chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Adverse drug reaction, Biopsy site unspecified normal, Blood aluminium increased, Laboratory test, Lymphadenitis
Clinical narrative: Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pyrexia, Rash, Recurring skin boils
Clinical narrative: Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Biopsy bone marrow, Blood lactate dehydrogenase increased, Blood test, Blood uric acid increased
Clinical narrative: Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bone scan, Chills, Computerised tomogram, Fatigue, Fungal infection
Clinical narrative: Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Hepatomegaly, Lumbar puncture, Lymphadenopathy, Migraine, Neck pain
Clinical narrative: Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging, Oropharyngeal pain, Pain in jaw, Pyrexia, Rash
Clinical narrative: Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Splenomegaly, Vomiting, Weight decreased, White blood cell count increased, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Clinical note from Dr. on 4/24/11.  17yo female was admitted to facility on 4/24/11 for possible lymphoma vs viral illness.  Initally presented to ER last week with a rash that was dx as a drug rx to tegretol (recently dx w/ bipolar disorder). Placed on oral steroids and returnd to hospital yest w/ fever, st, lymphadenitis.  Labs showed a change then pt was transferred to another ER and admitted to Heme/Onc.  Pt was then transferred to hospital for poss non-hodgkins lymphoma.  Biopsy was neg.  Pt. cont. w/ recurrent boils.  Aluminin level was elevated to 12.
Age: 1.49
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Reddened area 2" x 4 " around injection site. Warm to touch warm & hard to touch.
Age: 1.01
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Hypersomnia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient's mother states that patient had been sleeping a lot since vaccines. Also states patient's (L) leg is red, hot to touch & swollen and patient has temp of 99.9. Instructed to continue TYLENOL and to use ice packs on leg.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Blood test abnormal, Induration, Oedema peripheral, Skin warm, Ultrasound scan normal
Clinical narrative: The day after injection, she woke up with her arm swollen to her elbow, rock hard, and hot to touch. She went to Emergency. They did blood tests and were worried about an elevated enzyme for blood clot. An ultrasound was performed and normal. They sent her to hospital where she was admitted. She is on IV antibiotics and improving.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site oedema, Injection site urticaria
Clinical narrative: Approx 11 hrs after vaccine administered (PCV 13) pt developed acute onset facial edema, extremity edema & hives. Did not have tongue swelling, no wheezing or shortness of breath. Treated in ER with Epinephrine IM, BENADRYL oral & DECADRON oral resolution of symptoms 3 hrs later.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying
Clinical narrative: Patient with high pitched inconsolable cry after vaccine.
Age: 20.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Dyspnoea, Injection site erythema
Clinical narrative: Pneumonia vaccination given 5/27/11 at 3:10pm. 5/28/11 early evening breathing problems. Noted approx 3" redness (R) deltoid. Called on call MD at 10:15pm with trouble breathing - sent to ED. O2 Sat 100%, lungs clear, no resp distress. Has asthma. Albuterol didn't help. Given BENADRYL.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Blood pressure increased, Body temperature increased, Feeling abnormal, Respiratory tract congestion
Clinical narrative: Routine Dr. visit. ? The shot as 64 age of cut off - Dr said OK to give if pt. in good health - Rec'd DTAP apx 10:30 AM felt bad went to bed, slept - 1 PM woke with temp of 102.5 oral - congestion (heavy purulent). Lungs clear on Dr visit B/P has increased & stayed some since Imm 160/94 usual B/P 140/70-80.
Age: 27.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Erythema, Fatigue, Pain in extremity, Rash
Clinical narrative: On May 20 started feeling tired. May 21 arm was "really sore" & noticed "streak" of red moving towards armpit. May 22 streak moved down bicep. Went to ER on 22 May - given 2 IV antibiotics. Diagnosed by ER doctor - vaccine induced rash.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever max 102, began 12 hours after vaccine. Resolved w/in 24 hours. Myalgias, abdominal pain, bad headache, nausea. Taking Ibuprofen & TYLENOL. Illness improved gradually, At this time headache only.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Urine analysis normal
Clinical narrative: Fever max 102, began 12 hours after vaccine. Resolved w/in 24 hours. Myalgias, abdominal pain, bad headache, nausea. Taking Ibuprofen & TYLENOL. Illness improved gradually, At this time headache only.
Age: 0.27
Sex: M
Vaccine: HIBV, PNC
Symptoms: Crying, Hypotonia, Pallor
Clinical narrative: 4 hours after vaccine given child started crying inconsolably and became limp, pale. Episode lasted 10-15 minutes.
Age: 45.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Asthenia, Grip strength decreased, Joint stiffness
Clinical narrative: Inability to flex right side of body at joints;  pain in ankle, leg, arm and hands; slight paralysis in hand; unable to hold pencil.   It was debilitating for 3+ weeks and then seemed to get a little better from the end of February until mid March; made it painful to do my daily (exercise) walking routine only to come back with a vengeance in Mid March in my right foot, ankle, and lower leg and knee.
Age: 45.0
Sex: F
Vaccine: HEPAB, MMR, TDAP
Symptoms: Pain, Pain in extremity, Paralysis, X-ray
Clinical narrative: Inability to flex right side of body at joints;  pain in ankle, leg, arm and hands; slight paralysis in hand; unable to hold pencil.   It was debilitating for 3+ weeks and then seemed to get a little better from the end of February until mid March; made it painful to do my daily (exercise) walking routine only to come back with a vengeance in Mid March in my right foot, ankle, and lower leg and knee.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Local reaction, Skin warm
Clinical narrative: VERY LARGE LOCAL REACTION  + ERYTHEMA, WARMTH AND MINIMAL INDURATION FROM DELTOID TO ELBOW- NONTENDER
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Feeling abnormal, Flushing, Hypertension, Tachycardia
Clinical narrative: Per patients description of event, pt received pneumonia vaccine and within minutes felt flushed and "strange". Per record became tachycardic, tachypnic, hypertensive with a temp of 103 F ax.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Tachypnoea
Clinical narrative: Per patients description of event, pt received pneumonia vaccine and within minutes felt flushed and "strange". Per record became tachycardic, tachypnic, hypertensive with a temp of 103 F ax.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: IM injection of Engerix B - Glaxo Smith Kline - Lot # AHBVB845AA - Exp date 06/15/2012 - drove home after injection - felt fine - layed down - about 6:30PN, four hours after injection got up and felt weakness and parathesis in arms and legs - difficulty walking - had relative bring her to the ER - they treated her with fluids which helped but did not cure the symptoms.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apnoea, Band neutrophil percentage increased, Blood glucose increased, Chest X-ray abnormal, Lymphocyte count normal
Clinical narrative: APNEA
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Neutrophil percentage increased, Respiratory syncytial virus test negative, Urine analysis normal, White blood cell count normal
Clinical narrative: APNEA
Age: 57.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site mass, Injection site pustule
Clinical narrative: 1 inch red, knot palpated on L deltoid. Client phoned on 6/2/11 and visited our office.  Noted a 1 inch red area and 1/4 inch pus filled head in center of red area.
Age: 26.0
Sex: F
Vaccine: HPV2
Symptoms: Diarrhoea, Dysmenorrhoea, Metrorrhagia
Clinical narrative: dysmenorrhea, spotting, Diarrhea
Age: 22.0
Sex: F
Vaccine: YF
Symptoms: Blood glucose decreased, Hallucination, Hypotonia, Immediate post-injection reaction, Muscle rigidity
Clinical narrative: Patient went flaccid immediately following injection; Symptoms resembled seizure with patient going rigid briefly. Patient hallucinated, blood sugar=60; all other vitals signs wnl.
Age: 19.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia, Injection site pain, Injection site warmth
Clinical narrative: Pain and warmth at injection site on left arm, numbness of extremity on same side as injection 10 min after administration, monitored in ER x 2 hours.
Age: 14.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Lt arm red and swollen at vaccine site. Benadryl every 6hrs and dose at bedtime.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: MODERATE LOCAL REDNESS AND AREA SWELLING OF  LEFT DELTOID REGION. DIAMETER OF ERYTHEMA: 5 INCHES ACROSS DELTOID BUT NOT REACHING ELBOW.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Local swelling
Clinical narrative: Localized swelling, induration at the injection site of the right deltoid.  5 cm x 5 cm. Seen for CHDP physical examination 06/09/2011 (today). There is no increased swelling or induration over the past two days.
Age: 39.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of glands in the left side of my neck. The shot was given on the left side. The right side was slightly swollen, but the left side was extremely swollen. No treatment. The swelling went down enough so that I did not have trouble swallowing by 8:00 PM.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Presyncope
Clinical narrative: vaso vagal response
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Neck pain, Oedema peripheral, Pruritus
Clinical narrative: Swelling from my elbow to shoulder, red, itching, headache and sore neck
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Swelling from my elbow to shoulder, red, itching, headache and sore neck
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site pain, Joint range of motion decreased, Muscle injury, Musculoskeletal pain, Myositis
Clinical narrative: Seen 6/02/11 for shoulder pain throughout whole shoulder with inability to move above 90 degrees without pain. Initial soreness in deltoid after shot that resolve then 5/28/11 have increase soreness. Parents very concerned about report in news in 2008 of auto immune myofascitis s/p HPV. No clinic evidence beyond muscle injury. Will see infectious disease specialist if symptoms persist. Appears to be waning.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Pain
Clinical narrative: Seen 6/02/11 for shoulder pain throughout whole shoulder with inability to move above 90 degrees without pain. Initial soreness in deltoid after shot that resolve then 5/28/11 have increase soreness. Parents very concerned about report in news in 2008 of auto immune myofascitis s/p HPV. No clinic evidence beyond muscle injury. Will see infectious disease specialist if symptoms persist. Appears to be waning.
Age: 1.32
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Morbilliform rash.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site induration
Clinical narrative: Indurated area 6 cm around injection site.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysarthria, Heart rate increased
Clinical narrative: Pt said he had slurring, fast heartbeat and dizziness about 2hrs after vaccination. Symptom free 5 hrs later.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: C/O pain, itchy today 6/9/11 (L) leg swollen from upper thigh to knee with red blotches upper lateral thigh. Location of injection site.
Age: 10.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Rash, itchy.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Area injection site red & induration 50 mm by 60 mm, red to touch.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain of skin, Rash
Clinical narrative: Patient came back to clinic 2 days later with arm red where PNEUMOVAX vaccine given. Dr saw patient and states patient had erythema (skin) and painful rash. Dr advised Ibuprofen 400 mg TID, warm compresses, elevation. Follow-up if persistent or worsening.
Age: 46.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Injection site rash
Clinical narrative: Bilateral upper arm rash at site of injections. Rash still present on 6/9/11.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Client states his wife noticed his arm was swollen on 5-5-11. States put alcohol on it and a warm compress. States his arm hurt for one week. States his arm is sore at the end of the day.
Sex: F
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: 4cm x 2cm erythematous & swelling & tender.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: (L) deltoid red & itchy (5 1/4" x 5 1/2" area) warm to touch. The night of the vaccine date, the area was smaller. It continued to get larger and showed up today for us to look at it (6/9/11).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (R) thigh became red, warm, & hard. Diagnosed with cellulitis, started on antibiotics. (Pt. followed up PA).
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea, Retching, Vomiting
Clinical narrative: Pt. got shots at 9:44 am. At 2:45 PM pt started severe, relentless diarrhea and vomiting - she was vomiting bile and dry heaving and then falling asleep. Sent to hospital for admit.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: (R) thigh became red, swollen, hard, & tender. Advised to apply ice compress, antibiotic was not ordered. Patient to follow-up if symptoms persist. (Pt. followed up with MD).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: (R) thigh became red, swollen, hard & tender. Advised to apply ice compress, antibiotic was not ordered. Patient to follow-up if symptoms persist. (Pt followed-up with MD).
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus, Rash maculo-papular
Clinical narrative: 2 weeks after vaccine the child developed approximately 30 maculopapular spots (2 with vesicles) evenly distributed over her body. She was itchy but had no fever. No other siblings developed any similar dermatitis at the time.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypersensitivity, Injection site pain
Clinical narrative: Pain and tenderness with hypersensitivity at injection site.
Age: 29.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Biopsy muscle normal, Blood creatine phosphokinase normal, Blood creatinine normal
Clinical narrative: A serious spontaneous report of exertional rhabdomyolysis has been received from a non health professional concerning a 29-year-old female, subsequent to FLUMIST and H1N1 vaccine. The patient has no past medical history. She does not smoke, she drink alcohol occasionally and performs eccentric exercise. Family history was significant for an older sister who passed away one month prior from H1N1 complications. Concomitant medications included oral contraceptives. The patient received FLUMIST three weeks prior to the first episode of exertional rhabdomyolysis and H1N1 vaccine three weeks prior to the second episode. The patient was a soldier who presented with two day history of diffuse muscle pain associated with dark urine following a workout two days prior. The patient reported a typical workout consisting of squats, push-ups, sit-ups and shoulder press. The following morning she noted increasing diffuse muscle pain with severe upper arm and leg pain exacerbated by movement. She denied any recent heat exposure, medications or supplements. She recently completed a half Ironman triathlon and did weight training three times weekly. The patient was admitted for exertional rhabdomyolysis without renal complications. After CK peaked, the patient was discharged home with aggressive oral hydration & recommended physical rest. Two months later, after resuming low-impact exercise, the patient developed symptoms again. This time, she reported that she had received the H1N1 vaccine three weeks prior. Due to the recurrence of symptoms, an exercise intolerance mutation panel was done. Physical exam was significant for diffusely tender muscles and pain on passive ROM. The differential diagnosis was exertional rhabdomyolysis. The following lab tests were done: first episode: CK= 66,000; BUN 8; Cr 0.8; AST 441; ALT 220, UA 1.006, small blood, no RBCs. Second episode: CK 1,300; BUN 8; Cr 0.8; AST 99; ALT 40; UA 1.001, small blood, no RBCs. The exercise intolerance mutation panel showed no mutations for myophysphorylase deficiency, carnitine palmitoyltransferase II deficiency, or myoadenylate deaminase deficiency, muscle biopsy was negative. Per the reporters, this patient was used to eccentric exercise, it seemed rare that she would develop unprecipitated symptoms of rhabdomyolysis without a predisposing factor. Given the timeline of live-virus influenza vaccines three weeks prior to each episode of symptoms, as well as a negative genetic work-up, it is hypothesized that the live influenza virus vaccine in combination with eccentric exercise caused rhabdomyolysis. The outcome of the event was unknown. The reported assessed the event of exertional rhabdomyolysis as related to FLUMIST and H1N1 Vaccine.
Age: 29.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Blood urea decreased, Blood urine present, Carnitine normal, Chromaturia, Cytogenetic analysis normal
Clinical narrative: A serious spontaneous report of exertional rhabdomyolysis has been received from a non health professional concerning a 29-year-old female, subsequent to FLUMIST and H1N1 vaccine. The patient has no past medical history. She does not smoke, she drink alcohol occasionally and performs eccentric exercise. Family history was significant for an older sister who passed away one month prior from H1N1 complications. Concomitant medications included oral contraceptives. The patient received FLUMIST three weeks prior to the first episode of exertional rhabdomyolysis and H1N1 vaccine three weeks prior to the second episode. The patient was a soldier who presented with two day history of diffuse muscle pain associated with dark urine following a workout two days prior. The patient reported a typical workout consisting of squats, push-ups, sit-ups and shoulder press. The following morning she noted increasing diffuse muscle pain with severe upper arm and leg pain exacerbated by movement. She denied any recent heat exposure, medications or supplements. She recently completed a half Ironman triathlon and did weight training three times weekly. The patient was admitted for exertional rhabdomyolysis without renal complications. After CK peaked, the patient was discharged home with aggressive oral hydration & recommended physical rest. Two months later, after resuming low-impact exercise, the patient developed symptoms again. This time, she reported that she had received the H1N1 vaccine three weeks prior. Due to the recurrence of symptoms, an exercise intolerance mutation panel was done. Physical exam was significant for diffusely tender muscles and pain on passive ROM. The differential diagnosis was exertional rhabdomyolysis. The following lab tests were done: first episode: CK= 66,000; BUN 8; Cr 0.8; AST 441; ALT 220, UA 1.006, small blood, no RBCs. Second episode: CK 1,300; BUN 8; Cr 0.8; AST 99; ALT 40; UA 1.001, small blood, no RBCs. The exercise intolerance mutation panel showed no mutations for myophysphorylase deficiency, carnitine palmitoyltransferase II deficiency, or myoadenylate deaminase deficiency, muscle biopsy was negative. Per the reporters, this patient was used to eccentric exercise, it seemed rare that she would develop unprecipitated symptoms of rhabdomyolysis without a predisposing factor. Given the timeline of live-virus influenza vaccines three weeks prior to each episode of symptoms, as well as a negative genetic work-up, it is hypothesized that the live influenza virus vaccine in combination with eccentric exercise caused rhabdomyolysis. The outcome of the event was unknown. The reported assessed the event of exertional rhabdomyolysis as related to FLUMIST and H1N1 Vaccine.
Age: 29.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Myalgia, Pain, Pain in extremity, Red blood cells urine negative, Rhabdomyolysis
Clinical narrative: A serious spontaneous report of exertional rhabdomyolysis has been received from a non health professional concerning a 29-year-old female, subsequent to FLUMIST and H1N1 vaccine. The patient has no past medical history. She does not smoke, she drink alcohol occasionally and performs eccentric exercise. Family history was significant for an older sister who passed away one month prior from H1N1 complications. Concomitant medications included oral contraceptives. The patient received FLUMIST three weeks prior to the first episode of exertional rhabdomyolysis and H1N1 vaccine three weeks prior to the second episode. The patient was a soldier who presented with two day history of diffuse muscle pain associated with dark urine following a workout two days prior. The patient reported a typical workout consisting of squats, push-ups, sit-ups and shoulder press. The following morning she noted increasing diffuse muscle pain with severe upper arm and leg pain exacerbated by movement. She denied any recent heat exposure, medications or supplements. She recently completed a half Ironman triathlon and did weight training three times weekly. The patient was admitted for exertional rhabdomyolysis without renal complications. After CK peaked, the patient was discharged home with aggressive oral hydration & recommended physical rest. Two months later, after resuming low-impact exercise, the patient developed symptoms again. This time, she reported that she had received the H1N1 vaccine three weeks prior. Due to the recurrence of symptoms, an exercise intolerance mutation panel was done. Physical exam was significant for diffusely tender muscles and pain on passive ROM. The differential diagnosis was exertional rhabdomyolysis. The following lab tests were done: first episode: CK= 66,000; BUN 8; Cr 0.8; AST 441; ALT 220, UA 1.006, small blood, no RBCs. Second episode: CK 1,300; BUN 8; Cr 0.8; AST 99; ALT 40; UA 1.001, small blood, no RBCs. The exercise intolerance mutation panel showed no mutations for myophysphorylase deficiency, carnitine palmitoyltransferase II deficiency, or myoadenylate deaminase deficiency, muscle biopsy was negative. Per the reporters, this patient was used to eccentric exercise, it seemed rare that she would develop unprecipitated symptoms of rhabdomyolysis without a predisposing factor. Given the timeline of live-virus influenza vaccines three weeks prior to each episode of symptoms, as well as a negative genetic work-up, it is hypothesized that the live influenza virus vaccine in combination with eccentric exercise caused rhabdomyolysis. The outcome of the event was unknown. The reported assessed the event of exertional rhabdomyolysis as related to FLUMIST and H1N1 Vaccine.
Age: 29.0
Sex: F
Vaccine: FLUN(H1N1), FLUN3
Symptoms: Urine analysis abnormal
Clinical narrative: A serious spontaneous report of exertional rhabdomyolysis has been received from a non health professional concerning a 29-year-old female, subsequent to FLUMIST and H1N1 vaccine. The patient has no past medical history. She does not smoke, she drink alcohol occasionally and performs eccentric exercise. Family history was significant for an older sister who passed away one month prior from H1N1 complications. Concomitant medications included oral contraceptives. The patient received FLUMIST three weeks prior to the first episode of exertional rhabdomyolysis and H1N1 vaccine three weeks prior to the second episode. The patient was a soldier who presented with two day history of diffuse muscle pain associated with dark urine following a workout two days prior. The patient reported a typical workout consisting of squats, push-ups, sit-ups and shoulder press. The following morning she noted increasing diffuse muscle pain with severe upper arm and leg pain exacerbated by movement. She denied any recent heat exposure, medications or supplements. She recently completed a half Ironman triathlon and did weight training three times weekly. The patient was admitted for exertional rhabdomyolysis without renal complications. After CK peaked, the patient was discharged home with aggressive oral hydration & recommended physical rest. Two months later, after resuming low-impact exercise, the patient developed symptoms again. This time, she reported that she had received the H1N1 vaccine three weeks prior. Due to the recurrence of symptoms, an exercise intolerance mutation panel was done. Physical exam was significant for diffusely tender muscles and pain on passive ROM. The differential diagnosis was exertional rhabdomyolysis. The following lab tests were done: first episode: CK= 66,000; BUN 8; Cr 0.8; AST 441; ALT 220, UA 1.006, small blood, no RBCs. Second episode: CK 1,300; BUN 8; Cr 0.8; AST 99; ALT 40; UA 1.001, small blood, no RBCs. The exercise intolerance mutation panel showed no mutations for myophysphorylase deficiency, carnitine palmitoyltransferase II deficiency, or myoadenylate deaminase deficiency, muscle biopsy was negative. Per the reporters, this patient was used to eccentric exercise, it seemed rare that she would develop unprecipitated symptoms of rhabdomyolysis without a predisposing factor. Given the timeline of live-virus influenza vaccines three weeks prior to each episode of symptoms, as well as a negative genetic work-up, it is hypothesized that the live influenza virus vaccine in combination with eccentric exercise caused rhabdomyolysis. The outcome of the event was unknown. The reported assessed the event of exertional rhabdomyolysis as related to FLUMIST and H1N1 Vaccine.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning an 80 year old female patient with no drug reactions or allergies and no pertinent medical history who in 2007 was subcutaneously vaccinated with a dose of 0.65 mL of ZOSTAVAX (Merck) (Lot# and expiration not reported). Concomitant therapy included ATIVAN, ACTONEL, NEXIUM and PRISTIQ. Physician reported that the patient was administered ZOSTAVAX (Merck) in 2007 and about a month ago, in approximately May 2011, the patient developed herpes zoster and was hospitalized for severe pain. It was reported that the patient also had post herpetic neuralgia. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Headache, Neck pain, Oedema peripheral, Pruritus
Clinical narrative: Redness and swelling of entire UE
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling of entire UE
Age: 40.0
Sex: M
Vaccine: HEPA
Symptoms: Nausea, Presyncope
Clinical narrative: After receiving a Hepatitis A immunization, the client had a vasovagal response and lost consciousness briefly. He also suffered from extreme nausea for approximately an hour. We were concerned primary because most patients receiving this particular vaccine/lot number had at least symptoms of nausea.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Loss of consciousness, Moaning, Muscle rigidity
Clinical narrative: Pt was given vaccine while standing and a few minutes after vaccine asked for a glass of water.  I asked her if she felt lightheaded and she said yes, I had her sit in chair and pt began moaning, her hands turned blue and then patient threw her head back, body became rigid and she straightened her arms and legs.  Episode lasted approximately 10 seconds and she regained consciousness.  Patients eyes did not roll back in head, but gaze was fixed and pt did not appear to be breathing during episode.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Posture abnormal, Respiratory arrest, Staring
Clinical narrative: Pt was given vaccine while standing and a few minutes after vaccine asked for a glass of water.  I asked her if she felt lightheaded and she said yes, I had her sit in chair and pt began moaning, her hands turned blue and then patient threw her head back, body became rigid and she straightened her arms and legs.  Episode lasted approximately 10 seconds and she regained consciousness.  Patients eyes did not roll back in head, but gaze was fixed and pt did not appear to be breathing during episode.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Inflammation, Injection site reaction, Mobility decreased
Clinical narrative: Information has been received from a physician concerning a 10 year old male patient who on unspecified date in "end of January", was vaccinated with a dose of PNEUMOVAX 23 (lot # 664535/0060Z). Subsequently, the patient experienced a severe injection site reaction. No treatment was given for the adverse event. On an unspecified date, MRI of the left arm was performed (results not reported). The patient sought unspecified medical attention. The patient recovered on an unspecified date. Follow up information has been received from a physician concerning a 10 year old male student with amoxicillin allergy who on 13-JAN-2011 was vaccinated with the first dose of PNEUMOVAX 23, intramuscularly in left deltoid (lot number: 667712/1211Z) (dose not reported). On 14-JAN-2011, the patient experienced severe localized inflammation reaction, pain, low grade fever and unable to use arm (results not showed). The patient had Sinusitis at the time of the vaccination. MRI on left arm was performed. On 20-FEB-2011, the patient recovered from severe injection site reaction, pain, low grade fever and unable to use arm. Follow up information has been received from a registered nurse who stated that the patient's arm was swollen, red and hard. The patient was unable to move his arm. The registered nurse felt this was disabling for the patient. The patient had recovered (date unspecified). Arm was swollen, red, hard, and unable to move his arm were considered disabling by the nurse. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Nuclear magnetic resonance imaging, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 10 year old male patient who on unspecified date in "end of January", was vaccinated with a dose of PNEUMOVAX 23 (lot # 664535/0060Z). Subsequently, the patient experienced a severe injection site reaction. No treatment was given for the adverse event. On an unspecified date, MRI of the left arm was performed (results not reported). The patient sought unspecified medical attention. The patient recovered on an unspecified date. Follow up information has been received from a physician concerning a 10 year old male student with amoxicillin allergy who on 13-JAN-2011 was vaccinated with the first dose of PNEUMOVAX 23, intramuscularly in left deltoid (lot number: 667712/1211Z) (dose not reported). On 14-JAN-2011, the patient experienced severe localized inflammation reaction, pain, low grade fever and unable to use arm (results not showed). The patient had Sinusitis at the time of the vaccination. MRI on left arm was performed. On 20-FEB-2011, the patient recovered from severe injection site reaction, pain, low grade fever and unable to use arm. Follow up information has been received from a registered nurse who stated that the patient's arm was swollen, red and hard. The patient was unable to move his arm. The registered nurse felt this was disabling for the patient. The patient had recovered (date unspecified). Arm was swollen, red, hard, and unable to move his arm were considered disabling by the nurse. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Inflammation, Swelling
Clinical narrative: "Goose egg size swelling and inflammation."
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from an 18 year old female consumer, for GARDASIL, a Pregnancy Registry product, who in 2009, was vaccinated IM with 0.5 ml the first dose of GARDASIL (Lot#: not reported). The consumer stated that approximately on 09-AUG-2010 "two weeks ago", she got the third dose of GARDASIL (Lot#: not reported), and approximately on 16-AUG-2010 "a week ago", she found out she was pregnant. Last menstrual period (LMP): approximately on 19-JUL-2010 "5 weeks ago". Estimated Date of Delivery (EDD): 25-APR-2011. On an unspecified date, the patient had performed a pregnancy test and the result was positive. Follow up information has been received indicating that in the beginning of October (on approximately 01-OCT-2010), the patient had a miscarriage. Upon internal review miscarriage was considered to be an other important medical event. No further information is available.
Age: 1.57
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Decreased activity, Decreased appetite, Diarrhoea, Nausea
Clinical narrative: Elevated temp - 2 hrs after vaccine administration w/nausea, vomiting, diarrhea, decreased appetite, decreased activity.
Age: 1.57
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Elevated temp - 2 hrs after vaccine administration w/nausea, vomiting, diarrhea, decreased appetite, decreased activity.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure before pregnancy
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient who on 09-JUL-2010 was vaccinated with the first dose of GARDASIL (Lot # 663559/1178Y) (route and dose not reported). The nurse reported that the patient became pregnant after receiving the first and only dose of GARDASIL. No adverse event was reported. The patient's last menstrual period and estimated delivery date were unknown. Follow up information has been received from the registered nurse who reported that on 08-APR-2011 the patient delivered a viable healthy female neonate via caesarean section. Gestational age of neonate was unknown. Weight of the neonate was 8 pounds, 7 ounces. American Pediatric Gross Assessment Record (APGAR) scores were 9/9. The registered nurse reported that there were no congenital anomalies noted on the OB/delivery report. The patient would be followed by her OB/gynecologist for routine care. Upon internal review, caesarean section was determined to be an other important medical event. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Electroencephalogram normal, Hallucination
Clinical narrative: Hallucinations. Woke up seeing yellow bugs approximately 12 hours after vaccine. No fever, no vomiting, no headache. Persisted while wide awake, normal exam.
Age: 64.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Lymphadenopathy, Oedema peripheral, Pruritus
Clinical narrative: (L) axillary swelling on evening 5/12/11; progressed and then diminished by 5/15/11. Axillary node was soft & itchy no pain. Patient contact physician (primary). Physician aware states nodule was size of golf ball.
Age: 64.0
Sex: F
Vaccine: MMR, TDAP, MMR, TDAP
Symptoms: Nodule, Oedema peripheral, Pruritus
Clinical narrative: (L) axillary swelling on evening 5/12/11; progressed and then diminished by 5/15/11. Axillary node was soft & itchy no pain. Patient contact physician (primary). Physician aware states nodule was size of golf ball.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a registered nurse, concerning a female baby whose 26 year old female mother with no known allergies and no pertinent medical history, on an unspecified date in June 2010, was vaccinated with GARDASIL (lot number not reported). Her LMP was not reported. There was no concomitant medication. The registered nurse reported that on 11-FEB-2011 the mother delivered vaginally a female baby, with a congenital cardiac anomaly (specific type of anomaly was unknown), at 39 weeks of gestation. The baby's weight 7 pounds 11 ounces. The registered nurse stated the baby had cardiac surgery within a week of delivery an outcome of neonate's surgery was reported in record as favorable. Cardiac anomaly was considered a congenital anomaly by the registered nurse. Upon internal review cardiac surgery was considered to be an other important medical event. The mother's experiences were captured in WAES1008USA03991. Additional information has been requested.
Age: 1.43
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever, diffuse rash.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Gait disturbance, Oedema peripheral
Clinical narrative: This is a spontaneous report from a contactable reporter, who reported on behalf of the physician. A 30-month-old, male patient received a dose of PREVNAR 13 in the morning on 01Jun2011 to prevent pneumonia. There was no relevant medical history and no concomitant medication. Relevant past drug history included PREVNAR. At night on 01Jun2011, the patient started limping. On 02Jun2011, the patient developed redness and swelling on the entire left thigh. Relevant laboratory data were unknown. Therapeutic measures taken in response to the redness and swelling on the entire left thigh were KEFLEX at three times a day and BENADRYL at 6.25 mg as needed. The patient had not recovered from the events at the time of report. Base on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13.
Age: 18.0
Sex: M
Vaccine: IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Pallor
Clinical narrative: Patient became pale and reported being dizzy after receiving vaccines.
Sex: F
Vaccine: SMALL
Symptoms: Coma
Clinical narrative: Initial report received from a health care professional via another manufacturer on 08 June 2011. A patient (age and sex not reported) received on an unspecified date an injection (route and site not reported) of SMALLPOX VACCINE, manufacturer and lot number not reported. On an unspecified date described as "years ago", a patient subsequently lapsed into a coma. No further information was available. The outcome was not reported. Documents held by sender: None.
Age: 11.0
Sex: F
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Finger deformity, Muscle spasms, Muscle tightness
Clinical narrative: Initial case received from a pediatrician on 04 June 2011. An 11-year-old female patient, with no reported history, received the following vaccines on 17 May 2011: ADACEL (lot number C3518AA, MENACTRA (lot number U3779AA), hepatitis B (manufacturer and lot not reported), and VARIVAX (lot not reported). Within 2 weeks of vaccination, the patient developed a swan finger deformity, with muscle spasms and tightness. She was evaluated by orthopedic specialists, and per the reporter no cause had been established. No additional information was reported.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Parent of pt reports redness, swelling & hot to touch at Var injection site. Child relates area to back of area is tender to touch only. Noted around 430pm on 6/7/11. Health Dept recommended cool compresses to site, BENADRYL dose to child age & wgt. May be seen by doctor if symptoms persist.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Autoimmune disorder, Brachial plexopathy, Oedema peripheral
Clinical narrative: Initial case received from a healthcare professional on 31 May 2011. A 15-year-old female patient, with no reported illness at the time of vaccination, received a right deltoid first injection of MENACTRA (lot number U3841AA) and a left deltoid injection of HEP A (manufacturer and lot not reported) on 18 May 2011. The patient subsequently experienced distal swelling of the right arm, described as "swollen under elbow toward hand". She presented to the emergency room, and was diagnosed with "brachial plexy autoimmune response". She was treated with Medrol pack, and symptoms resolved as of 31 May 2011. Documents held by sender: None.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 27-MAY-2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). The registered nurse reported that on 27-MAY-2011 the patient experienced fainting and seizures after receiving GARDASIL immunization. At the time of the report, the patient's outcome was unknown. Upon internal review, seizures were considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Cellulitis
Clinical narrative: After Tdap injection to RUA - developed cellulitis - treated with AUGMENTIN by PMD.
Age: 1.01
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Erythema
Clinical narrative: Localized redness possible cellulitis.
Age: 37.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blister
Clinical narrative: States she broke out with blisters appx > 50 11 days after vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Itched and felt hard and was the size of a quarter to a half dollar at injection site.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction
Clinical narrative: Pt had localized reaction s/p Tdap. 9cm x 5cm erythema. No warmth/edema/tenderness.
Age: 15.0
Sex: M
Vaccine: TYP
Symptoms: Hypoaesthesia
Clinical narrative: Right arm numbness one day after 1st dose oral typhoid vaccine.  Seen in ER, resolved without intervention.
Age: 65.0
Sex: M
Vaccine: RAB
Symptoms: Blood pressure systolic decreased
Clinical narrative: Pt reported a drop in systolic blood pressure by 10 points.  This was not verified by a health care provider and was reported to us after the patient was at his home.
Age: 13.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Rash macular
Clinical narrative: Right upper arm: Increase arm circumference, Redness, huge blotch at injection site swelling, warm and hard to touch. Mother applied ice pack.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Pain, Paraesthesia, Skin induration
Clinical narrative: Swelling on front and back of shoulder, bicep, tricep.  5 in by 5 in.  Redness and warm to touch on entire area.  Pain with movement and tingling and in forearm and hand- radiating to fingers.  Skin leathery- 4 in height by 5 in.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Skin warm
Clinical narrative: Swelling on front and back of shoulder, bicep, tricep.  5 in by 5 in.  Redness and warm to touch on entire area.  Pain with movement and tingling and in forearm and hand- radiating to fingers.  Skin leathery- 4 in height by 5 in.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Abasia, Crying, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: fever of 103.3, sweating, constant crying, sore legs, could not walk
Age: 15.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Induration, Purpura
Clinical narrative: 4cm x 3cm Pruritic, erythematous induration.