chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Urticaria
Clinical narrative: Hives noted of both arms cheeks, chin, eyes, and across neck line.
Age: 5.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Rash
Clinical narrative: Right arm has red rash hot and edematous. Next morning after shot.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 103 started x 2 hours after immunizations continued through.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Erythema, Injection site pain
Clinical narrative: Right deltoid-red looks like sunburn from elbow to shoulder, painful to touch.  Started next day after immunization.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Headache, Migraine, Pyrexia, Vomiting
Clinical narrative: Low grade fever on Friday-Saturday temperature higher-went to bed Saturday with headache.  Had migraine Sunday and Monday before stopped eating or ate little since Saturday vomiting since Sunday.  Unable to eat Sunday and Monday no liquids.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Sore, reddened hardness at injection site.  When returned to clinic site of injection 55m width.  Warm soaks three times a day, Ibuprofen every 6-8 hours, BENADRYL at ns. Follow up telephone call 08/23/2005 area no longer sore to touch, knot remains but smaller in size.  Reassure this is common reaction post Td.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Pain, Swelling
Clinical narrative: Right deltoid swollen, warm to touch, pain in arm to leg, achy, no  fever.  Symptoms started  08/02/2005.
Age: 1.34
Sex: M
Vaccine: DTAPH, PNC
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Right Leg swollen, red, tender to touch
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Swelling, Urticaria
Clinical narrative: Signs: redness, swelling, wheel like spot the redness area was about 2 inches, the spot was like about the size of a quarter.
Age: 17.0
Sex: M
Vaccine: HEP, TD
Symptoms: Abdominal pain upper, Back pain, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: At time of injection, patient stated " Is that supposed to make me feel light headed like the shot I got at the dentist?' Two hours later developed severe stomach pain, then back pain fell to floor, became nauseated, shortness of breath, throat felt like it was closing up, face and lips numb.  Emergency room physician said could not be immunization reaction since no rash present.
Age: 17.0
Sex: M
Vaccine: HEP, TD
Symptoms: Hypoaesthesia oral, Nausea
Clinical narrative: At time of injection, patient stated " Is that supposed to make me feel light headed like the shot I got at the dentist?' Two hours later developed severe stomach pain, then back pain fell to floor, became nauseated, shortness of breath, throat felt like it was closing up, face and lips numb.  Emergency room physician said could not be immunization reaction since no rash present.
Age: 37.0
Sex: F
Vaccine: MMR, TD
Symptoms: Swelling, Swelling face
Clinical narrative: Client to emergency room with complaints of tongue and face swelling 1 hour after immunizations given.  BENADRYL given intravenous outpatient immediately.  Client had insurance.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: 2-3 days after Pedvax Hib, Prevnar, and Pediarix she got a rash that covered both legs and feet that lasted a little over 24 hours she was not taken to the doctor. She also ran a fever but didn't take a temperature. She did have pertussis at 2 months of age.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Rash
Clinical narrative: Broke out in red rash on face, chest, arms and legs approx. 15 mins after Hep A vaccine was administered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site induration, Injection site pain
Clinical narrative: Red circle size of a softball w/ red line appx 2 inches going up towards groin area hard and painful. Sent to ER. Pt was given in Antibiotic. Right thigh.
Age: 1.49
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site hypersensitivity, Injection site rash
Clinical narrative: Immunization were given and immediately a pink smooth rash appeared 3-4 cm around each injection site. After about 30 mins. It had gotten better but not completely gone. No other symptoms noted. Received order from physician for Benadryl. Called mother the next day. She stated that only a small red spot was there. No other problems occurred.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMR, VARCEL
Symptoms: Cyanosis, Diarrhoea, Oedema, Pyrexia, Rash
Clinical narrative: Sunday 4/24/05 in am had little raised bumps on hands to elbows bilateral. Sunburn rash from elbow to hands swelled up and blue line appeared at wrist the circulation was cutting off at the fingers, fever 100.5 diarrhea 4/27/05.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, HEPA, IPV, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Sunday 4/24/05 in am had little raised bumps on hands to elbows bilateral. Sunburn rash from elbow to hands swelled up and blue line appeared at wrist the circulation was cutting off at the fingers, fever 100.5 diarrhea 4/27/05.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema, Pyrexia
Clinical narrative: 04/20 right arm red swollen, warm to touch, fever, 4/22/05 decreased redness, decreased swelling no fever.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cellulitis, Dermatitis bullous, Erythema, Hypersensitivity, Injection site induration
Clinical narrative: Elevated Temp of 100.4 at 2:00 pm patient with red knot on right thigh and cranky. TX with Tylenol. Later in evening Temp at 102. Call to nurse hot line. Redness at right leg with red streak running up to mid abdomen. Tx with Motrin/Tylenol alternating every 3 hours 4/17/05. Rash on back, vomiting, cranky, rash spreading to head, trunk and legs. 04/19/05 looks like chicken pox referred to PP. Tx with Benadryl, pedialite. DX with allergic reaction to vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia, Rash, Vomiting
Clinical narrative: Elevated Temp of 100.4 at 2:00 pm patient with red knot on right thigh and cranky. TX with Tylenol. Later in evening Temp at 102. Call to nurse hot line. Redness at right leg with red streak running up to mid abdomen. Tx with Motrin/Tylenol alternating every 3 hours 4/17/05. Rash on back, vomiting, cranky, rash spreading to head, trunk and legs. 04/19/05 looks like chicken pox referred to PP. Tx with Benadryl, pedialite. DX with allergic reaction to vaccine.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth, Pruritus
Clinical narrative: Client returned to clinic 4/18/05. 3" x 2 1/4" red, hot, swollen, hive below injection site. Client reports painful, itchy. Nurse recommended icepacks, 4/18/05, oral Benadryl, Ibuprofen or Tylenol, Cortisone cream to area. Phone interview 4/20/05 itching stopped 4/19/05 no longer hot 4/20/05. Area still painful 4/20/05 per client 1" x 1" circle.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Client returned to clinic 4/18/05. 3" x 2 1/4" red, hot, swollen, hive below injection site. Client reports painful, itchy. Nurse recommended icepacks, 4/18/05, oral Benadryl, Ibuprofen or Tylenol, Cortisone cream to area. Phone interview 4/20/05 itching stopped 4/19/05 no longer hot 4/20/05. Area still painful 4/20/05 per client 1" x 1" circle.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: 04/16/2005 swelling of upper right arm, redness, warm to touch. Parents report child scratched at area approx 2 hours. No fever no other concerns reported per parents.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: 3/31/05 immunization given, 4/4/05 2am right arm from injection site to elbow (back of arm) red and swollen went to private physician. parents called 4/5/05 3pm referred by physician to call mother stated no antibiotics given doing warm and soaks better 4/5/05 on Zyrtec.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abasia, Condition aggravated, Crying, Laboratory test abnormal, Pain
Clinical narrative: Left leg pain, immobility, high fever. Discharge summary states immunization reaction, crying. msv
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Left leg pain, immobility, high fever. Discharge summary states immunization reaction, crying. msv
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 2 vaccines administered to left deltoid area. On Wednesday. Pt presented to clinic on Friday, playful, afebrile but left deltoid area swollen, erythematous, hot to touch, from deltoid to above elbow.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Nausea, Vomiting
Clinical narrative: Approx 1hr after immunizations. Pt became nauseated and started vomiting w/no fever. Returned to clinic approx 3pm administered Phenergan topical on right wrist. No local reaction.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Nausea, Urticaria
Clinical narrative: Client stated she woke up Sat morning with red welts on arm, nausea, shortness of breath.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Red raised area warm to touch TX with ATB.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Redness and swelling below immunization site.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site warmth
Clinical narrative: Day after receiving shots on 3/24/05 a 50 cent piece size reddened area appeared to LVL warm to touch, still has a marble sized knot today.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Hives and trouble breathing, felt like throat was closing up.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Febrile convulsion, Otitis media
Clinical narrative: 1 day after immunization went to ER had febrile seizure. Was diagnosed with bilat AOM.
Age: 1.53
Sex: M
Vaccine: DTAPH, IPV, MMR, PNC, VARCEL
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema
Clinical narrative: Mom reports arm right swollen, red, hard knot, he acts normal.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Mother reports that child had vomiting and diarrhea in middle of the night and still has diarrhea today. 3/9/05 diarrhea stopped at 9:30 3/8/05. Vomiting stopped 5:30 am 3/8/05. No one in family has become ill. Child is normal today.
Age: 38.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus
Clinical narrative: Complain of itching all over 20 minutes after measles, mumps and rubella, BENADRYL 50mg by mouth given 11:00am.  Improvement in itching 20 minutes later.
Age: 1.06
Sex: F
Vaccine: DTPIHI, DTPPHIB, MMR, VARCEL
Symptoms: Infection, Wheezing
Clinical narrative: Child started wheezing 2-3 hours after shots.  If mother elevates, child wheezing is less and child can go to sleep.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash to groin area, back and stomach.  Mom putting BENADRYL creme to area with some relief. Denies shortness of breath, no local reaction, no cough, no wheeze.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Swelling
Clinical narrative: Red, knot swollen.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Erythema, Headache, Nausea
Clinical narrative: Headache-TYLENOL, red, puffy left arm- ice to arm, nausea-PHERGAN administered by mom.
Sex: U
Vaccine: DTAPH, FLU3, PNC
Symptoms: Contusion, Oedema
Clinical narrative: Left arm has edema, heat and bruising. Parent's giving TYLENOL.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Left arm redness and swelling around site.  Site warm and hard to touch.  Redness all the way to the shoulder and down to elbow.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: Dad brought child in 08-24-2004 for number 2 Hepatitis A vaccine.  Informed us that child had a "hole in upper arm where DtaP was administer in February.  There is an indentation of approximately 10mm and over the deltoid muscle, there was no other problem noted at this site.  Dad was advised to have primary physician look at it.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypokinesia, Infection, Pain
Clinical narrative: Client complain of severe pain under right arm-axilla unable to move arm above 45 degree angle.  Pain sometimes radiate down arm to hand.  Upper inner arm is warm to touch.  Referred to Doctor, he diagnose lymph node infection patient put on Bextra 20mg daily.
Age: 50.0
Sex: M
Vaccine: HEPAB
Symptoms: Dehydration, Hot flush, Nausea, Retching
Clinical narrative: At 0945 flushing, nausea with dry heaves, cool cloth and ice applies to back of neck, turn fan on gave sierra mist after nausea past, sat for 10-15 minutes, felt better and left 1245 called location red, flushed again.  145pm contacted by location personnel "client fell bashed head and taken to hospital emergency room".
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pruritus, Pyrexia, Rash papular
Clinical narrative: Child with fever 3 days ago. Broke out in small red papules. At least 50 bumps. Child complains of itching. Recommended Calamine lotion, Benadryl and Aveeno bath or soda bath.
Age: 1.19
Sex: F
Vaccine: FLUX, HIBV, MMR, PNC, VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Client presented to clinic with small pink papules on face, stomach, back, arms. Legs 15-20 total, on 10/15/04. Mom states she started breaking out yesterday. Child scratching bumps. Recommended Calamine lotion, Aveeno bath and Benadryl.
Age: 1.81
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Mom called and said that the pt was diagnosed with Chickenpox and that she had received the chickenpox shot.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: chickenpox disease 3 yr after receiving vaccine.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Mom noticed dime size knot to LL at imm site became larger after several hr swelling and redness noted today (approx 40 mm) Child was assessed at well child visit by MD 10/8/04 with inst cont monitor. Mom denies fever, diff breathing or behavior
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Abdominal pain upper, Cold sweat, Dizziness, Feeling cold, Feeling hot
Clinical narrative: Mom of client states within 15 minutes after getting immunizations her daughter began complaining of a stomach ache and headache, states she was very hot, lightheaded, pale, clammy and cold, states she took daughter out to car and gave her some orange juice, symptoms gone within 15-20 mins. Mom states no other problems, states daughter is in school today.
Age: 13.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Headache, Pallor
Clinical narrative: Mom of client states within 15 minutes after getting immunizations her daughter began complaining of a stomach ache and headache, states she was very hot, lightheaded, pale, clammy and cold, states she took daughter out to car and gave her some orange juice, symptoms gone within 15-20 mins. Mom states no other problems, states daughter is in school today.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Chills, Hypoaesthesia, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Left arm went numb at the time shot was given. Neck became stiff and client c/o body aches during the evening that the shots were given. Client woke at 0300 with fever of 104 and chills. Was seen by MD at health dept 9/17/04.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Left upper arm, elbow to injection site (deltoid), entire circumference of upper arm: red, swollen, hot and hard to touch. Benadryl PO q 4 days, started 1 hr after onset of swelling. 3 hrs after injection.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Contusion, Injection site pain, Skin discolouration
Clinical narrative: 7/28/04 Client c/o arm hurting all day was given Motrin after leaving clinic. Next AM softball size, green colored bruised area to upper arm. Today 8/2/04. Bruising lessened, decreased soreness, leather like feeling to touch.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Cold sweat, Dyskinesia, Feeling cold, Gaze palsy, Headache
Clinical narrative: Pt ok after shots, left HD and 5-10 mins later in car pt grabbed head and said it hurt bad. Mom of pt states pt then laid back in seat, Eyes rolled back and pt started shaking and jerking and she called him name and ask him 2x's are you ok. Pt came to but was cold, clammy and sweating and said he felt numb all over. Mom took pt to ER. Pt had no probs, VS normal. Hospital kept pt 1 1/2 hr and released.
Age: 13.0
Sex: M
Vaccine: HEP, HEPA, TD
Symptoms: Hyperhidrosis, Hypoaesthesia, Tremor
Clinical narrative: Pt ok after shots, left HD and 5-10 mins later in car pt grabbed head and said it hurt bad. Mom of pt states pt then laid back in seat, Eyes rolled back and pt started shaking and jerking and she called him name and ask him 2x's are you ok. Pt came to but was cold, clammy and sweating and said he felt numb all over. Mom took pt to ER. Pt had no probs, VS normal. Hospital kept pt 1 1/2 hr and released.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Listless, Vaccine positive rechallenge, Vomiting projectile
Clinical narrative: Projectile vomiting, listlessness, went to urgent care, 48 hrs after vaccines due to vomiting. Per mom had similar reactions after 2 mo vaccines (9/7/05) and 4 mo vaccines (11/11/05).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Vaccine rxn, r leg, 2 x 1 1/4 cm red, warm area. Bactrim/Bactroban.
Age: 0.43
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Decreased appetite, Pyrexia, Vomiting
Clinical narrative: Received Pediarix, Hib and PCV vaccines on 7/18/06. Since 8PM on 7/18 PT with low grade fever whining, spitting up and decreased appetite.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Livedo reticularis, Pyrexia, Rash
Clinical narrative: On 07/11/06 at 10:30AM received 12 mo vaccines, Hib, Pneumococcal (PCV 7) and MMR. On 07/15/06 in the evening child started a fever. Temp reached 102 and alternating with Tylenol and Motrin temp was 99.8. Stopped Motrin and Tylenol evening of 7/18/06 and temp 99.3. Mottled rash noted across nose and neck. 7/20/06 Rash over entire body.
Sex: M
Vaccine: UNK
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Per mom pt with 101 temp, crops of pox developing and crusting over within 24 hr time frames. Varicella administered at other office in town per mom.
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt had Td booster and 3 days later developed redness and swelling with pain (no fever).
Age: 0.46
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Child had increased temp 100.4 and vomiting
Age: 1.02
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash papular, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Varicella vaccine breakthrough. Developed rash or torso, legs and face on 7/6/06. Had temp 100 for 24 hrs at onset. Diagnosed with varicella in our office on 7/12/06. Had 40-50 lesions, papules and vesicles mostly crusted.
Age: 1.86
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Cellulitis, Erythema, Skin ulcer
Clinical narrative: Erythematous round lesions with central scabs c/w varicella on trunk and 4 extremities face, scalp one lesion above BV area and on left thigh have upper erythematous margin. No d/c concerning of early cellulitis treated with Augmentin.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling over right thigh whole length. No induration, 7cm wide, no color, no pain.
Age: 57.0
Sex: U
Vaccine: MMR
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash starting 15 days after vaccine. Rash is raise, red and itching more consistent with contact dermatitis. It's all over body, arms, legs, chest and abdomen.  Seen at walk in clinic 07/08/2006, healthcare provider 07/11/2006 for follow up.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Pain, Pyrexia
Clinical narrative: Patient came in for PPD (purified protein derivative) read.  Left deltoid about one and a half times the size of right deltoid, positive redness, positive warmth, positive pain. temperature 99.6 F axillary. Sent to hospital emergency room for evaluation.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Skin ulcer
Clinical narrative: Marked swelling of left anterior thigh 19 centimeters by 30 centimeters area of redness with central area (around immunizations sites) with increased redness, warmth, and multiple clear yellow vesicular lesions, onset occurred within 24 hours of immunizations, antibiotics started 72 hours after immunizations. Currently being treated.
Age: 5.0
Sex: M
Vaccine: BCG, MMR
Symptoms: Asthenia, Cough, Rash erythematous, Sneezing, Vomiting
Clinical narrative: After shots child left the office started sneezing and coughing went to grandmother's, vomited got weak, returned to office 10:20.  Child had erythematous rash all over his body. Pulse oximetry 99 percent, blood pressure 96/63, PULSE 149.  BENADRYL post mouth given, 1.5 tablespoon child vomited times two. 10:30 4mg intramuscular dexamethasone given, blood pressure 97/58, pulse 137 child examined in office till 11:45. remained stable.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Complain of itchy rash, noticed one day after receiving measle, mumps and rubella vaccine, temperature 98.6 "red patches" noted on right arm a few on left upper arm, thighs, ankles, and back at waist band.  Nurse Practitioner referred to primary care provider and suggested antihistamine (over counter).
Age: 1.55
Sex: F
Vaccine: DTAP
Symptoms: Skin ulcer
Clinical narrative: 3 centimeters by 3 centimeters hot, hard, red lesion noted on left deltoid.  Apply ice administer children's ADVIL/MOTRIN.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Diarrhoea, Erythema, Rash pruritic
Clinical narrative: Patient received 5 year old immunization(DTaP, MMR, IPV) on 07/14/2006 at 2:30pm.  Left office and within approximately 10-20 minutes developed a cough.  Also had one episode of diarrhea prior to eventually breaking out in diffuse red rash pruritus rash (macular on face, extremities and chest) No wheezing. Also had eyelid edema when seen by me at 4:30pm.  Phone follow up 07/17/2006 rash resolved.
Age: 1.27
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Decreased appetite, Diarrhoea, Irritability, Pyrexia
Clinical narrative: 9 days fever off and on to 102 F. On 06/22/2006 105 F, fussy, decreased appetite for 9 days.  Increase sleep. NO meningeal signs and symptoms. Positive diarrhea every vaccine.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever to 102 developed about 3 hours after IZS Pediarix, Hib, PCV7, irritable, SX cont to 7/13/06 midday.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Local redness about 2", not tender, minimal swelling, no fever.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Left thigh red, swollen.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis
Clinical narrative: Local reaction right leg blue streaks on lower leg.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Pt DX with shingles
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site warmth, Tenderness
Clinical narrative: 11x6 cm tender, red, and warm left thigh, Amox 250 200ml 2tsp BID.
Age: 1.38
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site mass
Clinical narrative: IMMUNIZATIONS ADMINISTERED ON 7/17/06. ON 7/19/06 PT WAS SEEN WITH A SMALL NODULE APPROX. 1/2 CM IN MID LEFT THIGH. NOT OBVIOUSLY TENDER. GAIT APPEARED NORMAL.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Discomfort, Pruritus
Clinical narrative: No problems at time of administration.  Pt noted discomfort and especially itching after the dose, and the itching lasted for several months and still occasionally occurs at the site.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at site.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Nausea
Clinical narrative: Patient states she had a headache across whole head with nausea 2 hours post vaccination. Took tylenol had no relief, then went to bed and felt fine.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Injection site erythema, Injection site swelling, Pain, Sleep disorder
Clinical narrative: Swelling, bruising, redness, fever in general area, painful to touch, couldn't sleep well at night from the pain.  Took Motrin 800mg to help but didn't provide much relief.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Neck pain, Shoulder pain
Clinical narrative: Pain in shoulder radiates into neck and chest.
Age: 25.0
Sex: M
Vaccine: HEP, SMALL, TYP
Symptoms: Headache, Malaise, Nausea, Pain, Pericarditis
Clinical narrative: Initially admitted to hospital on 7/15/06 for HA, nausea, malaise. Was held overnight then d/c'd. According to reports was readmitted same day for temp of 106 degrees, however Transfer summary report places day of admission on 7/18/06. According to summary, presented on 7/18/06 with fever, malaise, and pain around lower edge of his ribs. Pain on scale of 1-10 rated at a 9. Temperature was 105.6 degrees. CXR noted perihilar opacities which radiologist felt to be consistent with viral pnuemonia or decreased lung volumes. ST segment elevation and elevated sed rate raised concerns of pericarditis. Echo was done and showed mild pericarditis. Admitted and treated with IV fluids. Treated with IV Toradol for HA, Ibuprofen taken orally prior to d/c for HA and was effective. Discharge diagnoses included Viral Syndrome with mild pericarditis. Follow up visit on 7/19/06 with diagnoses of possible Smallpox reaction based on medical history.
Age: 25.0
Sex: M
Vaccine: HEP, SMALL, TYP
Symptoms: Pyrexia, Viral infection
Clinical narrative: Initially admitted to hospital on 7/15/06 for HA, nausea, malaise. Was held overnight then d/c'd. According to reports was readmitted same day for temp of 106 degrees, however Transfer summary report places day of admission on 7/18/06. According to summary, presented on 7/18/06 with fever, malaise, and pain around lower edge of his ribs. Pain on scale of 1-10 rated at a 9. Temperature was 105.6 degrees. CXR noted perihilar opacities which radiologist felt to be consistent with viral pnuemonia or decreased lung volumes. ST segment elevation and elevated sed rate raised concerns of pericarditis. Echo was done and showed mild pericarditis. Admitted and treated with IV fluids. Treated with IV Toradol for HA, Ibuprofen taken orally prior to d/c for HA and was effective. Discharge diagnoses included Viral Syndrome with mild pericarditis. Follow up visit on 7/19/06 with diagnoses of possible Smallpox reaction based on medical history.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: Fainted after receiving vaccines.
Age: 54.0
Sex: M
Vaccine: HEPA, TD, YF
Symptoms: Oedema, Throat tightness
Clinical narrative: PT VACCINATED IN OUR CLINIC ON 7/13/06. PT RETURNED HOME AND STARTED TO EXPERIENCE SWELLING OF THE MOUTH AND FEELING OF A CLOSING AIRWAY. PT WENT TO THE ER AND WAS TX'D ON 3 VISITS AND RELEASED FROM THE HOSPITAL YESTERDAY 7/23/06. PT CALLED CLINIC AND SPOKE WITH NURSE TO LET HER KNOW THAT THE REACTION OCCURRED. PT WAS TOLD TO RETURN TO THE ER TO BE REEVALUATED DUE TO PROLONGED FEELING OF AIRWAY CLOSURE.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Pruritus, Pyrexia, Rash
Clinical narrative: CLIENT RECEIVED MMR ON 7/17/2006.  REPORTED SHE GOT SICK ON FIRST DAY AND REMAINS SICK 7/20/2006.C/O HAVING FEVER OF 100 FOR A FEW DAYS. WNE TO SEE MD 7/20/2006 AND MD SENT HER TO HD. AWOKE THIS A.M WITH RED RASH ALL OVER HER BODY. CLINIC NURSE OBSERVED RED RASH ON ARMS, LEGS, UPPER TORSO, BACK, FACE WITH REDNESS AND ITCHING.  TEMP 98.2.; CALL BY CENTRAL OFFICE NURSE ON 7/24 @ 3:23 P.M.CLIENT  STATES RASH STILL PRESENT.  PLANS TO RETURN 07/25/2006.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Upper arm pain, swelling, and redness.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Loss of consciousness, Nausea, Paraesthesia
Clinical narrative: Chills, Tingling in top of head, Headache, Nausea, LOC at work.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash papular, Skin ulcer
Clinical narrative: On 072206, noticed small papular lesion on L wrist.  Had a "patch" 3cmx15cm on L wrist just proximal to lesion.  States the patch was very itchy and prickly.  Then noticed papular lesions over both arms and both ankles.  10 - 12 total lesions noted.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: CSF test abnormal, Chest pain, Demyelination, Dizziness, Headache
Clinical narrative: This case was reported by a consumer who was a nurse and described the occurrence of multiple sclerosis in a 34 year old female subject who was vaccinated with Engerix-B for prophylaxis. A physician or other health care professional has not verified this report. Relevant medical history included 2 caesarean sections. There were no concurrent medications. On unspecified dates, the subject previously received 2 dose of Hep-B vaccine (unknown mfr and lot number) "without problem". On 11/16/04 at 13:39, the subject received 3rd dose of Engerix-B (lot AHBVAD64AA). She also received BCG tuberculosis test on the same day. In 12/05, within weeks of vaccination with Engerix-B, the subject experienced loss of sensation on the right side of her trunk and numbness in her feet. She waited a month to seek medical evaluation. On 1/16/05, an MRI was performed and revealed a demyelinating disorder that was later dx'd as multiple sclerosis. On 1/20/05, she was further evaluated by a lumbar puncture included lesion in her spine and mitral valve prolapse which occurred sometime in 2005, as well as, residual headaches and nausea, which she continued to experience at the time of reporting. In addition, at an unspecified time, she experienced chest pain due to the mitral valve prolapse. The subject also reported she experienced dizziness. On unspecified dates, treatment for the multiple sclerosis included three days of IV steroids and eleven months of interferon treatment. She was to continue interferon treatment chronically. The subject considered the events to be disabling, life-threatening and jeopardized her or required intervention. At the time of reporting, the cerebrospinal leak was improved, but the other events were unresolved.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Mitral valve incompetence, Multiple sclerosis, Nausea, Sensory disturbance
Clinical narrative: This case was reported by a consumer who was a nurse and described the occurrence of multiple sclerosis in a 34 year old female subject who was vaccinated with Engerix-B for prophylaxis. A physician or other health care professional has not verified this report. Relevant medical history included 2 caesarean sections. There were no concurrent medications. On unspecified dates, the subject previously received 2 dose of Hep-B vaccine (unknown mfr and lot number) "without problem". On 11/16/04 at 13:39, the subject received 3rd dose of Engerix-B (lot AHBVAD64AA). She also received BCG tuberculosis test on the same day. In 12/05, within weeks of vaccination with Engerix-B, the subject experienced loss of sensation on the right side of her trunk and numbness in her feet. She waited a month to seek medical evaluation. On 1/16/05, an MRI was performed and revealed a demyelinating disorder that was later dx'd as multiple sclerosis. On 1/20/05, she was further evaluated by a lumbar puncture included lesion in her spine and mitral valve prolapse which occurred sometime in 2005, as well as, residual headaches and nausea, which she continued to experience at the time of reporting. In addition, at an unspecified time, she experienced chest pain due to the mitral valve prolapse. The subject also reported she experienced dizziness. On unspecified dates, treatment for the multiple sclerosis included three days of IV steroids and eleven months of interferon treatment. She was to continue interferon treatment chronically. The subject considered the events to be disabling, life-threatening and jeopardized her or required intervention. At the time of reporting, the cerebrospinal leak was improved, but the other events were unresolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: TD after immunization, swelling, redness, warmth at site that progressed to include entire ant thigh over 24 hours. TX on day 2 started with po Cephalexin.
Age: 32.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dizziness, Fatigue, Headache, Pain
Clinical narrative: Afternoon after receiving Adacel, fell asleep tired 1 hr after, woke after 3 hrs with n/a, pain in area of brachial (collar bone right neck area). HA, dizziness and pain have persisted since injection last was 6 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Received Tdap and PPD. Within 5 minutes felt dizzy nauseated pale. Emesis X 1. Recovered within 15 minutes no LOC.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity
Clinical narrative: 5 in x 5 in red, pink area, upper right thigh.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Local redness, swelling, warmth, increased circumference of arm left side redness extends 19cm in length.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site oedema
Clinical narrative: Right thigh swelling
Age: 1.1
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Injection site erythema, Pyrexia
Clinical narrative: Varicella type rash about 1 week after vaccine given with low grade fever. injection site erythema 9 days after varicella and pneumococcus given.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Oedema, Skin nodule, Tenderness
Clinical narrative: Red, swollen, Knot, tender to touch.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Cellulitis, Guillain-Barre syndrome, Hypoaesthesia, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old white female visiting nurse co-worker with a lot of seasonal allergies, who on 12/30/04 in the PM was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 647657/0947N). There was no illness at the time of vaccination. Concomitant therapy included a dose of influenza virus whole virion 3v vaccine inactivated. On 1/2/05 in the PM, the patient experienced Guillain-Barre syndrome and was hospitalized. No other information was available regarding the adverse event. It was unknown as to whether the patient recovered. There was no product quality complaint involved. Follow up information received from a nurse indicated that 2-3 days post immunization, the patient reported having an extremely painful and swollen arm at the site of pneumococcal 23v polysaccharide vaccine administration. The physician treated for local cellulitis. The patient continued to feel progressively worse. It was noted that she started with back pain, which, on 1/22/05, progressed to pain and numbness and tingling to the extremities. On 1/27/05, the patient admitted to the hospital because she was unable to stand or walk. Neurogenic bladder was noted. On 2/6/05, an EMG was indicative of Guillain-Barre. She has been admitted to the hospital multiple times since for the symptoms of Guillain-Barre. There was no history of problems with any other vaccination. At the time of the report, the patient was still unable to work, with many cognitive and slurred speech problems. The outcome was reported as not recovered. The reporter indicated that the Guillain-Barre was considered to be disabling, life threatening, and an other important medical event (OMIC). No additional information is expected.
Age: 36.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction, Injection site swelling, Pain, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 36 year old white female visiting nurse co-worker with a lot of seasonal allergies, who on 12/30/04 in the PM was vaccinated IM with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 647657/0947N). There was no illness at the time of vaccination. Concomitant therapy included a dose of influenza virus whole virion 3v vaccine inactivated. On 1/2/05 in the PM, the patient experienced Guillain-Barre syndrome and was hospitalized. No other information was available regarding the adverse event. It was unknown as to whether the patient recovered. There was no product quality complaint involved. Follow up information received from a nurse indicated that 2-3 days post immunization, the patient reported having an extremely painful and swollen arm at the site of pneumococcal 23v polysaccharide vaccine administration. The physician treated for local cellulitis. The patient continued to feel progressively worse. It was noted that she started with back pain, which, on 1/22/05, progressed to pain and numbness and tingling to the extremities. On 1/27/05, the patient admitted to the hospital because she was unable to stand or walk. Neurogenic bladder was noted. On 2/6/05, an EMG was indicative of Guillain-Barre. She has been admitted to the hospital multiple times since for the symptoms of Guillain-Barre. There was no history of problems with any other vaccination. At the time of the report, the patient was still unable to work, with many cognitive and slurred speech problems. The outcome was reported as not recovered. The reporter indicated that the Guillain-Barre was considered to be disabling, life threatening, and an other important medical event (OMIC). No additional information is expected.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Feeling hot, Injection site mass, Injection site swelling, Pain
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old female with a history of transient ischemic attack, frequent falls, compression fracture T12, and a meningioma (right cerebral pontine angle and temporal lobe lacunar) who on the morning of 02-JUN-2005 was vaccinated intramuscularly in the left deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included acetaminophen (+) propoxyphene napsylate (DARVOCET), alendronate sodium, donepezil hydrochloride (ARICEPT), aspirin (ASA), and escitalopram oxalate (LEXAPRO).  That same day the patient complained of a burning sensation and pain in the left upper extremity and she had a medium size raised lump.  On 03-JUN-2005 the left arm was warm to touch with mild swelling and red streaking posteriorly above the elbow to her shoulder.  The patient stated that she could not raise her left arm.  She went to the emergency room and was given cephalexin (KEFLEX) 500mg by mouth every 6 hours for 7 days.  On 10-JUN-2005 the patient recovered.  No product quality complaint was involved.  No further information is expected.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Skin burning sensation, Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old female with a history of transient ischemic attack, frequent falls, compression fracture T12, and a meningioma (right cerebral pontine angle and temporal lobe lacunar) who on the morning of 02-JUN-2005 was vaccinated intramuscularly in the left deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included acetaminophen (+) propoxyphene napsylate (DARVOCET), alendronate sodium, donepezil hydrochloride (ARICEPT), aspirin (ASA), and escitalopram oxalate (LEXAPRO).  That same day the patient complained of a burning sensation and pain in the left upper extremity and she had a medium size raised lump.  On 03-JUN-2005 the left arm was warm to touch with mild swelling and red streaking posteriorly above the elbow to her shoulder.  The patient stated that she could not raise her left arm.  She went to the emergency room and was given cephalexin (KEFLEX) 500mg by mouth every 6 hours for 7 days.  On 10-JUN-2005 the patient recovered.  No product quality complaint was involved.  No further information is expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Anaemia, Cough, Infection, Laboratory test abnormal, Leukopenia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 65 year old white female homemaker with diabetes mellitus, mild sore throat, iodine allergy and a history of two bladder infections (early 2005), eye infection (early 2005) and cellulitis of the abdominal wall (early 2005), who "probably in the morning" on 30-JUN-2005 was vaccinated into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #647661/0055R). On 30-JUN-2005 the patient experienced immediate pain, "swelling in 2 hours" and began coughing that night. In October 2005, the patient developed MRSA in the abdomen and red man syndrome with vancomycin and status post bone marrow biopsy (the bone marrow was hypercellular at 70-75%). It was also reported that in approximately October 2005 the patient developed a high fever. In approximately October 2005, her hemoglobin improved to 12.3 while her white blood cell count was 3300 and neutrophil count was 1900. Her platelets remained around approximately 100,000. In November 2005 the patient experienced splenomegaly. On an unknown date, the patient developed thrombocytopenia with a platelet count of 1000,000, leukopenia and mild anemia. Some of this may have been due to the antibiotic she had taken linezolid (Zyvox). Some of her counts did improve after discontinuation of the antibiotic. However, she did continue to have cytopenias. Iron stores were increased. Hemophagocytosis was identified. In December 2005 the physician saw the patient and she had been doing well. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complain was involved. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Platelet disorder, Pyrexia, Swelling, Thrombocytopenia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 65 year old white female homemaker with diabetes mellitus, mild sore throat, iodine allergy and a history of two bladder infections (early 2005), eye infection (early 2005) and cellulitis of the abdominal wall (early 2005), who "probably in the morning" on 30-JUN-2005 was vaccinated into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot #647661/0055R). On 30-JUN-2005 the patient experienced immediate pain, "swelling in 2 hours" and began coughing that night. In October 2005, the patient developed MRSA in the abdomen and red man syndrome with vancomycin and status post bone marrow biopsy (the bone marrow was hypercellular at 70-75%). It was also reported that in approximately October 2005 the patient developed a high fever. In approximately October 2005, her hemoglobin improved to 12.3 while her white blood cell count was 3300 and neutrophil count was 1900. Her platelets remained around approximately 100,000. In November 2005 the patient experienced splenomegaly. On an unknown date, the patient developed thrombocytopenia with a platelet count of 1000,000, leukopenia and mild anemia. Some of this may have been due to the antibiotic she had taken linezolid (Zyvox). Some of her counts did improve after discontinuation of the antibiotic. However, she did continue to have cytopenias. Iron stores were increased. Hemophagocytosis was identified. In December 2005 the physician saw the patient and she had been doing well. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complain was involved. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 58 year old retired white male who on 21-JAN-2005 between 08:30 and 09:00 was vaccinated intramuscular into the left arm with a first dose of pneumococcal 23v polysaccharide vaccine.  There was no illness at the time of vaccination.  On 21-JAN-2005 at 16:30, the patient called the doctor's office and states that his left arm was swollen, red, and very painful where the injection was given.  The patient also complained of being " a little short of breath". It was noted that the pharmacist replaced the vials for the physician "about 6 months ago".  It was also noted that the physician sis not feel comfortable using the vials any longer.  Unspecified medical attention was sought.  No product quality complaint was involved. A lot check will be performed.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with the standards and was released.  Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Discomfort, Erythema, Flushing
Clinical narrative: Information has been received from a registered nurse concerning a 69-year-old male with asthma, hypercholesterolemia, and a penicillin allergy and a history of a "lung problem", asbestos exposure, questionable asbestosis, pneumonia in February 2005, and "reflux" who on 31-AUG-2005 was vaccinated intramuscular in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine.  Concomitant therapy included simvastatin (manufacturer unknown) (20mg), thiothixene (1mg), Terazosin hydrochloride (4mg), pantoprazole sodium (PROTONIX) (40mg), albuterol sulfate (+) ipratropium bromide (COMBIVENT) inhaler, ascorbic acid, and vitamin E.  The nurse indicated that the patient received the first dose out of the vial.  On 02-SEPT-2005, the patient called the physician complaining of a very sore arm, sore shoulder and neck and upper back discomfort aching all over. no energy, flushed, and had a fever the day before, on 01-SEP-2005.  A complete blood count and blood cultures were performed, (results not provided).  The patient was seen as the physician office on 02-SEPT-2005 and was still not feeling well.  A product quality complain was not involved.  Follow-up information was received from the registered nurse who reported that on the evening of 31-AUG-2005, the patient developed a very sore arm, was achy all over, had a low grade temperature, and decreased energy.  He was seen in the office of 02-SEP-2005 and was very achy, had decreased energy, a sore arm, and was flushed.  Erythema was noted.  He was afebrile at this time. A complete blood count and blood cultures were obtained which were normal.  He recovered on 06-SEP-2005.  No further information is expected.