were done. 2) Released and went to neurology clinic in another state for second opinion. 3) Admitted to another hospital and then transferred to a rehab facility in another state. 4) Family had him brought back to original hospital.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Alopecia, Antinuclear antibody positive, Antiphospholipid antibodies positive, Arthritis, Autoimmune disorder
Clinical narrative: Memory and cognitive deficit May to present - Hair loss, nose bleeds, fatigue, lethargy, dry eyes, positive ANA test for an autoimmune Dx for either lupus, MS, arthritis and Sjorgrens Dr - neuro hospital. Continues treatment.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Cognitive disorder, Dry eye, Epistaxis, Fatigue, Lethargy
Clinical narrative: Memory and cognitive deficit May to present - Hair loss, nose bleeds, fatigue, lethargy, dry eyes, positive ANA test for an autoimmune Dx for either lupus, MS, arthritis and Sjorgrens Dr - neuro hospital. Continues treatment.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Memory impairment, Multiple sclerosis, Sjogren's syndrome, Systemic lupus erythematosus
Clinical narrative: Memory and cognitive deficit May to present - Hair loss, nose bleeds, fatigue, lethargy, dry eyes, positive ANA test for an autoimmune Dx for either lupus, MS, arthritis and Sjorgrens Dr - neuro hospital. Continues treatment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Fundoscopy abnormal, Optic disc disorder, Optic neuropathy, Pallor, Papilloedema
Clinical narrative: Initial literature report received on 25 Oct 2010: Authors presented a case of optic neuropathy following influenza vaccination in a patient with rheumatoid arthritis. This patient with long-lasting rheumatoid arthritis undergoing regular supported treatment was vaccinated with influenza virus vaccine (manufacturer and batch number unknown). Three days after influenza vaccination, the patient noted an inferior altitudinal defect in the visual field of the left eye (OS). The fundus study revealed 2-3 diopters oedematous optic disc, worsened segmentally superiorly OS. A diagnosis of optic neuropathy was made. Despite intravenous application of methylprednisolone, her vision progressively worsened over several days to 20/300 OS. Ten days later, OS started to improve and after one month, neuro-ophthalmological examination showed partial visual recovery (20/70 OS). One year later after vaccination, visual acuity was 20/40 OS with pale optic disc in the affected eye. Authors speculated that present case suggests a possible link between ischemic optic neuropathy and influenza vaccine in an immunocompromised by rheumatic disease or this patient's treatment.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Visual acuity reduced, Visual field defect, Visual impairment
Clinical narrative: Initial literature report received on 25 Oct 2010: Authors presented a case of optic neuropathy following influenza vaccination in a patient with rheumatoid arthritis. This patient with long-lasting rheumatoid arthritis undergoing regular supported treatment was vaccinated with influenza virus vaccine (manufacturer and batch number unknown). Three days after influenza vaccination, the patient noted an inferior altitudinal defect in the visual field of the left eye (OS). The fundus study revealed 2-3 diopters oedematous optic disc, worsened segmentally superiorly OS. A diagnosis of optic neuropathy was made. Despite intravenous application of methylprednisolone, her vision progressively worsened over several days to 20/300 OS. Ten days later, OS started to improve and after one month, neuro-ophthalmological examination showed partial visual recovery (20/70 OS). One year later after vaccination, visual acuity was 20/40 OS with pale optic disc in the affected eye. Authors speculated that present case suggests a possible link between ischemic optic neuropathy and influenza vaccine in an immunocompromised by rheumatic disease or this patient's treatment.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Rash
Clinical narrative: Rash with redness and inflammation.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Muscle spasms, Muscle twitching, Muscular weakness, Paraesthesia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of weakness in arms and legs in a 22-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications or relevant medical history. On an unspecified date, the subject received 4th dose of ENGERIX B. On 1 September 2010 at 14:00 the subject received 5th dose of ENGERIX B (unknown, left arm). With both the 4th and 5th doses of ENGERIX B, the subject experienced extra dose administered. Less than one year after vaccination with 5th dose of ENGERIX B, the subject experienced weakness in her left leg and arm, tingling in her left hand and foot, and cramping and twitching in her left calf. The subject reported that she received a fourth and fifth injection because her physician wanted her titer to be higher, even though it was still within normal limits. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: On 9/27/10 GARDASIL # 1 given. On 10/20/10 Pt immunized with another dose of GARDASIL -mom noted H/A on 10/20/10 given Ibuprofen no vomiting pt is currently fine.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pruritus, Rash pustular
Clinical narrative: Patient presented to HD on 10/25/10 & reports that 2-3 days ago her left upper arm felt feverish. RN noted area of erythema with puss-filled center, similar looking as a pimple. Patient also had an area on the left side of her forehead, left side of neck & right jawline that had pimple-like sores. Patient c/o neck itching.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, No reaction on previous exposure to drug, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This case was reported by a physician and described the occurrence of severe knee, shoulders and hands joint pain in a 46-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergies, colon cancer with no treatment in four months and high blood pressure. Concurrent medications included BYSTOLIC, CLARITIN, Ibuprofen and PERCOCET. The subject had not experienced any adverse events following previous vaccinations. On 11 October 2010 at 15:00 the subject received unspecified dose of FLULAVAL (unknown, right arm). On 19 October 2010, 8 days after vaccination with FLULAVAL, the subject experienced severe knee, shoulders and hands joint pain and walking difficulty. On 23 October 2010, 12 days after vaccination with FLULAVAL, she experienced low grade fever. The subject required medical attention at a doctor's office. The physician considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included high sedimentation rate and high rheumatoid factor. She was evaluated by X-ray and there was no sign of rheumatoid arthritis. At the time of reporting, the severe knee, shoulders, and hands joint pain were worse and the low grade fever was unresolved. The physician considered the events were possibly related to vaccination with FLULAVAL.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid factor increased, X-ray normal
Clinical narrative: This case was reported by a physician and described the occurrence of severe knee, shoulders and hands joint pain in a 46-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included allergies, colon cancer with no treatment in four months and high blood pressure. Concurrent medications included BYSTOLIC, CLARITIN, Ibuprofen and PERCOCET. The subject had not experienced any adverse events following previous vaccinations. On 11 October 2010 at 15:00 the subject received unspecified dose of FLULAVAL (unknown, right arm). On 19 October 2010, 8 days after vaccination with FLULAVAL, the subject experienced severe knee, shoulders and hands joint pain and walking difficulty. On 23 October 2010, 12 days after vaccination with FLULAVAL, she experienced low grade fever. The subject required medical attention at a doctor's office. The physician considered the events were disabling and clinically significant (or requiring intervention). Relevant test results included high sedimentation rate and high rheumatoid factor. She was evaluated by X-ray and there was no sign of rheumatoid arthritis. At the time of reporting, the severe knee, shoulders, and hands joint pain were worse and the low grade fever was unresolved. The physician considered the events were possibly related to vaccination with FLULAVAL.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Lip swelling, Oedema mouth, Paraesthesia oral, Pruritus
Clinical narrative: States "Received FLUVIRIN injection at 10:00 AM. At 1900 had itchy palms, tingling lips. Had swollen, red mouth, nose, lips, eyes, face. Developed rash on torso that became raised hives. Also had rash on side of legs. Had itchy head". States "airway felt like I swallowed a pill that got stuck in my throat. Took ALLEGRA D and started on MEDROL Pack at 1945 which she had gotten from her husband who was a Dr. Applied ice to rash. 2045 Itching stopped. In the am all symptoms were resolved.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Sensation of foreign body, Stomatitis, Swelling face, Urticaria
Clinical narrative: States "Received FLUVIRIN injection at 10:00 AM. At 1900 had itchy palms, tingling lips. Had swollen, red mouth, nose, lips, eyes, face. Developed rash on torso that became raised hives. Also had rash on side of legs. Had itchy head". States "airway felt like I swallowed a pill that got stuck in my throat. Took ALLEGRA D and started on MEDROL Pack at 1945 which she had gotten from her husband who was a Dr. Applied ice to rash. 2045 Itching stopped. In the am all symptoms were resolved.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Myalgia, Pyrexia, Tremor
Clinical narrative: This case was reported by a physician and described the occurrence of fever in a 54-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 10 October 2010 at 11:00 the subject received a dose of FLUARIX (.5 ml, unknown route, right arm). On the evening of 12 October 2010, 2 days after vaccination with FLUARIX, the subject experienced fever (103.8 degrees Fahrenheit), myalgia and tremor. At the time of reporting the events were worse. The physician considered the events were probably related to vaccination with FLUARIX. Follow-up information received from the reporting physician on 26 October 2010: The physician reported the diagnosis as febrile adverse reaction. The physician considered the events were clinically significant (or requiring intervention) and indicated that medication (unspecified) was administered. At the time of reporting, the events were either improved or resolved on 19 October 2010; it was not specified which events were improved and which were resolved.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Musculoskeletal chest pain
Clinical narrative: Patient says her ribs got sore and because of that she could not get deep breath. Now she feels better. However, she has an appointment with MD next week to rule out cause.
Age: 31.0
Sex: F
Vaccine: FLU3, RAB, TYP
Symptoms: Eye pruritus, Syncope
Clinical narrative: Client stated that 15 minutes after leaving office experienced itching in ears & eyes. Went to hospital & fainted in the ER, and received BENADRYL, Epinephrine, SOLU-MEDROL & ZANTAC and was observed 5 hrs then released referred to allergist.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hyperaemia, Pain, Skin warm
Clinical narrative: Pt reports localized erythema, warmth, & pain. Onset 1 hour post administration of vaccine, on 10/19. 10/21 presents with 15cm x 6cm area of localized hyperemia, warmth. No resp. symptoms, no urticaria.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Cold sweat, Tinnitus
Clinical narrative: Patient became weak and clammy. He sat down for 15-20 minutes and felt good before leaving the pharmacy. He also said his ears were ringing.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Myalgia, Oedema peripheral
Clinical narrative: Patient came in 9 days post injection. She had complained of severe myalgia which was continuing. Also, she had swelling in arm. The area was "hard" to touch. Recommend physician visit.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Musculoskeletal stiffness, Nausea, Neck pain, Pain in extremity
Clinical narrative: Had flu vaccination on Thurs approx 12:00 P.M. noon. Awakened on Friday 10/15/10 - head spinning neck and back sore/stiff, nauseated and vomiting which lasted about 36 hrs. Neck is still sore on 10/20/10. Arm also hurt.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo, Vomiting
Clinical narrative: Had flu vaccination on Thurs approx 12:00 P.M. noon. Awakened on Friday 10/15/10 - head spinning neck and back sore/stiff, nauseated and vomiting which lasted about 36 hrs. Neck is still sore on 10/20/10. Arm also hurt.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Choking, Cough, Epistaxis, Musculoskeletal chest pain
Clinical narrative: 10-12: fever, nausea, extreme headache on top of head moved to forehead, sneezing, coughing, chills, extreme sore throat, choking & strangling. 10-13 to MD. Rx antibiotics for 10 days. Swollen sinus, yellow mucus w/ bloody discharge, nose bleeds, sore ribs.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Rhinitis, Sinus disorder
Clinical narrative: 10-12: fever, nausea, extreme headache on top of head moved to forehead, sneezing, coughing, chills, extreme sore throat, choking & strangling. 10-13 to MD. Rx antibiotics for 10 days. Swollen sinus, yellow mucus w/ bloody discharge, nose bleeds, sore ribs.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: 10-12: fever, nausea, extreme headache on top of head moved to forehead, sneezing, coughing, chills, extreme sore throat, choking & strangling. 10-13 to MD. Rx antibiotics for 10 days. Swollen sinus, yellow mucus w/ bloody discharge, nose bleeds, sore ribs.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Urticaria at injection site.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Injection site nodule
Clinical narrative: Pt returned to pharmacy area complaining of dizziness and shortness of breath (SOB). A lump had developed at injection site. I had her sit down and a technician kept her under observation. She never got any worse and improved enough to walk around for 5 minutes to be sure she was ok. Unable to follow up as pt provided disconnected phone number.
Age: 1.08
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Blood electrolytes normal, Body temperature increased, Computerised tomogram head, Computerised tomogram normal, Ear infection
Clinical narrative: 2:13 AM -> child shaking - "out of it", stopped, vomited went to ER -> temp 102.3, DX otitis & febrile seizure TX -> Amoxil X 10 days.
Age: 1.08
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Febrile convulsion, Tremor
Clinical narrative: 2:13 AM -> child shaking - "out of it", stopped, vomited went to ER -> temp 102.3, DX otitis & febrile seizure TX -> Amoxil X 10 days.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Localized allergic reaction to arm, further down from injection site, near elbow.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Diabetes mellitus, Hypersensitivity, Hypertension, Hypothyroidism, Injection site erythema
Clinical narrative: 50 y/o female with DM, HTN, Hypothyroidism received PNEUMOVAX (SQ) and Flu (IM) in right arm on 10/12/10. She began to experience pain & swelling in that arm the same evening - pain was a 10/10. Wanted to go the ER-but did not & was seen in office on 10/13/10 -swelling & erythema over the area of SQ injection - hypersensitivity to the touch - treated with MOTRIN/KEFLEX/PERCOCET. Spoke with pt via phone 12hrs later & sx had almost fully resolved. This was pt's 2nd PNEUMOVAX by mistake. She had gotten PNEUMOVAX on 4/8/10. Prior Flu shot 9/15/2009 & H1N1 on 11/21/09.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity
Clinical narrative: 50 y/o female with DM, HTN, Hypothyroidism received PNEUMOVAX (SQ) and Flu (IM) in right arm on 10/12/10. She began to experience pain & swelling in that arm the same evening - pain was a 10/10. Wanted to go the ER-but did not & was seen in office on 10/13/10 -swelling & erythema over the area of SQ injection - hypersensitivity to the touch - treated with MOTRIN/KEFLEX/PERCOCET. Spoke with pt via phone 12hrs later & sx had almost fully resolved. This was pt's 2nd PNEUMOVAX by mistake. She had gotten PNEUMOVAX on 4/8/10. Prior Flu shot 9/15/2009 & H1N1 on 11/21/09.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: After taking PNEUMOVAX 23 inj. pt had swelling & severe pain at the site of injection. Rash broke-out after two days. Pt just took aspirin to control pain. No anti-allergic taken. Situation resolved in 5-6 days. Reported on: 10/20/2010.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Second day chills & fever cough lasted several days running nose - fatigue got shot every year - never any problem before.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Second day chills & fever cough lasted several days running nose - fatigue got shot every year - never any problem before.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Chills, Malaise
Clinical narrative: Friday, day after shot was sick to my stomach. Sick in bed all day Sat. stomach pain, chills & fever. Sunday was weak & my stomach was sore. Never had a problem before.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Friday, day after shot was sick to my stomach. Sick in bed all day Sat. stomach pain, chills & fever. Sunday was weak & my stomach was sore. Never had a problem before.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Left arm swelled up and turned red patient complained of pain on 10/9/2010. Pt. returned to pharmacy on 10/11/2010 and arm was still red. Advised to see a physician. Swelling was gone.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Convulsion, Pyrexia
Clinical narrative: Dad reports " He ran a fever at home that eve. and had a seizure" (Has had febrile seizures in the past). His teacher said he got the injection vs nasal flu vaccine. Kept home two days. Parent hadn't yet contacted PCP, which I encouraged. Vaccine given at School District flu clinic.
Age: 13.0
Sex: F
Vaccine: FLUX
Symptoms: Body temperature increased, Headache, Nausea, Vomiting
Clinical narrative: 10/18/10 Mother called to report "Headache & nausea since vaccine - never had the nasal. Today T 101.5 & throwing up". Hadn't relayed info. to PCP. Encouraged Mom to notify child's doctor.
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Laboratory test normal, Oedema peripheral
Clinical narrative: Swelling (R) arm and axilla. (R) axilla swelling, no red, no adenopathy. BENADRYL OTC.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Nerve injury, Paraesthesia
Clinical narrative: Patient called 10-7 to report shot given too high, hit a nerve, no fever, no red arm or swollen, she stated tingling when shot given but did not tell person, called back 10-18, not better or worse, "we nicked a nerve", I told to call her Dr.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash stomach, left arm and left thigh. Started around 9/23/10. Immunized on 9/21/10. Pt. has been self medicating with BENADRYL w/c seems to be subsiding.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Cardiac failure congestive, Cough, Dizziness, Dysphonia
Clinical narrative: Cough, sore throat, extreme shortness of breath, slight dizziness, small headache, wheezing, congestive heart failure, heart attack. Was hospitalized Friday 10/15/10. Thursday 10/14/10 had cough, sore throat, hoarseness. They treated me for congestive heart failure and heart attack and pneumonia.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Echocardiogram, Headache, Myocardial infarction, Oropharyngeal pain
Clinical narrative: Cough, sore throat, extreme shortness of breath, slight dizziness, small headache, wheezing, congestive heart failure, heart attack. Was hospitalized Friday 10/15/10. Thursday 10/14/10 had cough, sore throat, hoarseness. They treated me for congestive heart failure and heart attack and pneumonia.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pneumonia, Pulmonary function test, Wheezing, X-ray
Clinical narrative: Cough, sore throat, extreme shortness of breath, slight dizziness, small headache, wheezing, congestive heart failure, heart attack. Was hospitalized Friday 10/15/10. Thursday 10/14/10 had cough, sore throat, hoarseness. They treated me for congestive heart failure and heart attack and pneumonia.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Husband called on 9/22 and said wife complaining of shortness of breath, but said she also had other health problems. He said a neighbor was taking her to the ER to get checked out. - She says MD said it might be due to flu shot - patient recovered.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Responded with dime size reaction at injection site evening of first day - red, slightly raised. Reaction expanded to greater than a nickel size on 2nd day. Today (3rd day post vaccine) is 6cm x 4cm red, slightly raised, firm, induration, warm to touch. Defined edges, no streaking.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient received flu shot in right deltoid on 10/18/2010. She presented to pharmacy again on 10/21/2010 with redness (about golf ball size), slight warmth & a small nodule at site of injection. It was not sore (per patient) & did not look infected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: 10-18-10 Evening - had fever, unk. degree. C/o pain 10-19-10 Mom noticed redness, swelling, heat & pt. c/o pain in (R) arm. Mom gave pt. TYLENOL on Tuesday.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: 10-18-10 Evening - had fever, unk. degree. C/o pain 10-19-10 Mom noticed redness, swelling, heat & pt. c/o pain in (R) arm. Mom gave pt. TYLENOL on Tuesday.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Blood immunoglobulin E, Eyelid oedema, Full blood count, Pyrexia, Rash
Clinical narrative: Fever, rash on nasal area, eyelids, earlobes & neck, swollen eyelids; vomiting.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Vomiting
Clinical narrative: Fever, rash on nasal area, eyelids, earlobes & neck, swollen eyelids; vomiting.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Infection
Clinical narrative: Patient claimed she had adverse reaction and her arm got infected.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hyperhidrosis, Influenza like illness, Nausea
Clinical narrative: I administered FLUVIRIN to patient on 10/23/10 about 5 AM. On 10/24/10 at 3:30 AM she came in to see me. She showed me a red patch on her arm below the injection site and told me she had nausea and sweating (flu like symptoms).
Age: 5.0
Sex: F
Vaccine: FLUN3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen (L) shoulder/deltoid surrounded by redness.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Dyspnoea, Pyrexia
Clinical narrative: Approx 4 hrs after vaccination patient felt short of breath followed by joint pain, chills, and fever: 102.5 & duration 24 hrs.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Generalized raised itchy rash. Went to PCP and given Prednisone 20mg BID x 3 days 30mg QD x 3 days 20mg QD x3 days ZYRTEC and PEPCID taken OTC dose. Rash lasted 1 month.
Age: 17.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Left lymph node swollen & fever.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Lip swelling, Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Received FLUZONE vaccine at 0920; one hour later pt. reports "I was just not feeling well" - trouble breathing; needed inhaler; felt need to lay down; swelling of lips, face & fingers; had fever.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: Received FLUZONE vaccine at 0920; one hour later pt. reports "I was just not feeling well" - trouble breathing; needed inhaler; felt need to lay down; swelling of lips, face & fingers; had fever.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Rash erythematous
Clinical narrative: Arms red rash, face red, states arms itching. Gave 75mg BENADRYL PO. Mom notified.
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Viral upper respiratory tract infection
Clinical narrative: Was administered FLUMIST - same day developed URI (viral) symptoms.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Blood pressure increased, Crying, Headache, Immobile, Loss of consciousness
Clinical narrative: BP 122/67 prior to vaccine. 8-24-10 vagal response after receiving immunizations. Pt. passed out for 10 seconds & awakening shaking & crying , water & candy given, cool compresses applied. Fan with cool air directed to pt. Instructed pt. to deep breathe. BP 160/100 while pt. remained shaking & crying. Pt. drank water & ate candy & began to calm down, after several deep breaths BP retaken 116/74, pt. remained on exam table and cont. to drink water. Instructed pt. to continue deep breathing. Shaking resolved. BP 112/72. 8-24-10 Pt. reported feeling fine. Pt. sat up in chair & FP visit continued. Pt. walked to front desk & cont. to report she was fine. Instructed mom to take child to ER if any problem should occur after leaving. 8-25-10 Called mother she reported child did not have any more problems after leaving clinic yesterday. Mom reports child had H/A this am & reported arms sore but felt well enough to go to school. Mom reported H/A's in past when child had vagal response. 08/24/10 continued - fine tremor noted (R) arm; lasting about 15-20 minutes, mom reports this has never occurred with previous vagal responses to vaccines.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Pain in extremity, Presyncope, Tremor
Clinical narrative: BP 122/67 prior to vaccine. 8-24-10 vagal response after receiving immunizations. Pt. passed out for 10 seconds & awakening shaking & crying , water & candy given, cool compresses applied. Fan with cool air directed to pt. Instructed pt. to deep breathe. BP 160/100 while pt. remained shaking & crying. Pt. drank water & ate candy & began to calm down, after several deep breaths BP retaken 116/74, pt. remained on exam table and cont. to drink water. Instructed pt. to continue deep breathing. Shaking resolved. BP 112/72. 8-24-10 Pt. reported feeling fine. Pt. sat up in chair & FP visit continued. Pt. walked to front desk & cont. to report she was fine. Instructed mom to take child to ER if any problem should occur after leaving. 8-25-10 Called mother she reported child did not have any more problems after leaving clinic yesterday. Mom reports child had H/A this am & reported arms sore but felt well enough to go to school. Mom reported H/A's in past when child had vagal response. 08/24/10 continued - fine tremor noted (R) arm; lasting about 15-20 minutes, mom reports this has never occurred with previous vagal responses to vaccines.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Pruritus, Urticaria
Clinical narrative: Sore & reddish around the site (R) deltoid Thursday night 10/28/10 then Friday had a 10cm by 6 cm welt below the IM site till Sunday. Today 11/1/10 raised area gone but still red & itchy. Took MOTRIN 10/28/10. Ice over area Friday.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Soreness, mild swelling at onset, following by increasing swelling, firmness of upper (L) arm, followed 10 hrs later with fever 101-101.8, chills, muscle and joint pain for duration of 48 hours and swelling, warmth at site persisted for 7 days.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: Soreness, mild swelling at onset, following by increasing swelling, firmness of upper (L) arm, followed 10 hrs later with fever 101-101.8, chills, muscle and joint pain for duration of 48 hours and swelling, warmth at site persisted for 7 days.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Appetite disorder, Arthralgia, Immediate post-injection reaction, Skin papilloma
Clinical narrative: After 7/23/10 joints aches, knees, shoulder, elbows started aching at about 3 wks post vaccination. 2nd vaccine 10/1/10 immediate extreme joint pain, appetite chg., & now has warts.
Sex: M
Vaccine: JEV
Symptoms: Balance disorder, Dysarthria, Lethargy, Muscle twitching, Pain
Clinical narrative: Within 3 hrs of vaccine pt felt lethargic, disoriented, difficulty with balance, twitching and shooting pain in feet bilat. Pt also c/o "grasping for words" difficulty articulating as normal. Pt had similar symptoms with 1st vaccine but milder lasting 2 days. Pt tx with BENADRYL 25mg po BID.
Sex: M
Vaccine: JEV
Symptoms: Pain in extremity, Similar reaction on previous exposure to drug
Clinical narrative: Within 3 hrs of vaccine pt felt lethargic, disoriented, difficulty with balance, twitching and shooting pain in feet bilat. Pt also c/o "grasping for words" difficulty articulating as normal. Pt had similar symptoms with 1st vaccine but milder lasting 2 days. Pt tx with BENADRYL 25mg po BID.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm with localized redness and swelling that does not extend below the mid forearm improving after 2 days.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Headache, Meningitis aseptic, Neck pain, Pain
Clinical narrative: Three days post vaccination pain in neck that escalated into intracranial sharp shooting pain. ANP in occupational health described it as "aseptic meningitis".
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Administered vaccine at 7:00 pm by 10 pm pt began feeling dizzy. By AM felt nausea & vomited X 2.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Oropharyngeal pain, Pruritus, Urticaria
Clinical narrative: Received flu vaccine on 10-18-10. 10-25-10 presented to hospital with "hives et itching". Received 60mg PO x1 of ORAPRED et discharged to home with instructions for allergic reactions. Presented at Center on 10-25-10 for an acute appt with provider. Area was erythematous, soft, et without drainage. Pt also displayed s/s of sore throat. Amoxicillin 400/5 1.5 tsp BID x 10 days given rx given to parent at time of exit.
Age: 12.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient received vaccines and was standing in a corner of the room and passed out in a sitting position not hitting her head on anything. Patient was then lowered safely to floor protecting her head. Blood pressure was taken and Ammonia smelling salts waved under patient's nose. Patient came to and was moved to exam table where she was monitored for 1 hour. Patient was still dizzy so 911 was called to transport to ER - EMT's arrived and cleared her as stable. Mom signed EMT papers for clearance and took patient home.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: Round circle size of quarter not raised & was red, spotted. No itchy, no pain. Rash is going away. Not sure when rash developed.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Local reaction, Pain, Sensation of heaviness
Clinical narrative: Pt complains of local site reaction. She also complains of numbness, heaviness and shooting sensation from the back of her neck to her fingers on the left side. She said symptoms started after receiving the vaccines and continued to get worse she was referred to a medical doctor.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection, Injection site mass, Injection site warmth
Clinical narrative: Pt said she acquired an infection at the site of injection. She went to a MD who said it was an infection at that site. Pt received antibiotics for it. Per pt warm to touch at site & a little bump.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site reaction, Local reaction, Streptococcus test, White blood cell count increased
Clinical narrative: Large local reaction at site of VARIVAX.
Age: 30.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Nausea, Skin burning sensation
Clinical narrative: Received immunizations 10-7-10 at 12:50 pm, pt reported onset at 7pm that evening. "Sunburned feeling to tops of arms & nausea". Pt called us at 8:45 am on 10-8-10. Pt was in touch with her MD's office & took dose of O.T.C. BENADRYL. Called pt back at 12:15 pm stated "I'm feeling better". Followed up via phone 10-21-10 at 2pm pt reported full recovery with no MD visits needed.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Anger, Pressure of speech, Psychomotor hyperactivity
Clinical narrative: Behavioral changes the evening of the shot & next day. Very talkative and talking manicly. He became angry easily, hyperactive. Symptoms lasted 24 hrs.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Partial seizures
Clinical narrative: Only moderately more sz than a previous weekend. Had several focal seizures day of vaccination 10-18-10. Last year hospitalized with probable H1N1 influenza and atypical febrile seizure.
Age: 47.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Lip swelling, No reaction on previous exposure to drug, Urticaria, Wheezing
Clinical narrative: Initial report was received 27 August 2010 from a health care professional.  A 47-year-old male patient with no reported medical history, had received a second dose of JE - VAX, lot number EJN234A (route and site of administration not reported) and one day later, he developed wheezing, swelling in his upper lip, and urticaria on his arms and legs.  The event required a doctors visit; however, at the time of the report, information was not provided regarding corrective treatments and laboratory or diagnostic testing.  On 18 August 2010, eight days prior to the event onset, the patient had previously been vaccinated with "Typhim", TWINRIX and BOOSTRIX (lot numbers, routes and site of administration not reported).  On 17 August 2010, the patient had received a first dose of JE - VAX (lot number, route and site of vaccination not reported) with no adverse event reported.  The event outcome was not recovered.  No additional information was provided at the time of the report.  Follow-up information was received from another manufacturer (Biken) on 02 September 2010.  The Biken case ID number was provided by the other manufacturer (Biken) of F0908.  Documents held by sender:  None.
Age: 47.0
Sex: M
Vaccine: JEV, JEV
Symptoms: Lip swelling, Urticaria, Wheezing
Clinical narrative: Initial report was received 27 August 2010 from a health care professional.  A 47-year-old male patient with no reported medical history, had received a second dose of JE - VAX, lot number EJN234A (route and site of administration not reported) and one day later, he developed wheezing, swelling in his upper lip, and urticaria on his arms and legs.  The event required a doctors visit; however, at the time of the report, information was not provided regarding corrective treatments and laboratory or diagnostic testing.  On 18 August 2010, eight days prior to the event onset, the patient had previously been vaccinated with "Typhim", TWINRIX and BOOSTRIX (lot numbers, routes and site of administration not reported).  On 17 August 2010, the patient had received a first dose of JE - VAX (lot number, route and site of vaccination not reported) with no adverse event reported.  The event outcome was not recovered.  No additional information was provided at the time of the report.  Follow-up information was received from another manufacturer (Biken) on 02 September 2010.  The Biken case ID number was provided by the other manufacturer (Biken) of F0908.  Documents held by sender:  None.
Age: 86.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Patient described pain and injection site and down left arm. Seen twice for this, last on 10/18/2010, with pain on palpation noted from left deltoid down to anterior wrist. Called clinic today "not feeling well", with increased sharp pain in arm.