chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.5
Sex: F
Vaccine: VARCEL
Symptoms: Somnolence, Tooth disorder, Weight decreased
Clinical narrative: Pt was given Varivax when actually had chickenpox. The doctor did not notice the spots upon 7 yr check up. She became very sick that night with very high temps. over 103 F lasting for a week. She screamed when the lesions burst and said it felt like an electric shock over her body. Very sleepy, not appetite, many lesions over entire body-ears, mouth, private parts. Doctor called us in to surgery. Said vaccine made it better. Gave creams and Tylenol. Lasted 10 days. For next 3 months of weight loss, no appetite, headaches, skin warts, earaches, asthma, teeth troubles, finally diagnosed Type I diabetic on 10/26/99. I believe with all my heart and with the natural instincts of a mother that the vaccine of chickenpox given at time being sick with natural chickenpox totally compromise pt's immune system and made her double sick and sick on and off for the next 3 months until she was "officially" diagnosed with Type 1 Juvenile Diabetes. i do not believe this would have happened if she was not given the Varicella vaccine. I truly hope you consider the necessity of the vaccine being one that a family doctor "bullies" you into giving your otherwise healthy child. Respectfully signature. PS. So my child has not recovered and will not recover  until a CURE id discovered for Type 1 Diabetes. Until that time, we are in " slavery" to the Pharmacuetic Industry" An annual follow up report received 10/09/2003 adds: Pt is a Type 1 diabetic and will remain so. This will only change if a cure is discovered. I want to stress once more that the CDC review this vaccine as a causer of diabetics in children.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Chills, Confusional state, Cyanosis, Fatigue, Feeling cold
Clinical narrative: Approximately 10 minutes post receipt of vaccine, chills long lasted of feeling cold. Then tired, became pale, diaphoretic, slight cyanosis HR decreased to 68. Child was confused. Improved in color and mental status after Epinephrine SQ. Hospitalized for observation for 24 hrs. No recurrence.
Age: 4.0
Sex: M
Vaccine: PNC
Symptoms: Hyperhidrosis, Pallor, Syncope
Clinical narrative: Approximately 10 minutes post receipt of vaccine, chills long lasted of feeling cold. Then tired, became pale, diaphoretic, slight cyanosis HR decreased to 68. Child was confused. Improved in color and mental status after Epinephrine SQ. Hospitalized for observation for 24 hrs. No recurrence.
Age: 0.7
Sex: M
Vaccine: DTAP, PNC
Symptoms: Abnormal behaviour, Agitation, Tremor
Clinical narrative: 8/20/02 at approx 4:30 to say infant had behaved "strange" following his immunizations. The day before, received DTaP and Prevnar said infant had trembling-cried a lot and stated after that afternoon said infant did not behave "normal" a few hours after shots at time of call said infant was okay now but was concerned about behavior.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Lymphadenopathy, Lymphangitis
Clinical narrative: Cellulitis due to vaccinia vaccination with lymphangitis and drainage. No systemic symptoms. 1cm lymphadenopathy.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash papular
Clinical narrative: Developed itchy red papules 24 hrs after vaccination on abdomen, back, lower leg. Consistant with allergic reaction, not generalized vaccine.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site reaction, Lymphangitis
Clinical narrative: Cellulitis with lymphangitic spread from vaccinia vaccination site to left axilla; Tequin 400mg x 5d.
Age: 48.0
Sex: F
Vaccine: SMALL
Symptoms: Cellulitis, Injection site reaction, Lymphadenopathy, Lymphangitis
Clinical narrative: cellulitis m/b & pain over  immunization site, Increased drainage, lymphangitis & lymphdenopathy at day 7, Primary reaction on revaccination (Prior vaccination as child, scar present), treated with 5 days of Levaquine
Sex: U
Vaccine: TTOX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness on left arm, 10 cm mild induration and swollen(?)
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None reported.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain, Blood glucose decreased, Hyperhidrosis, Loss of consciousness, Paraesthesia
Clinical narrative: Pt fainted LOC for "a few seconds" per father. Pt c/o left abdomen cramping, tingling in hands, arms & jaw diaphoresis. Pt had not eaten since previous day. All symptoms were relieved in 30 mins. Pt had a regular can of Coke stated he felt fine, Went home with parents (No hospitalization)
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Rash
Clinical narrative: Red knot noted on left deltoid- 2" with a small purple dot noted in the middle of injection. Small white bumps were noted starting at red knots and going down arm in 1 inch strip to the elbow, No fever, Knot warm, Cool compress applied
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 48 hrs after receiving DTaP- left upper arm swelled & reddened, Tender to touch
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: swelling left deltoid
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Erythema, Flushing, Injection site erythema
Clinical narrative: Pt legs (where vaccines given) turned red, arms & face turned red. No diff. breathing, Gave 85 mg Benadryl, Positive response
Age: 13.0
Sex: F
Vaccine: TD
Symptoms: Hypokinesia, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: A 2' long deep red rash appeared on the pt's arm about an inch below the injection site. She then developed a rash that spread from her arm to her chest and neck area. Her arm was extremely sore for over a weekand therefore she had difficulty in mobilization.
Age: 1.25
Sex: M
Vaccine: DTAP, HEP
Symptoms: Hypokinesia, Injection site erythema, Injection site warmth, Vomiting
Clinical narrative: Left deltoid, redness, warm to touch, no swelling or fever, T-97.0, vomiting, less active, Referred to MD, MD gave RX. Phergan supp 12.5 mg, Suprex & Pedialyte.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Abdominal pain, Nausea, Pyrexia
Clinical narrative: Awoke with fever-12 hrs after vaccines, Seen 24 hrs after vaccines with temperature to 103.5 & diffuse abd pain with nausea,  All Sx resolved
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt presents with one day history of erythema , swelling & warmth to touch at injection site, Erythema 6 X 3 & induration
Age: 34.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Complained of tenderness with obvious 2-3" oblong raised, pink "welt" over left triceps where vaccine given, SC.
Age: 1.08
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash vesicular
Clinical narrative: Redness, swelling and satellite (vesicles) small in size and number, close to area of injection.
Sex: U
Vaccine: UNK
Symptoms: Asthenia, Cough, Pyrexia, Vomiting
Clinical narrative: High fever 102-104 very weak couldn't eat, still doesn't want to. Real bad cough and vomiting. Got shot on Tues got sick Sunday stayed sick 12 days. Nurse said she had a reaction bu told me to take her to private Dr. No ins. No money.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Unevaluable event
Clinical narrative: Left biceps 6cm X 4cm.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: One hour after vaccine, had hives. Still have some problems with hives as of 8/19/02 even after taking Benadryl but it resolving.
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: L upper arm sore, swollen and hard. Keflex 500mg TID.
Age: 22.0
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approx. 8 hours after Meningitis shot, developed pain, swell and erythema approx. 1" in diameter.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure after immunization. Required ER visit.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Muscle contractions involuntary
Clinical narrative: Child had brief tonic/clonic episode while sleeping.
Age: 2.2
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Coma, Febrile convulsion, Pyrexia, Tremor
Clinical narrative: Pt had immunizations on 8/2/02 at approx 11am and approx 4 hrs later post having "shaking and unresponsive" was taken to ER and diagnosed with febrile seizure (temp was 100.2 and 101.4 appears so from ER record). Mother told ER that pt had a febrile seizure in the past-we have no record of this and cannot reach mother (found out about incident from ER report sent to this).
Age: 5.3
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Approx. 2-3 hours after vaccinated, pt complained of arm hurting and was given Tylenol and cold compresses applied to arm. In the morning, on 8/15/02, arm still painful and deltoid swollen to 2 X size of other arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: 103 deg Fever started 8pm on 8/21/02. Vomited X 2. Fever 101 Thurs am.
Sex: U
Vaccine: IPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Failure of vaccine. Dx'd with Chickenpox on 8/20/02.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Vaccine given 8/15/02 left deltoid. Arm is swollen, hot at site of vaccine measure approx 10 x 7 inches.
Age: 29.0
Sex: M
Vaccine: HEPAB
Symptoms: Facial palsy, Ophthalmoplegia
Clinical narrative: On 8/8/02, pt noted facial asymmetry and inability to blink right eye. Dx'd with Bell's Palsy. Treated with prednisone. Also has a positive Lyme titer on 8/9/02. Is on medicines and is not yet healed.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pyrexia, Urticaria
Clinical narrative: One week after vaccination, blister and hives on both legs were yellow outlined in red, some scabbed, fever of 103 rectally, was advised to put hydrocortisone cream on sores. Fever 4 days blisters 5 weeks to heal completely with scarring. No tests done-doctor unsure of diagnosis.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh swollen, hard to the touch, 20% larger than normal and hot to the touch. No fever. Limping/redness at injection site. Tx: Hydrocortisone, cool cloths and Benadryl PRN. DX: DTAP reaction (possibly IPV).
Age: 9.0
Sex: M
Vaccine: PNC
Symptoms: Injection site pain, Injection site swelling, Urticaria
Clinical narrative: C/O of tenderness with obvious 2-3 inch long raised, pink "welt" over L triceps where vaccine given SQ.
Age: 1.75
Sex: M
Vaccine: DTAP, HBHEPB
Symptoms: Injection site erythema, Rash
Clinical narrative: Red area on right leg and rash.
Age: 11.0
Sex: F
Vaccine: MMR, TD
Symptoms: Rash pruritic
Clinical narrative: Fine rash appeared over entire body 24 hrs (8/14/02/7pm) after Td-MMR-TB test. Bactrim discontinued; Benadryl given, Hydrocortisone cream applied. Nurse called at 5pm 8/15/02 to report incident. Child's rash and itching has decreased somewhat. MD notified at facility 5am of actions taken by nurse.
Age: 42.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Dyspnoea, Tremor
Clinical narrative: Approximately 24 hours 4th dose of RUA pt states she developed tremors of hands, neck and jaw and a shaky anxious feeling in chest with some SOB. No fever, hives or swelling of face. Appt. to see internist 7/18/02. States headache for approx. 24 hours after each dose of rabies vac. Dr seen 7/11/02. Tremors continue-medications adjusted tremors stopped within 24 hours. 8/6/02 recovered.
Age: 0.5
Sex: F
Vaccine: DTAPH, IPV
Symptoms: Drug administration error
Clinical narrative: Pt given inappropriate vaccine.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives post MMR, VZV, Comvax, no fever no respiratory distress, activity of appetite OK.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Joint stiffness, Lymphadenopathy, Pain, Pruritus, Pyrexia
Clinical narrative: 2 weeks after MMR given pt developed fever 101 deg F, swollen glands, achy, stiff joints. "Itchy skin" no rash visible.
Age: 18.0
Sex: M
Vaccine: UNK
Symptoms: Facial palsy, Hypoaesthesia, Muscular weakness, Swelling face
Clinical narrative: Vaccine adm. 8/16/02 at 1410-c/o numbness and decreased muscle control approx 2400 8/17/02. Also c/o facial swelling. Was seen in Emerg. Dept 8/18/02. Dx. with Bell's Palsy. Notified of events 8/19/02. pt seen by MD 8/20/02 and Tx with steroids and antibiotics. Mother notes 8/21/02 no signs of improvement at this time.
Age: 11.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and low grade temp 99.7 (A), vomiting during night of 4/22/02.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt's mom reports redness, warmth covering entire R thigh next AM follow DTaP.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction, Injection site swelling
Clinical narrative: A 63 year old female (now 75 years of age) reported that she received a dose of influenza virus vaccine (manufacturer unknown) in 1988, and subsequently developed an injection site reaction characterized by redness and swelling. She recovered. No further information was available at the time of the report. (See HQ3826430JUL2001).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site reaction, Injection site swelling
Clinical narrative: A 60 year old female (now 75 years of age) reported that she received a dose of influenza virus vaccine (manufacturer unknown) in 1985, and subsequently developed an injection site reaction characterized by redness and swelling. She recovered. No further information was available at the date of the report. (see HQ3896431JUL2001).
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction
Clinical narrative: A physician reported that a 61 year old female with a history of asthma received an injection of Pnu-Imune 23 on 10/22/01. Concomitant therapy included Theo-dur (theophylline), Ventolin, (salbutamol), and Serevent (salmeterol xinafoate). One minute post-immunization, she developed labored breathing and cyanosis. a diagnosis of anaphylaxis reaction was made and she was taken to the ER. She was stabilized in the ER and was sent home that evening. This event was considered medically important. FOLLOW-UP information received on 11/14/02 provided the county of vaccine administration.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: A nurse reported that a female patient in an assistant living facility inadvertently received an intradermal injection of Pnu-Imune 23 instead of PPD and subsequently developed an injection of site reaction characterized by redness, swelling,and inflammation. The reporter declined to provide additional information and declined to grant permission for FOLLOW-UP.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: A nurse reported that a 76 year old female received her second dose of Pnu-Imune 23 on 10/16/01. On 10/18/01,  she developed an injection site reaction  characterized by a 4 inch by 4 inch area of redness and tenderness. The patient's physician recommended treating it with warm compresses. She recovered.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Blood disorder
Clinical narrative: A pharmacist reported that a 70 year old female, with a history of multiple myeloma and recurrent bactermia, received a dose of Pnu-Imune 23 vaccine in January, 2002. The patient developed bacteremia subsequent to vaccine administration. No further information was available at the date of the report
Age: 18.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A physician reported that an 8 year old female inadvertently received an intradermal injection of Pnu-Imune 23 on 03/22/02, instead of a Tuberculin test. That same day,she developed an injection site reaction characterized by a "large" area of redness, swelling and pain. Additional information received from the reporter on 04/02/02, provided the lot number and stated that the patient recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A pediatrician reported that a patient who had a medical history of solid organ transplantation received a dose of Pnu-Imune-23 on 03/04/02. That day, 4.5 hours post vaccination, the patient developed an injection site reaction characterized by a  50 mm area of swelling, a 90 mm by 35 mm area of redness, and "severe" tenderness to palpation. The reporter indicated that the patient was unable to attend school on 03/05/02. The symptoms resolved completely on 03/06/02. FOLLOW-UP information was received from the physician on 04/04/02. The child had a medical history of heart transplantation. Concomitant medications included Prograf (tacrolimus) and trimethoprim/sulfamethoxazole).
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PPV
Symptoms: Drug administration error
Clinical narrative: A nurse reported that a 2 month old female inadvertently received an injection of Pnu-Imune 23 instead of Prevnar on 05/15/01. On that same date, the child received  Infantrix, Act-Hib, and IPV. No adverse  event was reported. FOLLOW-UP Information. FOLLOW-Up Information has been received on 07/30/01 from the infant's pediatrician. The day following vaccination with Pnu-Imune 23, Infanrix,Act-Hib and IPV, the infant experienced a temperature (100.3 deg. f) that continued for four days. The infants was listless but nursed well. The infant experienced a runny and stuffy nose. She had no diarrhea or vomiting. The pediatrician noted no other family members were ill.
Sex: U
Vaccine: PPV
Symptoms: Contusion, Injection site reaction, Injection site swelling
Clinical narrative: A pharmacist reported that an unidentified patient received Pnu-Imune 23 vaccine (pneumococcal vaccine polyvalent) in 2002. The patient developed an injection site reaction characterized by bruising and swelling. No additional information was available as of the date of this report. MANUFACTURER'SCOMMENT: The reporter indicated that 4 to 6 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: A nurse reported that a 22year old female received an injection of Pnu-Imune 23 vaccine on 07/08/01. Within 24 hours, the patient developed an injection site reaction characterized by an area of swelling measuring 5 to 6 inches in diameter  with pain and warmth. The patient developed fever of  101 degrees F, chills,  loss of appetite and achy joints. She was seen in the emergency clinic of the reporting office and was given 6 mg Calestone. On 07/10/01, the reporter indicated that the injection site symptoms are improving; however, achy joint persist. This is one of 2 patients from this facility who experienced an adverse event following receipt of Pnu-Imune 23lot 473-556.) Additional information received from the reporter on 07/30/01 provided the patient's idea of birth and medical history. ( See related HQ3184612JUL2001)
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: A nurse reported that a 37 year old female received an injection of Pnu-Imune 23 vaccine on 04/06/01. Within 24 hours, she developed an injection site reaction characterized by a 5 to 6 inch area of swelling, pain and warmth. The patient developed fever of 101 degrees F, chills and loss of appetite. She was seen in the emergency clinic of the reporting office and was given  6 mg Calestone. The patient recovered in one week. This is 1of 2 patients from this facility who experienced an adverse event following receipt of Pnu-Imune 23 lot 473-556.Additional information received from the reporter on 07/30/01 provided patient information. The patient remained recovered. (See related HQ3124411Jul2001
Sex: U
Vaccine: PPV
Symptoms: Drug administration error, Injection site inflammation, Injection site reaction, Tenderness
Clinical narrative: A nurse reported that a patient inadvertently received an intradermal injection of Pnu-Imune 23 on 09/10/2001 instead of PPD. Follow up information received on 10/1/2001 indicated that the patient developed an injection site reaction characterized by a 2-cm by 3-cm area of tenderness and inflammation. The reaction resolved after 3 days. No further information was available at the date of this report.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain, Pyrexia, Swelling
Clinical narrative: A nurse reported that a 52 year old female received an injection of Pnu-Imune 23 on 9/12/01. Subsequently, the patient developed a fever and body aches. She also developed an injection site reaction characterized by redness and swelling. This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 lot 473556. See MCN GQ6188520SEP2001.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 72 year old female received an injection of Pnu-Imune 23 on 09/17/01. That same day, the patient developed right shoulder pain. She also developed an injection site reaction characterized by swelling and redness. This is 1 of 2 patient from this facility who had an adverse experience following reipt of Pnu-imune 23 (lot 473-556) See MCN HQ6179720SEP2001
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: A nurse reported that a 48 year old female received Pnu-Imune 23 vaccine on 10/8/01. The injection was given in her left upper arm; however, it seemed lower than the deltoid muscle. Subsequent to immunization, she developed a "severe" injection site reaction characterized by swelling, redness, induration and pain. The area of induration measured 6" to 7". She also had developed swelling in her whole left arm and pain in her arm, shoulder and chest wall. No additional information was available as of the date of this report.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: A nurse reported that a 48 year old female received Pnu-Imune 23 vaccine on 10/8/01. The injection was given in her left upper arm; however, it seemed lower than the deltoid muscle. Subsequent to immunization, she developed a "severe" injection site reaction characterized by swelling, redness, induration and pain. The area of induration measured 6" to 7". She also had developed swelling in her whole left arm and pain in her arm, shoulder and chest wall. No additional information was available as of the date of this report.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: An MA reported that a female pt received an injection of Pnu-Imune 23 on 10/17/01. The following day, she developed an injection site reaction characterized by redness, pain and swelling. The pt was treated with Benadryl and unspecified steroids. No further information was available at the date of this report.
Age: 1.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: A nurse reported that a 12 month old female inadvertently received a dose of Pnu-Imune 23 instead of Prevnar on 6/19/01 and subsequently developed an injection site reaction characterized by a "quarter sized" area of redness and tenderness. The injection site reaction resolved after a week. No further information was available at the date of this report. Information was received which identified that this child also received an injection of Hep-B (mfr unk) on 6/19/01.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: A nurse reported that on 10/30/01, an 84 year old male was vaccinated with expired Pnu-Imune (expired 8/01). It was also discovered that the pt was previously immunized with Pnu-Imune in 1/01. The pt experienced a local reaction of redness, swelling and pain. He was unable to sleep all night due to the pain.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: An MA reported that a 60 year old male received an injection of Pnu-Imune 23 vaccine on 10/29/01. He subsequently developed an injection site reaction characterized by heat and redness. He was seen in the ER on 10/30/01; dx'd with cellulitis and treated with 1gm of Rocephin daily. Additional information received from the vaccine provider on 11/20/01, stated that a dx of allergic reaction to pneumococcal vaccine was made and subsequent treatment included antihistamine drugs which cleared the pt's erythema.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 54 year old female received an injection of Pnu-Imune 23 and Flu Shield (2001-2002 formula) on 10/30/01. The following day, she developed an injection site reaction characterized by redness and swelling extending to the elbow on the left arm. The pt was treated with ibuprofen, elevation of the extremity and application of heat to the area. The specific sites of vaccine administration were not reported.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: A consumer reported that her 77 year old mother received Pnu-Imune 23 vaccine on 10/30/01. On 10/30/01, the pt developed an injection site reaction characterized by swelling, soreness and itching. The injection site swelling and soreness resolved on 11/1/01. The injection site itching resolved on 10/31/01. No additional information was available as of the date of this report. Follow-up information received on 1/4/02 from physician. Physician confirmed consumer information reported previously.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Rash
Clinical narrative: A physician reported that a 42 year old female inadvertently received pneumococcal polyvalent and influenza virus, trivalent Types A & B vaccines mixed in the same syringe on 12/10/01 at a drug store clinic. Within a day of immunization, the pt developed a large, very painful injection site reaction characterized by redness, inflammation, induration and rash. She was prescribed unspecified antibiotics and NSAIDS. Additional information received from the physician on 1/11/02 indicated that 2 to 3 days, post vax, the pt "fully recovered".
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A 70 year old female consumer reported that she received Pnu-Imune 23 vaccine in March, 2002. Concomitant medication included Prempro. Medical history includes Fuchs' Dystrophy of the eyes. Two weeks, post vax, she developed an injection site reaction characterized by redness, heat and swelling. She stated that this also occurred 8 years ago following receipt of a pneumococcal vaccine (mfr unk). See case HQ1576603APR2002. No additional information was available as of the date of this report.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A 70 year old female consumer reported that she received pneumococcal vaccine polyvalent (mfr unk) when she was 64 years old. Concomitant medication included Prempro. Medical history includes Fuchs' Dystrophy of the eyes. Subsequent to immunization, she developed an injection site reaction characterized by redness, heat and swelling. The consumer reported she experienced a similar event following receipt of Pnu-Imune 23 vaccine in 2002. See case HQ1518028MAR2002. No additional information was available as of the date of this report.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction, Unevaluable event
Clinical narrative: A nurse reported that a pt received Pnu-Imune 23 and subsequently developed an injection site reaction. No further information was available at the date of this report. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot 470592. See related reports HQ1201422MAY2001 and HQ9390306APR2001.
Age: 3.2
Sex: M
Vaccine: PPV
Symptoms: Abasia, Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 3 year old male received a dose of Pnu-Imune 23 vaccine on 7/19/01. The next day, he developed an injection site reaction characterized by redness, swelling and was unable to bear weight. The child has a history of asthma and was concomitantly using inhalers. Additional information received from the reporter on 8/15/01, indicated that the pt was prescribed an oral antibiotic on approx. 7/21/01. The pt recovered.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported that an unidentified pt received Pnu-Imune 23 vaccine (pneumococcal vaccine polyvalent) and subsequently developed an injection site reaction characterized by redness, warmth and edema. No additional information was available as of the date of this report. The reporter indicated that 2 pts experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: A nurse reported that a 45 year old female received Pnu-Imune 23 vaccine (pneumococcal vaccine polyvalent) on 10/30/01. Concomitant therapy included Prozac, Amaryl, Altace and "Lantus", "Altos" and "Aziphex". On 10/31/01, the pt developed an injection site reaction characterized by swelling and tenderness. The area of the reaction measured 4-5" in diameter and resembled a  wheel. No additional information was available as of the date of this report. The reporter noted that 6 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow-up information received on 1/11/02, from physician. Pt identified as a 45 year old female. The pt recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red, swollen right upper arm the day after received vaccinations.  No pain or fever.  Advised cool cloth and acetaminophen.  Symptoms resolved 2-3 days after onset.
Age: 62.0
Sex: M
Vaccine: HEP, TD
Symptoms: Pruritus, Rash
Clinical narrative: rash on arms and neck, then flank, back and abdomen. Continued to spread and worsen. Puritic  60 Day follow up states "Unable to contact- no response"
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Contusion, Epistaxis, Jaundice, Leukaemia, Pruritus
Clinical narrative: Report A0377926A describes leukemia in a 5 year old female who received hepatitis A vaccine inactivated (Havrix). This report was received initially from the mother of the vaccinee and has been confirmed by a physician. The vaccinee was allergic to Keflex. There were no concurrent medications. She had not experienced any adverse events following previous vaccinations. **On 4/11/02, the subject received her first injection (lot # not provided) of Havrix w/out adverse expereince, 76 days later on 6/26/02, the subject began to experience nosebleeds.** On 6/28/02, the subject received her 2nd injection of Havrix (lot VHA709A2, expiry 4/5/02). Later that day, she subject's mother reported that the subject began to experience burning and itching sensations: the mother did not specify the location of these sensations. On 7/17/02, the subject had bruising and a rash while traveling. The mother reported, additionally that the subject had a low-grade fever "w/in one day of (the 2nd) vaccine" and jaundice w/in 3 weeks of (the 2nd) vaccine." **The reporting MD stated that a complete blood count was performed on 7/17/02 and the "results indicated leukemia." The diagnosis was confirmed by bone marrow biopsy performed on 7/18/02 (results not available to mnft'r).** The subject was hospitalized to receive chemotherapy. **The most recent info. was received on 9/17/02. The reporting MD stated** that the leukemia was possibly related to Havrix administration, but "could be coincidental w/shots". The subject's mother thought the leukemia could have been associated w/the 2 injections of vaccine being given too closely together. Although the nosebleeds began 2 days prior to the administration of the 2nd injection of Havrix, the MD indicated the onset of of leukemia to be after the 2nd injection. He considered the leukemia to be life-threatening and disabling. As of 9/17/02, the leukemia was ongoing.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia, Rash, Skin burning sensation
Clinical narrative: Report A0377926A describes leukemia in a 5 year old female who received hepatitis A vaccine inactivated (Havrix). This report was received initially from the mother of the vaccinee and has been confirmed by a physician. The vaccinee was allergic to Keflex. There were no concurrent medications. She had not experienced any adverse events following previous vaccinations. **On 4/11/02, the subject received her first injection (lot # not provided) of Havrix w/out adverse expereince, 76 days later on 6/26/02, the subject began to experience nosebleeds.** On 6/28/02, the subject received her 2nd injection of Havrix (lot VHA709A2, expiry 4/5/02). Later that day, she subject's mother reported that the subject began to experience burning and itching sensations: the mother did not specify the location of these sensations. On 7/17/02, the subject had bruising and a rash while traveling. The mother reported, additionally that the subject had a low-grade fever "w/in one day of (the 2nd) vaccine" and jaundice w/in 3 weeks of (the 2nd) vaccine." **The reporting MD stated that a complete blood count was performed on 7/17/02 and the "results indicated leukemia." The diagnosis was confirmed by bone marrow biopsy performed on 7/18/02 (results not available to mnft'r).** The subject was hospitalized to receive chemotherapy. **The most recent info. was received on 9/17/02. The reporting MD stated** that the leukemia was possibly related to Havrix administration, but "could be coincidental w/shots". The subject's mother thought the leukemia could have been associated w/the 2 injections of vaccine being given too closely together. Although the nosebleeds began 2 days prior to the administration of the 2nd injection of Havrix, the MD indicated the onset of of leukemia to be after the 2nd injection. He considered the leukemia to be life-threatening and disabling. As of 9/17/02, the leukemia was ongoing.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Crying, Depression, Insomnia, Suicide attempt
Clinical narrative: 9/17/98 - Received first anthrax injection. 10/01/98 - Received second injection. 10/15/98 Received third injection. 3/17/99 received fourth injection. 9/29/99 received 5th injection. 3/27/00 received 6th injection. October 1998 - started crying for no reason with feelings of worthlessness. Started having sleepless nights. 2/8/99 diagnosed with major depression by psychiatrist and prescribed Prozac and Ativan. Medication changes throughout the term of care. Used Zoloft, Effexor with small amounts of Buspar. Tried several anti-anxiety medications. Klonopin, Xanax, Ativan. 6/26/02 suicide attempt using large amounts of Xanax and Klonopin. 7/26/02 current medications--Remeron 30 mg taken at bedtime. Ritalin 5mg taken in the morning. Inderal 2.5mg taken as needed. Review of hospital discharge summary and medical records verifies diagnoses currently COSTARTED. Please add diagnosis of anxiety.
Age: 68.0
Sex: F
Vaccine: HEPA
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Tremendous shaking, chills, fever of 104.
Age: 4.4
Sex: F
Vaccine: PNC
Symptoms: Cellulitis
Clinical narrative: Cellulitis of L deltoid area-put on Cephalexin po and warm compresses.
Age: 69.0
Sex: M
Vaccine: HEP, HEPA, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: R arm erythematous, swollen at site distal to where pneumococcal was given subcutaneously R arm given 8/15/02. Went to ER on 8/17/02 saw MD.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Headache
Clinical narrative: This report describes arthritis in a 49 year old female who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. The subject had no relevant medical history and received no medications at the time of immunizations. She mentioned "pulling ticks off her during Lyme season". In approximately12/99, the subject received her second injection of Lymerix. Approximately two weeks later, she began to experience arthritis with joint pain that was "so bad that she could not hold a bag". She also began to experience "frequent headaches that are really bad". The subject was seen by her physician. The arthritis symptoms were treated with rofecoxib (Vioxx) 25 mg as needed. After one year of vioxx therapy, her symptoms have improved and are now experienced "off and on". The Lymerix immunization series was discontinued. On 08/07/02, a Western blot was performed. "It revealed Dalton band 41.the immunoglobulin was 1." the reporter stated that the subject's symptoms were probably related to Lymerix administration.
Age: 38.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis, Back pain, Difficulty in walking, Hypoaesthesia, Pain in extremity
Clinical narrative: The medical history included herpes virus NOS infection and Lyme disease (1996). She had no adverse experiences following receipt of prior unspecified immunizations. There were no concurrent medications. In 1999, the pt reportedly received her 1st and 2nd injections of Lymerix; exact dates of immunization were no recalled by the pt. In 1/00 or 2/00, she experienced "an episode of paralysis" which she described as "I suddenly stiffened up and couldn't move". She stated that the episode "lasted only briefly". She reported the episode to her physician in 4/00 or 5/00, when she received her 3rd dose of Lymerix. "Soon after" receiving the 3rd injection of Lymerix, she reportedly began to experience pain in her back and feet "that makes walking hard" and numbness in her arms. She returned to her family physician who referred her to a rheumatologist. The rheumatologist reportedly made a dx of arthritis. Treatment included "steroids and pain killers". The arthritis persisted as of 6/7/02. The adverse events "arthritis" and "paralysis" do not meet serious criteria.
Sex: U
Vaccine: LYME
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: The medical history reportedly included "chronic migraines" treated with Surmontil and Neurontin. The pt stated that she did not have gout, psoriasis, Crohn's disease or a previous history of Lyme disease. There reportedly was not family history of rheumatoid arthritis or lupus. On 1/9/02, the pt received her 1st injection of Lymerix. On injection, she reportedly experienced injection site soreness that resolved after an unspecified period of time. On 2/9/02, the pt received her 2nd injection of Lymerix. She reported that on 2/21/02, 12 days post vax, she experienced "pain and achiness in all muscles and joints of the body including hands and toes", headache, "extreme" fatigue and chills. These persisted as of 2/27/02 and the pt had an appointment to be evaluated by her physician. The adverse events "joint pain" and "headache" do not meat ICH serious criteria.
Age: 42.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: This report describes headache in a 42 year old female who received Lyme disease vaccine recombinant OspA (Lymerix0. It was received from the vaccinee and has not been verified by a physician or other healthcare professional. There was reportedly no relevant medical history, Concurrent conditions or concurrent medications. On 06/15/99, the vaccinee received her first injection of Lymerix (lot Ly128A2). She reported that she subsequently experienced headache and fever,which resolved after an unspecified period of time. On 06/15/00, the vaccinee received her second injection of Lymerix (lot LY128A2). She reported that she subsequently experienced headache and fever, which resolved after an unspecified period of time. On 06/04/01,the vaccinee received her third injection of Lymerix (lot ly128A2). She reported that in 09/01, she experienced nausea, fatigue, headache and general achiness. She stated that she had not sought medical attention for these events. They persisted as of 02/27/02.  Reported on 03/04/2003: "Report A061021 describes headache in a 42-year-old female who received Lyme disease vaccine recombinant OspA (LYMErix).  This report was received from the vaccinee and has not been verified by a physician or other healthcare professional.  There was reportedly no relevant medical history, concurrent conditions, or concurrent medications.  On 06/15/1999, the vaccinee received her first injection of LYMErix (lot LY128A2).  She reported that she subsequently experienced headache and fever, which resolved after an unspecified period of time.  On 06/15/2000, the vaccinee received her second injection of LYMErix (lot LY128A2).  She reported that she subsequently experienced headache and fever, which resolved after an unspecified period of time.  On 06/04/2001, the vaccinee received her third injection of LYMErix (lot LY128A2).  She reported that in 09/2001, she experienced nausea, fatigue, headache, and general achiness.  She stated that she had not sought medical attention for these events.  They persisted as of 02/27/2002.  On 12/02/2002, the vaccine provider stated, "the patient did not complain to our office of any symptoms after taking LYMErix.  She was not treated for anything right after vaccines either."
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Bronchitis, Dizziness, Fatigue, Headache
Clinical narrative: The pt received injections of Lymerix on 5/22/00 and 6/19/00 (lot numbers not recorded). On 2/11/02, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from severe joint and muscle pain and weakness in her hips and knees. In addition, she suffers from numbness in her hands and arms. She also experiences fatigue, headaches, swelling in her joints and nerve spasms. (She just found out her thyroid in under active). The following information was obtained from medical records. On 11/8/00, the vaccine provider referred the pt to a chiropractor for the treatment of "right cervical spine pain". On 4/14/01, the pt presented to the vaccine provider for Work-up Lyme". The pt was evaluated by another physician. Pharmacy records indicated that this physician prescribed Paxil, doxycycline, cyclobenzaprine and tramadol (Ultram) between 5/21/01 and 10/15/01. The pt present to the vaccine provider on 10/20/01 with chief complaints of dizziness, visual changes, nausea and vomiting after meals and lethargy which was worse in the "PM". She reported that she was being treated by another physician for "Lyme". On 10/29/01, the vaccine provider prescribed Levoxyl. Following the administration of Lymerix, the pt experienced bronchitis, UTI and Lyme disease. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent information, received 2/11/02, did not provide the outcome of the reported events. The adverse events of nerve spasms, joint pain, weakness, numbness, headache and joint swelling do not meet ICM serious criteria.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Hypoaesthesia, Hypothyroidism, Infection, Joint swelling, Laboratory test abnormal
Clinical narrative: The pt received injections of Lymerix on 5/22/00 and 6/19/00 (lot numbers not recorded). On 2/11/02, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from severe joint and muscle pain and weakness in her hips and knees. In addition, she suffers from numbness in her hands and arms. She also experiences fatigue, headaches, swelling in her joints and nerve spasms. (She just found out her thyroid in under active). The following information was obtained from medical records. On 11/8/00, the vaccine provider referred the pt to a chiropractor for the treatment of "right cervical spine pain". On 4/14/01, the pt presented to the vaccine provider for Work-up Lyme". The pt was evaluated by another physician. Pharmacy records indicated that this physician prescribed Paxil, doxycycline, cyclobenzaprine and tramadol (Ultram) between 5/21/01 and 10/15/01. The pt present to the vaccine provider on 10/20/01 with chief complaints of dizziness, visual changes, nausea and vomiting after meals and lethargy which was worse in the "PM". She reported that she was being treated by another physician for "Lyme". On 10/29/01, the vaccine provider prescribed Levoxyl. Following the administration of Lymerix, the pt experienced bronchitis, UTI and Lyme disease. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent information, received 2/11/02, did not provide the outcome of the reported events. The adverse events of nerve spasms, joint pain, weakness, numbness, headache and joint swelling do not meet ICM serious criteria.
Age: 51.0
Sex: F
Vaccine: LYME
Symptoms: Langerhans' cell granulomatosis, Lethargy, Muscular weakness, Myalgia, Nausea
Clinical narrative: The pt received injections of Lymerix on 5/22/00 and 6/19/00 (lot numbers not recorded). On 2/11/02, in a Statement of Injuries, the pt's attorney alleged that the pt "suffers from severe joint and muscle pain and weakness in her hips and knees. In addition, she suffers from numbness in her hands and arms. She also experiences fatigue, headaches, swelling in her joints and nerve spasms. (She just found out her thyroid in under active). The following information was obtained from medical records. On 11/8/00, the vaccine provider referred the pt to a chiropractor for the treatment of "right cervical spine pain". On 4/14/01, the pt presented to the vaccine provider for Work-up Lyme". The pt was evaluated by another physician. Pharmacy records indicated that this physician prescribed Paxil, doxycycline, cyclobenzaprine and tramadol (Ultram) between 5/21/01 and 10/15/01. The pt present to the vaccine provider on 10/20/01 with chief complaints of dizziness, visual changes, nausea and vomiting after meals and lethargy which was worse in the "PM". She reported that she was being treated by another physician for "Lyme". On 10/29/01, the vaccine provider prescribed Levoxyl. Following the administration of Lymerix, the pt experienced bronchitis, UTI and Lyme disease. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events. The most recent information, received 2/11/02, did not provide the outcome of the reported events. The adverse events of nerve spasms, joint pain, weakness, numbness, headache and joint swelling do not meet ICM serious criteria.