chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: 3 d. post immunization noted "aches in both legs-progressing to arms and legs." Tx with ASA with relief. Pt advised by MD to d/c HCT 2.25mg qd started 1 mo age as well as notify health dept. Pt states is "very sensitive" to meds. Pt has rec'd flu vaccine x many years without effect.
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Swelling, pain, red and warm Lt arm starting 3-3 1/2 hrs after inj LU arm. No prior hx or hx of allergy. 12/2/02 ok finish rx.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Dime size area where shot was given and area is red.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Joint range of motion decreased
Clinical narrative: 11/14/02 pt c/o upper pain, upper edema, limited ROm to L arm after receiving pneumonia vaccination 11/13/02. Pt advised to call MD apply warm clothes to affected area and elevate extremity. 11/15/02 pt now c/o redness to area. She saw MD 11/15/02 and wasput on Cepro.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Screaming
Clinical narrative: Prolonged crying night of vaccine from 8pm to 4am (night of 10/7/02).
Age: 2.0
Sex: M
Vaccine: YF
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: Temperature 104 rectally; gave Tylenol. Complained of back itchy (spread to belly from back); Benadryl given. On 12/6/02, patient's mother reported rash completely resolved with no other side effects reported.
Age: 32.0
Sex: F
Vaccine: IPV, YF
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Pain, Pruritus
Clinical narrative: 2-3 days after injection pt had redness size of two quarters around LA injection site swelling of left arm pt, took Motrin 800mg 1-2 times all day for three days, site was also itchy. Started to resolve on the 1st Dec. Also had pain in left hand. Pain and swelling resolved 12/02. Redness still there. On 12/6/02 pt only reported itching around LA inj site.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Many red papules on head, neck, back and chest.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Decreased appetite, Hot flush, Irritability, Malaise, Pyrexia
Clinical narrative: Ill feeling, few scattered maculo-papules across R face and head cheeks flushed, fever, decreased appetite, fussy.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash macular, Rash papular
Clinical narrative: Ill feeling, few scattered maculo-papules across R face and head cheeks flushed, fever, decreased appetite, fussy.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site induration, Urticaria
Clinical narrative: Onset of urticarial rash at 0730 on 12/3/02 received DTaP and IPV 12/2/02 at ~ 1520. Reaction appeared to have started on site of IPV. Advised to start Benadryl ~ 0810, but was not helping. Seen in ER 12/3 at 1425 and started on course of prednisolone 10mg bid x 6 doses. Had generalized urticaria 4 x 5cm area of induration L upper arm. Recovering but still has a rash on 12/11/02. Now also has nasal congestion again.
Age: 41.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Nasal congestion, Nausea, Rhinorrhoea, Sneezing
Clinical narrative: Nausea first 2 days. Cold symptoms next 3 days, stuffy, runny, sneezing, cough.
Age: 0.2
Sex: M
Vaccine: DT, DTPHIB, HEP, IPV
Symptoms: Coma, Dyspnoea, Respiratory arrest, Wheezing
Clinical narrative: Patient had the 1st Hepititus B shot on 11/27/2002.  On Sat. 11/30/02, patient was taking a nap and when he woke up at 2:45 p.m., he was having a very difficult time taking a breath.  Patient then was not breathing at all and we could not get him to respond to us.  We called 911 and went to the Emergency Room with him.  By the time we had arrived at the hospital, patient was breathing on his own but, he was wheezing and very short breathed.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema, Pain, Skin burning sensation, Skin nodule
Clinical narrative: Moderate burning and stinging x 2 minutes. Redness, heat, pain and swelling up to 4 inches x 3 days. Tender nodule less than 2 cm x 6 days. Non-tender nodule less than 1 cm x 3 weeks.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Pain
Clinical narrative: Second of three shot series. First shot given 26 Nov 02 with virtually no effect. Second shot given on 10 Dec 02. Initial reaction was minimal with no noticable effects. Starting about 24 hours later, arm very sore to touch, and body joints ache. Feels like when you worked out too hard the day before and now body is sore all over, especially in the joints. 48 hours later much more sore all over than the day before. No other symptoms.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Ear pain, Headache, Nausea, Pain
Clinical narrative: Headache, body chills, fever, body aches, sore throat, ears ringing/hurting, nausau
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngolaryngeal pain, Pyrexia, Tinnitus, Upper respiratory tract infection
Clinical narrative: Headache, body chills, fever, body aches, sore throat, ears ringing/hurting, nausau
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Crying, Cyanosis, Flushing
Clinical narrative: Baby had 2 month immunizations at 1000 12/11/02.At 2100hrs Baby had apnea episode at home at on 12/11/02. mother states baby was blue and performed CPR on the way to the hospital. On arrival to emergency room baby was criing and color was pink had temp.99.9, baby discharged home.Baby had another episode at 0300 12/12/02,was taken back to E.R. and discharged home. Respiratory services to be contacted for use of apnea monitor.  Nurse follow up on 06/18/04 states: "No new information received."
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Bursitis, Injection site pain
Clinical narrative: 24 hours post injection Pt. c/o pain at injection site (L Deltoid). Gradually increased to sore shoulder. Tx. NSAID, and Physical Therapy
Age: 19.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Vaccines administered. Seen 2 days later with pain, swelling, erythema to right arm from shoulder to elbow.Vitals BP118/50,P85,R16,T98. RX- Zyrtex, Naproxan, Benadryl.Patient monitored-then dc'd. Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.
Age: 19.0
Sex: F
Vaccine: FLU3, HEPAB, MER, PPV
Symptoms: Erythema, Hypertension, Oedema, Pain
Clinical narrative: Vaccines administered. Seen 2 days later at 4th BAS with pain, swelling, erythema to right arm from shoulder to elbow. Vitals BP 192/86, P 104, R 16, T 99.1.RX- Ciproflaxin, Naproxan, Benadryl, Patient monitored-then dc'd.  Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.
Age: 19.0
Sex: F
Vaccine: FLU3, HEPAB, MER, PPV
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Vaccines administered. Seen 2 days later at 4th BAS with pain, swelling, erythema to right arm from shoulder to elbow. Vitals BP 166/100, P 87, R 16, T 98.6. RX- Cephalexin, Atarax. Patient monitored-then dc'd.  Bedrestx24 hrs. Seen for f/u next day with decreased symptoms.
Age: 1.9
Sex: F
Vaccine: DTAP, HEPA, MMR, PNC
Symptoms: Rash pruritic
Clinical narrative: Client's mother reported the child had a severe rash to bilateral legs with itching 2 weeks after administration of several vaccines.  The mother stated that only the varicella was was new for the client.  Benadryl and hydrocortisone cream did not help rash go away.
Sex: M
Vaccine: MMR
Symptoms: Rash morbilliform, Tracheitis
Clinical narrative: Information has been received from a Registered Nurse who was the mother of a male pt who in 1999 was vaccinated with a dose of MMR II, (lot number not reported). In 1999, ten days post-vaccination the pt developed a "measles rash." Medical attention was sought. Subsequently, the pt developed "tracheitis" which required hospitalization. The pt was sent to ICU to be placed on a ventilator. At the time of the report, the pt was four years old. Additional info has been requested. Follow up info received on 1/28/03 from the physician revealed that the pt had not been to their clinic since 12/15/99 and MMR II was not given there. No additional info is expected.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Information has been received from a consumer and follow up information has been received from the physician concerning a 26 year old female who on 11/19/02 was vaccinated with penumococcal vaccine 23 polyvalent (lot # 644104/0873M). There were no concomitant medications and the patient had no known drug allergies. According to the physician, the patient had never received the pneumococcal vaccine 23 polyvalent prior to this one. The patient was well at the time of vaccination on 11/19/02. On 11/22/02 the patient developed severe cellulitis of the arms going to the neck beginning at the injection site. The patient was hospitalized on 11/22/02. The patient was treated with antibiotics (ampicillin sodium (+) sulbactam sodium (Unasyn) and clindamycin) and was referred to an infectious disease specialist. The patient was discharged from the hospital and has since recovered from severe cellulitis. The reporter expressed a concern regarding the lot number. *F/UP report on 12/23/02: The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. Add'l info. is not expected.*
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Musculoskeletal stiffness, Oedema peripheral, Swelling, Tenderness
Clinical narrative: Information has been received from a medical assistant concerning an adult male with an allergy to digoxin (LANOXIN) who on 11/22/02 was vaccinated IM in the left arm with his first dose of pneumococcal vaccine 23 polyvalent (lot # 643782/0675M). There were no concomitant medications. It was reported that the patient was well at the time of the visit. On the evening of 11/22/02, the patient's whole arm from his deltoid down to his fingers developed redness, tenderness, stiffness, and swelling. The patient was directed by the doctor to go to an emergency room where he was given IV and oral antibiotics, Indocin and Augmentin, and released. By 11/24/02, the patient's symptoms worsened and the patient was hospitalized and treated with IV antibiotics and warm compresses. He was discharged from the hospital on 11/27/02. The doctor reported that the patient is afebrile and WBC are normal. The reporter expressed concern regarding the lot number 643782-0675M. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested. The follow up received on 12/19/02 states on the evening of 11/22/02, the pt's whole left arm from his deltoid down to his fingers developed redness, tenderness, stiffness, warmth, and swelling. The pt was directed by the doctor to go to an ER where he was treated with warm compresses and given IV indomethacin. He was then sent home on Augmentin. By 11/24/02, the pt's symptoms worsened with marked warmth and redness from the deltoid to the ower forearm area. Upon physical examination, the report indicated that the male was in mild distress when seen. It was reported that his vital signs were stable and he was afebrile, head, eyes, ears, nose and throat were normal, lungs were clear, cardiac was regular, and his abdomen was soft and nontender. The examination also noted his left arm to be warm, red and tender fromt eh deltoid area down to the lower forearm with normal strength and reflex sensation. It was reported that he had no loss of strength or numbness, no fever, no chills, no chest pain, and no SOB. The pt was hospitalized and treated with Unasyn. It was reported that he had slow progressive improvement. Swelling,warmth, and redness improved dramatically. He had no further complication during the hospital stay. Lab data indicated that electrolytes, BUN, creatinine, calcium, CBC with differential, and glucose were all normal. He was discharged from the hospital to home on 11/27/02 on seven additional days of Augmentin 875mg bid, and to follow up in 7-10 days in the office. It was reported that the pt did recover. At the time of discharge, final diagnoses were "cellulitis, left arm atherosclerotic heart disease, chronic atrial fibrillation." Artherosclerotic heart disease and chronic atrial fibrillation were considered to be incidental findings. No further info is expected.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal distension, Abdominal pain, Apnoea, Asthenia, Bacterial infection
Clinical narrative: 2 days following the flu shot, developed numbness in right foot, numbness in both feet, hands legs. Weakness progressed to upper extremities, headache, pain over chest wall, rib cage, muscle across abdominal all and low back. Intubated and on ventilator.     60 Day Follow up States: Sorry do not have any follow up information on this pt post discharge from hospital     Per acknowledgement letter: Please note-this information was not available from the physician who gave the vaccine. Discharge summary states atrial fib.msv Medical recordsstates cellulitis, pneumonia, urinary tract infection, pancreatitis, aggrevation of previous condition, decreased reflexes, respitory failure, pleural effusion, abdomenal distention. msv
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Condition aggravated, Guillain-Barre syndrome, Headache, Hypoaesthesia
Clinical narrative: 2 days following the flu shot, developed numbness in right foot, numbness in both feet, hands legs. Weakness progressed to upper extremities, headache, pain over chest wall, rib cage, muscle across abdominal all and low back. Intubated and on ventilator.     60 Day Follow up States: Sorry do not have any follow up information on this pt post discharge from hospital     Per acknowledgement letter: Please note-this information was not available from the physician who gave the vaccine. Discharge summary states atrial fib.msv Medical recordsstates cellulitis, pneumonia, urinary tract infection, pancreatitis, aggrevation of previous condition, decreased reflexes, respitory failure, pleural effusion, abdomenal distention. msv
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Hyporeflexia, Leukocytosis, Muscular weakness, Pancreatitis, Pleural effusion
Clinical narrative: 2 days following the flu shot, developed numbness in right foot, numbness in both feet, hands legs. Weakness progressed to upper extremities, headache, pain over chest wall, rib cage, muscle across abdominal all and low back. Intubated and on ventilator.     60 Day Follow up States: Sorry do not have any follow up information on this pt post discharge from hospital     Per acknowledgement letter: Please note-this information was not available from the physician who gave the vaccine. Discharge summary states atrial fib.msv Medical recordsstates cellulitis, pneumonia, urinary tract infection, pancreatitis, aggrevation of previous condition, decreased reflexes, respitory failure, pleural effusion, abdomenal distention. msv
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia
Clinical narrative: 2 days following the flu shot, developed numbness in right foot, numbness in both feet, hands legs. Weakness progressed to upper extremities, headache, pain over chest wall, rib cage, muscle across abdominal all and low back. Intubated and on ventilator.     60 Day Follow up States: Sorry do not have any follow up information on this pt post discharge from hospital     Per acknowledgement letter: Please note-this information was not available from the physician who gave the vaccine. Discharge summary states atrial fib.msv Medical recordsstates cellulitis, pneumonia, urinary tract infection, pancreatitis, aggrevation of previous condition, decreased reflexes, respitory failure, pleural effusion, abdomenal distention. msv
Age: 65.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: Pt was given flu vaccine 10/30/02 in an outpatient setting. Pt admitted to hospital 11/8/02 with progressive ascending paralysis. Pt diagnosed as having developed Guillain Barr syndrome. Per aclnowledgement letter: I do not have any way of obtaining this information. pt did not receive the vaccine at our institution. 60 Day Follow up States: Pt expired (exact date unknown) Death affiliated to GBS
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Congenital anomaly, Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizures began 2 weeks after 2 month shots. Hospitalized x 4 days. 60 day follow up states the pt has not recovered. Pt continues to have seizure every day.  Annual follow-up on 01/05/04: "Vaccine recipient has not recovered from the adverse events that were reported for this vaccination.  Pt still with seizure disorder and developmental delay."
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema
Clinical narrative: Patient received 2nd done of anthrax vaccine. 2 days later developed marked left upper arm edema/erythema.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site oedema
Clinical narrative: Left arm (+) 3x4cm (+) swelling 11/19 progressive worsening will start Beandryl 25mg po qrn.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Cellulitis, redness, tenderness, induration. Antibiotics x 10D orally. Pt may received rest of Anthrax doses also prednisone 60mg 3//40/bd.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site reaction
Clinical narrative: Cellulitis, redness, tenderness, induration. Antibiotics x 10D orally. Pt may received rest of Anthrax doses also prednisone 60mg 3//40/bd.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Two days after vaccine 6" x 4" oval, red, mildly edematous area surrounding injection site. No fever. No fluctuance.
Age: 24.0
Sex: F
Vaccine: ANTH, FLU3, MEN
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Large local reaction. About 100x80mm red and tender (very), injection site hot/warm to touch. Hard lump. Had migraine about 15 min after shot. Lasted for day and a half. No fever.
Age: 24.0
Sex: F
Vaccine: ANTH, FLU3, MEN
Symptoms: Migraine
Clinical narrative: Large local reaction. About 100x80mm red and tender (very), injection site hot/warm to touch. Hard lump. Had migraine about 15 min after shot. Lasted for day and a half. No fever.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HEP, HIBV, PNC
Symptoms: Depressed level of consciousness, Laboratory test abnormal, Vomiting
Clinical narrative: 8-10PM on 12/9/02, patient had three episodes of vomiting and was difficult to arouse, was seen in ER. Labs and CT of brain (normal) done 12/10/02. Also rechecked in office 12/10/2002.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Rash
Clinical narrative: Client reported a rash on back of both legs the evening after vaccine was given. Following day others around patient noticed she had a flushing of her face.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Urticaria
Clinical narrative: Patient called into Family Healthcare 11/26/02 reporting she got a flu shot 11/21/02. On 11/22/02 she woke up with hives on her upper thighs and feeling warm. Patient had no trouble breathing or any other reported symptoms. The hives were gone by 11/23/02 patient stated.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass
Clinical narrative: 1/4" nickel size lump grew on top inboard of left wrist. I watched it grow from 5:00 - 5:30 PM.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Severe nausea, fever-103 degrees, chills, aches
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Pain
Clinical narrative: Pt related pain for approximately 10- 11 days when seen on 12/06/02. Related a deep aching in arm from shoulder to elbow left arm, middle of area especially.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Subcutaneous nodule
Clinical narrative: 11/28 - local redness, swelling @ injection site left deltoid, 11/29 -Swelling  from injection site to sternum, Palpable sub-clavicular node. Tylenol PO taken, 12/03 swelling gone, Area tender
Sex: U
Vaccine: FLUX
Symptoms: Dizziness, Headache
Clinical narrative: Very dizzy and had an unusual headache on & off for two days after vaccination
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Asthma, Cough, Dyspnoea, Rhinorrhoea
Clinical narrative: Difficulty breathing the evening of 11/21/02. The next day, developed into wheezing without a  cough. At 1st, thought, it was just nasal drainage, a bad case of it. But after I got into see my doctor, it was asthma + he gave Augmentin script to fill. I haven't had a bout of asthma alone for years. I need to call doctor again and see what else he wants me to be on.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pneumovax 12/03/02, 12/04/02 Upper left arm red, swollen, tender to touch. Not hot, No medical tx@ present. Pt preferred to not tx medically.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Varicella rash in vaccinated child
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Varicella rash in vaccinated child.
Age: 1.0
Sex: F
Vaccine: FLU3, HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash, Vasodilation procedure
Clinical narrative: Red, warm, lesion antimedial aspect left thigh. No temp 1.5cm x 2cm firm, red, non tender lesion
Age: 1.0
Sex: F
Vaccine: HBHEPB, IPV, VARCEL
Symptoms: Injection site hypersensitivity, Vasodilation procedure
Clinical narrative: Varivax given in left arm. Injection site became red, blotchy. Face became red, reaction occured within five minutes of injection. Child stabilized and sent home.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Oedema genital, Pain, Pyrexia
Clinical narrative: MMR administered 11/8/02. Patient states he developed testicular swelling and pain. 11/15/02 in addition to generalized joint pain, fever of 103.7, chills. Seen by PCP and treated with Levaquin.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: ? and slept almost 24 hours and temperature 101. Re-examined 12/6, neuro stable, no infection to explain, suspect vaccine reaction
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Influenza, Malaise, Myalgia, Urticaria
Clinical narrative: Hive localized to left arm - Malaise, dizziness, general flu symptoms - extreme arm and joint pain.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Hypersensitivity, Oedema
Clinical narrative: Within one hour allergic wheal was present. Then followed by swelling from shoulder to elbow. Area became red and inflamed. Painful to touch for 3-4 days. Swelling remained for 7-8 days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation, Injection site reaction
Clinical narrative: Inconsolable crying/local reaction at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site induration, Injection site swelling
Clinical narrative: Noticed right deltoid swelling at area of shot morning of 11/21. It got progressively wore as swelling spread up shoulder and near elbow. Indurated and hot to touch.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Intermittent fever of up to 101.3 degrees. Local swelling with no erythema. Good response to Tylenol and ice.
Age: 1.6
Sex: M
Vaccine: DTAP, HBPV, IPV, PNC
Symptoms: Apnoea, Convulsion, Crying, Tremor
Clinical narrative: Wake up to son having seizure and not breathing. He was flailing his arms and legs and had stopped breathing. I picked him up and it seemed that I shocked him into breathing again. He cried and shook for another 2 hours. Called office and was told to give him liquid Benadryl. No fever.
Age: 60.0
Sex: M
Vaccine: LYME
Symptoms: Pain, Shoulder pain
Clinical narrative: Right after the shots I experienced body aches to the point where I had to roll out of bed in the morning. This seemed to ease up somewhat, but now I am having problems in my shoulder joints.
Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Facial palsy, Hypoaesthesia, Neck pain, Shoulder pain
Clinical narrative: My face drops and returns. My face goes numb; my toes and feet sometimes go numb. I have pain in my neck and shoulders.
Age: 3.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Balance disorder
Clinical narrative: Mother states off balance, falling backwards. Referred to neurologist for evaluation; failed to keep appointment. Treated by Pediatrician with cough medicines, etc. Otherwise, physical findings unremarkable.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient called 12/9/02. Injection site red, swollen. Tried ice and Benadryl and did not help. Seen at ER; was given Medrol dose pack and Zithromax for Cellulitis
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Urticaria
Clinical narrative: Pt received IM Influenza vaccine 0.5cc in right deltoid at 10:18AM 12/11/02. She woke up this morning at 03:00 with swollen, hives on neck, upper arms and chest walls
Age: 27.0
Sex: F
Vaccine: MMR, TD
Symptoms: Chills, Fatigue, Lethargy, Malaise, Myalgia
Clinical narrative: @ 1 hour post vaccination, Lethargic, in am , @ 12 hours General bodyache + fatigue "didn't feel well, Self-adm aspirin. Went to work developed chills, At 6 pm, 6/11/02 went to ER Temp 103, Fluids admini,x-ray + labs done. DIC home with Vicodyn 12/12/02 called Imm clinic, Patient at work. Temp 99.8, Remains  tired with general muscle pain, taking Ibuprofen at work.
Age: 27.0
Sex: F
Vaccine: MMR, TD
Symptoms: Pain, Pyrexia
Clinical narrative: @ 1 hour post vaccination, Lethargic, in am , @ 12 hours General bodyache + fatigue "didn't feel well, Self-adm aspirin. Went to work developed chills, At 6 pm, 6/11/02 went to ER Temp 103, Fluids admini,x-ray + labs done. DIC home with Vicodyn 12/12/02 called Imm clinic, Patient at work. Temp 99.8, Remains  tired with general muscle pain, taking Ibuprofen at work.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Joint range of motion decreased
Clinical narrative: 11/25/02 5 pm sore RUE, decreased mobility, 11/26/02 - decrease soreness RUE, rash near RUE -> torso, 11/27/02 -Soreness resolved, rash decreased, (?) to call prim. MD, 12/02/02 -Never (?) with MD, Rash resolved (didn't know when).
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Rash
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Generalized rash, Fever.  Rash -varicalla like on 11/25/2002
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Generalized rash
Age: 48.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Dysgeusia, Flushing, Malaise, Pharyngolaryngeal pain, Rash erythematous
Clinical narrative: Checking out of clinic within 10 mins of adm Hep A Hep B vaccine. Pt reports 1) funny taste in mouth, Feeling whoozy, Throat feels funny, Face became flushed.  paramedics called - responded, Splotchy red rash on face forehead), Ringing in ears, B/P 120/94, pulse reg, Once crew arrived transported to ER
Age: 48.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Rash maculo-papular, Tinnitus
Clinical narrative: Checking out of clinic within 10 mins of adm Hep A Hep B vaccine. Pt reports 1) funny taste in mouth, Feeling whoozy, Throat feels funny, Face became flushed.  paramedics called - responded, Splotchy red rash on face forehead), Ringing in ears, B/P 120/94, pulse reg, Once crew arrived transported to ER
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Baby put to bed in good condition; found expired this AM.
Age: 20.0
Sex: F
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Anaphylactic reaction, Chest pain, Cough, Dyspnoea, Flushing
Clinical narrative: Patient received a total of four immunization (see below). Immediately after receiving these shots, she complained of having air in throat. She began to cough, developed left sided chest pain, rhinitis, became flush, stated she was having trouble breathing. Audible wheezes noted. Pulse 100 BPM. 911 called and transported to ED.
Age: 20.0
Sex: F
Vaccine: ANTH, MEN, TYP, YF
Symptoms: Rhinitis, Wheezing
Clinical narrative: Patient received a total of four immunization (see below). Immediately after receiving these shots, she complained of having air in throat. She began to cough, developed left sided chest pain, rhinitis, became flush, stated she was having trouble breathing. Audible wheezes noted. Pulse 100 BPM. 911 called and transported to ED.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abdominal pain, Injection site erythema, Injection site pain, Injection site warmth, Joint range of motion decreased
Clinical narrative: On 11/09/02 developed abdominal and leg cramps, sore throat and L arm pain. Noticed L arm redness, hot to touch. Had limited range of motion of L arm. Symptoms persisted. Began with nausea and vomiting on 11/11/02 and sought treatment at medical center. Hospitalized one day. 11/14/02, L arm remains reddened, warm to touch from mid-upper arm to elbows. Normal range of motion.
Age: 34.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Muscle spasms, Nausea, Pharyngolaryngeal pain, Vomiting
Clinical narrative: On 11/09/02 developed abdominal and leg cramps, sore throat and L arm pain. Noticed L arm redness, hot to touch. Had limited range of motion of L arm. Symptoms persisted. Began with nausea and vomiting on 11/11/02 and sought treatment at medical center. Hospitalized one day. 11/14/02, L arm remains reddened, warm to touch from mid-upper arm to elbows. Normal range of motion.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Injection site mass, Injection site swelling, Pain, Rash
Clinical narrative: Burning sensation and pain radiating up to shoulder-10 minutes.  3 hours later- warmth,pain, swelling at site. 24 hours after vaccination,to present- rash 3" diameter at site (fading) tenderness (fading) skin warmth (gone after 1 week) swelling (gone after 1 week) lump under skin (visible and palpable). Also 2 weeks skeletal/joint pain major joints-shoulders, rt. elbow, hips, knees, cervical and lumbar spine. BACKGROUND: The only reaction from shot #1 was localized pain for 4 days.
Age: 46.0
Sex: M
Vaccine: HEPA
Symptoms: Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: Headache, lethargic, nausea, fever.
Age: 48.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: After getting the injection, my health started to deteriorate.  I felt severely ill, dizzy, extreme fatigue, extreme neurological disturbance, I couldn't even stand up.  I would try to get dressed and then I would collapse.  This continued for several days, then I finally went to the doctor and I told him how I could even stand up without collapsing, how I was so fatigue and I had no ability to take care of myself.  I was bedridden. I had the chills.  I was extremely cold and I couldn't warm myself up.  When I went to the doctor they took some blood work and it came up that my white blood count dropped down to 2600--normal is 4500.  My immune system is compromised the doctor told me.  I had to go through a barrage of tests, bone biopsy to see if I had leukemia.  They finally diagnosed me with lupus, then they changed it to fibromyalgia, arthritis, chronic fatigue, neurological disorder.  I have been ill ever since these injections.  My thinking has been affected.  My short-term is compromised.  Sometimes making a decision (a simple one) it isn't possible.  I am confused and my concentration level is poor.  Sometimes my judgement is poor.  I am agitated and easily upset, depressed most of the time.  My health dropped severely after getting my first vaccination. The medical record states hep B series was given on the following dates: 10/14/00, 12/29/00, 6/11/01. No lot#s were provided.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Convulsion
Clinical narrative: Non febrile seizure lasting approximately 30 seconds described as generalized tonic clinic with eyes rolling straight back.
Age: 1.5
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Convulsion, Eye movement disorder
Clinical narrative: Non febrile seizure lasting approximately 30 seconds described as generalized tonic clinic with eyes rolling straight back.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Bradycardia, Shock
Clinical narrative: A healthcare professional reported that a 3 month old male received his second dose of Prevnar on 11/27/02 in the left leg. Concomitant vaccines included Comvax, DTaP (manuf unk), IPOL, and synagis. The concomitant vaccines were administered in the right and left legs. Medical histroy included Down's syndrome, Klinefelter's syndrome, tracheomalacia, and tracheo-eosphageal fistula. Approximately 15 minutes post-immunization, the child developed apnea and bradycardia. The nurse practitioner began rescue breathing and chest compressions. The child was treated with oxygen and 911 was notified. Paramedics arrived and transferred the child to the emergency room; he was evaluated by a physician. He recovered and was discharged from the ER. This event is considered medically important (OMIC). Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. The follow up #1 states: upon review of information, ti was deemed necessary to change the product coding for HIB/Hep B combined vaccine.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Bradycardia
Clinical narrative: A healthcare professional reported that a 3 month old male received his second dose of Prevnar on 11/27/02 in the left leg. Concomitant vaccines included Comvax, DTaP (manuf unk), IPOL, and synagis. The concomitant vaccines were administered in the right and left legs. Medical histroy included Down's syndrome, Klinefelter's syndrome, tracheomalacia, and tracheo-eosphageal fistula. Approximately 15 minutes post-immunization, the child developed apnea and bradycardia. The nurse practitioner began rescue breathing and chest compressions. The child was treated with oxygen and 911 was notified. Paramedics arrived and transferred the child to the emergency room; he was evaluated by a physician. He recovered and was discharged from the ER. This event is considered medically important (OMIC). Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. The follow up #1 states: upon review of information, ti was deemed necessary to change the product coding for HIB/Hep B combined vaccine.
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Bradycardia, Respiratory arrest
Clinical narrative: A healthcare professional reported that a 3 month old male received his second dose of Prevnar on 11/27/02 in the left leg. Concomitant vaccines included Comvax, DTaP (manuf unk), IPOL, and synagis. The concomitant vaccines were administered in the right and left legs. Medical histroy included Down's syndrome, Klinefelter's syndrome, tracheomalacia, and tracheo-eosphageal fistula. Approximately 15 minutes post-immunization, the child developed apnea and bradycardia. The nurse practitioner began rescue breathing and chest compressions. The child was treated with oxygen and 911 was notified. Paramedics arrived and transferred the child to the emergency room; he was evaluated by a physician. He recovered and was discharged from the ER. This event is considered medically important (OMIC). Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. The follow up #1 states: upon review of information, ti was deemed necessary to change the product coding for HIB/Hep B combined vaccine.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Bradycardia, Shock
Clinical narrative: A medical assistant reported the occurrence of apnea and bradycardia in a 4-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infarix) for prophylaxis. The subject had no known allergies. On November 27, 2002, the subject received his second injection of Infanrix (lot DTPA575A2). ON the same date, he also received injections of combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax), inactivated poliomyelitis virus vaccine (IPOL), 7-valent pneumococcal conjugate vaccine (Prevnar) and palivizumao (Synagis). The reporting medical assistant stated that 15 minutes after receiving his immunizations, the subject became "apneic bradycardic." A nurse practitioner administered chest compressions and the subject was transported to the local emergency room by emergency medical personnel. He recovered and was sent home from the emergency room. The apnea and bradycardia in this report are considered medically serious because the event was treated with chest compressions.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Bradycardia
Clinical narrative: A medical assistant reported the occurrence of apnea and bradycardia in a 4-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infarix) for prophylaxis. The subject had no known allergies. On November 27, 2002, the subject received his second injection of Infanrix (lot DTPA575A2). ON the same date, he also received injections of combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax), inactivated poliomyelitis virus vaccine (IPOL), 7-valent pneumococcal conjugate vaccine (Prevnar) and palivizumao (Synagis). The reporting medical assistant stated that 15 minutes after receiving his immunizations, the subject became "apneic bradycardic." A nurse practitioner administered chest compressions and the subject was transported to the local emergency room by emergency medical personnel. He recovered and was sent home from the emergency room. The apnea and bradycardia in this report are considered medically serious because the event was treated with chest compressions.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Bradycardia, Respiratory arrest
Clinical narrative: A medical assistant reported the occurrence of apnea and bradycardia in a 4-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infarix) for prophylaxis. The subject had no known allergies. On November 27, 2002, the subject received his second injection of Infanrix (lot DTPA575A2). ON the same date, he also received injections of combination Haemophilus influenzae type b conjugate/hepatitis B vaccine (Comvax), inactivated poliomyelitis virus vaccine (IPOL), 7-valent pneumococcal conjugate vaccine (Prevnar) and palivizumao (Synagis). The reporting medical assistant stated that 15 minutes after receiving his immunizations, the subject became "apneic bradycardic." A nurse practitioner administered chest compressions and the subject was transported to the local emergency room by emergency medical personnel. He recovered and was sent home from the emergency room. The apnea and bradycardia in this report are considered medically serious because the event was treated with chest compressions.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Unevaluable event
Clinical narrative: Infant found deceased at home in parent's bed.
Sex: M
Vaccine: FLU3
Symptoms: Paralysis
Clinical narrative: A consumer reported that a male adult received Influenza Virus vaccine, Trivalent, Types A & B (1995-1996 formula) vaccine (date of immunization not identified). Subsequent to immunization he experienced paralysis and the patient died in connection with a flu vaccination. The consumer also reported that this individual experienced adverse events following immunization with smallpox in 1950. See Case ID HQ5610404DEC2002. This report was received from a department at a manufacturer. No additional information was available as of the date of this report.
Sex: M
Vaccine: FLU3
Symptoms: Drug toxicity, Mental retardation severity unspecified, Neurodevelopmental disorder
Clinical narrative: A legal complaint was received on 12/03/02 from an attorney alleging that a child received series of Engerix B, Tripedia, Tetramune, Hib-Titer, Tri-Immunol and Flu Shield vaccines from 12/31/92 through 11/12/98 and subsequently experienced "toxic neurological effects of mercury poisoning." The legal complaint also stated that the pt experienced "mental and intellectual incapacity, developmental incapacity, learning disabilities, and affect disorders and impairments." The pt's symptoms resulted in persistent or significant disability/incapacity. Vaccine info contained in the legal complaint indicated that the child received Engerix B, Tripedia, Tetramune, Hib-Titer, Tri-Immunol, and Flu shield vaccines during the first years of life.
Sex: U
Vaccine: DTPHIB
Symptoms: Drug toxicity, Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: A legal complaint was received from an attorney alleging that a child (birth date not specified) received a 3rd dose of Tetramune vaccine on 4/9/96. Previously the child had received Engerix B on 9/14/95 and haemophiluss B conjugate vaccine on 1/28/97. The child also received hep B vaccine on 9/25/96. According to the legal complaint, as a result of the vaccinations administered during the period September 1995 through July 1997, the child "was subjected to very high doses of the mercury contained in Thimerosal, a highly toxic preservative intentionally added to the vaccines he received." It is alleged that 'as a result of the mercury in the Thimerosal containing vaccinations that Minor child received, Minor child now suffers, and in the future will continue to suffer, from the toxic neurological effects of mercury poisoning." It is also alleged that the child has "sustained mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." This case was serious since these events were considered medically important (OMIC) in this case. No additional info was available as of the date of this report.
Sex: F
Vaccine: OPV
Symptoms: Dyspnoea, Lung disorder, Neoplasm malignant, Pleural mesothelioma
Clinical narrative: A legal complaint was received from an attorney alleging that a female received Orimune vaccine. As an adult, she was diagnosed with mesothelioma on or about May, 2000 and died 3/24/01. "The decedent had mesothelioma in which SV40 was a substantial factor, and therefore a cause of decedent's mesothelioma." It is alleged that the "decedent's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the decedent, including but not limited to breathing difficulties, asbestosis, lung and/or cancer, mesothelioma, and/or lung damage. The reporter stated that the "Decedent stopped working on 4/27/00, due to her mesothelioma."
Sex: M
Vaccine: HIBV, MMR
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: A mother reported that her son received a series of vaccines including Hib-TITER, Acel-Imune, MMR, hep B, varicella and poliomyelitis virus from 5/4/00 through 8/6/01. She began to notice developmental delays at 9 to 12 months of age. A diagnosis of autism was made in September 2002 at 2 years of age. She is currently trying to detoxify him of mercury with "DMSA" without physician support. Her "son's physician feels that the autism is hereditary, not related to the vaccines." The reporter noted that she also has a 4 year old son with no health or developmental issues. These events were considered medically important (OMIC). Info regarding this event have been sent to manufacturers of vaccines. No further info was available at the date of this report.
Age: 1.7
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated
Clinical narrative: Follow-up info received 11/20/02 from investigator. The subject experienced asthma exacerbation on 10/13/02 and was subsequently hospitalized on 10/14/02. He was treated with Ventolin, Atrovent, paracetamol and prednisolone. He recovered and was discharged on 10/16/02 with Flixotide inhalers for preventative therapy. The investigator, who remains blinded, has changed his assessment to "probably not related" to the study vaccine. The original assessments made by the medical monitor remain unchanged. An investigator reported that a 20 month old male received a 2nd dose of influenza virus vaccine on 3/26/02, when he was 14 months old, as part of the study entitled: "A Randomized, Placebo-Controlled, Trial To Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A & B, Live, Cold Adapted (FluMist) and MMR II, and Varivax Vaccines Administered Concurrently To Healthy Children." On 2/4/02, the subject received a 1st dose of FluMist, along with Varivax and MMRII. On 5/9/02, the subject also received Placebo. Medical history includes tow previous hospitalizations on 6/20/02 and 7/1/02, for asthma exacerbation and an emergency department visit on 8/21/02 for asthma. On 10/1/02, the pt was re-admitted for asthma exacerbation. On 10/3/02, he was discharged following a complete recovery. The investigator (who remains blinded) assessed the event as severe and "probably not related" to the study vaccine and definitely "not related" to MMR II and Varivax. The medical monitor considers the event "probably not related" to the study vaccine due to the lack of a temporal relationship between vaccination and event onset.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Acidosis, Atrioventricular block, Cardiac failure, Cardiomyopathy, Hypotension
Clinical narrative: Information has been received from an investigator concerning a 3 month old female. On 7/17/02, at 2 months of age, she received her first dose of Prevnar as part of a post-marketing safety surveillance trial. That same day, she also received first doses of DTaP, IPV, and ACT-HIB, with a second dose of Hep B. On 8/28/02, she was hospitalized with acute respiratory distress and a diagnosis of pneumonia was made. Later that day, the child expired due to A/V block complete, acute respiratory failure and heart failure with primary cardiomyopathy and other cardiac dysrhythmias, hypotension, acidosis, and other lung disorders. Resuscitation attempts were unsuccessful. The child's medical history consisted of diaphragmatic/phrenic paralysis with mechanical ventilation leading to chronic lung disease, meconium aspiration and pulmonary hypertension which required extracorporeal circulation membrane oxygenation, pylorospasm, and feeding problems which required feedings via N-J tube. The investigator's assessment of relatedness of these events (all except pneumonia, unexpected as per USPI) to the vaccines administered was *not related.* *Add'l info received as result of combining duplicate cases on 12/13/02 provided an investigator's assessment of NOT RELATED."*