chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nerve damage, Pain in extremity, Paraesthesia
Clinical narrative: Pt contacted Health Dept. on 11-4-2013 stating received a flu vaccine on 10-23-2013 in her left arm.  Began having pain in L arm almost immediately and the pain has gotten worse.  She now has some tingling in her fingers.  She has been icing it and taking pain meds for it. Has not seen a physician.  Encouraged to see a physician.  Saw her Primary Care Physician on 11/5/2013.  After examining her arm the Dr. told her that a nerve was hit when the shot was administered.  She was told this happens sometimes.  Treated with a Medrol Dose Pack and Keflex for 3 days. Already feels better today.
Age: 86.0
Sex: F
Vaccine: FLUX
Symptoms: White blood cell count increased
Clinical narrative: Pt w/ MDS received flu shot, was found to have rapid increase in her WBC. Family is concerned that this is AE from flu shot vs transformation of MDS to acute leukemia.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: AFTER RECEIVING THE FLU SHOT THE PATIENT PRESENTED WITH RASH IN BOTH ARMS IN THE BICEPS AREA.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Local swelling, Pain, Rash
Clinical narrative: Pt was sore. parent Noticed Swelling and a rash or redness go down arm. No fever.Pt took Tylenol and motrin and they even did Benadryl to help with the swelling and rash. The redness measured 6 in long and 5 in across pt upper arm.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Discomfort, Erythema, Induration, Local reaction, Skin warm
Clinical narrative: Large local reaction left posterior arm, no systemic symptoms. Significant discomfort; indurated, erythematous, warm from shoulder down to almost elbow.   Started Prednisone course PO.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Pain, Pyrexia, Wheezing
Clinical narrative: Wheezing & cough x 1-2 hours; Fever 100 degrees & body aches today 11/6/13.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient states that she had arm pain after receiving vaccine. After the pain at injection site dissipated, she has had pain in her upper arm and should that has increased in intensity and persists to this day.  The patient was counseled to seek help from her physician.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: None. Pt given 2nd dose influenza vaccine in error. No adverse side effects.
Age: 78.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Anaphylactic reaction, Chills, Dizziness, Hypotension, Intensive care
Clinical narrative: 78 y/o F with h/o HTN, HLD, prediabetes, presented to ED with pruritus, throat/tongue swelling, hypotension s/p zoster vaccine. Approx. 11am zoster vaccine -> several minutes later - pruritus hands and back, then lightheadedness, chills and blurry vision. Hypotensive to 50s in ED. Then developed tongue swelling and throat constriction. She was given SOLUMEDROL 125mg IV, epi 0.5mg IM x2, and BENADRYL 25mg IV x1, and 3L NS. Tongue swelling quickly resolved following epi injections and SBPs improved to 100s. Symptoms felt to be 2/2 to anaphylactic reaction to vaccine. Patient was monitored overnight in the ICU without recurrence of symptoms and discharged with instructions to immediately return if symptoms recurred.
Age: 78.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pharyngeal oedema, Pruritus, Swollen tongue, Throat tightness, Vision blurred
Clinical narrative: 78 y/o F with h/o HTN, HLD, prediabetes, presented to ED with pruritus, throat/tongue swelling, hypotension s/p zoster vaccine. Approx. 11am zoster vaccine -> several minutes later - pruritus hands and back, then lightheadedness, chills and blurry vision. Hypotensive to 50s in ED. Then developed tongue swelling and throat constriction. She was given SOLUMEDROL 125mg IV, epi 0.5mg IM x2, and BENADRYL 25mg IV x1, and 3L NS. Tongue swelling quickly resolved following epi injections and SBPs improved to 100s. Symptoms felt to be 2/2 to anaphylactic reaction to vaccine. Patient was monitored overnight in the ICU without recurrence of symptoms and discharged with instructions to immediately return if symptoms recurred.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Injection site erythema, Laboratory test
Clinical narrative: Anaphylactic reaction - Right arm red from shoulder radiation down to wrist. Difficulty breathing.
Age: 19.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Full blood count, Injection site rash, Injection site swelling, Metabolic function test
Clinical narrative: Rash and swelling at injection site. Supportive therapy with ibuprofen, diphenhydramine, and ice to right shoulder.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Visible swelling and aching left deltoid injection site; no redness except at bandaide site, which he states is not unusual; site not particularly warm to touch. Swelling measures 90mm laterally and 65mm proximally. Denies shortness or breath or difficulty swallowing. Self treatment with ice and analgesic suggested.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphonia, Dyspnoea, Pharyngeal oedema
Clinical narrative: Employee felt like her throat was swelling shut.  Voice was high pitched and squeaky. Gasping respirations. Was given PO Benadryl and Epinephrine 0.3 ml IM.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: localized site reaction with warmth and erythema
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient called to say she had dizziness that started a couple of hours after receiving her flu shot and had continued the next day. Patient had called the day after her shot and my supervisior had recommended she see a MD.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site pain, Mobility decreased, Winged scapula
Clinical narrative: My right shoulder began hurting in the evening, and became progressively more painful. I took some Advil and went to sleep. When I woke up, it felt very weak, and I could no longer lift my arm above my head. I also had severe "winging" of my scapula.   I saw a doctor who sent me to physical therapy. I began physical therapy and had no change for several months. I kept up with exercises, and now, just over one year later, have regained most mobility. Also, the "winging" has diminished significantly.
Age: 0.19
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, RVX
Symptoms: Crying, Diet refusal, Pain, Screaming
Clinical narrative: From 2:00 PM until 11:30 PM my baby refused to eat. She was screaming crying non stop. No matter what position we tried holding or calming her she cried in pain. This was the first time she recieved vaccines, and the first time she had such behavior.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Eye swelling, Rash
Clinical narrative: Rash to face, swollen eyes, raised bumps on back. Child transported to hospital by ambulance.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Itching vesicular rash on right arm, spreading to right mid-lateral torso.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Arm was red, swollen and hot to the touch. Fever/chills.  Body aches.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Arm was red, swollen and hot to the touch. Fever/chills.  Body aches.
Age: 1.31
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash to back, chest, antecubital area, face 5 minutes after flu shot administration.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain in left arm moved to fingertips and then to neck and severe headache; then sleepiness set in extremely tired and throbbing arm/neck pain.  ICE PACK on head AND arm helped some and took painkiller - Advil. Went home and slept for 5 hours and was up all night with headache and arm pain; went to work and arm pain increased - fingertips to neck - called my doctor.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Pain in left arm moved to fingertips and then to neck and severe headache; then sleepiness set in extremely tired and throbbing arm/neck pain.  ICE PACK on head AND arm helped some and took painkiller - Advil. Went home and slept for 5 hours and was up all night with headache and arm pain; went to work and arm pain increased - fingertips to neck - called my doctor.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Client reports pain in left arm, starting at neck and extending to elbow.  Reports difficulty raising left arm.  Saw physician and has been taking anti-inflammatories and apply cold to site, had MRI done.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site oedema, Injection site warmth
Clinical narrative: Patient states that on day after subq Zoster immunization she noticed a "red area 2"x4" round" and "felt fluid" at the injection site. On 11/6 in AM it was replaced with "bigger than an egg" size "knot"  and was warm to touch. Denied fever or malaise.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Per patient site is itchy, swolllen, red, feverish arm, firm, size of a softball.  marked the margins. went to urgent care today, on bactrim, goes back to urgent care in 24 hours unless worsens before then
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Autonomic nervous system imbalance, Myalgia, Radical neck dissection, Wheelchair user
Clinical narrative: She had 3 HPV shots (7/29/2010, 1/11/2011, 7/17/2012) each time afterwards had muscle pain, joint pain, was diagnosed with RND one year afterwards, later retracted, diagnosed with dysautonomia 08/10/2013 and is now confined to wheelchair.
Age: 0.75
Sex: F
Vaccine: FLU3, HEP
Symptoms: Diarrhoea, Lethargy, Pyrexia
Clinical narrative: Severe diarrhea. High fever (over 102). Lethargy. Still treating at day 2 of symptoms.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Cough, Dizziness, Epistaxis, Fatigue
Clinical narrative: Pain and swelling of injection site (right deltoid) and swollen axillary lymph nodes on right side. 12 hours post injection: low grade fever (99.2), swelling of injection site, joint pain, fatigue. 24 hours post injection: fever (100), chills, joint pain, fatigue, sore throat, nasal stuffiness. 36 hours post injection: fever (102), chills, joint pain, fatigue, sore throat, nasal stuffiness. 48 hours post injection: joint pain, fatigue, sore throat, nasal stuffiness, cough. 5 days post injection: severe nosebleeds, 10x/day, heavy bleeding resulting in lightheadedness and pallor, nasal stuffiness, cough. 6 days post injection: moderate nosebleeds, 6x/day, moderate bleeding, nasal stuffiness, pallor 7 day post injection: mild nosebleeds, 3x/day light bleeding, nasal stuffiness, fatigue, pallor. 8 days post injection: fatigue, nasal stuffiness.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage, Injection site pain, Injection site swelling, Lymphadenopathy, Nasal congestion
Clinical narrative: Pain and swelling of injection site (right deltoid) and swollen axillary lymph nodes on right side. 12 hours post injection: low grade fever (99.2), swelling of injection site, joint pain, fatigue. 24 hours post injection: fever (100), chills, joint pain, fatigue, sore throat, nasal stuffiness. 36 hours post injection: fever (102), chills, joint pain, fatigue, sore throat, nasal stuffiness. 48 hours post injection: joint pain, fatigue, sore throat, nasal stuffiness, cough. 5 days post injection: severe nosebleeds, 10x/day, heavy bleeding resulting in lightheadedness and pallor, nasal stuffiness, cough. 6 days post injection: moderate nosebleeds, 6x/day, moderate bleeding, nasal stuffiness, pallor 7 day post injection: mild nosebleeds, 3x/day light bleeding, nasal stuffiness, fatigue, pallor. 8 days post injection: fatigue, nasal stuffiness.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Oropharyngeal pain, Pallor, Pyrexia
Clinical narrative: Pain and swelling of injection site (right deltoid) and swollen axillary lymph nodes on right side. 12 hours post injection: low grade fever (99.2), swelling of injection site, joint pain, fatigue. 24 hours post injection: fever (100), chills, joint pain, fatigue, sore throat, nasal stuffiness. 36 hours post injection: fever (102), chills, joint pain, fatigue, sore throat, nasal stuffiness. 48 hours post injection: joint pain, fatigue, sore throat, nasal stuffiness, cough. 5 days post injection: severe nosebleeds, 10x/day, heavy bleeding resulting in lightheadedness and pallor, nasal stuffiness, cough. 6 days post injection: moderate nosebleeds, 6x/day, moderate bleeding, nasal stuffiness, pallor 7 day post injection: mild nosebleeds, 3x/day light bleeding, nasal stuffiness, fatigue, pallor. 8 days post injection: fatigue, nasal stuffiness.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Insomnia, Muscular weakness, Pain in extremity
Clinical narrative: First, the person giving the vaccine injected me high in the left shoulder, near the top of the biceps tendon. It was higher up than any flu shot I have ever had and not in the fat part of the muscle. I have been experiencing intermittent  weakness and pain radiating down my left arm. It sometimes extends around to the back of the shoulder but mainly running down the arm. It seems to get worse as the day progresses and makes it hard to get comfortable when sleeping. I do not generally do hard physical labor with that arm so there is no reason for it to suddenly become weak and painful.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Blepharospasm, Excessive eye blinking, Muscle twitching, Tic
Clinical narrative: Developed severe eye twitching, eye blinking, twitching of hands and feet.
Age: 41.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Condition aggravated, Eye disorder, Eye pain, Ocular hyperaemia, Optical coherence tomography abnormal
Clinical narrative: This 41 year old patient reported having bilateral 20/20 vision prior to receipt of his smallpox vaccination and oral typhoid on 2/18/2013. He advised that evening he couldn't read large highway signs driving home having to close his left eye 1/2 way to get clear vision. A few days later he noted same problem had extended to his right eye. He advised he was very careful not to touch SPV site; and that he did not touch his eyes after dressing changes. His SPV site progressed normally with a normal site reaction. His medical records document on 3/1/2013 (day 10 after vaccinations) he reported to optometry complaining of "major changes in left eye vision". Provider noted left eye had 20/25 vision with right 20/20 uncorrected. Cornea had "diffuse superficial keratitis (SPK) with RTBUT and left eye showing oblique scar thru pupil from 2-8 superior mid pupil" otherwise a normal exam (surrounding eyelid and eye had no pustules, lesions, abrasions, abnormalities, etc). An optical tomography showed left eye with "temp thickening of macular zone and right eye was fine". He was given a diagnosis of astigmatism, presbyopia, and superficial keratitis left eye and treated with prednisolone 1% ophth susp drops. Follow up complaints of painful redness in left eye 3/8/2013 (day 17) was treated with lubricant eye drops which did not help his pain (3/10). On 3/11/2013 his eyes felt better but still hurt. A slit lamp exam again showed diagonal scar thru left eye line of sight (denied injury or surgery) with right eye 20/20 and left eye 20/20+1.00 added. He was instructed to taper ophth steroids over next 10 days then stop. On 6/5/2013 he was seen by flight surgeon for SFFP. Prior aviation examinations were held due to March eye issues and he was given a medication refill for herpes simplex (Acyclovir prescribed since 2/2009 for recurrent cold sore outbreaks-no documentation of frequency of outbreaks). On 6/25/2013 he completed his aviation SFFP physical. Another medical exam on 7/10/2013 listed patient "wants a second opinion as he may resume flying and is required to have vision corrected to 20/20/OU. He currently denies any issues with distance vision." Visual exam: 20/25 OS, 20/20 OD and 20/20 OU. He was diagnosed with presbyopia and referred to ophthalmology.
Age: 41.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Presbyopia, Slit-lamp examination, Visual impairment
Clinical narrative: This 41 year old patient reported having bilateral 20/20 vision prior to receipt of his smallpox vaccination and oral typhoid on 2/18/2013. He advised that evening he couldn't read large highway signs driving home having to close his left eye 1/2 way to get clear vision. A few days later he noted same problem had extended to his right eye. He advised he was very careful not to touch SPV site; and that he did not touch his eyes after dressing changes. His SPV site progressed normally with a normal site reaction. His medical records document on 3/1/2013 (day 10 after vaccinations) he reported to optometry complaining of "major changes in left eye vision". Provider noted left eye had 20/25 vision with right 20/20 uncorrected. Cornea had "diffuse superficial keratitis (SPK) with RTBUT and left eye showing oblique scar thru pupil from 2-8 superior mid pupil" otherwise a normal exam (surrounding eyelid and eye had no pustules, lesions, abrasions, abnormalities, etc). An optical tomography showed left eye with "temp thickening of macular zone and right eye was fine". He was given a diagnosis of astigmatism, presbyopia, and superficial keratitis left eye and treated with prednisolone 1% ophth susp drops. Follow up complaints of painful redness in left eye 3/8/2013 (day 17) was treated with lubricant eye drops which did not help his pain (3/10). On 3/11/2013 his eyes felt better but still hurt. A slit lamp exam again showed diagonal scar thru left eye line of sight (denied injury or surgery) with right eye 20/20 and left eye 20/20+1.00 added. He was instructed to taper ophth steroids over next 10 days then stop. On 6/5/2013 he was seen by flight surgeon for SFFP. Prior aviation examinations were held due to March eye issues and he was given a medication refill for herpes simplex (Acyclovir prescribed since 2/2009 for recurrent cold sore outbreaks-no documentation of frequency of outbreaks). On 6/25/2013 he completed his aviation SFFP physical. Another medical exam on 7/10/2013 listed patient "wants a second opinion as he may resume flying and is required to have vision corrected to 20/20/OU. He currently denies any issues with distance vision." Visual exam: 20/25 OS, 20/20 OD and 20/20 OU. He was diagnosed with presbyopia and referred to ophthalmology.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Oedema peripheral
Clinical narrative: Pt noticed (L) arm becoming edematous approx 6 hours after PNEUMOVAX23 injection was administered. Today pt presents with (L) arm red, edematous, warm to touch below injection site-primarily over biceps muscles (L) arm is 1 1/2 in larger in diameter than (R). 8 in in width for redness/edema; 7 in in length. Instructed warm compress et TYLENOL every 4 hours - if no better to PMD.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 11/4/13 Given FLUZONE at 1400. 11/5/13 1400 noticed redness pain swelling to injection site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Swelling, lump, soreness, redness at injection site.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Injection site pain which required doctor visit. Pain began 1 day following administration. MD recommended TYLENOL and cold compress.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Itching, red and hot to touch. Was notified to take BENADRYL and ice area.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Discomfort, Injection site pain
Clinical narrative: No discomfort noted at injection. Usual discomfort (mild) on the next day. Then as days passed, pain in left deltoid became worse with weakness noted because of intense pain at injection area.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: After 1 month since receiving vaccine, patient still sore and hurts to raise arm above her head.
Age: 1.46
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Skin lesion, Urticaria
Clinical narrative: Developed diffuse urticarial rash to body, lesions > 1 cm in diameter same day as injections.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: Swollen injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Rash
Clinical narrative: Swollen injection site. Rashes from chest down.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: 1 hour after administration, patient developed sore throat; 3-4 hours after administration patient developed fever running at 102.4 degrees F and was shivering.
Age: 62.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Pt arm had significant swelling that required oral steroid treatment; MD thought pt had an allergic reaction to vaccine; as of 11/6/13 this issue has resolved.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Redness and swelling of right upperarm after receiving flu vaccination, redness and edema is approximately 13 cm's by 8 cm's.
Age: 80.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 23-Oct-2013) concerns a 80-year-old female patient. On an unreported date, the patient was administered an unspecified influenza virus vaccine (batch number not reported) and ZOSTAVAX (batch number not reported) concomitantly. On an unreported date, the patient developed a high fever and was hospitalised overnight. The patient responded well to unspecified treatment given and went home the next day. Outcome was not reported.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Pt reports redness, edema, tenderness, heat noted to left deltoid injection site within 8 hrs of receiving varicella vaccine. Pt did not tell parents and entered job on 11/5/13.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Nodule, Tenderness
Clinical narrative: Received vaccine Thursday afternoon, Friday noticed a little knot. Saturday morning had erythema and tenderness. Went to ER. Received prednisone x one dose and Rx for CLARITIN and antihistamine cream. Reaction resolved by Monday morning. Pt never filled either prescription but is doing well now.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm, 101 degrees fever taken at MD office.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis allergic, Eye swelling, Pruritus, Rash
Clinical narrative: Pt develop rash/allergic itching on face and head by 11-3-13. Has subsided since then on 11-6-13 eyes are swollen. Pt was advised to see MD and to take antihistamine, took CLARITIN.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Nausea, arm soreness (not severe), pain.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, Tendonitis
Clinical narrative: Sore arm, limited range of motion. Went to MD, thinks it was placed in wrong position, caused tendonitis. Taking ALEVE and is improving.
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Large local reaction at site of injection. Prednisone.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypersensitivity, Urticaria
Clinical narrative: Systemic hypersensitivity reaction lightheaded, urticaria. BENADRYL/hydrocortisone; albuterol/prednisone.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Papule, Skin mass
Clinical narrative: Pt states (L) arm has been sore since vaccination no redness or swelling. Hep B vaccine recd on 10-30-13 in (L) arm. Pt has small palpable knot under skin. Encouraged to use heat pad and seek medical care if increased in size or redness appears.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11/5 - pm noted pain, swelling (L) upper arm - 11/6 arm sl warm to touch pink (L) upper arm 4" x 2 3/4" rx BENADRYL/cool compress.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient came in 11/6/13 and stated he's been having burning pain/sensation around injection site. No redness/swelling.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Crying, Retching, Vomiting
Clinical narrative: Child received flu shot on 10/28/13, and next day vomited 2 times. Crying in school from 10/29/13. Gaggs many times, but not vomiting now. vomited once every day on 10/29, 10/30, 10/31, 11/1 also according to mother. Refuses to go to school.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initially, bruise at right arm vaccine site, then enlarging red, swollen, painful area. Associated fever 99.4, chills. Currently under treatment.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Initially, bruise at right arm vaccine site, then enlarging red, swollen, painful area. Associated fever 99.4, chills. Currently under treatment.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Pt reports 10/30/13 evening swelling, redness, "rash" pain at injection site. States fever, chills, sweating, nausea, general aches. Took NYQUIL with some relief. Reports symptoms improved/resolved by 11/1/13.
Age: 41.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Pt reports 10/30/13 evening swelling, redness, "rash" pain at injection site. States fever, chills, sweating, nausea, general aches. Took NYQUIL with some relief. Reports symptoms improved/resolved by 11/1/13.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized redness and swelling just below injection sight. Oral antibiotic from MD.
Sex: F
Vaccine: HPV4
Symptoms: Fall, Head injury
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL, intramuscular (dose and lot number were not provided). No concomitant medications were reported. On an unknown date, the patient fell while walking out of the office and "cracked her head". The patient was then treated in the office. The outcome of the events was unknown. This is one of several reports received the same source (MARRS#1310USA011247). Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: Erythema was self limited, 3 in long and circumferential, 3 days of erythema following FLUARIX Quadrivalent site where given.
Age: 84.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: None.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Generalised erythema, Herpes zoster, Hypersensitivity
Clinical narrative: This spontaneous report as received from a 76 year old female subject which reported that a patient of unspecified age and gender was vaccinated with ZOSTAVAX (dose, therapy route and indication not reported) (Lot # not reported) on an unspecified date. On an unspecified date, the patient experienced blisters that appeared at her waist, the doctor confirmed shingles. On an unspecified date, the patient had experienced allergic reaction to medication and redness all over the body. This is a case of two from the same reporter. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Severe pain in left upper arms warmth in upper arm area about 4 days later had inflammation in elbow. Resolved after 7 days.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. This week, approximately on 28-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The next day, approximately on 29-OCT-2013, the patient had a headache and felt lightheaded. On 01-NOV-2013, the patient's blood pressure was 150/84. Patient's outcome was unknown. The patient sought medical attention by calling the reporting pharmacist. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II (lot # H018949. expiry date: 18-OCT-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. The outcome of the event was unknown. This is one of several reports that received from the same source. Additional information is not expected.
Age: 1.59
Sex: M
Vaccine: HEPA
Symptoms: Croup infectious, Stridor
Clinical narrative: This spontaneous report as received from a licensed Visiting Nurse refers to a 1 year old male patient. On 15-OCT-2013, the patient was vaccinated with VAQTA (dose, route and lot were not reported). Unspecified date after 15-OCT-2013, in October 2013, the patient was diagnosed with croup and stridor at urgent care center and on 18-OCT-2013, the patient was prescribed with unspecified oral steroids. The outcome of croup and stridor was unknown. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Axillary pain, Local swelling, Lymphadenopathy, Pyrexia, Urticaria
Clinical narrative: I received pneumonia vaccine on Monday at 1:30 pm. Glands swelled under arm by midnight. By 12 pm next day I had 102 degrees fever. I received steroid shot at 3:30 on Tuesday. Fever continued until Saturday. Two small welts appeared Tuesday. They continued until they became 1 large welts covering all of bicep area. Doctor said Friday it had become a secondary infection. Given steroid pack, antibiotic, 400 mg MOTRIN.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia, Urticaria
Clinical narrative: I received pneumonia vaccine on Monday at 1:30 pm. Glands swelled under arm by midnight. By 12 pm next day I had 102 degrees fever. I received steroid shot at 3:30 on Tuesday. Fever continued until Saturday. Two small welts appeared Tuesday. They continued until they became 1 large welts covering all of bicep area. Doctor said Friday it had become a secondary infection. Given steroid pack, antibiotic, 400 mg MOTRIN.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: I was given the flu shot too high in my left arm/shoulder resulting in visit to primary care doctor proceeded my orthopedic doctor and now in I am half way through 8 physical therapy visits with pain not going away.  Follow up with orthopedic on 11/13/2013.
Age: 43.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test normal, Drug administered at inappropriate site, X-ray normal
Clinical narrative: I was given the flu shot too high in my left arm/shoulder resulting in visit to primary care doctor proceeded my orthopedic doctor and now in I am half way through 8 physical therapy visits with pain not going away.  Follow up with orthopedic on 11/13/2013.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site joint pain, Injection site joint redness, Injection site joint swelling
Clinical narrative: This spontaneous report was received from an approximately 64 year old female patient regarding herself. Current condition of the patient included undifferentiated connective tissue disease. There were no drug reactions or allergies. On 26-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) into flabby arm skin. Concomitant therapies included PLAQUENIL and methotrexate. On 26-SEP-2013, the patient experienced reaction to ZOSTAVAX which began with immediate pain when the shot went in and got progressively worse. On 26-SEP-2013, the patient experienced a lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site, and persistent pain. The pain was located especially in the elbow of the injection arm of the patient. The patient sought medical attention. The patient spoke with an unspecified pharmacist. The patient was treated with Ibuprofen. No lab tests were performed. At the time of report, the patient was experiencing a little redness and swelling at the injection site and also joint pain in the injection arm elbow which she felt with certain movements and could not tell if the pain was in the tendon or the muscle of the joint. The outcome of lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site and persistent pain was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Joint crepitation, Pain, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous report was received from an approximately 64 year old female patient regarding herself. Current condition of the patient included undifferentiated connective tissue disease. There were no drug reactions or allergies. On 26-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) into flabby arm skin. Concomitant therapies included PLAQUENIL and methotrexate. On 26-SEP-2013, the patient experienced reaction to ZOSTAVAX which began with immediate pain when the shot went in and got progressively worse. On 26-SEP-2013, the patient experienced a lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site, and persistent pain. The pain was located especially in the elbow of the injection arm of the patient. The patient sought medical attention. The patient spoke with an unspecified pharmacist. The patient was treated with Ibuprofen. No lab tests were performed. At the time of report, the patient was experiencing a little redness and swelling at the injection site and also joint pain in the injection arm elbow which she felt with certain movements and could not tell if the pain was in the tendon or the muscle of the joint. The outcome of lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site and persistent pain was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site joint pain, Injection site pain
Clinical narrative: This spontaneous report was received from an approximately 64 year old female patient regarding herself. Current condition of the patient included undifferentiated connective tissue disease. There were no drug reactions or allergies. On 26-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) into flabby arm skin. Concomitant therapies included PLAQUENIL and methotrexate. On 26-SEP-2013, the patient experienced reaction to ZOSTAVAX which began with immediate pain when the shot went in and got progressively worse. On 26-SEP-2013, the patient experienced a lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site, and persistent pain. The pain was located especially in the elbow of the injection arm of the patient. The patient sought medical attention. The patient spoke with an unspecified pharmacist. The patient was treated with Ibuprofen. No lab tests were performed. At the time of report, the patient was experiencing a little redness and swelling at the injection site and also joint pain in the injection arm elbow which she felt with certain movements and could not tell if the pain was in the tendon or the muscle of the joint. The outcome of lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site and persistent pain was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Local swelling, Pain in extremity, Skin warm
Clinical narrative: This spontaneous report was received from an approximately 64 year old female patient regarding herself. Current condition of the patient included undifferentiated connective tissue disease. There were no drug reactions or allergies. On 26-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified) into flabby arm skin. Concomitant therapies included PLAQUENIL and methotrexate. On 26-SEP-2013, the patient experienced reaction to ZOSTAVAX which began with immediate pain when the shot went in and got progressively worse. On 26-SEP-2013, the patient experienced a lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site, and persistent pain. The pain was located especially in the elbow of the injection arm of the patient. The patient sought medical attention. The patient spoke with an unspecified pharmacist. The patient was treated with Ibuprofen. No lab tests were performed. At the time of report, the patient was experiencing a little redness and swelling at the injection site and also joint pain in the injection arm elbow which she felt with certain movements and could not tell if the pain was in the tendon or the muscle of the joint. The outcome of lot of swelling in a 2 inch by 3 inch section of her injection arm, redness, heat at the swelling site and persistent pain was unknown. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Pain in extremity
Clinical narrative: This spontaneous report as received from a healthcare worker(Certified Medical Assistant) refers to a 67 year old female patient with drug allergy to penicillin (unspecified). The patient's medical history included herpes. On 27-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# J007059, exp date 07/31/2014)(dose not reported), intramuscularly in left arm. The patient was also vaccinated with a dose of FLUARIX in the same arm, separate site. The healthcare worker reported that the patient developed an injection site reaction following administration of PNEUMOVAX23. The healthcare worker reported that the injection site reaction was reported to the Vaccine Adverse Event Reporting System. The healthcare worker reported that on the evening of 27-SEP-2013 the patient's left arm ached intensely from the shoulder to the neck and down the arm to the hand. The next day a painful, non-itching, raised red rash developed in a wide band from the injection site to the patient's armpit. The patient remembered that 7 years previously she (the patient) developed a Herpes outbreak that had a similar presentation. The patient increased their dose of acyclovir and the adverse reaction was completely gone by 01-OCT-2013. None lab diagnostics studies was performed. The patient didn't seek medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site pain, Injection site reaction, Pain in extremity, Rash erythematous
Clinical narrative: This spontaneous report as received from a healthcare worker(Certified Medical Assistant) refers to a 67 year old female patient with drug allergy to penicillin (unspecified). The patient's medical history included herpes. On 27-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# J007059, exp date 07/31/2014)(dose not reported), intramuscularly in left arm. The patient was also vaccinated with a dose of FLUARIX in the same arm, separate site. The healthcare worker reported that the patient developed an injection site reaction following administration of PNEUMOVAX23. The healthcare worker reported that the injection site reaction was reported to the Vaccine Adverse Event Reporting System. The healthcare worker reported that on the evening of 27-SEP-2013 the patient's left arm ached intensely from the shoulder to the neck and down the arm to the hand. The next day a painful, non-itching, raised red rash developed in a wide band from the injection site to the patient's armpit. The patient remembered that 7 years previously she (the patient) developed a Herpes outbreak that had a similar presentation. The patient increased their dose of acyclovir and the adverse reaction was completely gone by 01-OCT-2013. None lab diagnostics studies was performed. The patient didn't seek medical attention. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: CSF test abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (Guillain-Barre).
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: CSF protein increased, Guillain-Barre syndrome
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (Guillain-Barre).
Age: 74.0
Sex: M
Vaccine: VARZOS, FLU3, FLU3
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome, Paraesthesia
Clinical narrative: Acute inflammatory demyelinating polyneuropathy (Guillain-Barre).
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Blood test, Chills, Erythema, Flushing
Clinical narrative: A spontaneous report was received from a consumer whose 25 year old daughter was advised by her physician to receive GARDASIL injections. On 08MAY2013 the patient received her first GARDASIL injection. Shortly after administration the patient became flushed and broke out in a rash, which appeared on her face and arms and lasted a few hours. The physician reviewed the patient's condition, and they went home. Two weeks to a month later, the patient began to experience severe stomach pain, chills, shaking and fever. These symptoms have been experienced by the patient "three to five times per week." There have also been sporadic episodes of fainting. Subsequent dose (two and three) were not administered. The reported state "we tried eliminating certain foods, sulfites any suspect allergens, but nothing was shown." The patient was also tested for a urinary tract infection after a course of antibiotics. The patient was seen by another physician- "bloodwork showed no infection." The reporter considered GARDASIL to be the suspect. Patient is otherwise, and "has always been" healthy and active and in good physical condition, according to the reporter. The patient's present status is not recovered. No further information has been provided.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: A spontaneous report was received from a consumer whose 25 year old daughter was advised by her physician to receive GARDASIL injections. On 08MAY2013 the patient received her first GARDASIL injection. Shortly after administration the patient became flushed and broke out in a rash, which appeared on her face and arms and lasted a few hours. The physician reviewed the patient's condition, and they went home. Two weeks to a month later, the patient began to experience severe stomach pain, chills, shaking and fever. These symptoms have been experienced by the patient "three to five times per week." There have also been sporadic episodes of fainting. Subsequent dose (two and three) were not administered. The reported state "we tried eliminating certain foods, sulfites any suspect allergens, but nothing was shown." The patient was also tested for a urinary tract infection after a course of antibiotics. The patient was seen by another physician- "bloodwork showed no infection." The reporter considered GARDASIL to be the suspect. Patient is otherwise, and "has always been" healthy and active and in good physical condition, according to the reporter. The patient's present status is not recovered. No further information has been provided.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pollakiuria, Pyrexia, Rash, Syncope, Tremor
Clinical narrative: A spontaneous report was received from a consumer whose 25 year old daughter was advised by her physician to receive GARDASIL injections. On 08MAY2013 the patient received her first GARDASIL injection. Shortly after administration the patient became flushed and broke out in a rash, which appeared on her face and arms and lasted a few hours. The physician reviewed the patient's condition, and they went home. Two weeks to a month later, the patient began to experience severe stomach pain, chills, shaking and fever. These symptoms have been experienced by the patient "three to five times per week." There have also been sporadic episodes of fainting. Subsequent dose (two and three) were not administered. The reported state "we tried eliminating certain foods, sulfites any suspect allergens, but nothing was shown." The patient was also tested for a urinary tract infection after a course of antibiotics. The patient was seen by another physician- "bloodwork showed no infection." The reporter considered GARDASIL to be the suspect. Patient is otherwise, and "has always been" healthy and active and in good physical condition, according to the reporter. The patient's present status is not recovered. No further information has been provided.
Age: 25.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine analysis
Clinical narrative: A spontaneous report was received from a consumer whose 25 year old daughter was advised by her physician to receive GARDASIL injections. On 08MAY2013 the patient received her first GARDASIL injection. Shortly after administration the patient became flushed and broke out in a rash, which appeared on her face and arms and lasted a few hours. The physician reviewed the patient's condition, and they went home. Two weeks to a month later, the patient began to experience severe stomach pain, chills, shaking and fever. These symptoms have been experienced by the patient "three to five times per week." There have also been sporadic episodes of fainting. Subsequent dose (two and three) were not administered. The reported state "we tried eliminating certain foods, sulfites any suspect allergens, but nothing was shown." The patient was also tested for a urinary tract infection after a course of antibiotics. The patient was seen by another physician- "bloodwork showed no infection." The reporter considered GARDASIL to be the suspect. Patient is otherwise, and "has always been" healthy and active and in good physical condition, according to the reporter. The patient's present status is not recovered. No further information has been provided.