chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: RAB
Symptoms: Tremor, Vomiting
Clinical narrative: Pt received Imovax and Imogan IG in ER for possible rabies exposure. Aprox 6 1/2 hrs later pt returned to ER by family, diaphoretic, pallor, nausea, dry heaves, tremors, fixed eyes and drooling. No motor activity. Admitted and started on enteric coated ASA. Recoverred well, ambulated without difficulty and discharged the following day.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Eye movement disorder, Muscle spasms
Clinical narrative: Spasm and jerking of right extremity followed by eye movements to the right. Sustained for few seconds then tonic/clonic convulsions of entire body.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Epilepsy, Pyrexia, Strabismus
Clinical narrative: Spasm and jerking of right extremity followed by eye movements to the right. Sustained for few seconds then tonic/clonic convulsions of entire body.
Age: 0.25
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion, Muscle spasms, Pyrexia, Status epilepticus, Strabismus
Clinical narrative: Spasm and jerking of right extremity followed by eye movements to the right. Sustained for few seconds then tonic/clonic convulsions of entire body.
Age: 1.9
Sex: M
Vaccine: PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Right thigh increased circumference 12 5/8 in, lower right leg 8 3/4 in and ankle swelling, warm to touch with erythema.
Age: 32.0
Sex: M
Vaccine: YF
Symptoms: Nasal congestion, Urticaria
Clinical narrative: Urticaria and blocked nose. Shot given and pt symptomatic in 1-2 hrs. Seen and treated in Er (WHMC)
Age: 1.25
Sex: F
Vaccine: MMR, PNC
Symptoms: Erythema, Pyrexia, Rash papular
Clinical narrative: Pt received MMR and Prevnar on 7/18/02. On 7/19/02, developed fever of 103F, followed by an erythematous papular rash. Rash and fever persisted to when I saw the pt on 7/23/02. Language barrier. More info no known.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Screaming
Clinical narrative: Persistent irritability and inconsolable crying more than 24 hours.
Age: 1.6
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Pulmonary congestion, Pyrexia, Rhinorrhoea, Urticaria
Clinical narrative: Child received immunizations in the am and in the pm of the same day broke out in hives on her arms, legs, and face. the next day the hives disappeared for 2 hrs and then returned. Mom has applied Calamine lotion and given 1/4 tsp doses of Children's Benadryl, but it "didn't help". On 5/26 child developed runny nose, fever which progressed to chest congestion. She started Robitussin 5/28. Mom was encouraged to take child to Dr. or bring her to WCCHC. She did not come to WCCHC.
Age: 0.4
Sex: F
Vaccine: IPV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: "High fever" and vomiting x T wk starting on day of vaccine (child not seen- office unaware)
Age: 1.25
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site mass
Clinical narrative: Reliable caregiver reported onset/ observed about 5 days after DaPT and Comvax- "dramatic",3-4 cm mass at injection site, no erythema, warmth, or limp within about 48 hrs decreased to about 1 cm, resolved in about 5 days. No fever, or systemic symptoms. A follow up report received 9/12/2002 adds: Problem was on left thigh-involved DTaP and Comvax.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Headache, Hypoaesthesia, Joint stiffness, Paraesthesia
Clinical narrative: Client states she began to experience numbness and tingling in left arm, leg, and foot on 07/14/2002. She was evaluated 07/15/2002- blood work done-all WNL. Relates she also had severe headaches with some blurred vision. CT scan of head- WNL on 07/26/2002. Is now experiencing stiffness of neck with h/a. to see PMD 8/13/2002. Conts. to c/o severe h/a.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: Facial swelling vomiting x 2 days. Temp 103 max. Phenergan supp
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site oedema
Clinical narrative: MD's office called nurse-stated "L arm from shoulder to elbow is swollen, red, warm." DTaP #5 give L deltoid, varicella #1 L SC given on 7/22/02.
Age: 2.7
Sex: M
Vaccine: DTAP
Symptoms: Agitation, Decreased appetite, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Arm got really swollen, and red; he's been fussy, decrease in appetite. Have give Motrin. 07/22/2002 arm cont. swollen hard, but child better now.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Arm swelled up big and got hard with some red, raised bumps out from it. Continued to eat ok and he pretty much left it alone.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NONE As of this report, not completed.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hypertension, Swelling, Throat tightness
Clinical narrative: 10 minutes after vaccine, employee developed tightness in throat and all over: "feels like swelling"; coloration very red. BP-183/95, P-88, R-20. Treatment 25mg IV Benadryl. Feeling better within 5 minutes with normal color, BP-157/95, P-81. Tightness subsiding 20 minutes and symptoms gone.
Age: 1.5
Sex: U
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Approx. 6-8 hours after vaccine administration, began to complain of "boo-boo" (pain), mild erythema and edema of thigh. Child complaint of "hurts" when walking. Right thigh received DTAP and left rectus femaris.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Vaccine (DTaP) given two days ago. Pt developed 3cm erythema and heat surrounding site with minimal swelling.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Dizzy, nausea, vomiting, headache.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema
Clinical narrative: Erythematous area 3in x 2in at site of presumed DPT booster.
Age: 4.4
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: 5x5cm erythema L arm. DTaP and MMR given on that arm on 8/16/02.
Age: 47.0
Sex: M
Vaccine: TTOX
Symptoms: Cellulitis, Injection site pain, Injection site reaction
Clinical narrative: Employee received a dose of Deptheria/Tetanus on 8/05/2002 and began having arm pain at injection site. Employee reported to medical on 08/08/2002 with marked cellulitis just distal to site. From 1 in below to elbow.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia
Clinical narrative: Fever of 103 degrees on 08/16/2002
Age: 5.2
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Local reaction at shot site with redness, induration, warm and tenderness 5cm x 7cm started 8 hours after immunization. Symptoms worsened till 48 hours after imm. then slowly started to improve. Treated with ice, Tylenol and then heat to area 72 hours later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left arm where shot was given swelled, hardened and was hot. Shot was given in the afternoon on Friday and arm swelled by Saturday AM to about 4" in diameter. Saturday PM was 6" in diameter and on Sunday PM, down to elbow and under arm. On Monday swelling shrinks.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site reaction, Throat tightness
Clinical narrative: Type III local reaction and pt complaining of throat fullness, trouble catching breath. Started a few hours, post vax. Seen in ER the next day and treated with Benadryl for local reaction. Other symptoms resolved.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm the size of a baseball, red and warm to touch.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Oedema peripheral, Skin discolouration, Urticaria
Clinical narrative: 10 hours after Hep-B #1 given, child developed hives on back and torso. Neck became red and hot; left hand became swollen, red, purple and hot.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site pain, Pruritus
Clinical narrative: On 8/20/2002 presented to health center with c/o itch x 2 days. Vesicles on arms and trunk large vesicles and pain at injection site.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Fatigue, Headache, Pyrexia, Vomiting
Clinical narrative: Child had MMR #2 at 4pm on 8/15/02. Child got sick at 2am 8/16/02-fever 102 degrees, headache, tired, vomiting. Mom called MD at 2pm on 8/16/02-stated if not better in 24 hrs. to go to ER. Client saw MD on 8/19/02. Did raid strep test-was negative, placed on Cefzil-rest of family having flu-like symptoms. Still recovering.
Age: 52.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Pain, Tremor
Clinical narrative: Pt has "chronic neuropathy" of hands X 2 years. This morning reported numbness, pain and trembling of hands "is much worse than ever before since taking Recombivax yesterday.
Age: 15.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Anxiety, Convulsion
Clinical narrative: Client's mother reported he had a seizure in car about five minutes after his vaccination. He was examined by private physician who does not believe the child had a seizure, but likely an anxiety rxn.
Age: 13.0
Sex: M
Vaccine: HEPA, TD
Symptoms: Back pain, Haematuria, Injection site pain
Clinical narrative: L arm pain, low back CVA pain no dystaria or frequency.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Agitation, Contusion, Injection site erythema, Insomnia
Clinical narrative: Fussy last night, restless in sleep. Reddened area 15mm x 11mm at injection site. Slight bruising at injection site. T 97.0
Age: 15.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Dyspnoea, Erythema, Paraesthesia, Swelling face, Urticaria
Clinical narrative: On 7/20/02 at approx. 13:30, client stated he started tingling, face felt swollen. Dad reports face very red and breathing became difficult. Went to ER after 45 minutes. One hour with no treatment. Client's condition improved. Whelps developed on back prior to ER visit. Parent reported medicine given in ER but not sure what it was.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash macular
Clinical narrative: Within 10-15 minutes after DTAP administration, IM into left deltoid, arm at site was swollen, reddened and tender with a blotchy rash. No dyspnea or other signs or symptoms of anaphylaxis. Given cold compresses and Motrin, 1 tsp in office.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and warm to touch on left upper arm approx. 6cm X 7cm area of redness and very tender. Will not allow compress to area.
Age: 13.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Syncope, Tremor
Clinical narrative: Five minutes, post vax, pt stood, walked a few steps and fell to the floor with slight tremors of extremities X 5 seconds.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injury
Clinical narrative: On 8/8/02, after giving IPV injection, child moved and sustained a laceration approx. 1 1/2"-2" at injection site; dressing applied. Instruction given to check area for fever, achiness on pain and to call MD or go to ER and to call the next day. On 8/9/02, family called and said site is healing and child is fine.
Age: 4.4
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warm to touch 1 1/2 x 4cm area R deltoid in 2nd day post vaccine given had sl redness in 8/14/02. Woke up this am with larger area of redness and warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Redness, swelling and very warm to touch entire upper right arm from shoulder to within 2cm of elbow encircling almost entire inner arm.
Age: 4.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Blister, Injection site erythema, Injection site swelling
Clinical narrative: On 8/15/02, at time of physical appt, received 2 vaccines: DTAP 0.5cc, IM, in right arm and IPV 0.5cc, IM, in the left arm. No prior reaction to vaccines. On 8/17/02, seen in walk-In care center. Appeared with skin reaction, blister 1/2cm with clear fluid, redness and swelling. No other symptoms.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Cyanosis, Hyperhidrosis, Hypotonia, Pallor
Clinical narrative: 08/15/02 10:10 The pt became diaphoretic, pale, lips cyanotic, limbs flaccid a few seconds after receiving vaccine, no loss of consciousness, episode lasted for 30 minutes off and on-was evaluated at ER and by his private doctor. Mother to follow with private doctor.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: Golf ball-sized knot on left arm.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Developed vesicular rash, went to ER.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Swelling on right thigh started out pea-sized and gradually increased, On 08/10/02, swelling was 2-3 inches across and into the groin area, so Mom took child to his private physician. Physician told mom it was a reaction to one of the vaccine. Mom called vaccine provider to report the reaction, 08/12/02 Swelling persisted at the time.
Age: 2.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Child got up with light red raised rash on face. Mom and child came to health dept at 10:00 am. rash now spread to legs, upper back, and both arms. Child's private physician not in office today. Instructed to take child to walk-in clinic at nearby physicians complex. TC received from mom late in day. Physician gave prescription medication (Vistaril). (Child is asthmatic and could not take Benadryl.) Child has no temp. but has wanted to scratch at arms and legs. One dose of medication administered by mom, 08/12/2002: TC to residence. Rash almost completely gone. 08/14/2002: TC to residence, child ok.
Age: 4.8
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Child came to clinic to have Tb test red, noticed left arm, red, tender and warm. NO Tx administered. Advised mother to watch arm for increased redness and tenderness. To contact pediatrician if arm became worse.
Age: 1.25
Sex: M
Vaccine: DTAPH, MMR
Symptoms: Injection site erythema
Clinical narrative: Onset of redness on left thigh, medial to injection site (24 hours after time of injection), Area of redness 10.5 X 10.5 cm, Upon exam @ 1730 on 08/22/2002, Tx w/topical steroid creme.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Redness, swelling, pain L arm.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Broke out with chicken pox on 06/29/02- generalized -approx 500 pox. Febrile prior  & 1-2 days post 101 degree F, rash was itchy, Felt miserable, Seen MD- Dx  chickenpox secondary to chicken pox shot, MD felt this was an adverse reaction because of how many pox this child had. symptomatic tx only.
Age: 1.4
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Rash on back of neck Saturday evening 06/01/02. On Sunday afternoon, the patient was scratching both arms and rash was on both arms. On Sunday night, rash was noticed on her abdomen,chest, back and legs. On Monday, her eyes were swollen, Taken to doctor, Doctor  stated probably vaccine reaction and prescribed (?),Referred to HD. Rash on back, abdomen, arms, legs and face, red & raised.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: DTAP administered in the afternoon of 8/20/02 and within a few hours after, pain was noted and several hours after that it was red, warm and swollen leg from hip to knee. No fever or itching. Use ice, Benadryl, Tylenol or Advil for pain.
Age: 1.08
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh warm and swollen to the size of a fist. Not fussy and no temperature.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg with swelling, redness and warmth.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Middle 1/3 of R thigh erythematous, warm to touch, indurated.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Aphasia, Autism, Eye swelling, Fatigue, Lethargy
Clinical narrative: Swollen eyes, spots on body, every lethargic. Body was very tired. Has not spoken since. Has signs of an autistic child.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Rash maculo-papular
Clinical narrative: Swollen eyes, spots on body, every lethargic. Body was very tired. Has not spoken since. Has signs of an autistic child.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Feeling hot, Injection site induration, Injection site reaction, Pain
Clinical narrative: Administered tetanus-diphtheria vaccine on 8/23/02 to left deltoid per usual protocol.  States she woke 8/24/02 with hard, warm, painful area at site of injection; area became increasingly more painful and warm.  Presented to me 8/26/02.  Indurated area was approx. 4x4 cm, warm to touch, painful with light palpation,with erythematous border.  Full ROM. No systemic effects.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Anxiety, Asthenia, Confusional state, Constipation
Clinical narrative: Received 2nd dose of Lymerix 9/15/2000. That evening developed severe headache,stiff neck, febrile seizures, photophobia, extreme weakness, fever 105, fatigue.Seen in ER OF READING hOSPITAL.dIAGNOSED WITH encephalitis. Since that time had progressive fatigue, muscle aches, joint pain,severe depression,memory loss, mental confusion,anxiety, 55 lbs. weight loss, insomnia,constipation,bed wetting, magnified hearing loss, loss of muscle strength. Diagnosed with Fibromyalgia & CFS. Unable to perform normal activities of daily living or continue to work.This all continues to present.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Depression, Fatigue, Febrile convulsion, Fibromyalgia, Headache
Clinical narrative: Received 2nd dose of Lymerix 9/15/2000. That evening developed severe headache,stiff neck, febrile seizures, photophobia, extreme weakness, fever 105, fatigue.Seen in ER OF READING hOSPITAL.dIAGNOSED WITH encephalitis. Since that time had progressive fatigue, muscle aches, joint pain,severe depression,memory loss, mental confusion,anxiety, 55 lbs. weight loss, insomnia,constipation,bed wetting, magnified hearing loss, loss of muscle strength. Diagnosed with Fibromyalgia & CFS. Unable to perform normal activities of daily living or continue to work.This all continues to present.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Hypoacusis, Insomnia, Musculoskeletal stiffness, Pain, Photophobia
Clinical narrative: Received 2nd dose of Lymerix 9/15/2000. That evening developed severe headache,stiff neck, febrile seizures, photophobia, extreme weakness, fever 105, fatigue.Seen in ER OF READING hOSPITAL.dIAGNOSED WITH encephalitis. Since that time had progressive fatigue, muscle aches, joint pain,severe depression,memory loss, mental confusion,anxiety, 55 lbs. weight loss, insomnia,constipation,bed wetting, magnified hearing loss, loss of muscle strength. Diagnosed with Fibromyalgia & CFS. Unable to perform normal activities of daily living or continue to work.This all continues to present.
Age: 54.0
Sex: M
Vaccine: LYME
Symptoms: Pyrexia, Urinary incontinence, Weight decreased
Clinical narrative: Received 2nd dose of Lymerix 9/15/2000. That evening developed severe headache,stiff neck, febrile seizures, photophobia, extreme weakness, fever 105, fatigue.Seen in ER OF READING hOSPITAL.dIAGNOSED WITH encephalitis. Since that time had progressive fatigue, muscle aches, joint pain,severe depression,memory loss, mental confusion,anxiety, 55 lbs. weight loss, insomnia,constipation,bed wetting, magnified hearing loss, loss of muscle strength. Diagnosed with Fibromyalgia & CFS. Unable to perform normal activities of daily living or continue to work.This all continues to present.
Age: 9.0
Sex: M
Vaccine: HEPA, PPV
Symptoms: Basedow's disease, Weight decreased
Clinical narrative: A mother reported that her 9 year old son received 1st doses of 23-valent pneumococcal (mfr unk) and Hep-A (mfr unk) vaccines on 6/2/00 and that subsequently, her son was dx'd with Graves disease. Follow-up information received from the child's pediatrician on 10/8/01, stated that he had examined the child on 3/16/01 for a physical exam. At that time, the child had lost 10 lbs between 7/6/00 and 3/16/01. This weight loss was attributed to increased exercise. At this visit, the child was administered his 2nd dose of Hep-A (mfr unk), tetanus and diphtheria booster (mfr unk) and his 1st dose of Prevnar. On 5/6/01, he was dx'd with Graves disease after continued weight loss. The physician stated that "I believe (retrospectively) that the pt's weight loss by 3/16/01 represented his early Graves disease. His only Prevnar was given after his weight loss had begun. Therefore, it is my medical opinion that his shots on 3/16/01 did not cause or contribute to his Graves disease". (see HQ5158324AUG2001).
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: A physician reported that a 73 year old female received an injection of Pnu-Imune 23 on 10/03/01. On 10/05/01, the patient developed an injection site reaction characterized by redness and inflammation. The patient was seen by the physician who stated that the reaction "appears to be localized cellulitis". This is 1 of 2 patients from his facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 476-952). Follow-up information received on 11/26/01 from the physician indicated that this patient developed an injection site reaction characterized by pain, swelling, and redness. She was treated with Keflex (cephalexin) and cool compresses. The patient recovered.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Myalgia
Clinical narrative: A physician reported that a 79 year old female received an injection of Pnu-Imune 23 on 10/3/01. Subsequently, she developed a sore and achy muscles. The pt was seen by the physician. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Pnu-Imune 23 (lot 476952). Follow-up information received on 11/26/01 indicated that the pt developed pain at the injection site. She was treated with applications of ice, an unspecified anti-inflammatory and Darvocet. The pt recovered.
Age: 1.7
Sex: F
Vaccine: HIBV, PPV
Symptoms: Diarrhoea, Drug administration error, Injection site reaction, Pyrexia, Vomiting
Clinical narrative: A healthcare professional reported that a female child inadvertently received an injection of Pnu-imune 23 vaccine instead of Prevnar on 10/15/01. She also received Pedvax-HIB vaccine at that time. That same day, the child developed a "severe" localized reaction at the site of Pnu-Imune 23 administration which the reporter did not describe. She also developed a fever, diarrhea, and vomiting. On 10/19/01, the child was seen in an emergency room. The reporter indicated that the symptoms lasted for 4 days. Information regarding this event has been forwarded to manufacturer. Follow-up info received on 12/18/01 indicated that the child was a 20 month old female.
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Headache, Injection site warmth, Oedema
Clinical narrative: A medical assistant reported that a 56 year old male received an injection of Pnu-imune 23 on 2/8/02. Later that day, he developed an injection site reaction characterized by pain, redness and swelling (baseball size lump). As of 2/14/02, the symptoms persisted. This is one of two patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 473-554. Additional info received from the physician on 3/14/02 indicated that the pt recovered. Additional information was received from the consumer on 4/23/02. He indicated that in addition to the above reaction both he and his wife also developed nausea, chills, loss of sleep, and injection site warmth following immunization. The consumer indicated that this report has been forwarded to the FDA. A separate report, HQ0723815FEB2002, has been created for his wife. Follow-up info was received on 5/6/02 from the physician's office. The office indicated that they received conflicting information regarding the pt's past exposure to pneumococcal vaccines. The pt's wife indicated that both she and her husband had not received a pneumococcal vaccine in the past 10 years; however, the husband reported that both he and his wife received Pneumovax last year. The husband believes that both he and his wife have received a total of 3 doses of pneumococcal vaccine.
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site oedema, Injection site pain
Clinical narrative: A medical assistant reported that a 56 year old male received an injection of Pnu-imune 23 on 2/8/02. Later that day, he developed an injection site reaction characterized by pain, redness and swelling (baseball size lump). As of 2/14/02, the symptoms persisted. This is one of two patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 473-554. Additional info received from the physician on 3/14/02 indicated that the pt recovered. Additional information was received from the consumer on 4/23/02. He indicated that in addition to the above reaction both he and his wife also developed nausea, chills, loss of sleep, and injection site warmth following immunization. The consumer indicated that this report has been forwarded to the FDA. A separate report, HQ0723815FEB2002, has been created for his wife. Follow-up info was received on 5/6/02 from the physician's office. The office indicated that they received conflicting information regarding the pt's past exposure to pneumococcal vaccines. The pt's wife indicated that both she and her husband had not received a pneumococcal vaccine in the past 10 years; however, the husband reported that both he and his wife received Pneumovax last year. The husband believes that both he and his wife have received a total of 3 doses of pneumococcal vaccine.
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site reaction, Injection site warmth, Nausea, Sleep disorder
Clinical narrative: A medical assistant reported that a 56 year old male received an injection of Pnu-imune 23 on 2/8/02. Later that day, he developed an injection site reaction characterized by pain, redness and swelling (baseball size lump). As of 2/14/02, the symptoms persisted. This is one of two patients from this facility who experienced this event following receipt of Pnu-Imune 23 lot 473-554. Additional info received from the physician on 3/14/02 indicated that the pt recovered. Additional information was received from the consumer on 4/23/02. He indicated that in addition to the above reaction both he and his wife also developed nausea, chills, loss of sleep, and injection site warmth following immunization. The consumer indicated that this report has been forwarded to the FDA. A separate report, HQ0723815FEB2002, has been created for his wife. Follow-up info was received on 5/6/02 from the physician's office. The office indicated that they received conflicting information regarding the pt's past exposure to pneumococcal vaccines. The pt's wife indicated that both she and her husband had not received a pneumococcal vaccine in the past 10 years; however, the husband reported that both he and his wife received Pneumovax last year. The husband believes that both he and his wife have received a total of 3 doses of pneumococcal vaccine.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site oedema, Injection site warmth, Insomnia
Clinical narrative: An MA reported that a 51 year old female received an injection of Pnu-Imune 23 on 2/8/02. Later that day, she developed an injection site reaction characterized by pain, redness and swelling (baseball size lump). As of 2/14/02, the symptoms persisted. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 473554). Additional information received from the physician on 3/14/02, indicated that the pt recovered. Additional information received from the pt's husband on 4/23/02. He indicated that in addition to the above reaction, both he and his wife also developed nausea, chills, loss of sleep and injection site warmth following immunization. As of 4/23/02, his wife still had a dark mark at the injection site. A 2nd report, HQ0723815FEB2002, has been created for the husband. Follow-up information was received on 5/6/02 from the physician's office. The office indicated that they received conflicting information regarding the pt's past exposure to pneumococcal vaccine in the past 10 years; however, the husband reported that both he and his wife received another pneumococcal vaccine last year. The husband believes that both he and his wife, have received a total of 3 doses of pneumococcal vaccine.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Nausea
Clinical narrative: An MA reported that a 51 year old female received an injection of Pnu-Imune 23 on 2/8/02. Later that day, she developed an injection site reaction characterized by pain, redness and swelling (baseball size lump). As of 2/14/02, the symptoms persisted. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 473554). Additional information received from the physician on 3/14/02, indicated that the pt recovered. Additional information received from the pt's husband on 4/23/02. He indicated that in addition to the above reaction, both he and his wife also developed nausea, chills, loss of sleep and injection site warmth following immunization. As of 4/23/02, his wife still had a dark mark at the injection site. A 2nd report, HQ0723815FEB2002, has been created for the husband. Follow-up information was received on 5/6/02 from the physician's office. The office indicated that they received conflicting information regarding the pt's past exposure to pneumococcal vaccine in the past 10 years; however, the husband reported that both he and his wife received another pneumococcal vaccine last year. The husband believes that both he and his wife, have received a total of 3 doses of pneumococcal vaccine.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: An MA reported that a 51 year old female received an injection of Pnu-Imune 23 on 2/8/02. Later that day, she developed an injection site reaction characterized by pain, redness and swelling (baseball size lump). As of 2/14/02, the symptoms persisted. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 473554). Additional information received from the physician on 3/14/02, indicated that the pt recovered. Additional information received from the pt's husband on 4/23/02. He indicated that in addition to the above reaction, both he and his wife also developed nausea, chills, loss of sleep and injection site warmth following immunization. As of 4/23/02, his wife still had a dark mark at the injection site. A 2nd report, HQ0723815FEB2002, has been created for the husband. Follow-up information was received on 5/6/02 from the physician's office. The office indicated that they received conflicting information regarding the pt's past exposure to pneumococcal vaccine in the past 10 years; however, the husband reported that both he and his wife received another pneumococcal vaccine last year. The husband believes that both he and his wife, have received a total of 3 doses of pneumococcal vaccine.
Age: 51.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Nausea, Skin discolouration, Sleep disorder
Clinical narrative: An MA reported that a 51 year old female received an injection of Pnu-Imune 23 on 2/8/02. Later that day, she developed an injection site reaction characterized by pain, redness and swelling (baseball size lump). As of 2/14/02, the symptoms persisted. This is 1 of 2 pts from this facility who experienced this event following receipt of Pnu-Imune 23 (lot 473554). Additional information received from the physician on 3/14/02, indicated that the pt recovered. Additional information received from the pt's husband on 4/23/02. He indicated that in addition to the above reaction, both he and his wife also developed nausea, chills, loss of sleep and injection site warmth following immunization. As of 4/23/02, his wife still had a dark mark at the injection site. A 2nd report, HQ0723815FEB2002, has been created for the husband. Follow-up information was received on 5/6/02 from the physician's office. The office indicated that they received conflicting information regarding the pt's past exposure to pneumococcal vaccine in the past 10 years; however, the husband reported that both he and his wife received another pneumococcal vaccine last year. The husband believes that both he and his wife, have received a total of 3 doses of pneumococcal vaccine.
Age: 74.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: A 74 year old male reported that he received an injection of Pnu-Imune 23 on 8/23/01. Twenty-four hours later, he developed a fever of 104F lasting for 36 hours. He subsequently, began to experience sporadic febrile events every few days, progressing to every day. The consumer reported that his physician performed an extensive work-up which yielded negative results. He indicated a dx of fever of unknown origin was made.
Age: 18.0
Sex: M
Vaccine: MEN, MEN
Symptoms: Chest discomfort, Chest pain, Paraesthesia, Syncope
Clinical narrative: It was reported that a male pt, born on 2/28/1984, received a dose of Menomune A/C/Y/W-135 and PPD on 8/9/02. Pt experienced paresthesia to the left arm and left leg, and chest pain on 8/10/02. Pt also experienced a syncopal episode on 8/11/02. *F/UP #1 correspondence received on 11/11/02 indicated that the PT recovered fully after 8/11/02. No further info was provided. The case is closed.*
Age: 18.0
Sex: M
Vaccine: MEN, MEN
Symptoms: Chest pain, Paraesthesia, Syncope
Clinical narrative: It was reported that a male pt, born on 2/28/1984, received a dose of Menomune A/C/Y/W-135 and PPD on 8/9/02. Pt experienced paresthesia to the left arm and left leg, and chest pain on 8/10/02. Pt also experienced a syncopal episode on 8/11/02. *F/UP #1 correspondence received on 11/11/02 indicated that the PT recovered fully after 8/11/02. No further info was provided. The case is closed.*
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion
Clinical narrative: Information has been received through a pregnancy registry concerning a 14 year old black female with no past medical history and no allergies who on 11/28/01 was vaccinated with a dose of varicella virus vaccine live (site unknown). There was no concomitant medication. On 12/12/01 it was reported that the pt was eight weeks pregnant (LMP: 10/3/01). The pt had no previous pregnancies. It was also noted that there was no local reaction at the vaccination site. It was reported to be unknown if the pt was tested for varicella antibodies before vaccination. The pt sought unspecified medical attention. Follow-up info reported that on 1/23/02, 16 weeks from LMP, there was an elective termination of the pregnancy. It was reported to be unknown if the fetus was normal. No further information is available.
Age: 1.5
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Autism, Encephalopathy, Immune system disorder, Neurodevelopmental disorder, Rash
Clinical narrative: Autism/encephalopathy. Starting only since vaccine. Severe rash. Dx given by MD. Follow up states pt did not recover. Encephalopathy, autism. Large gross delays in language, auditory processing, social interaction, immunological development, G I absorption. Also very strange behaviors that are involuntary (such as banging head) occur virtually constantly. Pt may not have been a good candidate for 3 vaccines to be given at one time because he might've had a poorly developed immune system and may have been fighting an earlier infection.
Age: 1.5
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Cough, Dyspnoea, Eye swelling, Generalised oedema, Skin discolouration
Clinical narrative: Pt received Varivax #1 and Hib #2 in left thigh. About 6 hours later had face, eye and generalized body swelling with pink color to skin. Pt's mom reported that +SOB/cough. When pt seen in ED, no resp. distress, but generalized swelling.
Age: 1.5
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Swelling face
Clinical narrative: Pt received Varivax #1 and Hib #2 in left thigh. About 6 hours later had face, eye and generalized body swelling with pink color to skin. Pt's mom reported that +SOB/cough. When pt seen in ED, no resp. distress, but generalized swelling.
Age: 1.5
Sex: F
Vaccine: HIBV, VARCEL, HIBV, VARCEL
Symptoms: Anaphylactic reaction, Eye swelling, Hot flush, Oedema, Pyrexia
Clinical narrative: Pt received Varivax #1 and Hib #2 in left thigh. About 6 hours later had face, eye and generalized body swelling with pink color to skin. Pt's mom reported that +SOB/cough. When pt seen in ED, no resp. distress, but generalized swelling.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain, Diarrhoea, Gastroenteritis, Gastrointestinal disorder, Leukocytosis
Clinical narrative: Diarrhea, fever, nausea and vomiting began 11 days MMR vaccine, 6 days after Varivax vaccine. The discharge summary states abdominal pain. Also states gastroenteritis and Crohn's disease.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, fever, nausea and vomiting began 11 days MMR vaccine, 6 days after Varivax vaccine. The discharge summary states abdominal pain. Also states gastroenteritis and Crohn's disease.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Agitation, Cough, Electroencephalogram abnormal, Epilepsy, Eye movement disorder
Clinical narrative: He began experiencing seizures 4 days after the shot. He has Grand Mal Seizures and has been diagnosed with epilepsy. He takes 2 bc of Trileptal 2 x per day.  Had episode of blue around the mouth face pastey "seemed unresponsive, eyes rolled "back in head. Lethargic. Doing ok now breathing ok . Was not eating at time- had just woke up. Had laid on bed- was crying. Acting ok now- was pastey gray for a while. Mom tried mouth to mouth- didn't see chest rise. Passed out? How long 2-3 mins. Breath holding spell. (URI) Mom uncomfortable with dx- doesn't believe it was.   EEG for seizure activities. Has no development so will not do further w/u unless has other episodes or symptoms.  Bright red diaper rash- tried ointment no help. Getting worse. now 4-5 open, draining now in diaper area. Cold for 2 weeks. no fever. Kept waking up fussy. Seen 04/24 and Dx with URI- seems to be getting worse. Breathing shallow, crying out in pain during sleep. no fever. Generally very happy, nose stopped up, lungs/chest clear.  Nose congested 2hrs to URI and allergies. OK Claritan, Sudifed or Triamic Night. Time just at night.  Dx with URI on 04/24. Still cough, congest and RN. Has seizures- more when he is sick- last couple days- having seizures. 06/27/2002 p.c. with mother- had 2 seizures last night . Has been more cranky since yesterday. Call allergy test until seen by neurologist faxed all work to MD. Spoke to dad- several seizures today. Wants to make sure everything is OK. P UC tonight.  06/27/2002 Screaming all day today, seizure last NOC and today. A febrile, decreased appetite.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Grand mal convulsion, Hyperventilation, Irritability, Loss of consciousness, Nasal congestion
Clinical narrative: He began experiencing seizures 4 days after the shot. He has Grand Mal Seizures and has been diagnosed with epilepsy. He takes 2 bc of Trileptal 2 x per day.  Had episode of blue around the mouth face pastey "seemed unresponsive, eyes rolled "back in head. Lethargic. Doing ok now breathing ok . Was not eating at time- had just woke up. Had laid on bed- was crying. Acting ok now- was pastey gray for a while. Mom tried mouth to mouth- didn't see chest rise. Passed out? How long 2-3 mins. Breath holding spell. (URI) Mom uncomfortable with dx- doesn't believe it was.   EEG for seizure activities. Has no development so will not do further w/u unless has other episodes or symptoms.  Bright red diaper rash- tried ointment no help. Getting worse. now 4-5 open, draining now in diaper area. Cold for 2 weeks. no fever. Kept waking up fussy. Seen 04/24 and Dx with URI- seems to be getting worse. Breathing shallow, crying out in pain during sleep. no fever. Generally very happy, nose stopped up, lungs/chest clear.  Nose congested 2hrs to URI and allergies. OK Claritan, Sudifed or Triamic Night. Time just at night.  Dx with URI on 04/24. Still cough, congest and RN. Has seizures- more when he is sick- last couple days- having seizures. 06/27/2002 p.c. with mother- had 2 seizures last night . Has been more cranky since yesterday. Call allergy test until seen by neurologist faxed all work to MD. Spoke to dad- several seizures today. Wants to make sure everything is OK. P UC tonight.  06/27/2002 Screaming all day today, seizure last NOC and today. A febrile, decreased appetite.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Pallor, Respiratory tract infection
Clinical narrative: He began experiencing seizures 4 days after the shot. He has Grand Mal Seizures and has been diagnosed with epilepsy. He takes 2 bc of Trileptal 2 x per day.  Had episode of blue around the mouth face pastey "seemed unresponsive, eyes rolled "back in head. Lethargic. Doing ok now breathing ok . Was not eating at time- had just woke up. Had laid on bed- was crying. Acting ok now- was pastey gray for a while. Mom tried mouth to mouth- didn't see chest rise. Passed out? How long 2-3 mins. Breath holding spell. (URI) Mom uncomfortable with dx- doesn't believe it was.   EEG for seizure activities. Has no development so will not do further w/u unless has other episodes or symptoms.  Bright red diaper rash- tried ointment no help. Getting worse. now 4-5 open, draining now in diaper area. Cold for 2 weeks. no fever. Kept waking up fussy. Seen 04/24 and Dx with URI- seems to be getting worse. Breathing shallow, crying out in pain during sleep. no fever. Generally very happy, nose stopped up, lungs/chest clear.  Nose congested 2hrs to URI and allergies. OK Claritan, Sudifed or Triamic Night. Time just at night.  Dx with URI on 04/24. Still cough, congest and RN. Has seizures- more when he is sick- last couple days- having seizures. 06/27/2002 p.c. with mother- had 2 seizures last night . Has been more cranky since yesterday. Call allergy test until seen by neurologist faxed all work to MD. Spoke to dad- several seizures today. Wants to make sure everything is OK. P UC tonight.  06/27/2002 Screaming all day today, seizure last NOC and today. A febrile, decreased appetite.
Age: 7.5
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Asthma, Blood glucose increased, Dermatitis bullous, Diabetes mellitus
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: 7.5
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Headache, Infection, Pyrexia, Skin papilloma
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.