chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: IPV, MEN, YF
Symptoms: Eyelid oedema, Urticaria
Clinical narrative: Information has been received on 10/10/02 from a nurse concerning a 13 year old female that was vaccinated with a dose of YF-VAX (lot number UB213AA), IPOL (lot number U10821), and Menomune (UB076AA) on 6/19/02. She developed hives and swelling of the eyelids two hours after vaccination. She was given oral Benadryl by her mother prior to going to the physician's office. She was treated with epinephrine and oxygen at the physician's office. The symptoms resolved per reporter. It was stated by the reporter that the pt, was vaccinated with YF-VAX in the past without incident. Mother denied allergy history. Pt does have sickle cell anemia but is on no medications. It was also reported byt he mother that pt was consuming food prepared by a local vendor when the symptoms developed. Reporter stated, "We are assuming it was the yellow fever vaccine." The cause of the symptoms has not been medically confirmed. Seriousness criteria: other medically significant (OMIC). The follow up received on 7/17/03: New version created in preparation of addendum report (6/1/02-12/31/02): data entry error correction within the system, case is medically confirmed.  A 15-day follow up report received 09/09/2003 adds: From additional info received on 09/02/2003 from the vaccine administrator, it was reported that on 06/19/2002 the pt received her second dose of YF-VAX, administered subcutaneously in the left arm, a second dose of Menomune A/C/Y/W-135, administered subcutaneously in the left arm, and a fifth dose of IPOL, administered subcutaneously in the right arm. The pt info and the reporting physician's info were also updated. Additional info is not anticipated, this case is considered closed.
Age: 29.0
Sex: F
Vaccine: UNK
Symptoms: Antisocial behaviour, Convulsion, Dyskinesia, Rash, Staring
Clinical narrative: Pt took her 14 mo booster and about 10 days later I found her unconscious in her bed. Her eyes were set and we rushed her to the hospital. After test the doctor couldn't find anything until she broke out in rash over stomach. She had a reaction to the measles part of vaccine. She don't know they were done was having convulsions. She was on phenobarbitol for about a year. Lay in her bed and jerked when sleeping still does sometimes and also prefers sleeping in a chair. She can't get along with anyone well enough to hold a job and I had to take her out of school because she couldn't get along with her teachers. She has had a serious accident because she was having convulsions with high fever (she always does). She has been in hosp several times because of convulsions and stayed in a seizure for a long time, possibly over an hr. She has to sleep a lot and tires very quickly.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Swelling, redness, and warm to touch below immunization site. No c/o's pain.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Irritability
Clinical narrative: Fever, fussy all night especially at 1am. Tylenol given before vaccination, 4pm and again at 1am. Seizure at 5am. Taken to ER. Temp 102 degrees per ear. Motrin given. Stayed in hospital for observation until 4pm 10/4/02.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Cellulitis, Dehydration, Diarrhoea, Fall
Clinical narrative: Both flu and pneumonia shots given on 10/4/02 in different arms. One day later arm became very swollen and sore R arm where pneumonia shot given. She became very weak and fell x 2. Went to MD and he placed in hospital x 2 days with IV antibiotics. Vomiting, diarrhea, and dehydration.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injection site oedema, Injection site pain, Pyrexia, Vomiting
Clinical narrative: Both flu and pneumonia shots given on 10/4/02 in different arms. One day later arm became very swollen and sore R arm where pneumonia shot given. She became very weak and fell x 2. Went to MD and he placed in hospital x 2 days with IV antibiotics. Vomiting, diarrhea, and dehydration.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Asthenia, Fall, Injection site oedema, Injection site pain
Clinical narrative: Both flu and pneumonia shots given on 10/4/02 in different arms. One day later arm became very swollen and sore R arm where pneumonia shot given. She became very weak and fell x 2. Went to MD and he placed in hospital x 2 days with IV antibiotics. Vomiting, diarrhea, and dehydration.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Vomiting
Clinical narrative: Two hours (2pm) after leaving clinic baby vomited profusely. Mom had just changed formula to Alsoy due to spitting. By 4pm vomiting continued and parents took baby to ER where he was admitted. Pt was on IV's then Pedialite, then Isomil. He kept formula down on 9/19/02 and was discharged at 10:30pm. Vomited again 9/20/02. PCP changed formula to Almenlam on 9/21/02 okay now.
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Flushing, Nausea
Clinical narrative: Nausea, flushed face, difficulty swallowing, short of breath. Seen in ED, treated with Solumedrol, Pepcid IV, Discharged home with Prednisone dose pack and Tagamet. Seen in ED again 10/16 then hospitalized 10/17 for continued
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Flushing, Leukocytosis, Nausea
Clinical narrative: Nausea, flushed face, difficulty swallowing, short of breath. Seen in ED, treated with Solumedrol, Pepcid IV, Discharged home with Prednisone dose pack and Tagamet. Seen in ED again 10/16 then hospitalized 10/17 for continued
Age: 45.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Thrombocythaemia
Clinical narrative: Nausea, flushed face, difficulty swallowing, short of breath. Seen in ED, treated with Solumedrol, Pepcid IV, Discharged home with Prednisone dose pack and Tagamet. Seen in ED again 10/16 then hospitalized 10/17 for continued
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Bronchospasm, Erythema, Face oedema, Rash, Rash macular
Clinical narrative: 6/25/02 Rash developed; Mom gave Aveeno Bath and Benadryl. 6/26/02 Large, blotchy reddened areas on legs, arms, back and chest. Lower lip swelling, diffuse erythema of face, trunk, extremities, bronchospasm. 6/25/02 Benadryl 12.5mg PO for 6 hours; Solumedrol 12mg IV for 6 hours.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site reaction, Pyrexia
Clinical narrative: 6/20/02 L arm was war, pink-swollen. Temp 102 degrees-sent to medical center-was admitted. DX: cellulitis (10pm 6/20/02) left arm. Discharge DX: cellulitis of arm/drug reaction 6/21/02. Discharged 6/21/02.
Age: 4.5
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Torticollis
Clinical narrative: 6/20/02 L arm was war, pink-swollen. Temp 102 degrees-sent to medical center-was admitted. DX: cellulitis (10pm 6/20/02) left arm. Discharge DX: cellulitis of arm/drug reaction 6/21/02. Discharged 6/21/02.
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Convulsion, Loss of consciousness, Otitis media, Vomiting
Clinical narrative: Begun vomiting 9/20/02. Acted normal 9/21/02. 9/22/02 6am had seizure lost consciousness and transported by ambulance to hospital. Diagnosed with mild ear infection. Told to give Tylenol-child afebrile at that time. Before left ER had another seizure. CT scan of head normal spinal tap normal. Started on Tegretol 9pm 9/22/02. Per 60 day follow up: Pt has recovered. Off seizure meds. No further seizures.  Follow up on 11/05/2003: "Vaccine recipient did recover from adverse event.  No further seizures as of 09/28/2003."
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Had 104 degree F temperature and non-stop crying for 3 hours or more on 9/10/02.
Age: 0.5
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: High fever to 103. Reaction to previous injection but was unsure this was cause.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Injection site erythema, Pyrexia, Screaming
Clinical narrative: Screaming, red at immunization site. Right, bright red size of nickel. Temperature 101. Screaming/unconsolable for 8-10 hours.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Injection site rash, Rash papular
Clinical narrative: Had DTaP administered on 10/15/02 L thigh within 48 hours had papular rash starting at site of injection over next 24 hours rash spread to arms/legs/face/abdomen.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Patient reports after getting home, noticed redness and swelling. States swelling occurred from injection site to elbow. Redness, swelling and warmth noted to elbow today. Patient states improving since 10/02/02.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Has swelling at injection site R arm. Redness as well.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Feeling hot, Injection site swelling
Clinical narrative: Fever and swelling at site of injection.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Eye oedema, Fatigue, Injection site pain, Musculoskeletal stiffness
Clinical narrative: On the after post receiving flu vaccine, pt began feeling dizzy. By 3-4 hours later pt woke up and eyes were swollen shut. By am, pt was feeling generalized fatigue, neck was stiff, arm where shot was administered was very sore.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: Reddened area quarter size; soreness; warm to touch.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Flu shot given 9/30/02 at 3:30pm. 10//02 around 3pm arm began to become sore and warm to touch. Arm check 10/3/02 area slight warm to touch with no swelling. Cold to area, to take Advil and Benadryl.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Pyrexia, Swelling
Clinical narrative: Cellulitis left arm, extreme swelling left arm and fever of 100.4. Discomfort lasted approximately 1 week. Note: reported 10/10/02 to us.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives/urticaria. Treatment = Claritin 10mg #10.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia
Clinical narrative: Soreness of index and middle finger of the left hand. Difficult to bend index finger. Fingers are still sore but not difficulty in bending. No numbness. Circulation fine.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt seen 10/16/02 12x8cm erythema/induration at site of injection, developed over lost 24 hours since injection. Resolving as of 10/18/02.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Half-dollar size swelling and itching at injection site. Accompanied with fever at injection site noticed about 3 hours after vaccine administered. Treated with Allegra 180mg PO QD for 7 days prescribed by PMD.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Eye oedema, Face oedema, Hypokinesia, Injection site erythema
Clinical narrative: Pt denies fever, chills. Shortly after injection site red, arm swollen. Next day still with swelling redness to affected arm. Two days after injection couldn't raise arm, eyes swollen, cheeks inflammed. Three days some SOB. Seen 10/14/02-face swollen, swelling pain left arm. Tx: Madrol dose pak and Benadryl. Still resolving.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site oedema, Pain
Clinical narrative: Pt denies fever, chills. Shortly after injection site red, arm swollen. Next day still with swelling redness to affected arm. Two days after injection couldn't raise arm, eyes swollen, cheeks inflammed. Three days some SOB. Seen 10/14/02-face swollen, swelling pain left arm. Tx: Madrol dose pak and Benadryl. Still resolving.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Erythema, Injection site swelling, Pruritus
Clinical narrative: Patient denies fever or chills. Swelling of left arm above elbow to the shoulder. Initially 3" circle at affected area, redness, itching, swelling. Received Solumedrol injection 125mg. 10/17/02 Still itches; faded bruising yellow/green
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Client Employee called to say today that her Lt arm above the elbow is red, sore and swollen since site had the flu vaccination Monday 10/14/02.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Injection site oedema, Injection site pain
Clinical narrative: Chills. Arm (left) continues to swell down to elbow and around inside arm-almost completely circles arm. Arm extremely sore to touch where swollen. Swollen area of arm very hot. Thurs. was freezing and by afternoon had the shakes. I was so cold, my hands were numb. Took bath to get warm. Took my temperature-it was 104. Had sweats. Missed work on 10/18/02.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Pyrexia, Tremor
Clinical narrative: Chills. Arm (left) continues to swell down to elbow and around inside arm-almost completely circles arm. Arm extremely sore to touch where swollen. Swollen area of arm very hot. Thurs. was freezing and by afternoon had the shakes. I was so cold, my hands were numb. Took bath to get warm. Took my temperature-it was 104. Had sweats. Missed work on 10/18/02.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea
Clinical narrative: Diarrhea starting 48 hours after vaccine, lasting 3 days, untreated, no nausea or other discomfort.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: Red rash.
Age: 4.25
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Mom brought child on 9/24/02 for four year old shots, which was DTaP, IPV and MMR. DTaP given in R deltoid with a 1" needle/syringe. On 9/25/02 client brought in by mom to show us arm where DTaP given R arm red and warm from deltoid down to elbow. Child is not running fever or fretting. Told mom use cold compresses and Benadryl po. If it does not get better return to clinic very large area of red and warm to touch.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Diarrhoea, Pyrexia, Tremor
Clinical narrative: Reported to health department 10/7/02 that after Hepatitis B (#3) vaccine on 10/3/02 became very weak, trembling; had joint pain approximately 2-3 hours after shot. Later that night, had temperature of 103-104 and diarrhea. Went to ER 10/4/02. Received IV fluid due to diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Red 5 1/2" x 2 1/2" LD no swelling warm to touch. 10/2/02 saw MD this am-advised Benadryl po qid x 5 days and ice per mom.
Age: 64.0
Sex: F
Vaccine: HEP, HEPA, TD
Symptoms: Abdominal pain, Diarrhoea, Lethargy
Clinical narrative: Abdominal pain - moderate to severe; diarrhea; lethargic.
Age: 13.0
Sex: M
Vaccine: TD
Symptoms: Musculoskeletal stiffness, Pyrexia, Sinusitis
Clinical narrative: Elevated temp 105.0 for three day: heavy feeling in head stiffness at base of neck. Has an appt. with MD on 9/23/02. F/U on MD appt; blood work doneon ABT +2. Dx with sinus infection.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: 9/11/02 Mother brought child in with itching and rash on arms, legs, back, abdomen and face. States noticed rash at 05:30. Referred to MD and was advised no more Hepatitis B; Rx for steroid for allergic reaction.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 9/14/02 pm L arm red, hot, swollen size of small apple, no fever-was seen in ER on 9/14/02 late pm-was given antibiotics. Saw Md on 9/16/02.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 9/15/02 pm-L arm red, hot, swollen size of small apple no fever-ER started on antibiotics. Saw MD on 9/16/02.
Age: 11.7
Sex: F
Vaccine: HEP, TD, VARCEL
Symptoms: Chest pain, Dysphagia, Eye swelling, Wheezing
Clinical narrative: Child had shots at approximately 3:45PM. Child and mom back in clinic at 4:09; child had wheezing, eyes swollen, chestpain, some difficulty swallowing. Epinephrine 1:1000 0.3 given. Patient sent to ER.
Age: 40.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Headache, Lymphadenopathy, Pain, Rash, Vomiting
Clinical narrative: 9/3/02 phone call from client c/o "pin and pain, headache, vomiting, swollen nodes in neck and arm pits." 9/6/02 states broke out in rash-all over body and still c/o painful nodes in neck and armpit.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received DTaP 9/4/02. On 9/5/02, mom noticed left arm at DTaP site swollen and red. Clinic nurse reports area 5"x5" swollen and tight. No fever reported per mom. Child otherwise OK. Has been placed on Neosporin/warm compresses to area. 9/9/02 Mom reports child ok.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Pain, Pruritus, Swelling
Clinical narrative: Vaccinated on 9/3/02. Did not report any problems until 9/6/02 at 11:56AM. Patient states received Hepatitis B vaccine at 4:30PM while waiting in lobby waiting on her ride. Started itching around eyes, then up forehead, about 10 minutes after injection. Cleaning lady was cleaning lobby at time. Patient did not report to anyone at health department but left department building around 7 PM. Cheeks started itching around 8-830PM. Nasal itching and swelling which continued around 12:30PM. No other swelling were noted. 9/6/02 at 12:15 itching is better today, but feels achy body, no energy; took Benadryl 75mg. Patient at 6:30PM on 9/5/02 will go to MD.
Age: 0.7
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Feeling hot, Myalgia, Pyrexia
Clinical narrative: Tylenol given after shots. Woke up this am with Temp of 103 degrees. Arms and legs warm and sore
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Alopecia
Clinical narrative: On Tuesday, 9/24/02, received HBV then on Wednesday and Thursday, 9/25 and 9/25/02, 2/3 of hair on top of head fell out at root. Went to DR who performed complete thyroid work-up - normal.
Age: 4.2
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Developed rash chest, face and back. No fever. No rash on legs or arms; no vesicles; denies itching. No known allergies; receiving no medications. Mom stated has previously developed a rash 1 month after shots but is unable to state when.
Age: 39.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness
Clinical narrative: Complained of rush upon rabies vaccine injection. BP 138/78. Seen at health clinic. Diagnosis acute reaction to stress.
Age: 15.0
Sex: M
Vaccine: MMR, OPV, TD
Symptoms: Autism
Clinical narrative: Autism
Age: 14.0
Sex: M
Vaccine: HEP, IPV, MMR, TD
Symptoms: Dizziness, Syncope, Visual disturbance
Clinical narrative: Client fainted and hit head on cement floor shortly after receiving MMR. Td, Hepatitis B and IPV vaccination. Complained of dizziness and seeing spots before his eyes.
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Swelling
Clinical narrative: Within 24 hours, red/swollen thigh. Walking no obvious discomfort.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Swollen, redness, and warm to touch below immunization site. No complaints of pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient developed swelling of 4" diameter with warmth, induration and erythema left deltoid. Advised warm soaks, acetaminophen, ibuprofen. RTC if worsens
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Pain, Rash erythematous, Urticaria, Wheezing
Clinical narrative: 1.5 hours after MMR immunization, became dyspeneic with wheezing breathings. Red, raised, bumpy hive-like rash at injection site that spread to left shoulder and left upper back. outer area reddened and hurting. Complained of headache. To ER 1.5 hours later for Rx. Given inhaler and Benadryl at discharge.
Age: 6.0
Sex: M
Vaccine: DTP, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Chicken pox after vaccination. Onset 10/14/02.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site swelling, Tenderness
Clinical narrative: Developed 4cmX6cm swollen, tender, red, warm area at site of vaccination.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: 48 hours after receiving MMR, patient experience soreness, swelling and erythema at injection site. Patient sought medical care on 10/08/2002 and placed on PO antibiotics. Returned to DR on 10/14/02 for further treatment.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Pharyngolaryngeal pain, Pruritus, Rash
Clinical narrative: Gave vaccine at 15:00, started clearing throat immediately in our car. Went home; no difficulty breathing or wheezing. Gave Benadryl. Said throat hurt; got better after Benadryl. At 20:00 was giving bath; noticed itchy rash--raised on abdomen/neck flat. Called MD on call. Told to give 25mg Benadryl. Rash resolved. No other problems.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Right arm swollen and red starting 24 hours later with redness in upper arm radiated to lower forearm with increased swelling during the day; low grade temperature. Mom called doctor; instructed to give Benadryl and Motrin.
Age: 4.75
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Redness on the left deltoid area. No tenderness or fever. Given Motrin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Rash
Clinical narrative: 10/7/02 Patient received DTaP, IPV, MMR at our office. Called 10/9/02 with report right thigh with red rash at injection site. Patient evaluated 10/13/02 and treated.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: 10/8/02 pt received DTaP #5 in R delt at our office. Called 10/10/02 with report R delt was warm to touch, red and swollen. Pt was eval and treated 10/10/02.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling and redness at left deltoid.
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling at site of injection. Called care provider on 8/9/02 to report. Pt was active, playing, and afebrile. Home care treatment with instruction to take pt to cc if needed.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Paraesthesia
Clinical narrative: C/O left upper ext. paresthesia after 3rd Engerix B injection.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Rash started on 9th day post MMR. Rash started on neck and face first and then spread down the rest of the body. Large erythemaotus maculo papular rash. Rash resolved in approx 3 days.
Age: 31.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site urticaria
Clinical narrative: Pt received vaccine 8/23/02, persisted 8/27/02 with c/o redness, swelling and hives about site. No SOB. Swelling began 1-2 days post injection.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling left deltoid 8.5cm by 9.5cm and started 10/8/02 mid afternoon. Same size today, very warm to touch today. Entire lateral left arm swollen, with darker red area of deltoid. Keflex Rx.
Age: 8.0
Sex: M
Vaccine: DTPHIB, OPV, VARCEL
Symptoms: Drug ineffective, Rash vesicular
Clinical narrative: Patient received varivax vaccine 10/9/95. Complained of chicken pox > 50 spots about 10/11/2002.
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling, Pain, Rash, Urticaria
Clinical narrative: 2 hours after hepatitis B injection, left arm began to ache and swell. Patient took 2 Tylenol and did not report to clinic. 4 hours after injection, pain and swelling increased, rash/hives occurred from shoulder to elbow. Rx Benadryl 50mg PO, Tylenol, ice pack. Patient felt better. Rash/hives returned following day and was relieved with Benadryl for 2 days.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR
Symptoms: Rash erythematous, Rash papular, Urticaria
Clinical narrative: MMR and HIB given 10/4/02. 10/8/02 Mom reports fine rash. 10/13/02 Mom reports pin-point rash. 10/14/02 Physician visit- mixed rash/fine scattered papular and erythematous/hive-like on cheeks and trunk. Recommended soda baths, Benadryl syrup 1/4 to 1/2 teaspoon QID.
Age: 18.0
Sex: F
Vaccine: MEN, MMR
Symptoms: Musculoskeletal stiffness
Clinical narrative: Patient had stiff neck in arms of 8/15/02. Took Tylenol and taken to college by parents that day and participated in color guard twirling, rifle and saber. Has continued to participate in all activities. No medical attention sought. As of 9/16/02, still has stiff neck, hurts to look up. Mom and patient sure discomfort from Menomune.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Drug ineffective
Clinical narrative: Received phone call from school nurse, who said patient's new physician reported patient has contracted mild case of chicken pox.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash pustular, Skin ulcer
Clinical narrative: Several papular/pustular lesions on head, trunk. Some on extremities.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Urticaria
Clinical narrative: 4/1/02 DTaP, MMR, and IPV - all given in right upper arm. Immediate redness and progressed over 3 days to possible cellulitis. No response over 3 days to Motrin. Significant response to antibiotics. However, has had a single urticaria, positive peripheral erythema right side of one injection. Has recurred 5 times since vaccinated.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Agitation, Headache, Rash
Clinical narrative: Developed rash/skin colored bumps 10 minutes after receiving hepatitis B vaccine in left upper arm. Developed similar rash in right arm within 20 minutes. No respiratory problems. Rash lasted 3 days. Also had a headache/agitation for 1 hour, 3 hours after shot.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Insomnia, Pain
Clinical narrative: Severe pain in right arm, soreness, difficulty sleeping. Severe chills.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Pruritus, Rash
Clinical narrative: Rash with itching on chest. Consulted primary health provider. He advised rash maybe tow hep B vaccine. NO fever or other adverse reactions reported. Also reported stomach ache, initially. Meds Adderal, Clariten, Confeclar.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Rash, Urticaria
Clinical narrative: Flu like sxs-during night 9/27/02. Treated with Advil. Full body rash-bumps/face: hives 9/27/02 am. ER 9/29/02 pm-tx with Benadryl. MD 9/30/02 am. Dx Prednisone, Allegra. Still on Prednisone. Total of three seizures on 9/22. 9/23 am woke up hungry, but would not beat wt. cranky wanted held, curled into fetal position on mother's lap. To ER on 9/23/02 per advise of his pediatrician. Had EEG on 9/24/02. After being admitted to medical center on 9/23/02 for dehydration and IV's given for dehydration. Was discharged from hospital 9/24/02. Will be followed up by MD pediatric neurologist.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass
Clinical narrative: from telephone contact with reporting nurse supervisor, it was reported that a  4 year old male patient received his 5th dose  of Tripedia  Lot # UO532CA on 08/23/01 administered in the gluteus. A large lump developed with warmth to the touch on 04/25/01. This event resolved and the patient fully recovered.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: From telephone contact with reporting nurse supervisor, it was stated that a 4 year male patient received a Tripedia vaccination, Lot # UO532CA administered in the gluteous on 08/24/2001. The next day, 08/25/01, parent reported that the patient had a large area, the size of a baseball, reaction with redness. Resolved within a few days.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: From telephone contact with reporting nurse supervisot, it was stated that a 4 year old female patient received her 5th dose of Tripedia lot # UO532CA administered in the gluteal on 04/13/01. On 08/14/01, a large red area developed at the injection site. It resolved within a few days.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Oedema peripheral, Rash pruritic
Clinical narrative: From telephone contact with reporting LPN hat a 5 year old patient received a Tripedia vaccination Lot # UO532DA administered in left deltoid on 08/21/01. The patient's entire  arm from shoulder to elbow became red, swollen and itchy. The next day 08/22/01 with a 19.5 cm area. Physician saw the patient and prescribed Benadryl and Keflex. By 08/23/01, redness, swelling & itchiness were relieved.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash
Clinical narrative: From telephone contact received at a manufacturer's on 08/28/01, it was stated that a 4 year old received his 5th dose of Tripedia on 08/21/01. patient was seen on 08/23/01 at physician's office, his left thigh from thigh to knee was warm to the touch  with erythema and a rash with a lacey horder. Placed on Keflex,by 08/26/2001, all syptoms were resolved. It was reported on 10/25/01- Resolved, no addition information. This case is closed.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: From telephone conversation with reporting nurse it was stated that a 4 year old patient  (1 of 2) was administered Tripedia, Lot UO532CA administration date not provided. Sometimes after the vaccination, the patient developed a large local reaction consisting of redness, swelling and warmth from shoulder to elbow area. Patient was seen in office. This case is linked to case # U2001-01014.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: From telephone conversation with reporting nurse, it was stated that 4 year old patient (2 of 2) was administered Tripedia Lot #UO532CA, administered date not provided. Sometimes after the vaccination, the patient developed a large local reaction consisting of redness, swelling and warmth from shoulder to elbow area. Patient was seen in office. This case is linked with case # U200100975
Sex: U
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a patient  (1 of 2) received a Tripedia vaccination (Lot # UO536AA), administration date not specified). Reportedly, sometimes after the vaccination, the patient developed a severe local reaction with 5-6 cm swelling and erythema. Linked case U2001-001194
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site vesicles
Clinical narrative: Tripedia administered 10/24/01 in  same arm as IPOL Lot T1391 exp. 12/06/03 and MMR Lot # 0158L exp 1/31/03. Next day developed large local reaction and blisters on upper arm-treated symptomatically
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Dermatitis bullous, Injection site reaction
Clinical narrative: It was reported that a 5 year old female patient received an IPOl and a Tripedia vaccination in September 2000, (dosage, route, site and lot information was not reported). The patient developed a "severe site reaction to the Tripedia dose". The patient's mother sought medical attention for her daughter's experience.
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: It was reported that a male patient received a Tripedia vaccination on 11/16/1998. According to the reporter, the child experienced an immediate injection site reaction characterized by redness and swelling, fever and vomiting. He recovered after an unspecified period of time.
Sex: U
Vaccine: DTAP
Symptoms: Injection site oedema, Injection site reaction, Rash
Clinical narrative: It was reported that a patient (2 of 2) received a Tripedia  vaccination )Lot #U0536AA), administration date not specified. Reportedly. sometimes after the vaccination, the patient developed a severe local reaction with 5-6 cm swelling and erythema. Linked case: U2001-01022.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction
Clinical narrative: It was reported that an 18 month old male patient received a Tripedia vaccination administered IM in is right thigh on 09/24/01. On 09/25/01, the patient developed a swollen area at the site of injection the size of a jelly jar lid The area  was red, swollen, hardened and warm. Patient was given 1 tsp Benadryl every 6-8 hours PRN and cool compresses PRN. The patient recovered from this experience.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: It was reported that a 16 month old female patient received a Tripedia vaccination on 09/24/01. On 09/28/01, the patient developed red spots on her chest that were flat, blanching, the size of pimples No treatment was given, patient was just monitored. The patient reportedly recovered from this experience.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Oedema peripheral
Clinical narrative: It was reported that a 15month old male patient received a Tripedia vaccination ,lot 3 UO532CA, given IM in his left thigh on 09/12/01. On 09/13/01, the patient's leg became swollen at the thigh all the way to the top of the knee, thigh was red and warm. Treatment of Ibuprofen 100 mg per oral every 6-8 hours PRN and cool compresses PRN was given to the patient. He recovered from this experience.
Age: 29.0
Sex: F
Vaccine: HEPA, JEV
Symptoms: Anxiety, Chest pain, Hyperhidrosis, Hypertension, Vasodilatation
Clinical narrative: It was reported that a 29 year old female patient received a JE-VAX (SC) and a Hepatitis A (IM) (Merck) vaccination on 02/13/01 at 7:35 pm. Reportedly at 7:40 pm, the patient complained of feeling hot, sweaty and slightly faint. The patient was placed in supine position, blood pressure 134/70, pulse 94. Her doctor was notified STAT. At 7:42 pm, blood pressure 131/70, pulse 70, patient complained of tightness in chest, very anxious, funny feeling in chest. Epinephrine 1:1000 given IM left deltoid at 7:45 pm. At 7:50 pm, patient states she feels shaky all over, blood pressure 138/69, and pulse 100. 7:53 pm patient states she's not feeling good, blood pressure 155/67, and pulse 111. 7:57 pm blood pressure 163/69, pulse 101. Patient still shaking. Blood pressure 163/75, pulse 117, blood pressure 136/68, pulse 101, blood pressure 149/67, pulse 113, blood pressure 142/57. At 8;20 pm Benadryl 50 mg IM: STAT blood pressure 120/67, pulse 141. 8:23 pm, Oxygen given 2L by nasal cannula. Blood pressure 154/57, pulse 127 blood pressure 145/60, pulse 119, blood pressure 154/62, pulse 129, blood pressure 155/64, pulse 131. Patient transferred to another hospital. The patient reportedly recovered from this experience.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Arrhythmia, Hyperhidrosis, Nausea, Throat tightness
Clinical narrative: It was reported that a 40 year old female patient received a Fluzone SV '01-'02 vaccination, lot number U0681AA, on 10/26/01 at 6:20PM administered in her left deltoid. Within ten minutes the patient experienced heart arrythmia, her airway became tight, she was nauseous and sweating. Patient was administered EpiPen 0.3mg and 911 was called. Patient taken to emergency room. The employee of the pharmacy that administered the product spoke with the patient and the patient stated the doctors at the ER determined her reaction was due to lactose intolerance. She recovered from this experience.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Urticaria
Clinical narrative: It was reported that a 44 year old male patient received a Fluzone SV '01 -02 vaccination, Lot number U0593AA, administered on 09/24/01. The patient was seen in physician's office on 09/28/01 with a large local reaction - 17 X 10 cm reddened area at the injection site and also small hives on her chest. Upon examination, the patient's lungs were clear.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: From correspondence received on 11/12/01, it was reported that a 39 year old patient received a Fluzone SV '01-'02 vaccination lot #UO685Aa, exp. 06/02. Patient received the dose on 11/09/01. She experienced a local reaction consisting of site very red with red streaks. The patient also received a pneumonia vaccine.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site hypersensitivity, Pruritus, Rash macular, Urticaria
Clinical narrative: It was reported that a 52 year old male patient received a Fluzone SV 2001-2002 vaccination on 11/15/01 at 17:00 administered in his right deltoid. On 11/16/01 the patient developed itchy red spots on the right deltoid area. By 11/17/01, the patient developed itching all over both arms. By 20:30 Saturday 11/17/01, patient has itching and red blotches which the patient calls hives over entire body. Took honey and oatmeal solution bath, applied anti-itch ointment and this calmed itching. Seen 11/18/01, 16:45 itching and red blotches reappeared. Repeat bath and ointment helped very little. At 20:00 patient went to ER. HE was given Prednisone 20mg bid PO x5 days. He has an appointment with primary physician on Friday 11/23/01. Patient reports he continues to have break-through itching and blotches between doses of Prednisone. Has occasionally taken Benadryl for itching. Patient works in a lumbar yard; is exposed to wood products, insulation, paints, stains, chemicals and concrete building products. Patient also works at building construction.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Dysphonia, Fatigue, Nasal dryness, Urine analysis abnormal
Clinical narrative: It was reported by the patient that she; an 81 year old female received a Fluzone SV 2001-2002 vaccination on 10/6/01. The patient states, I dwindled into 4 weeks of complete misery, spending nights coughing my head off, not eating and sleeping well, and losing more than 12 pounds. The patient reportedly also lost her voice, which is finally slowly coming back after 6 weeks. The patient was prescribed antibiotic Zithromax on the 19th (month not specified) which helped. The patient's current recovery status is unknown. From additional correspondence received at manufacturer on 1/28/02 additional patient, vaccine, responsible physician and vaccine administrator information was provided. From follow up telephone conversation on 1/30/02 with the office manager at clinic, it was confirmed that the patient did receive Fluzone as reported and did experience laryngitis but all symptoms have resolved since then. Correction of vaccination date to 10/13/01.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Cough, Decreased appetite, Insomnia, Laryngitis, Pharyngitis
Clinical narrative: It was reported by the patient that she; an 81 year old female received a Fluzone SV 2001-2002 vaccination on 10/6/01. The patient states, I dwindled into 4 weeks of complete misery, spending nights coughing my head off, not eating and sleeping well, and losing more than 12 pounds. The patient reportedly also lost her voice, which is finally slowly coming back after 6 weeks. The patient was prescribed antibiotic Zithromax on the 19th (month not specified) which helped. The patient's current recovery status is unknown. From additional correspondence received at manufacturer on 1/28/02 additional patient, vaccine, responsible physician and vaccine administrator information was provided. From follow up telephone conversation on 1/30/02 with the office manager at clinic, it was confirmed that the patient did receive Fluzone as reported and did experience laryngitis but all symptoms have resolved since then. Correction of vaccination date to 10/13/01.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Rhinitis, Weight decreased
Clinical narrative: It was reported by the patient that she; an 81 year old female received a Fluzone SV 2001-2002 vaccination on 10/6/01. The patient states, I dwindled into 4 weeks of complete misery, spending nights coughing my head off, not eating and sleeping well, and losing more than 12 pounds. The patient reportedly also lost her voice, which is finally slowly coming back after 6 weeks. The patient was prescribed antibiotic Zithromax on the 19th (month not specified) which helped. The patient's current recovery status is unknown. From additional correspondence received at manufacturer on 1/28/02 additional patient, vaccine, responsible physician and vaccine administrator information was provided. From follow up telephone conversation on 1/30/02 with the office manager at clinic, it was confirmed that the patient did receive Fluzone as reported and did experience laryngitis but all symptoms have resolved since then. Correction of vaccination date to 10/13/01.
Age: 81.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Cough, Laryngitis, Oral intake reduced, Sleep disorder, Weight decreased
Clinical narrative: It was reported by the patient that she; an 81 year old female received a Fluzone SV 2001-2002 vaccination on 10/6/01. The patient states, I dwindled into 4 weeks of complete misery, spending nights coughing my head off, not eating and sleeping well, and losing more than 12 pounds. The patient reportedly also lost her voice, which is finally slowly coming back after 6 weeks. The patient was prescribed antibiotic Zithromax on the 19th (month not specified) which helped. The patient's current recovery status is unknown. From additional correspondence received at manufacturer on 1/28/02 additional patient, vaccine, responsible physician and vaccine administrator information was provided. From follow up telephone conversation on 1/30/02 with the office manager at clinic, it was confirmed that the patient did receive Fluzone as reported and did experience laryngitis but all symptoms have resolved since then. Correction of vaccination date to 10/13/01.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: From faxed correspondence received on 1/4/02 it was reported that a 52 year old male patient received a Fluzone SV 2001-2002 vaccination on 11/20/01. On 12/19/01 the patient was diagnosed with Guillain Barre Syndrome. He was hospitalized for eight days and is recuperating at home. His complete recovery may take three months. It is not expected that the patient will have any permanent disability. From additional correspondence received on 2/20/02 at manufacturer, it was reported: 2/6/02 I was notified that this person was readmitted to the hospital for 6 days for relapse of Guillain Barre. I have been in contact with the FDA. I believe they have a copy of this report.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Injection site haemorrhage, Injection site mass, Injection site pain
Clinical narrative: From faxed correspondence received 01/17/2002, it was reported that 64 year old  female received a Fluzone SV '01-'02 USP injection on 11/29/01 in left deltoid. Immediately shot was painful, bled a lot. Given high on shoulder, one finger below bone. Bruised within 15 minutes. Arm ached all day, night and next day Knot at side still dime-sized. Administered IM in left deltoid.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Ecchymosis, Injection site mass, Pain
Clinical narrative: From faxed correspondence received 01/17/2002, it was reported that 64 year old  female received a Fluzone SV '01-'02 USP injection on 11/29/01 in left deltoid. Immediately shot was painful, bled a lot. Given high on shoulder, one finger below bone. Bruised within 15 minutes. Arm ached all day, night and next day Knot at side still dime-sized. Administered IM in left deltoid.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Hypokinesia, Injection site pain, Injection site warmth, Pain
Clinical narrative: From correspondence received at manufacturer on 1/17/02 it was reported that a 51 year old female patient received a Fluzone SV 01-02 vaccination administered IM in her right deltoid on 11/29/01. That same day the patient's shoulder and arm became sore and warm. Upper forearm hurt Saturday night. Can't lift arm straight out or back such as to unhook bra or retrieve seat belt. Patient was seen by physicians and tried Ibuprofen (800mg) with heat on arm but no relief. Bursitis and Hergein anti-imflammatory and ice tried without relief. Seen by physician and was given Cortizone injection and diagnosed with tendonitis.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis
Clinical narrative: From correspondence received at manufacturer on 1/17/02 it was reported that a 51 year old female patient received a Fluzone SV 01-02 vaccination administered IM in her right deltoid on 11/29/01. That same day the patient's shoulder and arm became sore and warm. Upper forearm hurt Saturday night. Can't lift arm straight out or back such as to unhook bra or retrieve seat belt. Patient was seen by physicians and tried Ibuprofen (800mg) with heat on arm but no relief. Bursitis and Hergein anti-imflammatory and ice tried without relief. Seen by physician and was given Cortizone injection and diagnosed with tendonitis.
Age: 51.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling hot, Injection site reaction, Joint range of motion decreased, Tendonitis
Clinical narrative: From correspondence received at manufacturer on 1/17/02 it was reported that a 51 year old female patient received a Fluzone SV 01-02 vaccination administered IM in her right deltoid on 11/29/01. That same day the patient's shoulder and arm became sore and warm. Upper forearm hurt Saturday night. Can't lift arm straight out or back such as to unhook bra or retrieve seat belt. Patient was seen by physicians and tried Ibuprofen (800mg) with heat on arm but no relief. Bursitis and Hergein anti-imflammatory and ice tried without relief. Seen by physician and was given Cortizone injection and diagnosed with tendonitis.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Hypokinesia, Injection site oedema, Injection site pain, Muscular weakness, Pain
Clinical narrative: From correspondence received at manufacturer on 1/17/02 it was reported that a 44 year old female patient received a Fluzone SV 01-02 vaccination administered in her left deltoid, IM on 10/8/01. The injection was immediately painful and deltoid area swelled. Patient now has decreased ROM. Arm can't swing towards back and unhook bra or buckle a seat belt. Arm is weak, can't reach arm above head. Painful at night, aches all the time. Lying down causes increase in pain. Bursitis, given VIOXX with no relief. Per patient...now January, two to three times a week she sees muscle therapist or the doctor.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3, FLU3, FLU3
Symptoms: Bursitis, Injection site pain, Injection site swelling, Joint range of motion decreased, Neck pain
Clinical narrative: From correspondence received at manufacturer on 1/17/02 it was reported that a 44 year old female patient received a Fluzone SV 01-02 vaccination administered in her left deltoid, IM on 10/8/01. The injection was immediately painful and deltoid area swelled. Patient now has decreased ROM. Arm can't swing towards back and unhook bra or buckle a seat belt. Arm is weak, can't reach arm above head. Painful at night, aches all the time. Lying down causes increase in pain. Bursitis, given VIOXX with no relief. Per patient...now January, two to three times a week she sees muscle therapist or the doctor.