chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Loss of consciousness, Malaise, Muscular weakness, Neck pain
Clinical narrative: Loss of consciousness and seizure at Dr. office.  Later that evening:  headache, neck pain, extreme muscle weakness, inability to walk, confusion.  She also missed the next two days of school.  Felt very sick.  I called the Dr's office thinking I would have to bring her to the emergency room.  The nurse called the Dr. saying she didn't know anything about the vaccine.  Dr. called her back to say keep an eye on her.
Age: 3.0
Sex: M
Vaccine: HEPA, HIBV, PNC13
Symptoms: Blood culture negative, Full blood count normal, Injection site cellulitis, Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling at site of vaccine, rapidly progressing.  ER visit x 2, office visit x 1, admitted for IV antibiotics for cellulitis right thigh.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Contusion, Electrocardiogram normal, Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: c/o severe pain night of day received shot in Right deltoid.  c/o pain radiation from shoulder down to antecubital space and around to shoulder blade.  Also had runny nose and sniffles. On a 1-10 scale of pain, that night it was an "8."  He could only lift his arm half way to shoulder level.  No swelling at time he called (10 days later on the 28th of Oct.), but had a light brown circular bruise.  As of Nov 4, 2011, still cannot raise his arm past 90 degrees.  It's feeling slightly better. On Nov. 1 he was seen by a doctor, had an EKG and a shoulder x-ray.  Both were WNL.  He is feeling slightly better today (Nov. 4, 2011).
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rhinorrhoea, X-ray limb normal
Clinical narrative: c/o severe pain night of day received shot in Right deltoid.  c/o pain radiation from shoulder down to antecubital space and around to shoulder blade.  Also had runny nose and sniffles. On a 1-10 scale of pain, that night it was an "8."  He could only lift his arm half way to shoulder level.  No swelling at time he called (10 days later on the 28th of Oct.), but had a light brown circular bruise.  As of Nov 4, 2011, still cannot raise his arm past 90 degrees.  It's feeling slightly better. On Nov. 1 he was seen by a doctor, had an EKG and a shoulder x-ray.  Both were WNL.  He is feeling slightly better today (Nov. 4, 2011).
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electrocardiogram normal, Injected limb mobility decreased, Injection site haematoma, Injection site pain, Musculoskeletal pain
Clinical narrative: c/o severe pain night of day received shot in Right deltoid.  c/o pain radiation from shoulder down to antecubital space and around to shoulder blade.  Also had runny nose and sniffles. On a 1-10 scale of pain, that night it was an "8."  He could only lift his arm half way to shoulder level.  No swelling at time he called (10 days later on the 28th of Oct.), but had a light brown circular bruise.  As of Nov 4, 2011, still cannot raise his arm past 90 degrees.  It's feeling slightly better. On Nov. 1 he was seen by a doctor, had an EKG and a shoulder x-ray.  Both were WNL.  He is feeling slightly better today (Nov. 4, 2011).
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac disorder, Condition aggravated, Syncope
Clinical narrative: PT WAS VACCINATED ON 10/17. NO DISTRESS IMMEDIATELY FOLLOWING VACCINATION. PER REPORT FROM SCHOOL NURSE, PT COLLAPSED ON PLAYGROUND ON 10/21. REPORTEDLY, CHILD HAD UNDISCLOSED HEART CONDITION.
Age: 60.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: Rash and pain in forearm: diagnosed by provider as shingles.
Age: 50.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity, Tenderness
Clinical narrative: Muscle aches to both arms approximately 2 hrs. after vaccines.  Tenderness started same day.  Wakes up 4-5 times a night due to pain in arms.  Pain in back of neck and across shoulders day after vaccines.  Saw PA at Clinic.  States told vaccines caused "blood vessels to swell".  Given Flexeril one three times a day.  Continues with pain in both arms today.  Has followup appt with private MD on Monday per patient.
Age: 50.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Vasodilatation
Clinical narrative: Muscle aches to both arms approximately 2 hrs. after vaccines.  Tenderness started same day.  Wakes up 4-5 times a night due to pain in arms.  Pain in back of neck and across shoulders day after vaccines.  Saw PA at Clinic.  States told vaccines caused "blood vessels to swell".  Given Flexeril one three times a day.  Continues with pain in both arms today.  Has followup appt with private MD on Monday per patient.
Age: 0.51
Sex: M
Vaccine: DTAP, FLUX, HIBV, RVX
Symptoms: Cough, Irritability, Nasal congestion, Pyrexia
Clinical narrative: Fever, stuffy nose, cough, irritability.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Started wheezing and having difficulty breathing at approximately 8 Pm. Symptoms continued through the night and subsided by morning after several nebulizer treatments. Has history of asthma.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: CLIENT CAME IN AT 8:00 AM WITH A 50 CENT SIZE REDDENED AND SLIGHTLY SWOLLEN AREA ON LEFT ARM (UPPER ARM). ADVISED USING A COOL COMPRESS TO THE ARE FOR FIRST 24 AND THEN SWITCH TO A WARM COMPRESS.
Age: 54.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: ON 10/25/11 TELEPHONE CALL RECEIVED FROM PT C/O DEVELOPED RASH TO (R) (L) SIDE OF NECK. THE FOLLOWING DAY STATED HER DAUGHTER WAS THE ONE NOTICED IT. C/O ITCHING. 10/28/11 - CLIENT ASSESSED - SLIGHT RASH TO LET SIDE NECK - APPLIED CORTISONE TO AREA WHICH RELIEVED ITCHING.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash generalised, Rash maculo-papular
Clinical narrative: PT HAD REDNESS AND SWELLING AT INJECTION SITE FOLLOWED BY A GENERALIZED MACULOPAPULAR RASH.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Lymphadenopathy, Pain, Swelling
Clinical narrative: Pt described red and inflamed axillary lymph nodes, having received Fluvirin in L deltoid.  When went to MD, the pt (who is an experienced RN) received antibiotics for a suspected cellulitis of the axilla, but pt states swelling and pain did not quickly respond to antibiotic treatment and that she still suspects the vaccine.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pyrexia
Clinical narrative: Pt stated she began to feel achy at about 4pm the day she received the injection of Pneumococcal Vaccine 23. She developed a fever as high as 102 which resolved by the next morning. Pt complained of severe pain at the site of the injection to the extent she could not use her arm for 12 hours. Pt denied swelling or redness at the injection site. Patient emailed the Immunization Assistance Program Coordinator and reported the vaccine reaction. Coordinator phone patient and again later in the day. She is feeling much better and is able to use her arm.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Mass, Pruritus, Rash
Clinical narrative: 1.5 inch long red lump for 3 days, then extensive rash on face including lumps on left cheek, itching; rash also on trunk.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Headache, Lethargy, Malaise, Nausea, Pain
Clinical narrative: On 11/3/11...lethargic and sore.  On 11/4/11, still lethargic and general malaise with the beginning of a terrible headache and nausea which became vomiting around 5 PM.
Age: 43.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Vomiting
Clinical narrative: On 11/3/11...lethargic and sore.  On 11/4/11, still lethargic and general malaise with the beginning of a terrible headache and nausea which became vomiting around 5 PM.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue, Myalgia, Vomiting
Clinical narrative: Vomiting; chills, muscle aches; fatigue.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Antibody test negative, Arthralgia, Bacterial test negative, Bone pain, Borrelia test negative
Clinical narrative: Itching/redness @ injection site..next day: red induration of injection site + pain in shoulder joint...10/20/2011 @ 1500: mild flu-like symptoms + bone/joint pain in all bones + joints...bone + joint pain continue w/o relief at the current time. Hospitalized 10/28/2011-10/29/2011. Seen by Inf. Dis/Allergist/Neurologist: all tests negative/normal. Unable to achieve pain relief w/ steroids/narcotics/gabapentin.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Cytomegalovirus test negative, Epstein-Barr virus test negative, Full blood count normal, Influenza like illness, Influenza virus test negative
Clinical narrative: Itching/redness @ injection site..next day: red induration of injection site + pain in shoulder joint...10/20/2011 @ 1500: mild flu-like symptoms + bone/joint pain in all bones + joints...bone + joint pain continue w/o relief at the current time. Hospitalized 10/28/2011-10/29/2011. Seen by Inf. Dis/Allergist/Neurologist: all tests negative/normal. Unable to achieve pain relief w/ steroids/narcotics/gabapentin.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Metabolic function test
Clinical narrative: Itching/redness @ injection site..next day: red induration of injection site + pain in shoulder joint...10/20/2011 @ 1500: mild flu-like symptoms + bone/joint pain in all bones + joints...bone + joint pain continue w/o relief at the current time. Hospitalized 10/28/2011-10/29/2011. Seen by Inf. Dis/Allergist/Neurologist: all tests negative/normal. Unable to achieve pain relief w/ steroids/narcotics/gabapentin.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Parvovirus B19 test negative, Red blood cell sedimentation rate normal, Viral test negative
Clinical narrative: Itching/redness @ injection site..next day: red induration of injection site + pain in shoulder joint...10/20/2011 @ 1500: mild flu-like symptoms + bone/joint pain in all bones + joints...bone + joint pain continue w/o relief at the current time. Hospitalized 10/28/2011-10/29/2011. Seen by Inf. Dis/Allergist/Neurologist: all tests negative/normal. Unable to achieve pain relief w/ steroids/narcotics/gabapentin.
Age: 1.26
Sex: M
Vaccine: DTAP, FLUX, MMR
Symptoms: Conversion disorder, Irritability, Pyrexia
Clinical narrative: Patient developed a fever that peaked at 103.5, and lasted for four days. Waking up hysterical during naps and bedtime, even after the fever has subsided. In addition, patient is very cranky.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Heart rate increased, Oxygen saturation decreased
Clinical narrative: Patient couldn't breathe, low O2 level, increased HR.
Age: 16.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Activities of daily living impaired, Exercise tolerance decreased, Fall, Fatigue, Laboratory test
Clinical narrative: Oct. 1 - Fatigue, leg weakness, athlete says his legs now "feel like jello." Oct 17 - Missed school. Falling down. Dr. run labs. Moved to different medical provider. Oct 19 - Hospital. Testing r/o tumor. R/O Guillain Barre because not ascend. Dx poss virus. Oct 24 - To Rehab for 10d (now wheel chair). Oct 30 - Home. Now walking - still endurance issues.
Age: 16.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Muscular weakness, Wheelchair user
Clinical narrative: Oct. 1 - Fatigue, leg weakness, athlete says his legs now "feel like jello." Oct 17 - Missed school. Falling down. Dr. run labs. Moved to different medical provider. Oct 19 - Hospital. Testing r/o tumor. R/O Guillain Barre because not ascend. Dx poss virus. Oct 24 - To Rehab for 10d (now wheel chair). Oct 30 - Home. Now walking - still endurance issues.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes, Dizziness, Electrocardiogram, Erythema, Feeling hot
Clinical narrative: Felt warm, felt like I was going to pass out. Shaking, heart racing - went to ER. SVT meds: face red, chest red - no rash.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Palpitations, Tremor
Clinical narrative: Felt warm, felt like I was going to pass out. Shaking, heart racing - went to ER. SVT meds: face red, chest red - no rash.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Moderate pain at site: 11/2/11 - 11/4/11. Moderate tenderness at site: 11/2/11-ongoing. Moderate erythema at site about 1 1/2": 11/2/11-ongoing. Moderate warmth at site: 11/2/11-ongoing. Moderate fatigue: 11/2/11 - 11/3/11. No treatment for all AEs.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Vomiting
Clinical narrative: Onset chills, headache with vomiting approximately 5 hours after vaccine administration. Mild headache persisted late pm 11/2/11. Chills and vomiting resolved 6am 11/2/11. 11/03/11 am feels fine now. Individual advised to discuss sxs with PMP prior to next years flu season.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient claims soreness on injection site. Patient says soreness still persists up to today's date.
Age: 0.1
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Irritability, Nasal congestion, Skin warm
Clinical narrative: About 10 hours after receiving hep B vaccine had episode of "gasping for air". Lasted about 1 hour. Did feel warm at that time, then irritable. Seen following day had some nasal congestion otherwise normal.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dyspnoea, Nausea, Pyrexia
Clinical narrative: Pt had flu shot & within 3 hrs felt chest tightness & dyspnea proceeded to have nausea later in the day (8 hours later) and at HS same day had fever & chills - the next day had lingering nausea & dyspnea. Day 3 she felt "fine" - no tx sought - pt called with these symptoms.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Patient came in the next day after getting the flu vaccine complaining of ringing in the ear, or tinnitus. Patient said the symptom started happening shortly after getting the flu shot.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt reports arm soreness a month after the shot is given. Arm hurts especially while driving.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthma, Chest discomfort, Erythema, Flushing, Painful respiration
Clinical narrative: Approx 3 minute after admin - pt. became flushed - redness in face & chest, then c/o sharpness of breath/chest tightness - within 10 minute wheezing, audible - pt. administered EPIPEN - instant symptoms resolved.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Wheezing
Clinical narrative: Approx 3 minute after admin - pt. became flushed - redness in face & chest, then c/o sharpness of breath/chest tightness - within 10 minute wheezing, audible - pt. administered EPIPEN - instant symptoms resolved.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Erythema, Flushing, Headache, Palpitations
Clinical narrative: Approx 3 minute after admin - pt. became flushed - redness in face & chest, then c/o sharpness of breath/chest tightness - within 10 minute wheezing, audible - pt. administered EPIPEN - instant symptoms resolved.
Age: 37.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Throat irritation, Wheezing
Clinical narrative: Approx 3 minute after admin - pt. became flushed - redness in face & chest, then c/o sharpness of breath/chest tightness - within 10 minute wheezing, audible - pt. administered EPIPEN - instant symptoms resolved.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Myocardial infarction, Pyrexia, Trismus
Clinical narrative: The evening of vaccination - pt felt as if jaw was locking up. She was running 103 degree fever. She went to hospital - they suspected heart attack. Pt saw & felt redness in Rt arm. Went back to hosp 10/19/11 diagnosed with cellulitis from vaccine given antibiotics for tx.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Vaccination complication
Clinical narrative: The evening of vaccination - pt felt as if jaw was locking up. She was running 103 degree fever. She went to hospital - they suspected heart attack. Pt saw & felt redness in Rt arm. Went back to hosp 10/19/11 diagnosed with cellulitis from vaccine given antibiotics for tx.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: After 30 min pt develops swelling & blinking leg then mom put ice on her thigh and getting better.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Neck pain, Pain in extremity
Clinical narrative: Patient could not sleep due to pain that radiated up neck and down arm. Pain improved but still uncomfortable for at least 5 days. Patient left for another country for 2 week. Pain was tolerable during this period. Radiating pain returned upon return.
Age: 37.0
Sex: U
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Paraesthesia, Tenderness
Clinical narrative: Swelling, pain, tingling down arm x 2 plus days and still painful/tender.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Diarrhoea, Feeling hot, Pruritus
Clinical narrative: About 3 1/2 hours after receiving the FLUZONE, the patient called & said that she had diarrhea, & felt hot & itchy, & said her asthma was acting up...she didn't think the nebulizer was helping, so advised to go to E.R. if nebulizer not helping.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Rash macular, Swelling
Clinical narrative: Redness, soreness, patchy red blotches, swelling.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Dizziness, Full blood count normal, Headache, Laboratory test normal
Clinical narrative: Within 24 hrs: headache, dizziness, weakness, vertigo, paresthesia. Seen 10/24 & 10/25/11. HA & vertigo (intermittent) persist. Dramamine helped.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia, Red blood cell sedimentation rate normal, Vertigo
Clinical narrative: Within 24 hrs: headache, dizziness, weakness, vertigo, paresthesia. Seen 10/24 & 10/25/11. HA & vertigo (intermittent) persist. Dramamine helped.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: On 10/21, pt called to report itching and welts all over arms and legs and neck. Pt advised to go to ED. Dr. spoke to pt on 10/27 advised pt. to come in to walk in clinic. Pt reported on 10/27/11 to walk in clinic with symptoms of mild rash resolving with BENADRYL prn.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Oedema peripheral
Clinical narrative: (R) arm swelling, erythematous, tenderness around circumference of (R) upper arm.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm erythematous, warm to touch (+) swelling. No SOB. Symptoms started on 10/5/11. Treatment - ice BID & TYLENOL 325 mg 2 tablets PO BID PRN.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Erythema multiforme, Oedema peripheral, Pruritus, Rash
Clinical narrative: Vaccine administered 8/19/11. Presented to clinic on 8/22/11 with swelling, itching and redness of rt arm. Administered methylprednisolone 125 mg IM x1. Discharged to home with prednisone taper and also instructed that he could use OTC diphenhydramine prn. Rash, Erythema Multiforme & Uriticaria Pruritus METHYLPREDNISOLONE 125 MG ONCE.
Age: 63.0
Sex: M
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Vaccine administered 8/19/11. Presented to clinic on 8/22/11 with swelling, itching and redness of rt arm. Administered methylprednisolone 125 mg IM x1. Discharged to home with prednisone taper and also instructed that he could use OTC diphenhydramine prn. Rash, Erythema Multiforme & Uriticaria Pruritus METHYLPREDNISOLONE 125 MG ONCE.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Patient complained that she have been experiencing muscle tenderness and painful to touch in her upper left arm where.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Chest X-ray normal, Chills, Cyanosis, Full blood count normal, Loss of consciousness
Clinical narrative: Pt became stiff, turned blue, vomited, shivering, unconscious with 104 F fever about 7 hrs after shots. Pt. appeared normal without fever until then. Paramedic was called & brought him to ER. Chest x-ray & CBC - normal. Released him. Bluishness, stiffness lasted approximately 10 min. Awake in 30 min.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Musculoskeletal stiffness, Pyrexia, Vomiting
Clinical narrative: Pt became stiff, turned blue, vomited, shivering, unconscious with 104 F fever about 7 hrs after shots. Pt. appeared normal without fever until then. Paramedic was called & brought him to ER. Chest x-ray & CBC - normal. Released him. Bluishness, stiffness lasted approximately 10 min. Awake in 30 min.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Headache
Clinical narrative: Red, swollen upper arm, Painful, itchy, chills, tired, sore joints, headaches.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Oedema peripheral, Pain, Pruritus
Clinical narrative: Red, swollen upper arm, Painful, itchy, chills, tired, sore joints, headaches.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Burning sensation, Fibromyalgia, Immediate post-injection reaction, Impaired work ability, Muscular weakness
Clinical narrative: This case was reported by a physician and described the occurrence of fibromyalgia in a 49-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). On 8 October 2010 the subject received a dose of Flu vaccine (unknown route, left arm). On 8 October 2010, immediately after vaccination with Flu vaccine, the subject experienced left arm burning. One to two days after vaccination with Flu vaccine, the subject developed generalized musculoskeletal pain and musculoskeletal weakness. The subject consulted a rheumatologist and was subsequently diagnosed with fibromyalgia. The physician considered the events were disabling. The subject was unable to work and was on disability at the time of reporting. At the time of reporting the events were unresolved. The physician was still investigating which brand of vaccine was administered. He stated that the events may have been related to the vaccine or may have been incidental.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a physician and described the occurrence of fibromyalgia in a 49-year-old female subject who was vaccinated with Flu vaccine (manufacturer unspecified). On 8 October 2010 the subject received a dose of Flu vaccine (unknown route, left arm). On 8 October 2010, immediately after vaccination with Flu vaccine, the subject experienced left arm burning. One to two days after vaccination with Flu vaccine, the subject developed generalized musculoskeletal pain and musculoskeletal weakness. The subject consulted a rheumatologist and was subsequently diagnosed with fibromyalgia. The physician considered the events were disabling. The subject was unable to work and was on disability at the time of reporting. At the time of reporting the events were unresolved. The physician was still investigating which brand of vaccine was administered. He stated that the events may have been related to the vaccine or may have been incidental.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received 3 vaccines - DTAP, flu (L) deltoid and polio (IPV) (R) deltoid. Received vaccines at approximately 4pm. Mom called office at 530PM with report of significant reaction (L) deltoid area 5-6# area of redness & warmth as of 11/4/11 - redness decreased but still warm to touch & swollen.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever of 105.5.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Epistaxis
Clinical narrative: Mom c/o after pt got 1st HPV she noticed a nosebleed the following day & every day after for 1 mo. She states the same thing happened with pts 16 yo sib & denies either of them had nosebleeds before. Also denies other hematologic problems (prolonged bleed, etc).
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Eye pruritus, Headache, Lacrimation increased
Clinical narrative: Itchy/watery eyes, trouble breathing, headache, vomiting, diarrhea. - Started afternoon/evening of 11/3/11 & ended am of 11/4/11.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Itchy/watery eyes, trouble breathing, headache, vomiting, diarrhea. - Started afternoon/evening of 11/3/11 & ended am of 11/4/11.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Dyspnoea, Eye pruritus, Headache, Lacrimation increased
Clinical narrative: Itchy/watery eyes, trouble breathing, headache, vomiting, diarrhea. Started afternoon/eve of 11/3/11 & ended AM of 11/4/11.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Itchy/watery eyes, trouble breathing, headache, vomiting, diarrhea. Started afternoon/eve of 11/3/11 & ended AM of 11/4/11.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Gait disturbance, Hyporeflexia, Limb discomfort, Movement disorder
Clinical narrative: Aug 27 - Athlete (cross-country) has difficulty moving legs. Sept 1 - Gait changes. 4-5min slower times. Sept 3 - To ER. Some increase in muscle enzymes. Decreased knee reflexes. Athletic/PE restriction per Dr. Sept 9 - Improved. Sept 12 - Fever 101 degrees. Sept 15 - Difficulty walking. Upper thigh discomfort. Today: still muscle wasting/decreased strength: thighs.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Muscle atrophy, Muscle enzyme increased, Muscular weakness, Pyrexia
Clinical narrative: Aug 27 - Athlete (cross-country) has difficulty moving legs. Sept 1 - Gait changes. 4-5min slower times. Sept 3 - To ER. Some increase in muscle enzymes. Decreased knee reflexes. Athletic/PE restriction per Dr. Sept 9 - Improved. Sept 12 - Fever 101 degrees. Sept 15 - Difficulty walking. Upper thigh discomfort. Today: still muscle wasting/decreased strength: thighs.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: The night of shot was awaken by severe pain in chest at 2:30AM couldn't hardly breathe. Also within 2 days have a red/bumpy rash on injection site. Swollen and very sore.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous
Clinical narrative: The night of shot was awaken by severe pain in chest at 2:30AM couldn't hardly breathe. Also within 2 days have a red/bumpy rash on injection site. Swollen and very sore.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Crying, Dyspnoea, Inappropriate affect, Injected limb mobility decreased
Clinical narrative: Patient had HPV and flu vaccine on her left deltoid area, then she had the meningococcal vaccine on the right deltoid area. Almost immediately after meningococcal vaccine was given child started to laugh uncontrollably and then to cry. She complained of shortness of breath and inability to move right arm. Vital signs were stable and normal. There was no change in color, no fainting episodes observed. She was conscious at all times and breathing spontaneously. No treatment was administered at this time, EMS was called immediately. EMS arrived 5-7 minutes later. Patient was transferred to hospital for further evaluation and management. Child left medical office walking without assistance to the ambulance.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendon disorder
Clinical narrative: Stiffness & pain in arm 3-4 days after administration. Went to MD who referred to rehab. The massaged arm to spread vaccine but still no relief. Started on steroids & had MRI which indicated needle punctured tendon.
Age: 44.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site erythema
Clinical narrative: Pt has DTaP 10/31/11 at hospital. Redness next day. 11/01/11 - 8 cm x 14 cm erythema (R) deltoid. No adenopathy. T 97.8. Pt rxn seen at hospital. Rxn (R) deltoid. Seen on 11/4/11.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Difficulty breathing & swallowing. Treated in ER w/ IV medication; albuterol nebulizer (I believe the IV med. was a steroid & BENADRYL). Then discharged w/ prednisone 20mg 2x day x3 days & BENADRYL 25mg q4h x 24 hrs then prn.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Biopsy, Blister, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Described local redness & swelling at site of injection (LA) shortly after adm. lasting 3-4 days. - Painful about 11-1-11, began developing pruritic, dense, papular rash beginning on arms, spreading to trunk, lower extremities becoming systemic, except face. Family dr sent him to see dermatologist, who decided it was "chickenpox" describing lesions as vesicles. Rx's ALLEGRA.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rash pruritic, Varicella post vaccine
Clinical narrative: Described local redness & swelling at site of injection (LA) shortly after adm. lasting 3-4 days. - Painful about 11-1-11, began developing pruritic, dense, papular rash beginning on arms, spreading to trunk, lower extremities becoming systemic, except face. Family dr sent him to see dermatologist, who decided it was "chickenpox" describing lesions as vesicles. Rx's ALLEGRA.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Fever, Chills: 3days+; Viral like diarrhea: 14hrs 11/3/11; numbness and tingling and pain in the right hand and forearm: 3days+; headache contained in the upper left side of brain: lasting 3 days+; constant sneezing every morning since shot: lasting 2-3 hrs each morning; shortness of breath: 3 days+ not constant; fatigue 4+ days, with trouble sleeping, cannot rest normally; Odd chest pains: 1 day, sporadic.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Influenza virus test negative, Insomnia, Pain in extremity, Paraesthesia
Clinical narrative: Fever, Chills: 3days+; Viral like diarrhea: 14hrs 11/3/11; numbness and tingling and pain in the right hand and forearm: 3days+; headache contained in the upper left side of brain: lasting 3 days+; constant sneezing every morning since shot: lasting 2-3 hrs each morning; shortness of breath: 3 days+ not constant; fatigue 4+ days, with trouble sleeping, cannot rest normally; Odd chest pains: 1 day, sporadic.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Restlessness, Sneezing, Streptococcus test negative, Viral diarrhoea
Clinical narrative: Fever, Chills: 3days+; Viral like diarrhea: 14hrs 11/3/11; numbness and tingling and pain in the right hand and forearm: 3days+; headache contained in the upper left side of brain: lasting 3 days+; constant sneezing every morning since shot: lasting 2-3 hrs each morning; shortness of breath: 3 days+ not constant; fatigue 4+ days, with trouble sleeping, cannot rest normally; Odd chest pains: 1 day, sporadic.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Nasopharyngitis, Rhinorrhoea
Clinical narrative: After receiving high dose influenza vaccine, patient had a reaction that began with mild sniffles and occasional cold-like symptoms for several days.  On November 1, began to have strong flu-like symptoms that have continued for several days.
Age: 35.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain, Pyrexia, Swelling
Clinical narrative: MODERATE TO SEVERE PAIN, SWELLING, FEVER (100.5), NAUSEA.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Foetal hypokinesia, Headache, Maternal exposure during pregnancy, Myalgia, Oropharyngeal pain
Clinical narrative: Fever, muscle aches, severe sore throat, headache, Decreased/absent fetal movement.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: Fever, muscle aches, severe sore throat, headache, Decreased/absent fetal movement.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Chest pain, Dizziness, Electrocardiogram, Hypoaesthesia
Clinical narrative: Numbness in extremities, dizziness, chest pain, raised B/P.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Abnormal sensation in eye, Asthenia, Chills, Dizziness, Headache
Clinical narrative: Redness swelling around shot. Aching pain.  Then on 11/04/2011 develop severe flu like symptoms. Chills then fever, total aches & pain thru whole body, felt like eyes were going to pop out of socket. Arm rash grew to 3x4 in size & painful! Dizzy faint & severe headache. Heart rate kept going up!  Almost went to emergency room but doc visit stated minor reaction!  Patient took 2 Benadryl tablets & tossed & turned all night.  Woke up feeling 75% better.  Still aches & pain mostly in left arm & very weak.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Influenza like illness, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Redness swelling around shot. Aching pain.  Then on 11/04/2011 develop severe flu like symptoms. Chills then fever, total aches & pain thru whole body, felt like eyes were going to pop out of socket. Arm rash grew to 3x4 in size & painful! Dizzy faint & severe headache. Heart rate kept going up!  Almost went to emergency room but doc visit stated minor reaction!  Patient took 2 Benadryl tablets & tossed & turned all night.  Woke up feeling 75% better.  Still aches & pain mostly in left arm & very weak.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Poor quality sleep, Pyrexia, Rash, Syncope
Clinical narrative: Redness swelling around shot. Aching pain.  Then on 11/04/2011 develop severe flu like symptoms. Chills then fever, total aches & pain thru whole body, felt like eyes were going to pop out of socket. Arm rash grew to 3x4 in size & painful! Dizzy faint & severe headache. Heart rate kept going up!  Almost went to emergency room but doc visit stated minor reaction!  Patient took 2 Benadryl tablets & tossed & turned all night.  Woke up feeling 75% better.  Still aches & pain mostly in left arm & very weak.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Cough, Pyrexia
Clinical narrative: Severe coughing, weakness, fever, "shivers".
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Tenderness and aching at injection site, feels bruised by no sign of bruising, swollen. Feels like punched in arm. Treatment includes ice and ibuprofen. Pain continues.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Myalgia
Clinical narrative: MUSCLE ACHES, COUGH, CHILLS.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Asthenia, Fatigue, Injection site erythema, Pain
Clinical narrative: Tired, achy on 10/3. On 10/4, increasing tiredness & weakness, baseball sized flat red spot at injection site on arm. Symptoms did not resolve until 10/5.
Age: 1.01
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Malaise, Pyrexia, Rash generalised
Clinical narrative: Seemed under the weather in the morning and started running a fever of about 101 rectally. Fever spiked to 103.6 that evening.  Fever was reduced with ibuprofen and Tylenol.  Spiked again the next evening. Fever broke on Nov. 5, 2011. He then broke out in a spotty rash on his whole body.  He is not recovered yet as of 11/5/11. He previously had roseola, so that's not what it was.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea, nausea, vomiting, chills, 99.6 degree temperature.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Injection site discolouration, Injection site erythema, Oropharyngeal pain, Sneezing
Clinical narrative: Flu-like symptoms (sore throat, sneezing, big area of redness/purple color at injection site.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Laboratory test, Mobility decreased, Neck pain
Clinical narrative: Pain in the neck, unable to move his neck on the right side.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Chills and nasal congestion progressing throughout the afternoon to wheezing with mild pain and inflammation at injection site. During the evening hours, advanced redness and swelling with pain around injection site. Large hive like raised (approx. size of apple) area around injection site. Skin around injection site hot to touch and very tender. Low grade fever of 100 on morning of 11/05/2011. Difficulty using right arm with increased wheezing/upper respiratory congestion with right eye severely bloodshot. Refused to be seen by physician at local urgent center clinic Sat. 11/05/2011. Will contact Clinic Monday in AM. Will go to emergency room if condition or symptoms become severe. At home on bed rest until then.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site swelling, Injection site urticaria, Injection site warmth, Nasal congestion, Ocular hyperaemia
Clinical narrative: Chills and nasal congestion progressing throughout the afternoon to wheezing with mild pain and inflammation at injection site. During the evening hours, advanced redness and swelling with pain around injection site. Large hive like raised (approx. size of apple) area around injection site. Skin around injection site hot to touch and very tender. Low grade fever of 100 on morning of 11/05/2011. Difficulty using right arm with increased wheezing/upper respiratory congestion with right eye severely bloodshot. Refused to be seen by physician at local urgent center clinic Sat. 11/05/2011. Will contact Clinic Monday in AM. Will go to emergency room if condition or symptoms become severe. At home on bed rest until then.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Upper respiratory tract congestion, Wheezing
Clinical narrative: Chills and nasal congestion progressing throughout the afternoon to wheezing with mild pain and inflammation at injection site. During the evening hours, advanced redness and swelling with pain around injection site. Large hive like raised (approx. size of apple) area around injection site. Skin around injection site hot to touch and very tender. Low grade fever of 100 on morning of 11/05/2011. Difficulty using right arm with increased wheezing/upper respiratory congestion with right eye severely bloodshot. Refused to be seen by physician at local urgent center clinic Sat. 11/05/2011. Will contact Clinic Monday in AM. Will go to emergency room if condition or symptoms become severe. At home on bed rest until then.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Rhinitis, Swelling, Throat tightness
Clinical narrative: Severe coughing, hoarseness, larynx swelling, feeling of fullness in throat. Within 30 minutes: Rhinitis. One Benadryl orally (25 mg Diphenhydramine HCl) at signs of serious airway symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pustule
Clinical narrative: Approximately 4 days after vaccination, 2 white pustules appeared in injection site.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Feeling hot, Headache, Nasopharyngitis
Clinical narrative: At 1 am on 11-3-11 pt was cold & had chills in chest, arms & hands all night long & could not sleep. At 6am on 11-3-11 pt felt hot & had pain in neck, head, & jaw & was dizzy with headache. On 11-4-11 pt rested all day & feeling better. Pt called us at 9:20 pm on 11-4-11 to tell us her experience.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in jaw
Clinical narrative: At 1 am on 11-3-11 pt was cold & had chills in chest, arms & hands all night long & could not sleep. At 6am on 11-3-11 pt felt hot & had pain in neck, head, & jaw & was dizzy with headache. On 11-4-11 pt rested all day & feeling better. Pt called us at 9:20 pm on 11-4-11 to tell us her experience.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Dyspnoea, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Approx. 3 hrs after vaccine; experienced shortness of breath, swelling at injection site, feeling sick ie....fever, dizziness.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Nausea, Oropharyngeal pain, Throat tightness
Clinical narrative: Nausea, sweating, throat sore/tightness.  - Monitor pt lungs clear.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: (L) elevated ext: First size redness - elevate - hot to touch.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site rash, Pruritus, Rash
Clinical narrative: AFLURIA given in left arm on 10/13/11. Rash developed in area of shot about 10/29/11. Localized rash, redness, itching still evident as of 11-5-11.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Disturbance in attention, Memory impairment, Speech disorder
Clinical narrative: Patient called after receiving flu shot and complained of the following symptoms: difficulty remembering things, difficulty communicating, unable to concentrate.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased
Clinical narrative: Pt. is having numbness on her left arm which made it difficult for her to lift or move it. Pt. was advised by Primary Care Physician to see a neurologist to determine at the same time of a nerve was hit when the shot was done - per patient.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site swelling, Local swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm of injection swelled in a 35-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), Flu vaccine. Concurrent medical conditions included hypertension. Concurrent medications included HCTZ and Birth control pill. On an unknown date in 2010 the subject received a dose of Flu vaccine (unknown route, right arm). At an unspecified time after vaccination with Flu vaccine, the subject experienced hardness injection site and swelling injection site. On 28 September 2011 at 14:00 the subject received a dose of FLUARIX (unknown route, left arm). On 29 September 2011, 1 day after vaccination with FLUARIX, the subject experienced arm of injection (left ) swelled, swelling of left chest wall and pain. The subject was referred to an urgent care facility. At the time of reporting the events were unresolved. Additional information was received on 29 September 2011 via healthcare professional who reported an additional event was reported for the Flu vaccine received on an unknown date in 2010 of possible hematoma that lasted over one week. The healthcare professional also reported the subject received FLUARIX (0.5ml, intramuscular, left deltoid) injection on 28 September 2011 and on 29 September 2011 she complained of swelling at the injection site that radiated from her upper left arm down to her left chest wall. The outcome of swelling at the injection site that radiated to chest wall was unknown. Follow-up information was received on 02 November 2011. It was reported that the subject experienced an anaphylactic reaction starting on 29 September 2011 (the day after vaccination with FLUARIX) with symptoms of arm of injection swelled, swelling of chest wall, pain and swelling spread. The events were unresolved at the time of follow-up. No information was provided regarding the flu vaccination in 2010 with regard to adverse events.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic reaction, Injection site induration, Injection site swelling, Musculoskeletal chest pain, Oedema peripheral
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm of injection swelled in a 35-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), Flu vaccine. Concurrent medical conditions included hypertension. Concurrent medications included HCTZ and Birth control pill. On an unknown date in 2010 the subject received a dose of Flu vaccine (unknown route, right arm). At an unspecified time after vaccination with Flu vaccine, the subject experienced hardness injection site and swelling injection site. On 28 September 2011 at 14:00 the subject received a dose of FLUARIX (unknown route, left arm). On 29 September 2011, 1 day after vaccination with FLUARIX, the subject experienced arm of injection (left ) swelled, swelling of left chest wall and pain. The subject was referred to an urgent care facility. At the time of reporting the events were unresolved. Additional information was received on 29 September 2011 via healthcare professional who reported an additional event was reported for the Flu vaccine received on an unknown date in 2010 of possible hematoma that lasted over one week. The healthcare professional also reported the subject received FLUARIX (0.5ml, intramuscular, left deltoid) injection on 28 September 2011 and on 29 September 2011 she complained of swelling at the injection site that radiated from her upper left arm down to her left chest wall. The outcome of swelling at the injection site that radiated to chest wall was unknown. Follow-up information was received on 02 November 2011. It was reported that the subject experienced an anaphylactic reaction starting on 29 September 2011 (the day after vaccination with FLUARIX) with symptoms of arm of injection swelled, swelling of chest wall, pain and swelling spread. The events were unresolved at the time of follow-up. No information was provided regarding the flu vaccination in 2010 with regard to adverse events.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of arm of injection swelled in a 35-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline), Flu vaccine. Concurrent medical conditions included hypertension. Concurrent medications included HCTZ and Birth control pill. On an unknown date in 2010 the subject received a dose of Flu vaccine (unknown route, right arm). At an unspecified time after vaccination with Flu vaccine, the subject experienced hardness injection site and swelling injection site. On 28 September 2011 at 14:00 the subject received a dose of FLUARIX (unknown route, left arm). On 29 September 2011, 1 day after vaccination with FLUARIX, the subject experienced arm of injection (left ) swelled, swelling of left chest wall and pain. The subject was referred to an urgent care facility. At the time of reporting the events were unresolved. Additional information was received on 29 September 2011 via healthcare professional who reported an additional event was reported for the Flu vaccine received on an unknown date in 2010 of possible hematoma that lasted over one week. The healthcare professional also reported the subject received FLUARIX (0.5ml, intramuscular, left deltoid) injection on 28 September 2011 and on 29 September 2011 she complained of swelling at the injection site that radiated from her upper left arm down to her left chest wall. The outcome of swelling at the injection site that radiated to chest wall was unknown. Follow-up information was received on 02 November 2011. It was reported that the subject experienced an anaphylactic reaction starting on 29 September 2011 (the day after vaccination with FLUARIX) with symptoms of arm of injection swelled, swelling of chest wall, pain and swelling spread. The events were unresolved at the time of follow-up. No information was provided regarding the flu vaccination in 2010 with regard to adverse events.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Guillain-Barre syndrome, Red blood cells CSF positive
Clinical narrative: Guillain Barre.
Age: 77.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram, Guillain-Barre syndrome, Laboratory test, Nuclear magnetic resonance imaging, Paralysis
Clinical narrative: Guillain Barre.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Streptococcus test, Urine analysis
Clinical narrative: Chickenpox looking red bumps all over body, stomach, back, neck, armpits, and face. Fever of 102.5.