chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and small hives 16 hours after shot. Took 2 Benadryl tablets and put cortisone ointment on hives.
Age: 3.25
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Wheezing started approx 4pm by 5pm wheezing worsened, rapid respirations. Mom gave Pulmicort, Xopenex neb. Sx Continued, was given Prednisolone 4ml oral. Treatment continued with Pulmicort and Xopenex through Sun 10/20/02.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint range of motion decreased, Swelling
Clinical narrative: Patient experienced left arm swelling from mid-arm to wrist approximately 24 hours after receiving both vaccines. Swelling persisted for about 3 days and then gradually resolved. Patient could not touch his nose because the swelling in elbow/forearm was so bad.
Age: 55.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: 12 hours following 2002 flu shot, extreme body pain, chills, 102 fever. 36 hours 100 degree fever. Next 2 days, headache, body aches.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Pruritus
Clinical narrative: Influenza virus received on 10/18/02. Immediately after the injection, the site was itchy. After about 10 minutes, itching subsided. The following day, the injection site developed a hardened spot around it. The spot (area) is still hard today, measuring approximately 1"x1".
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site nodule, Pruritus
Clinical narrative: Patient received flu vaccine on 10/21/02. Starting itching on 10/22/02. Still itching 10/23/02 and a knot appeared at injection site. Told patient to take Benadryl. Call back if blood pressure changes, nausea, or rash.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Hive-like rash on left arm and neck with itching on both arms, neck and face. No SOB, no LOC, no lethargy. Treated with Benadryl.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Chills, Night sweats, Pyrexia, Rash
Clinical narrative: Fever/chills starting 10/23/02. Night sweats 10/23 through 10/25. Red rash all over body for 2 days starting yesterday. No sore throat, some abdominal cramping. Hasn't seen doctor yet.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Acute nausea, vomiting and diarrhea starting 15 minutes after injection. Elevated WBC 24,00.
Age: 1.0
Sex: F
Vaccine: DTAP, FLU3, HBHEPB
Symptoms: Injection site mass
Clinical narrative: Next day a lump was on left and right leg.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Localized reaction--bright red, swollen, hot to touch, sore--approximately 4"x2.5". Increase in size for 36 hours after injection.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness of left upper arm; edema of arm.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema, Oedema peripheral
Clinical narrative: Oedema; swelling of entire arm
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Nausea
Clinical narrative: Day of injection, patient felt nauseated with dry heaves. Continued for 1.5 days on and off. No other symptoms or adverse effect. Stated that she may have had the series of hepatitis B before but couldn't remember.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Temperature of 103, unwitnessed apparent seizure.
Age: 11.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site hypersensitivity, Pruritus, Rash erythematous, Sneezing
Clinical narrative: Client received varicella and hepatitis B in left arm at about 2:45PM. Client and father returned to clinic at 4:15PM. Father states that within 5 minutes after leaving clinic, client started sneezing and complained of itching at site, around neck and eyes. Upon return to clinic, client had raised, reddened area around varicella administration site about 2cm in diameter. Neck area reddened (not raised). Clients father stated that at this time, all symptoms are much improved. Client denied any difficulty with breathing.
Age: 31.0
Sex: U
Vaccine: ANTH
Symptoms: Contusion
Clinical narrative: Deep purple bruising approximately 25mm and surround bruising approximately 50mm. Bruising appeared in the right arm at injection site.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Pain
Clinical narrative: Patient had 4cm induration with redness and pain. Patient treated with Tomadol IM and Keflex PO and discharged with keflex. Vaccine administered 10/22/02. Symptoms started same day.
Age: 14.2
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mom called 10/24/02 describing pain, swelling at site of left upper arm. Take Tylenol or Motrin. Client seen 10/25/02--arm warm to touch, minimal swelling, no redness. Continue Tylenol. Return for check up; no firm knot at injection site. Compresses.
Sex: F
Vaccine: LYME
Symptoms: Headache, Pain, Pyrexia, Sinus headache
Clinical narrative: Fever, headache, body ache, sinus headache. Tylenol.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Apnoea, Eye movement disorder, Hypotension, Hypotonia, Pallor
Clinical narrative: About 6-8 hours after receiving vaccine, had hypotensive/hyporesponsive episode: turned white, not breathing, hands/feet cold and purple, limp, eyes rolled back. Lasted about 10 seconds, recovered spontaneously. Seen in ER immediately afterwards. Normal exam; nothing done.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Stupor
Clinical narrative: About 6-8 hours after receiving vaccine, had hypotensive/hyporesponsive episode: turned white, not breathing, hands/feet cold and purple, limp, eyes rolled back. Lasted about 10 seconds, recovered spontaneously. Seen in ER immediately afterwards. Normal exam; nothing done.
Age: 0.7
Sex: F
Vaccine: HEP, IPV, HEP, IPV
Symptoms: Pyrexia
Clinical narrative: Approximately 9-10 hours from the vaccine, patient had a 102 temperature and this 102/103 temperature lasted for 24 hours. Tylenol only brought fever down a little; fever spiked every 5 hours. Day 2, fever stayed 100.4F for 18-24 hours. On 10/10/02 patient seen by family pediatrician who confirmed this was a shot reaction. Fever continued for the next 4 days.
Age: 0.7
Sex: F
Vaccine: HEP, IPV, HEP, IPV
Symptoms: Decreased appetite, Pyrexia, Urticaria
Clinical narrative: Approximately 9-10 hours from the vaccine, patient had a 102 temperature and this 102/103 temperature lasted for 24 hours. Tylenol only brought fever down a little; fever spiked every 5 hours. Day 2, fever stayed 100.4F for 18-24 hours. On 10/10/02 patient seen by family pediatrician who confirmed this was a shot reaction. Fever continued for the next 4 days.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: 12/17/01 Arm where pneumovax was given started to itch. 12/18/01 Arm began to swell. Seen by provider in clinic. Noticed redness, warmth in left upparm. Given Allegra 60mg bid. Use cold packs.
Age: 12.0
Sex: M
Vaccine: HEP, TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass
Clinical narrative: Large knot and redness/inflammation of area.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, IPV, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia, Tenderness
Clinical narrative: Fever 102 for 5 days. Red, swelling, tender area on site of administration, warmth area about 5cmx5cm. Oral antibiotics were used (Keflex).
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: had fever and arm was sore on day of shot. Next day from elbow to shot area was very red/swollen down to mid arm with sack of fluid hanging from elbow to forearm; hot with fever.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Petechiae, Rash
Clinical narrative: About 1 hour after the shot the child broke out in petiachiae all over. Spoke to Peds ID. He had never heard of petichiae about 1 hour after a shot. Child sent to ER; got washed out for petiachiae. Was diagnosed for rash; resolved.
Age: 1.75
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Contusion, Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Swollen, red, warm left thigh. Anterior bruising; size of softball. Reaction to MMR.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: Diffuse, erythematous rash.
Age: 4.08
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Swollen, warm, red upper left arm. Tender.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Right arm warm to touch, red, swollen. Circumference 22.5/23.5 compared to left arm 18/19. Seen in doctors office 10/24/02.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Contusion, Feeling hot, Injection site erythema
Clinical narrative: 24 hours after injection on left thigh, 3cm erythema papule with increased redness in center, medial to injection site; warm and tender to touch. Right thigh small 2-5mm erythema papule at shot site. 10/18/02 Mom called--increased redness, swelling and bruising on right leg and left leg bruising on thigh spreading. Keflex 500 PO BID for 10 days. Diagnosis - cellulitis vs sot reaction.
Age: 1.25
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child developed red, raised area on left thigh approximately 2" in diameter at injection site. No fever, but on Advil/Tylenol. Does not mind it--active.
Age: 26.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Bronchospasm, Dyspnoea, Face oedema, Urticaria
Clinical narrative: 12:30 MMR and Hepatitis B vaccine given. 13:30 complained of SOB, hives on neck, trunk back, swollen lips, bronchospasm. Rx - epinephrine/solumedrol. Albuterol.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red area RUE at injection site, site warm to touch (+) edema. Tx: Beandryl 25mg bid x 3d, Augmentin 875 bid x 5d.
Age: 5.0
Sex: F
Vaccine: DTAPH, IPV, VARCEL
Symptoms: Drug ineffective
Clinical narrative: Breathrough with chicken pox. Comfort measures.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Evening of immunization of varicella about 11PM noticed area burning. Woke up 10/22/02, hard reddened area; applied heat and felt better, but still hardened and reddened. 10/23/02 returned to clinic; area 2"x3" still hardened and slightly reddened.
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Injection site reaction, Pruritus
Clinical narrative: Localized raised vesicular reaction in circular shape. Lightheadedness, itching localized.
Age: 1.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, VARCEL
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: 1 week after shots, fever for four days, clear nasal and throat phlegm. Taken to ER and was given medications to dry up secretions. Mom reports she was told he had a viral infection. He was well after 5 days.
Age: 32.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site mass, Pain, Swelling
Clinical narrative: Red, swollen, knot, painful.
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: 18 month old female dev. R upper thigh cellulitis after receiving DTaP and varicella vaccine at that site on 9/25/02. Pt was treated with Augmentin 200mg/5ml x 7 days. Pt improved with Augmentin.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Intense local swelling, tenderness, redness and increased local warmth with lymphangitic at the level of L arm where it was injected; reaction 3-4 hours after injection.
Age: 67.0
Sex: M
Vaccine: HEPA
Symptoms: Anorexia, Asthenia, Diarrhoea
Clinical narrative: Weakness, anorexia, diarrhea.
Age: 11.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site warmth, Oedema
Clinical narrative: Day after vaccine, large red area bigger 24 hours has 50 cent piece, painful. Next day, 48 hours later was swollen to knee, hot to touch and cried continually. Lasted about one week.
Age: 3.3
Sex: M
Vaccine: DTAP
Symptoms: Fall, Pallor, Respiratory disorder
Clinical narrative: One day after he received vaccine while he was playing he suddenly turned white, was pale and fell to the floor and was "not breathing" for a second. The parents stimulated him and he recovered at once. The ambulance was called, he wastaken to ER. Was examined and released. No tx needed.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Insomnia, Tachycardia
Clinical narrative: experienced tachycardia, difficulty sleeping and difficulty breathing.  It started within several hours of receiving the vaccination and persisted for more than 24 hours
Age: 51.0
Sex: U
Vaccine: FLUX
Symptoms: Asthenia, Chills, Dry mouth, Muscle spasms, Pain
Clinical narrative: 11 hours preceeding injection,high fever, chills, dry mouth,ache, large muscle cramps in legs weak feeling. low grade fever after.
Age: 51.0
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: 11 hours preceeding injection,high fever, chills, dry mouth,ache, large muscle cramps in legs weak feeling. low grade fever after.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Hot flush, Hyperhidrosis, Nausea, Pain
Clinical narrative: 1.5 hours after receiving vaccine pt began having pain from shoulder to waist on the side of body where he received the vaccination, felt nauseated and was having "hot flashes", was mildly diaphoretic with flushed skin and began erperiencing rhinorrhea.  B/P ranged 130-80 to 114-80 with HR 72-82, RR 20.  Denied dizziness or dyspnea.  Pt was observed for approximately 30 minutes, and began feeling better.  Advised to take tylenol, not ASA, for back pain, and Benadryl 25 mg and was sent home for the rest of the day from work.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: 1.5 hours after receiving vaccine pt began having pain from shoulder to waist on the side of body where he received the vaccination, felt nauseated and was having "hot flashes", was mildly diaphoretic with flushed skin and began erperiencing rhinorrhea.  B/P ranged 130-80 to 114-80 with HR 72-82, RR 20.  Denied dizziness or dyspnea.  Pt was observed for approximately 30 minutes, and began feeling better.  Advised to take tylenol, not ASA, for back pain, and Benadryl 25 mg and was sent home for the rest of the day from work.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Patient complained of tightness in throat and face after receiving vaccine.  benadryl given. VSS. No other symptoms.  Symptoms resolved automatically.
Age: 0.3
Sex: M
Vaccine: PNC
Symptoms: Dyspnoea, Haematocrit decreased, Respiratory failure, Sepsis
Clinical narrative: Prevnar was administered on 10/28/02. The following day patient had difficulty breathing and low hematocrit. Admitted to PICU for respiratory failure/rule out sepsis. Patient is a 24 week gest. preemie. The discharge summary states, "sepsis." Baby remaines in the PICU as of 11/1/02 in critical condition. Lab studies indicate child has group B Strep Sepsis and para-influenza.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: Received flu vaccine on Oct. 25,2002 at 0910am in the Rt. Gluteus Max.  Awakened at 1100am (works nights) with severe muscle and body aches, esp. in the lower part of body.  Was unable to move legs briskly and felt like a load of bricks were sitting on legs.  Felt restless and could not get comfortable because of body pain and soreness.  Has chills and was dozinf off and on.  Had some confusion, found self running down the halway at home very dizzy, lightheaded.  Had sensation of blacking out, did not fall.  HR 120 - 130  BP 112/88 T- 99.4 - 101.8 Has audible wheez  wiht exertion.  Severe weekness, fatique. No discomfort at injection site.  Hve feeling of heart pounding.  Nausea wiht dry heaves, loss of appitite.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Restlessness, Retching, Syncope
Clinical narrative: Received flu vaccine on Oct. 25,2002 at 0910am in the Rt. Gluteus Max.  Awakened at 1100am (works nights) with severe muscle and body aches, esp. in the lower part of body.  Was unable to move legs briskly and felt like a load of bricks were sitting on legs.  Felt restless and could not get comfortable because of body pain and soreness.  Has chills and was dozinf off and on.  Had some confusion, found self running down the halway at home very dizzy, lightheaded.  Had sensation of blacking out, did not fall.  HR 120 - 130  BP 112/88 T- 99.4 - 101.8 Has audible wheez  wiht exertion.  Severe weekness, fatique. No discomfort at injection site.  Hve feeling of heart pounding.  Nausea wiht dry heaves, loss of appitite.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Received flu vaccine on Oct. 25,2002 at 0910am in the Rt. Gluteus Max.  Awakened at 1100am (works nights) with severe muscle and body aches, esp. in the lower part of body.  Was unable to move legs briskly and felt like a load of bricks were sitting on legs.  Felt restless and could not get comfortable because of body pain and soreness.  Has chills and was dozinf off and on.  Had some confusion, found self running down the halway at home very dizzy, lightheaded.  Had sensation of blacking out, did not fall.  HR 120 - 130  BP 112/88 T- 99.4 - 101.8 Has audible wheez  wiht exertion.  Severe weekness, fatique. No discomfort at injection site.  Hve feeling of heart pounding.  Nausea wiht dry heaves, loss of appitite.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Coma, Convulsion, Gastrointestinal disorder, Hypersensitivity
Clinical narrative: 3 seizure-like events occurring approximately 48 hrs after administration of vaccines. All three very brief, all occurring over a period of a few hours. No further signs or symptoms before or after. Observed in hospital for three days.  Nurse follow up on 07/09/04 states: "Unresponsive."  Nurse follow up on 07/20/04 states: "Reaction to Pertussis vaccine, Gastroesophageal reflux."
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Vaccine received on October 25, 2002 in the AM at 1600 was chilling, had severe aches, very tired, felt Ice Cold (did not take a temp)  Felt better by the evening of the 27th.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Tachycardia
Clinical narrative: Generalized flushed feeling, tachycardia, dizzyness
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Erythema, Oedema, Urticaria
Clinical narrative: Mother called health department 10/30/02 to inform public health nurse  was treated in ER 9/12/02 approximately 4 hours after vaccines administered.  Shortness of breath and generalized hives.  Right arm was swollen from elbow to shoulder and area where vaccine given was blanched with surrounding erythema.  Upper arm remained swollen for 10 days.  Completely resoved after 10 days.  DTaP was the opnly vaccine administered in the right deltoid area.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Oedema, Pain, Pruritus
Clinical narrative: Pain, itching, swelling, hot area approximately 10cm surrounding injection site
Age: 16.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives on the next day on the arms and legs.
Age: 34.0
Sex: M
Vaccine: DT, HEPA
Symptoms: Dermatomyositis
Clinical narrative: Developed dermatomyositis after hepatitis A #2. Previous report stated it was hepatitis A #1.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Flushing, Nausea
Clinical narrative: From faxed correspondence received at manufacturer on 10/22/02, it was reported by a health care professional that a 45 year old female, who on 10/15/02 at 15:00 was vaccinated Fluzone (lot # U0910AA) IM in the left deltoid. Five minutes after vaccination, the patient experienced nausea, flushed face, difficulty swallowing, and shortness of breath. She was seen in the ER and treated with Solu-medrol IV, Pepcid IV, and oxygen. She was discharged to home with Prednisone dose pack and Tagamet. On 10/16/02, the patient presented in the ER again and was hospitalized on 10/17/02 for two days. Patient recovered. From additional information received on 10/2/03 from the employee health deparmtent at a hospital, it was reported that the patient was hospitalized for two days. (admitted on 10/17/02 and discharged on 10/19/02) for having a fairly severe allergic reaction to the FLUZONE vaccine. The patient experienced a persistent flushing, but it was unclear if it was a persistent allergic reaction as opposed to a pyrogenic response to the vaccine. No definite allergic reactions were noted, although she did have an episode of flushing and felt poorly. Treatment included steroids and H2 and H1 blockade. The patient was discharged on 40mg of Prednisone for four days, then tapered off of it, Zyrtec once daily and 400mg of Tagamet twice a day. on the day of discharge, there was no evidence of any severe end-organ damage, such as shock, bronchospasm or stridor. The patient was eating, walking and desired to be discharged. The patietn was discharged in improved contidion, but did not have a headache, for which Advil and/or Ultracet were not very effective. It was not reported whether the patient recovered from these events.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Flushing, Leukocytosis, Nausea
Clinical narrative: From faxed correspondence received at manufacturer on 10/22/02, it was reported by a health care professional that a 45 year old female, who on 10/15/02 at 15:00 was vaccinated Fluzone (lot # U0910AA) IM in the left deltoid. Five minutes after vaccination, the patient experienced nausea, flushed face, difficulty swallowing, and shortness of breath. She was seen in the ER and treated with Solu-medrol IV, Pepcid IV, and oxygen. She was discharged to home with Prednisone dose pack and Tagamet. On 10/16/02, the patient presented in the ER again and was hospitalized on 10/17/02 for two days. Patient recovered. From additional information received on 10/2/03 from the employee health deparmtent at a hospital, it was reported that the patient was hospitalized for two days. (admitted on 10/17/02 and discharged on 10/19/02) for having a fairly severe allergic reaction to the FLUZONE vaccine. The patient experienced a persistent flushing, but it was unclear if it was a persistent allergic reaction as opposed to a pyrogenic response to the vaccine. No definite allergic reactions were noted, although she did have an episode of flushing and felt poorly. Treatment included steroids and H2 and H1 blockade. The patient was discharged on 40mg of Prednisone for four days, then tapered off of it, Zyrtec once daily and 400mg of Tagamet twice a day. on the day of discharge, there was no evidence of any severe end-organ damage, such as shock, bronchospasm or stridor. The patient was eating, walking and desired to be discharged. The patietn was discharged in improved contidion, but did not have a headache, for which Advil and/or Ultracet were not very effective. It was not reported whether the patient recovered from these events.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Thrombocythaemia
Clinical narrative: From faxed correspondence received at manufacturer on 10/22/02, it was reported by a health care professional that a 45 year old female, who on 10/15/02 at 15:00 was vaccinated Fluzone (lot # U0910AA) IM in the left deltoid. Five minutes after vaccination, the patient experienced nausea, flushed face, difficulty swallowing, and shortness of breath. She was seen in the ER and treated with Solu-medrol IV, Pepcid IV, and oxygen. She was discharged to home with Prednisone dose pack and Tagamet. On 10/16/02, the patient presented in the ER again and was hospitalized on 10/17/02 for two days. Patient recovered. From additional information received on 10/2/03 from the employee health deparmtent at a hospital, it was reported that the patient was hospitalized for two days. (admitted on 10/17/02 and discharged on 10/19/02) for having a fairly severe allergic reaction to the FLUZONE vaccine. The patient experienced a persistent flushing, but it was unclear if it was a persistent allergic reaction as opposed to a pyrogenic response to the vaccine. No definite allergic reactions were noted, although she did have an episode of flushing and felt poorly. Treatment included steroids and H2 and H1 blockade. The patient was discharged on 40mg of Prednisone for four days, then tapered off of it, Zyrtec once daily and 400mg of Tagamet twice a day. on the day of discharge, there was no evidence of any severe end-organ damage, such as shock, bronchospasm or stridor. The patient was eating, walking and desired to be discharged. The patietn was discharged in improved contidion, but did not have a headache, for which Advil and/or Ultracet were not very effective. It was not reported whether the patient recovered from these events.
Age: 14.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Amnesia, Dizziness, Feeling abnormal, Headache, Hypersensitivity
Clinical narrative: It was reported that a 14 year old male pt, received TD ADS Adult on 9/24/02. Four hours following vaccination, the pt was taken to hospital complaining of severe pain in his lower back and both legs, headache, and amnesia. Blood work included a Lyme titer and blood chemistry. A CT scan of the head was negative. He was evaluated by a neurologist and neurological examination was normal. He was evaluated again by a physician on 9/25/02. Reportedly, the pain resolved, but he continues to have episodes of intermittent amnesia. From additional correspondence received via telephone on 10/22/02 it was reported four hours post vaccination the pt was rushed to ER of a local hospital with difficulty breathing, myalgia in back and lower extremities and mental confusion. The respiratory distress abated, pain was controlled with analgesics and the pt was sent home and advised to return to physician. The pt has and continues to have total amnesia, with a negative neurological evaluation and negative CT scan. The pt has a history of historical blindness last year for 3-4 weeks. However, he has been an active student and core member of the local football team. The pt will be further evaluated by physician. Seriousness criteria: other medically significant event (OMIC). A 15-day follow up report received 9/9/2003 adds: From additional info received on 09/02/2003 from the reporting physician, it was reported that the pt had a routine physical taken at the time of vaccination on 09/24/2002. The pt info was also updated. No additional info is anticipated, this case is considered closed.
Age: 14.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Nausea, Pain, Photosensitivity reaction
Clinical narrative: It was reported that a 14 year old male pt, received TD ADS Adult on 9/24/02. Four hours following vaccination, the pt was taken to hospital complaining of severe pain in his lower back and both legs, headache, and amnesia. Blood work included a Lyme titer and blood chemistry. A CT scan of the head was negative. He was evaluated by a neurologist and neurological examination was normal. He was evaluated again by a physician on 9/25/02. Reportedly, the pain resolved, but he continues to have episodes of intermittent amnesia. From additional correspondence received via telephone on 10/22/02 it was reported four hours post vaccination the pt was rushed to ER of a local hospital with difficulty breathing, myalgia in back and lower extremities and mental confusion. The respiratory distress abated, pain was controlled with analgesics and the pt was sent home and advised to return to physician. The pt has and continues to have total amnesia, with a negative neurological evaluation and negative CT scan. The pt has a history of historical blindness last year for 3-4 weeks. However, he has been an active student and core member of the local football team. The pt will be further evaluated by physician. Seriousness criteria: other medically significant event (OMIC). A 15-day follow up report received 9/9/2003 adds: From additional info received on 09/02/2003 from the reporting physician, it was reported that the pt had a routine physical taken at the time of vaccination on 09/24/2002. The pt info was also updated. No additional info is anticipated, this case is considered closed.
Age: 14.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Amnesia, Back pain, Confusional state, Dyspnoea, Headache
Clinical narrative: It was reported that a 14 year old male pt, received TD ADS Adult on 9/24/02. Four hours following vaccination, the pt was taken to hospital complaining of severe pain in his lower back and both legs, headache, and amnesia. Blood work included a Lyme titer and blood chemistry. A CT scan of the head was negative. He was evaluated by a neurologist and neurological examination was normal. He was evaluated again by a physician on 9/25/02. Reportedly, the pain resolved, but he continues to have episodes of intermittent amnesia. From additional correspondence received via telephone on 10/22/02 it was reported four hours post vaccination the pt was rushed to ER of a local hospital with difficulty breathing, myalgia in back and lower extremities and mental confusion. The respiratory distress abated, pain was controlled with analgesics and the pt was sent home and advised to return to physician. The pt has and continues to have total amnesia, with a negative neurological evaluation and negative CT scan. The pt has a history of historical blindness last year for 3-4 weeks. However, he has been an active student and core member of the local football team. The pt will be further evaluated by physician. Seriousness criteria: other medically significant event (OMIC). A 15-day follow up report received 9/9/2003 adds: From additional info received on 09/02/2003 from the reporting physician, it was reported that the pt had a routine physical taken at the time of vaccination on 09/24/2002. The pt info was also updated. No additional info is anticipated, this case is considered closed.
Age: 14.0
Sex: M
Vaccine: TTOX, TD
Symptoms: Myalgia
Clinical narrative: It was reported that a 14 year old male pt, received TD ADS Adult on 9/24/02. Four hours following vaccination, the pt was taken to hospital complaining of severe pain in his lower back and both legs, headache, and amnesia. Blood work included a Lyme titer and blood chemistry. A CT scan of the head was negative. He was evaluated by a neurologist and neurological examination was normal. He was evaluated again by a physician on 9/25/02. Reportedly, the pain resolved, but he continues to have episodes of intermittent amnesia. From additional correspondence received via telephone on 10/22/02 it was reported four hours post vaccination the pt was rushed to ER of a local hospital with difficulty breathing, myalgia in back and lower extremities and mental confusion. The respiratory distress abated, pain was controlled with analgesics and the pt was sent home and advised to return to physician. The pt has and continues to have total amnesia, with a negative neurological evaluation and negative CT scan. The pt has a history of historical blindness last year for 3-4 weeks. However, he has been an active student and core member of the local football team. The pt will be further evaluated by physician. Seriousness criteria: other medically significant event (OMIC). A 15-day follow up report received 9/9/2003 adds: From additional info received on 09/02/2003 from the reporting physician, it was reported that the pt had a routine physical taken at the time of vaccination on 09/24/2002. The pt info was also updated. No additional info is anticipated, this case is considered closed.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia
Clinical narrative: Information has been received from an 81 year old female pt, born on 12/27/1920, who was vaccinated with Fluzone SV '2002-'2003 USP on 10/17/02. The day after vaccination, she felt weak-had no strength. She was admitted to hospital on 10/20/02 and was discharged the next day. The outcome of the event was not reported.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, VARCEL
Symptoms: Respiratory distress, Sepsis
Clinical narrative: A pediatric infectious disease physician reported that a 12 month old male child received a 3rd dose of Prevnar, 2nd dose of HibTiter, 2nd dose of Infanrix, 2nd dose of Polio vaccine, and Varivax vaccines on 1/11/02. Medical history includes cough and fever. The onset date of pneumococcal illness was reported as 3/12/02, when the pt was 14 months old. On 3/18/02, the child presented to the health care providers office in respiratory distress. On 3/18/02, the child was hospitalized and diagnosed with bacteremia due to streptococcus pneumoniae from pneumonia and empyema. A "chest x-ray was C/W (consistent with) fluid, and pneumonia." A blood culture and pleural fluid culture were positive for streptocuccus pneumoniae, serotype 19A (not a Prevnar serotype) and a white blood cell count was 30,000. The child underwent a thorascopic decortication and was treated with antibiotics. On 3/28/02, the pt was discharged from the hospital to home. He recovered and "did well." These events were considered life-threatening and required medical intervention. No additional info was available as of the date of this report.   A 15-day followup report dated 01/23/2003 adds:  PNEUMOCOCCAL SEPSIS (LLT PNEUMOCOCCAL SEPSIS): Pneumonia pneumococcal (LLT Pneumonia Pneumococcal); Empyema NOS (LLT Empyema NOS): Drug ineffective (LLT Drug ineffective)  PNEUMOCOCCAL SEPSIS. Follow-up information received 1/10/2003 contained test results and other medical records from hospitalization.
Age: 2.2
Sex: M
Vaccine: DTAP
Symptoms: Asthma, Cellulitis, Fungal infection
Clinical narrative: Cellulitis left thigh. Admitted through the ER and IV antibiotics to admitted to hospital x 3 days. Resolved cellulitis. No sequelae. No complications.   Nurse follow up on 07/08/04 states: "candidal diaper rash, reactive airway disease."
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: On 10/10/02 pt noticed red spots on calf, by 10/12/02 pt had wide spread rash, physician on-call notified by pt andwas placed on medrol pk. Hosp admit on 10/15/02 for urticaria.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site rash, Purpura
Clinical narrative: Developed a rash around the injection site within several hours of receiving shot. Rash looked similar to her eruption the previous year. Within 2 days the pruritic rash erupted over her entire body surface except for palms and soles of the feet. She was treated by primary care but has no documentation of the type. At one point, the lesions revealed fungal elements on culture. She used Lotrimin as well as cortisone cream. The rash subsided in 2 weeks everywhere but her legs and the antecubital fossa. The condition was active from March 2000 through February 2002.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Pruritic rash to face and body.
Age: 25.0
Sex: F
Vaccine: HEPAB, YF
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema, Pruritus
Clinical narrative: 10/16/02 injection site edema and warm to touch, pruritis and erythema. On 10/17, patient called office and instructed to use cold compresses 20 minutes on/20 minutes off and NSAID analgesic. Call office 10/18 if no improvement. Patient called office 10/18/02, instructed to return to office. Injection site edema, erythema, pruritis with induration about 10cm. Center firm and warm to palpitation. Instructed to apply head 20 minutes on/20 minutes off.
Age: 15.0
Sex: M
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: Developed urticaria 24 hours after Pediatric DT and Prevnar.
Sex: U
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling hot, Injection site erythema, Pain, Rash
Clinical narrative: The infection control nurse at hospital received reports of two employees--one male and one female--with localized red, hot reaction at the site of an influenza vaccine injection. The male reported additional pain under the arm. A third employee reported a rash 12 hours after receiving the vaccine plus shortness of breath. Our nurse contacted the manufacturer about her concern that the 5/8 inch needle on the pre-filled syringe was too short in most cases for proper administration of this IM preparation. If the vaccine was being delivered into the SC tissue instead of muscle, would adverse reactions be increased and would clinical efficacy be diminished. Response from manufacturer quoted that decision on needle size must be individualized and that 1 to 1.5 inch need length is recommended for IM injection into the deltoid muscle in all adults. Based on this information, we are puzzled why manufacturer chose to package their products with a 5/8 inch needle.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Abnormal behaviour, Insomnia, Listless
Clinical narrative: Took pt to doctor on 10/14/02 for check up and to get scripts for services for school. While there they said he needed a TD shot. They gave it to him. The next day the school called and said he was pacing back and forth saying the same phrase over and over -they had never seen before-the next day after this he was raging by the weekend we at home had notice he was flapping and by Sunday he had developed a what I think is a vocal tic, and yesterday the 23rd he has developed insomnia. These things tend to happen late at night or when he may be under stress but hav never happened before.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Soreness and weakness in left arm since shot.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Heart rate increased, Pharyngolaryngeal pain, Wheezing
Clinical narrative: Chills-sore throat-cough-wheezing and some fast heart beat-was all gone in 3 days, doing fine now.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Eye disorder, Facial palsy, Feeling abnormal, Hot flush
Clinical narrative: Received flu shot 10/17/02. Early Fri morning felt achy all over, but resolved. On 10/22/02 felt 'bad" in general. Wed 10/23 became achy again; flushed that evening. Thurs aft. 10/24/02 noticed L side of face drooping, mouth feeling "funny." Unable to blink L eye or drink well mouth not closing completely. Saw MD dx. with Bell's palsy. Given eye oint. on 10/31/02. Also c/o pain L ear.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Received flu shot 10/17/02. Early Fri morning felt achy all over, but resolved. On 10/22/02 felt 'bad" in general. Wed 10/23 became achy again; flushed that evening. Thurs aft. 10/24/02 noticed L side of face drooping, mouth feeling "funny." Unable to blink L eye or drink well mouth not closing completely. Saw MD dx. with Bell's palsy. Given eye oint. on 10/31/02. Also c/o pain L ear.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Headache, sweating, nausea, vomiting, diarrhea.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Cognitive disorder, Injection site hypersensitivity, Pruritus, Vision blurred
Clinical narrative: 45 min after to receiving IM flu vaccine noticed itching at injection site, arm and trunk. Blurred vision and cognitive impairment. Went to hospital ER.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Anorexia, Body temperature increased, Lethargy, Pain
Clinical narrative: Pt had lethargy, body aches, chilled and slight increase of temp. no appetite.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Feeling hot, Pain
Clinical narrative: Pt c/o redness and pain, hot to touch.
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Headache, Myalgia
Clinical narrative: 10/09/2002 evening- temp 100-102.7, muscles aches , headache, 10/10/2002- temp increase 102.7. pt has had increase of temp for 7 days since 10/08/2002. Last pt seen by MD on day 6 given antibiotics and Allegra. Last night temp 103.7. Pt took 2 ASA BID- History triple bypass. 05/01 concerned with notting. MD examined pt. No apparent infection on OE
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Wife reported within 1 hour of receiving vaccine, severe h/a. During that night, achy , chills, sweats, temp 101 degrees. Remained in bed for 19 hrs. Notified MD- Tylenol and liquids- treatment . 2nd day after vaccine. sweating, nausea, dizzy. Last flu vaccine apprx. 10 yrs
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pyrexia
Clinical narrative: Wife reported within 1 hour of receiving vaccine, severe h/a. During that night, achy , chills, sweats, temp 101 degrees. Remained in bed for 19 hrs. Notified MD- Tylenol and liquids- treatment . 2nd day after vaccine. sweating, nausea, dizzy. Last flu vaccine apprx. 10 yrs
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Chest discomfort, Dizziness, Pallor
Clinical narrative: Pt became dizzy, pale, felt faint. We laid pt down. BP 99/45, pulse 57 following BP 15 minutes 113/57 with pule 55. No airway difficulties but tightness in chest after 30 minutes felt better and left.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: 10/25/2002 Pt received flu shot and pheumonia shot . Arm received pheumonia shot in QT red and warm to touch. Started on 10/26/2002
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Tachycardia, Vomiting
Clinical narrative: Nausea, vomiting, dry heaves, tachycardia until 5am 10/17/02. Pt noted similar reaction from previous hep B vaccination. (Possible reaction preservative component?)
Age: 80.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Hypokinesia, Myalgia
Clinical narrative: Dizziness. Couldn't move and get up. Muscle aches. Patient recovered within 3 days. Has not seen or called physician. Change to non-serious.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Blood creatine phosphokinase increased, Leukocytosis, Rash, Thrombocythaemia
Clinical narrative: Pt admitted for 48 hrs due to rash on abdomen and buttocks, possible bacterial infection. Seen by ID and dermatologist, diagnosed with fixed drug reaction most likely due to the vaccine given prior to admission.
Age: 2.5
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Bronchitis, Convulsion, Rash
Clinical narrative: On 5/5/01 she had 4 seizures and was hospitalized for 5 days. On 04/24/2002, child was diagnosed with bronchitis and treated with Zithromax. After a rash developed, the Zithromax was discontinued on approximately 04/30/2002 and Benadryl prescribed. Rash abated. (Above information is in addition to seizures previously reported for 05/05/2001)On May 5th 2001 she had four seizures and was hospitalized for five days.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Large area of swelling and redness in and around the injection site for Dipt-Tet injection Lot # V0817AA.
Age: 21.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Large redness, painful are on L arm at injection site. Rx with steroids, Benadryl and antibiotics.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nausea, Rash macular, Swelling face, Vertigo
Clinical narrative: Sudden onset vertigo, nausea, vomiting followed by facial swelling and red blotches went to ER given o2 and Phenergan.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Sudden onset vertigo, nausea, vomiting followed by facial swelling and red blotches went to ER given o2 and Phenergan.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Back pain, Eye discharge, Eye pain, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Intensive pain left back-deltoid-pectoral muscles 5 days. 2nd day whole shoulder area turned red like bad sun burn. 3rd day whole area real itchy. First three days mucus discharge would glue eyes shut in mornings. Eyes painful for 3 days.
Age: 75.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Pruritus
Clinical narrative: Intensive pain left back-deltoid-pectoral muscles 5 days. 2nd day whole shoulder area turned red like bad sun burn. 3rd day whole area real itchy. First three days mucus discharge would glue eyes shut in mornings. Eyes painful for 3 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: On 10/18/02 bruising at site of injection then redness/itching started on 10/19/02.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis R arm given Dynabac 250mg #16.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives on trunk, Benadryl 25-50 q 4-6h. Prednisone 40mg T QD x 5 days.
Age: 1.6
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 15cm x 10cm erythema around injection site/5cm x 5cm induration around inj site/L thigh. Minimal tenderness.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Erythema, Pulse absent
Clinical narrative: Influenza vaccine administered at library. Client denied allergy to eggs. Had never experienced contact with thimerosal. Denied allergy to latex. Reported never having had a flu vaccine. Flu vaccine administered as prescribed by CDC. Instructed to stay for 20 minutes. As client walking to chair, client collapsed. Right side of face and body to midline turned red. Shallow respirations and weak or no pulse. 911 activated. 0.3mg epinephrine x2 administered IM right thigh. Client regained consciousness and was transported to hospital. Called 10/24/02 and spoke with father of client and he reported that client was discharged from ER at 5:00PM and was resting. Called 10/25/02 and spoke with father of client and he reported that client was sore in neck and chin but was doing OK. Suggested that client should see her family MD and not take any more flu vaccine in future.
Age: 76.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Injection site pain, Injection site swelling, Skin discolouration
Clinical narrative: Injection site right upper arm. Patient reported swelling from elbow to lower arm next day. Area from elbow down was red, warm to touch, swollen, discoloration noted on elbow. State slight soreness at injection site. Questionnable cellulitis.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Erythema, Injection site pain, Nervousness, Pruritus
Clinical narrative: itching, redness & slight soreness in injection area along left arm, slight nervousness, mild scratchy throat/cough post injection.  Patient took P/O Ephedrine hydrachloride & Diphenhydramine hydrachloride
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site induration, Rash
Clinical narrative: Coarse rash on chest and right thigh with induration; developed 1 day after immunizations; right thigh site of Comvax and Prevnar; treated with diphenhydramine
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Chills
Clinical narrative: Time: 13 hours after administration of flu vaccine.  Patient awoke 1 hour after going to sleep and experienced episode of extreme full-body shivering.  Went on for about 1/2 to 1 hour or so and then subsided.
Age: 57.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Erythema, Joint stiffness, Joint swelling, Pain
Clinical narrative: It was reported that a 57 year old female patient received an injection of IPOL and Hepatitis A on 5/30/00. Reportedly the patient experienced sensation of a knot in her throat, pain in both great toes and redness, stiffness and swelling of the fingers on both hands. The patient was treated with rofecoxib and recovered. From additional information received on 2/20/01, it was reported 24 hours after injections, knot in throat for 1 week. 30 hours after pain in both large toes for 1-2 weeks. 48 hours after redness, stiffness, swelling in fingers both hands--migrated finger to finger. Placed on VIOXX for 5 weeks by PCP. Patient states arthritis panel and Lyme tests negative. Reportedly the patient recovered from this experience.