chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Musculoskeletal pain
Clinical narrative: 3-inch area around injection site on upper left arm turned red and swelled; 27 hours later there was a 5-inch strip of redness and swelling on the arm along the edge of the armpit closest to the chest; pain through left shoulder, armpit, upper arm, and chest prevented moving arm for about 18 hours; 1.5 inch red area of swelling then developed on another portion of the upper left arm.  All symptoms disappeared after 5 days.
Age: 0.58
Sex: M
Vaccine: 6VAX-F, PPV
Symptoms: Pain, Rash generalised, Rash pruritic, Screaming
Clinical narrative: Immediately broke out in a itchy, raised, rash all over his body. Screaming in pain. After given a large dose of Benadryl he calmed down enough to nurse and after a few of hours the rash faded.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Muscular weakness, Pyrexia
Clinical narrative: Fever, chills, limb weakness.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Headache, Oropharyngeal pain
Clinical narrative: Barking cough for 3-4 days. No fever. Sore throat and headache. Prescribed dexamethasone 6 mg PO. Cool mist humidifier, push plenty of fluids.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Induration, Injection site erythema, Injection site mass
Clinical narrative: On Fri. 10-7-11, I went to get my annual flu shot. When asked if I wanted the air shot or needle, I told them I didn't know the difference so it didn't matter. I got the air shot. 11:30 AM - I went on with my shopping but about 15 minutes later my arm began to hurt - I rubbed it a little through my jacket and could feel a bump - thinking it was the cotton ball under the band aid I tried to ignore it. I got home about 12:30 PM - took off the band aid and no cotton ball - it was a large red bump with a black center. I called the pharmacist and told him how hot and swollen my arm was and he said to ice it. That I did. It still continued to swell, was red hot and hard. The next morning my upper arm was all colors - red, pink, splotchy purple beginning to look like bruises. I returned to show my arm to the pharmacist and he looked stunned. He called someone and gave my name and phone # - but no one ever called me. I just continued to ice it and take aspirin. To this day 11-6-11 I still have a small lump with a black center and its still tender.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Oedema peripheral, Pain in extremity, Rash macular, Skin warm
Clinical narrative: On Fri. 10-7-11, I went to get my annual flu shot. When asked if I wanted the air shot or needle, I told them I didn't know the difference so it didn't matter. I got the air shot. 11:30 AM - I went on with my shopping but about 15 minutes later my arm began to hurt - I rubbed it a little through my jacket and could feel a bump - thinking it was the cotton ball under the band aid I tried to ignore it. I got home about 12:30 PM - took off the band aid and no cotton ball - it was a large red bump with a black center. I called the pharmacist and told him how hot and swollen my arm was and he said to ice it. That I did. It still continued to swell, was red hot and hard. The next morning my upper arm was all colors - red, pink, splotchy purple beginning to look like bruises. I returned to show my arm to the pharmacist and he looked stunned. He called someone and gave my name and phone # - but no one ever called me. I just continued to ice it and take aspirin. To this day 11-6-11 I still have a small lump with a black center and its still tender.
Age: 13.0
Sex: M
Vaccine: DTAPIPV, HPV4, MNQ, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient given KINRIX & should have been BOOSTRIX.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain, Limb discomfort, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHEH2011US009359 is an initial spontaneous report received from a consumer on 10 Nov 2011. This case refers to a 71-year-old female patient. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into her left arm on 01 Oct 2011. She experienced pain approximately three hours after injection. She continued to have pain in left shoulder and arm at the time of this report although she had used BIO FREEZE, seen the chiropractor, etc. and still she had no relief and could not raise her arm comfortably. She stated that she had spoken to her treating physician about her symptoms.
Age: 0.56
Sex: M
Vaccine: DTAP, IPV, RV5
Symptoms: Barium enema, Intussusception, Ultrasound abdomen
Clinical narrative: Intussusception 11/15/11. ROTATEQ given 11/11/11 (3rd dose).
Age: 12.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP
Symptoms: Decreased appetite, Fatigue, Laboratory test, Nasal congestion, Nausea
Clinical narrative: Fatigue for one week after receiving vaccines; napping throughout day, nausea; reduced appetite extreme tiredness; nasal congestion since vaccine was given.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Client was given Flu vaccine with preservation (FLULAVAL) by accident. There was no unusual signs or symptoms noted after the shot. No treatment was needed.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Disorientation, Dysarthria, Fatigue, Pruritus
Clinical narrative: Severe itching. Pt states that she felt disoriented, felt tired all the time & had experienced some slurred-speech and she ended up going to the ER on 9/27/11.
Age: 64.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Vaccination complication
Clinical narrative: Severe itching. Pt states that she felt disoriented, felt tired all the time & had experienced some slurred-speech and she ended up going to the ER on 9/27/11.
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Activities of daily living impaired, Local swelling, Pain, Pruritus, Sleep disorder
Clinical narrative: My daughter received her first injection of GARDASIL 07/28/11. Within days of the first injection she experienced hives. The hives presented themselves every few days, the average being 2 maybe 3 times a week. She received the second injection 09/28/11 within days the hives were presenting themselves on a daily basis. She is now on medication daily to control the hives. The medication should be lasting 24 hours however the drug can only fend off the hives for about 8-10 hours, in some cases even a shorter period of time. She is now taking a pill twice a day which could affect her liver/kidneys. Quite often she is woken in the middle of the night by the hives which interrupts her sleep schedule. The only way to lessen the severity of the itching and pain is to take a tepid shower and to remain as still as possible. The hives also interrupt her daily school and activities schedules. The hives are large (hand size) lesions that look like large water blisters and protrude from the surface of her skin. The hives cover the entire body; torso, legs, arms, feet, hands, face and lips. Her hands, feet and mouth/lips swell with no visible patch. Immediately following the first onset of hives we took her to an Allergist. The Allergist ordered lab work to determine if this could be an auto-immune disorder (other than type 1 diabetes) and environmental influences. The lab work reflected she does not have an underlying auto-immune disorder that could trigger the hives and there is not an environmental cause the doctor thinks could be triggering the hives. We also began a food log at home. However our family is organic and our food brand/type hasn't changed in years along with detergents, soaps, etc...
Age: 14.0
Sex: F
Vaccine: FLUX, HPV4
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: My daughter received her first injection of GARDASIL 07/28/11. Within days of the first injection she experienced hives. The hives presented themselves every few days, the average being 2 maybe 3 times a week. She received the second injection 09/28/11 within days the hives were presenting themselves on a daily basis. She is now on medication daily to control the hives. The medication should be lasting 24 hours however the drug can only fend off the hives for about 8-10 hours, in some cases even a shorter period of time. She is now taking a pill twice a day which could affect her liver/kidneys. Quite often she is woken in the middle of the night by the hives which interrupts her sleep schedule. The only way to lessen the severity of the itching and pain is to take a tepid shower and to remain as still as possible. The hives also interrupt her daily school and activities schedules. The hives are large (hand size) lesions that look like large water blisters and protrude from the surface of her skin. The hives cover the entire body; torso, legs, arms, feet, hands, face and lips. Her hands, feet and mouth/lips swell with no visible patch. Immediately following the first onset of hives we took her to an Allergist. The Allergist ordered lab work to determine if this could be an auto-immune disorder (other than type 1 diabetes) and environmental influences. The lab work reflected she does not have an underlying auto-immune disorder that could trigger the hives and there is not an environmental cause the doctor thinks could be triggering the hives. We also began a food log at home. However our family is organic and our food brand/type hasn't changed in years along with detergents, soaps, etc...
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: 2.5 cm circular area of what appears to be shingles on (R) thigh at site of Varicella vaccine - received vaccine 10/11/11 - shingles appeared 10/12/11.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Drug hypersensitivity
Clinical narrative: Allergic drug reaction.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Lip swelling, Oedema mouth, Wheezing
Clinical narrative: Her lips started swelling and inside of her mouth also began swelling.  Lips felt numb and she experienced some wheezing.
Age: 50.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Asthenia, Chest X-ray, Chest discomfort, Cough, Dyspnoea
Clinical narrative: COUGHING WHEEZING TIGHTNESS IS CHEST, DIFFICULITY BREATHING, COUGHING UP BLOOD, FEVER, FATIGUE, WEAKNESS.
Age: 50.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Fatigue, Haemoptysis, Pyrexia, Wheezing
Clinical narrative: COUGHING WHEEZING TIGHTNESS IS CHEST, DIFFICULITY BREATHING, COUGHING UP BLOOD, FEVER, FATIGUE, WEAKNESS.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Injection site erythema, Injection site rash
Clinical narrative: Transient diarrhea, a rash, and erythema at the injection site (no induration).
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Induration, Injection site swelling, Injection site warmth, Local swelling, Oedema peripheral
Clinical narrative: INJECTION SITE SWOLLEN, HOT, looked like a bull's eye, neck/shoulder/clavicle swollen, tender with hardened lymph node.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: INJECTION SITE SWOLLEN, HOT, looked like a bull's eye, neck/shoulder/clavicle swollen, tender with hardened lymph node.
Age: 49.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema
Clinical narrative: Redness and Erythema.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Asthenia, Computerised tomogram head, Computerised tomogram normal, Dysarthria, Full blood count normal
Clinical narrative: Presented to ER with ascending weakness that started in foot, shakes/tremors, slurred speech.  Lab workup done, Head CT done, IV started.  Patient transferred to another facility for evaluation by neurologist, suspected Guillain-Barre syndrome.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Haematocrit decreased, Haemoglobin decreased, Lipase normal, Liver function test normal, Metabolic function test normal
Clinical narrative: Presented to ER with ascending weakness that started in foot, shakes/tremors, slurred speech.  Lab workup done, Head CT done, IV started.  Patient transferred to another facility for evaluation by neurologist, suspected Guillain-Barre syndrome.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Red blood cell sedimentation rate normal, Tremor
Clinical narrative: Presented to ER with ascending weakness that started in foot, shakes/tremors, slurred speech.  Lab workup done, Head CT done, IV started.  Patient transferred to another facility for evaluation by neurologist, suspected Guillain-Barre syndrome.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Ocular hyperaemia, Ophthalmological examination abnormal, Retinal exudates
Clinical narrative: Pt got a flu shot on 9/23/2011 after 4 days her left eye started to turn red. The redness continued and after 2 weeks she started to lose vision in her left eye, after a few dr visits and with the start of vision loss in both eyes she was sent to ophthalmologist who diagnosed her with white dot syndrome (possible birdshot). He vision is returning but is still not normal as of 11/18/2011.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Mom states noticed puffy red area to L arm on 11/8/11 afternoon. States afternoon of 11/9/11 the whole left arm was puffy and very red. Denies any pain or elevated temp. States carried child to local ER. States MD stated having "local reaction"  Steroid shot given in ER and also gave prescription for oral Benadryl.  States morning, 11/10/11,  his arm still red but less puffy.
Age: 0.18
Sex: F
Vaccine: HEP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site scar, Irritability, Screaming
Clinical narrative: No fever, became highly irritable later that evening with high pitched screams, left a hardened red mark on both thigh; however, the mark on right thigh turned into what looked to be a black oval shaped burn mark.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Soreness at site leading to pain in shoulder.  By mid morning "stabbing pain" radiating down arm. Painful to move arm and shoulder.  "Inability to hold anything in hand due to shoulder pain" Took Tylenol without relief. 11/18/11 Symptoms relieved except for "dull ache".
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis
Clinical narrative: This medically confirmed spontaneous report (initial receipt 03-Nov-2011) concerns a female patient. On an unknown date the patient received a flu shot and PNEUMOVAX 23 shot in the same arm and experienced cellulitis. The patient sought medical attention and was given an antibiotic. The event outcome was recovered. PNEUMOVAX 23 was not rechallenged.
Age: 26.0
Sex: F
Vaccine: DT
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Pt seen in EC with reddened indurated painful area at site of tetanus injection (left glut) and fever (at time of examination 99.8 - per pt had taken acetaminophen earlier that day). Pt discharged from EC to home with rx's for Ibuprofen 800 mg, Diphenhydramine 25 mg, Cephalexin 500 mg, and Diflucan 150 mg.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Severe body aches, high temperature, chills.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness
Clinical narrative: Dizziness.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Arm was sore at injection site. Pain became worse with each passing day until excruciating after 3 weeks. Unable to to sleep or lift arm. At 3 weeks, sought Dr.'s care. Was given 6 days of Prednisone. Pain & weakness diminished during Prednisone and returned afterwards.
Age: 32.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Dizziness, Feeling abnormal, Headache, Paraesthesia, Tremor
Clinical narrative: Immediate lightheadedness, tremor of hands and tingling of toes. Complained of "foggy" sensation. Symtoms resolved after 48 hours.  Also complaint of headache the following day.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Lethargy, Malaise
Clinical narrative: Began with fever of 100 degrees and lethargy and soreness and redness at injection site. As time went on, the redness, swelling, and pain expanded to cover area about the size of a paperback book. Fever remained at 100, sweating, feeling ill.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Began with fever of 100 degrees and lethargy and soreness and redness at injection site. As time went on, the redness, swelling, and pain expanded to cover area about the size of a paperback book. Fever remained at 100, sweating, feeling ill.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus, Tenderness
Clinical narrative: Left arm became red, swollen, painful, and itchy. Swelling increased for a week. Itching continued for 3 weeks. Pain/tenderness still remains.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Arteriogram coronary, Back pain, Chest pain, Echocardiogram abnormal, Electrocardiogram abnormal
Clinical narrative: Pt. developed low back pain and body aches. Late evening 11/15 he developed chest pain and diaphoresis.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Myocardial infarction, Myopericarditis, Pain, Troponin increased
Clinical narrative: Pt. developed low back pain and body aches. Late evening 11/15 he developed chest pain and diaphoresis.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Joint range of motion decreased
Clinical narrative: Localized erythema, warmth and swelling about 5cm x 5cm with one hive, altered ROM specifically difficulty with abduction, increased pain, day two additional sweling and redness below site of original redness aprox 2cm x 3 cm all on left arm where vaccine given.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain, Urticaria
Clinical narrative: Localized erythema, warmth and swelling about 5cm x 5cm with one hive, altered ROM specifically difficulty with abduction, increased pain, day two additional sweling and redness below site of original redness aprox 2cm x 3 cm all on left arm where vaccine given.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Hives, redness, itching at site and surrounding skin for approx. 20cm diameter.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Developed swelling, redness and pain in her left deltoid where injection was given. Also started to run a fever. Given oral atbx, did not respond. Dx of cellulitis at injection site, poss adverse reaction to pneumo vaccine.
Age: 1.27
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Blood test normal, Convulsion, Lethargy, Muscle twitching, Screaming
Clinical narrative: Screaming (was sleeping), lethargy, staring, twitching/seizing (leg, arm, head); lasted about 15-20 minutes; transferred to ER; bld work normal; suggested EEG for follow-up.
Age: 1.27
Sex: M
Vaccine: MMR, UNK, VARCEL
Symptoms: Staring
Clinical narrative: Screaming (was sleeping), lethargy, staring, twitching/seizing (leg, arm, head); lasted about 15-20 minutes; transferred to ER; bld work normal; suggested EEG for follow-up.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Severe tightness in shoulder and pain; unable to close car door with normal arm; unable to undress without help. Pain still exists as of 11/18/11.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Cellulitis, Chills, Pain, Pyrexia
Clinical narrative: c/o fever aches and chills evening of shot. Was also diagnosed with sinus infection and bronchitis in addition to cellulitis.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Sinusitis
Clinical narrative: c/o fever aches and chills evening of shot. Was also diagnosed with sinus infection and bronchitis in addition to cellulitis.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood culture negative, Cellulitis, Erythema, Full blood count, Incorrect route of drug administration
Clinical narrative: Emp developed redness, tenderness, pain after a partial dose of Tdap was inadvertently administered ID. Was seen in the ER and admitted with a diagnosis of cellulitis.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Tenderness
Clinical narrative: Emp developed redness, tenderness, pain after a partial dose of Tdap was inadvertently administered ID. Was seen in the ER and admitted with a diagnosis of cellulitis.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Drug administered at inappropriate site, Incorrect route of drug administration, Injection site erythema, Injection site haemorrhage, Injection site reaction
Clinical narrative: Emp developed redness, tenderness, pain after a partial dose of Tdap was inadvertently administered ID. Was seen in the ER and admitted with a diagnosis of cellulitis.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site swelling, Injection site vesicles, Open wound, Rash macular, Wound drainage
Clinical narrative: Emp developed redness, tenderness, pain after a partial dose of Tdap was inadvertently administered ID. Was seen in the ER and admitted with a diagnosis of cellulitis.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (12mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 15.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MNQ, PNC13
Symptoms: Haematocrit decreased, Haemoglobin decreased, Nausea, Neutrophil count decreased, Pancytopenia
Clinical narrative: Fever, nausea, vomiting, pancytopenia.
Age: 15.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, MNQ, PNC13
Symptoms: Platelet count decreased, Pyrexia, Vomiting, White blood cell count decreased
Clinical narrative: Fever, nausea, vomiting, pancytopenia.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (26mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Red, swollen injection site; Fever 99.3.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (6mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 75.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Body temperature increased, Chills, Pyrexia, Tremor
Clinical narrative: Temperature, chills, fever, shaking. Went to ER & stayed overnight.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV1
Symptoms: Incorrect dose administered
Clinical narrative: Patient given double dose of Hib. One through PENTACEL & one ACTHIB. Medical assistant followed provider order. Sanofi contacted and informed us no increase reaction should occur.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Hypersensitivity, Oedema peripheral, Pain in extremity
Clinical narrative: Pt went to ER for evaluation of painful swollen arms where immunizations were given. No fever no chills. Diagnosis in ER - acute allergic reaction vs. cellulitis.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Arthralgia, Cough, Fatigue, Pyrexia
Clinical narrative: Pt states he had fever, cough, sleep problems, upset stomach, joint pain, fatigue all bad enough to go & see his physician.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Sleep disorder
Clinical narrative: Pt states he had fever, cough, sleep problems, upset stomach, joint pain, fatigue all bad enough to go & see his physician.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 11/17 9:30 pm - Increased swelling of pain to upper (R) arm; felt feverish with chills. 11/18 0900 am - took naproxen sodium - pain /other sx. improved.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture stool, Diarrhoea, Irritability, Occult blood, Stool analysis
Clinical narrative: 24 hours after ROTATEQ given developed diarrhea, vomiting & irritability. Diarrhea & vomiting lasted from Mon - Wed but has remained irritable.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: 24 hours after ROTATEQ given developed diarrhea, vomiting & irritability. Diarrhea & vomiting lasted from Mon - Wed but has remained irritable.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Contusion, Erythema, Nuclear magnetic resonance imaging abnormal, Oedema, Pain
Clinical narrative: Pt received multiple injections on 6/7/11 & 6/9/11 for travel. Sx began after she received typhoid inj. Initially arm was very sore; erythema & pain resolved after 10 days, but since then has had persistent pain in posterior deltoid area. Constant dull ache, pain increased when she moves her arm, worst when reaches over head.
Age: 35.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Pain in extremity, X-ray limb normal
Clinical narrative: Pt received multiple injections on 6/7/11 & 6/9/11 for travel. Sx began after she received typhoid inj. Initially arm was very sore; erythema & pain resolved after 10 days, but since then has had persistent pain in posterior deltoid area. Constant dull ache, pain increased when she moves her arm, worst when reaches over head.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain, Burning sensation, Colonoscopy, Computerised tomogram head, Dizziness
Clinical narrative: Ongoing nausea. Difficulty swallowing, fatigue, hypersensitivity, headaches, migraines, dizziness, syncope, abdominal pain, hot flashes, severe weight loss, numbness, burning, tingling, muscle spasms.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dysphagia, Electroencephalogram, Endoscopy, Fatigue, Headache
Clinical narrative: Ongoing nausea. Difficulty swallowing, fatigue, hypersensitivity, headaches, migraines, dizziness, syncope, abdominal pain, hot flashes, severe weight loss, numbness, burning, tingling, muscle spasms.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Hot flush, Hypersensitivity, Hypoaesthesia, Laboratory test, Migraine
Clinical narrative: Ongoing nausea. Difficulty swallowing, fatigue, hypersensitivity, headaches, migraines, dizziness, syncope, abdominal pain, hot flashes, severe weight loss, numbness, burning, tingling, muscle spasms.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Muscle spasms, Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Syncope
Clinical narrative: Ongoing nausea. Difficulty swallowing, fatigue, hypersensitivity, headaches, migraines, dizziness, syncope, abdominal pain, hot flashes, severe weight loss, numbness, burning, tingling, muscle spasms.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Weight decreased
Clinical narrative: Ongoing nausea. Difficulty swallowing, fatigue, hypersensitivity, headaches, migraines, dizziness, syncope, abdominal pain, hot flashes, severe weight loss, numbness, burning, tingling, muscle spasms.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Dyspnoea, Influenza like illness, Nausea
Clinical narrative: In evening of vaccine administration patient developed flu-like symptoms, temp 104 degrees, chills, nausea, aches and SOB. Patient rested and took TYLENOL.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: In evening of vaccine administration patient developed flu-like symptoms, temp 104 degrees, chills, nausea, aches and SOB. Patient rested and took TYLENOL.
Age: 11.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RD injection site 3 hrs after swelling & redness x 2 days. Day 3 also warm to touch. Initially Tx ice & BENADRYL. 11-18-11 seen in office - rec elevate, ice if not improved will take KEFLEX.
Age: 10.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: - upper (R) arm red/swollen at injection site and warm to touch. - tender to touch. - fever noted 11/17/2011
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain
Clinical narrative: 8-10 cm erythema, induration & pain onset in evening & progressed over 24 hours then stable.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site warmth, Lymphadenopathy
Clinical narrative: Redness, warmth, induration about 10 cm diameter about injection site & lymphadenopathy in axilla & pain.
Age: 1.05
Sex: M
Vaccine: FLU3, HEPA, PNC13, VARCEL
Symptoms: Full blood count, Varicella post vaccine
Clinical narrative: Chickenpox rash. Must avoid POM on chemo for cancer.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm is sore can not lift it (11/14/11 AM).
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Dizziness, Full blood count, Headache, Urine analysis
Clinical narrative: Headache, Vomiting, Abdominal Pain, Dizziness.  Was seen at ER and given IV fluids and antinausea medication.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Headache, Vomiting, Abdominal Pain, Dizziness.  Was seen at ER and given IV fluids and antinausea medication.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (5mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Eye irritation, Influenza like illness, Lacrimation increased, Vomiting
Clinical narrative: Eyes burned and watered, got sick to stomach - was throwing up for about 2 hours, chills, felt flu like symptoms.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (6 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 37.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Mouth ulceration, Oedema mouth, Oropharyngeal blistering
Clinical narrative: Swelling along roof of mouth and blisters/ulcers along the inside of the facial cheeks.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (11 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (6 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (5 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Ocular hyperaemia, Vision blurred
Clinical narrative: Right eye became bloodshot, later became blurry. I washed my eye with sterile solution. It became much worse over the weekend. I saw Dr on 10/17/2011. He diagnosed a severe case of shingles in my right eye. Dr treated me every day for the week. My eye was administered antibiotic on 10/17 and taped shut. My eye was very painful and my vision blurry. I was prescribed antiviral oral medication and antibiotic eye drops. On 10/18 the bandage was removed and I continued antiviral oral medication and antibiotic eye drops. My vision was blurry for @ 3 weeks.
Age: 61.0
Sex: F
Vaccine: DTP, FLUX, FLU3, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: Arm hurt and alot of swelling and redness where shot was given. Got red and hard like a baseball got very large. It really hurt and stayed that way for about two weeks, than the hardness and the big red spot went away. I still have alot of pain in tha area of the shot. Pain inside my arm, when I more it lift it out and away from my body. I cannot lay at night on my arm it becomes very painful. When I even put a coat on I cannot lift my arm high enough without alot of pain. This is my left arm. I can still see where the needle was put in. I am in alot of pain and it has been about two months. I cannot use my arm it is too painful.
Age: 61.0
Sex: F
Vaccine: DTP, FLUX, FLU3, TDAP
Symptoms: Pain in extremity
Clinical narrative: Arm hurt and alot of swelling and redness where shot was given. Got red and hard like a baseball got very large. It really hurt and stayed that way for about two weeks, than the hardness and the big red spot went away. I still have alot of pain in tha area of the shot. Pain inside my arm, when I more it lift it out and away from my body. I cannot lay at night on my arm it becomes very painful. When I even put a coat on I cannot lift my arm high enough without alot of pain. This is my left arm. I can still see where the needle was put in. I am in alot of pain and it has been about two months. I cannot use my arm it is too painful.
Age: 61.0
Sex: F
Vaccine: DTP, FLUX, FLU3, TDAP
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm hurt and alot of swelling and redness where shot was given. Got red and hard like a baseball got very large. It really hurt and stayed that way for about two weeks, than the hardness and the big red spot went away. I still have alot of pain in tha area of the shot. Pain inside my arm, when I more it lift it out and away from my body. I cannot lay at night on my arm it becomes very painful. When I even put a coat on I cannot lift my arm high enough without alot of pain. This is my left arm. I can still see where the needle was put in. I am in alot of pain and it has been about two months. I cannot use my arm it is too painful.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness postural, Urticaria
Clinical narrative: Dizziness getting out of bed, then large hives on arm and shoulder over the next 5-6 days. I double-dosed on Zyrtec for several days, then continued with 1 pill a day.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain, Rotator cuff syndrome, X-ray limb normal
Clinical narrative: Persistent Lt deltoid pain and decreased range of motion of Lt shoulder after Lt deltoid injection of influenza vaccine. Temporary relief of sx with brief course of oral steroids. (pt intolerant to NSAIDS) orthopedics eval at 4 weeks post -vaccine -> dx of impingement with bursitis/tendonitis. Treated with lidocaine/bupivacaine/CELESTONE injection with physical therapy. Sx improving.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: Severe sore throat, achiness.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (5 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Fatigue, Pyrexia, Sluggishness
Clinical narrative: Dizziness and confusion, followed at approximately 8pm by fever (un-measured). Sluggishness and tiredness continued through 11/18/2011.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Electrocardiogram
Clinical narrative: Pt reported onset of chest pain (pressure) and cough, shortness of breath.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Pulmonary function test
Clinical narrative: Pt reported onset of chest pain (pressure) and cough, shortness of breath.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (6 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Gastrointestinal disorder, Hallucination, Vomiting
Clinical narrative: Vomiting, hallucinations, stomach pain.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Nodule, Tenderness, Wrong drug administered
Clinical narrative: Had an unexpected and unusual localized reaction to the PPD test. Symptoms included increased erythema, tenderness, and a nodule (6 mm). It is suspected that a 0.1 ml of anthrax vaccine was erroneously administered to the sm instead of the standard PPD solution.
Age: 18.0
Sex: F
Vaccine: FLUN3, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warmth and tenderness of L upper arm extending all the way to lower arm, not quite to wrist.
Age: 18.0
Sex: F
Vaccine: FLUN3, MNQ
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Redness, swelling, warmth and tenderness of L upper arm extending all the way to lower arm, not quite to wrist.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: Report from patient: Pain at injection site with immunization. Left arm/ right side tingling, weakness, dizziness and vertigo immediately took place. Sat down, drank 8 oz water. Felt weak, Nurse stated looked pale. Weakness and vertigo remained through evening. Emesis x 4 beginning at 10:00 pm, then 11:30pm, 2:00am and 5:00am. Body aches, weakness and increased amounts of nausea throughout the following day along with left side arm pain at injection site. No redness.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pallor, Paraesthesia, Vertigo, Vomiting
Clinical narrative: Report from patient: Pain at injection site with immunization. Left arm/ right side tingling, weakness, dizziness and vertigo immediately took place. Sat down, drank 8 oz water. Felt weak, Nurse stated looked pale. Weakness and vertigo remained through evening. Emesis x 4 beginning at 10:00 pm, then 11:30pm, 2:00am and 5:00am. Body aches, weakness and increased amounts of nausea throughout the following day along with left side arm pain at injection site. No redness.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Cyanosis, Electroencephalogram normal
Clinical narrative: Infant had first clonic tonic seizure grand mal type, lasting approx 5 minutes with perioral cyanosis. EMS responded and evaluated in emergency room, no documented fever but parental report of feeling warm.  Subsequently has had at least 4 more seizures over the next 5 days, and recently dx with Parinfluenza upper resp infection. Documented fever with 3rd seizure on 11/11/2011.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Grand mal convulsion, Nuclear magnetic resonance imaging brain normal, Parainfluenzae virus infection, Postictal state, Pyrexia
Clinical narrative: Infant had first clonic tonic seizure grand mal type, lasting approx 5 minutes with perioral cyanosis. EMS responded and evaluated in emergency room, no documented fever but parental report of feeling warm.  Subsequently has had at least 4 more seizures over the next 5 days, and recently dx with Parinfluenza upper resp infection. Documented fever with 3rd seizure on 11/11/2011.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Skin warm, Upper respiratory tract infection
Clinical narrative: Infant had first clonic tonic seizure grand mal type, lasting approx 5 minutes with perioral cyanosis. EMS responded and evaluated in emergency room, no documented fever but parental report of feeling warm.  Subsequently has had at least 4 more seizures over the next 5 days, and recently dx with Parinfluenza upper resp infection. Documented fever with 3rd seizure on 11/11/2011.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Burning sensation, Hypoaesthesia, Injection site pain, Laboratory test
Clinical narrative: Stabbing pain at sight of injection, intense pain running up to neck and down to fingers. Burning sensation on back of left hand, Thumb and fore finger on left hand number and tingly. The pain is constant sometimes milder then others. The pain runs from neck to fingers and is most prominent in elbow, forearm and sight of injection. Arm shakes and is weak when the pain is at peak.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Neck pain, Pain in extremity, Paraesthesia, Tremor
Clinical narrative: Stabbing pain at sight of injection, intense pain running up to neck and down to fingers. Burning sensation on back of left hand, Thumb and fore finger on left hand number and tingly. The pain is constant sometimes milder then others. The pain runs from neck to fingers and is most prominent in elbow, forearm and sight of injection. Arm shakes and is weak when the pain is at peak.
Age: 49.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Cough, Dysphonia, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Cough, chest congestion, hoarse-ness, rapid heart rate, shortness of breath, tired.
Age: 49.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Respiratory tract congestion
Clinical narrative: Cough, chest congestion, hoarse-ness, rapid heart rate, shortness of breath, tired.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Myalgia, Pyrexia, Serum sickness
Clinical narrative: High dose vaccine at clinic followed by mild viral syndrome that resolved in 48 hours. Then 96 hours later woke and had fever, severe debilitating myalgias (arms, legs, back) and felt weak. Did not notice rash. Very fatigued. Very slow to resolve - sx still present 11-18-11. Suspect serum sickness rxn.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection
Clinical narrative: High dose vaccine at clinic followed by mild viral syndrome that resolved in 48 hours. Then 96 hours later woke and had fever, severe debilitating myalgias (arms, legs, back) and felt weak. Did not notice rash. Very fatigued. Very slow to resolve - sx still present 11-18-11. Suspect serum sickness rxn.
Age: 17.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Vaccine found to be compromised by elevated refrigerator temperature to 62 degrees. Patient tolerated well without adverse effect but it unclear for how long temperature excursion occurred.
Age: 52.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Injection site pain, Injection site swelling
Clinical narrative: Initial report was received 30 September 2010 from a health care professional. A 52-year-old female patient had received an intramuscular left deltoid injection of H1N1, lot number UP006AA on 22 October 2009 and an unknown amount of time after vaccination, the patient developed pain, swelling and tenderness at the site lasting six months. The patient had concurrent illness of diarrhea at the time of vaccination. She had known allergies to codeine, penicillin, tetracycline and NAPROSYN. The event did not require a doctor's visit. According to the reporter, the patient recovered. Follow-up information was received from the health care professional on 10 November 2010. The reporter clarified that the patient did not have diarrhea at the time of vaccination, but developed it following vaccination. The patient had no illness at the time of vaccination, and did not receive any other vaccines within 4 weeks pandemic influenza vaccine. Concomitant medications included ALLEGRA D, NORVASC, DIOVAN, and hydrochlorothiazide. According to the reporter, the patient subsequently received influenza vaccine in 2010 without incident. No additional information was available. Documents held by sender: None.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Hypoaesthesia, Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial report received from a consumer on 18 October 2010. A 77-year-old female patient, with a medical history of GERD and thyroid disease, received on 21 September 2010 a left deltoid intramuscular (IM) injection of INFLUENZA VACCINE, lot number not reported. Her concomitant medications included LIPITOR, SYNTHROID AND PREVACID. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks prior to the FLUZONE. The patient had soreness of the left deltoid and the whole arm for 3-4 days after vaccination. The patient now has tingling of the arm from the deltoid to the fingers. The sensation comes and goes and she feels as if her arm was falling asleep. The outcome was reported as not recovered. Follow-up information was received from a health care professional on 06 December 2010. The patient received on 21 September 2010 at 4:15 PM FLUZONE, lot number U3565AA. The patient had intravenous (IV) dye and many test done since vaccination. The patient stated that anxiety makes the tingling worse. The patient has not been seen by a physician specifically for this reaction nor has she required treatment. The patient still has some tingling. The outcome remained not recovered. Follow-up information received was received from a health care professional on 27 January 2011 reported that the patient had a left breast lumpectomy in December. The patient's soreness and tingling experienced after injection has gone away. She still has different tingling across the back and shoulder, "like champagne bubbles", occasionally but all the pain has gone away. The outcome remained not recovered. Follow-up information was received from a health care professional on 23 February 2011 reported that there was no additional information to add at this time. The outcome remained not recovered. Follow-up information was received from a health care professional on 21 March 2011, who reported that there was no additional information to add at this time. The outcome remained not recovered. Follow-up information was received from a health care professional on 04 August 2011. The patient reported that her arm problems persisted for approximately one month after vaccination. The patient's outcome was reported as fully recovered. Documents held by sender: None.