chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: The pt had a rash, was treated with Benadryl and Medrol dose pack. MD thinks the reaction was due to preservative thimerosal.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Joint stiffness, Malaise, Pyrexia
Clinical narrative: 5 minutes post vax, the pt complained of a temp, rapid heart beat, dizziness, not feeling well. 50-60 minutes post vax, still didn't feel well. Fingers felt clenched and tight. Still had feeling of temp.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: The pt experienced a 11 cm x 6cm swollen, red, warm, and itchy area. Treated with Benadryl. 3 days later the reaction is resolving.
Age: 44.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Pyrexia, Urticaria
Clinical narrative: Approximately 6 hour post vax, the pt felt feverish, had a fever of 102, left arm was sore tot he touch. The next evening (1/10/01) the pt noticed a 3 inch whelp on the left arm. Treated with Tylenol. Fever abated after 36 hours.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Difficulty in walking, Joint swelling
Clinical narrative: One day post vax, the pt began to have pain in all joints. The pt continues to have problems with right knee and left ankle. The pt cannot stand or walk for any length of time. There is pain and swelling most of the time in both.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: 45 minutes post vax, the pt experienced itching on arm. 1 hour post vax, the pt experienced whole body itching, red flushing. Treated with Benadryl. 4 hours later was repeated because of symptoms.
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cough, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: The pt experienced a headache, fever of 101.9 for 15-20 hours. Fever began 24 hours post vax. The pt took Advil for the fever. The pt also experienced muscular aches. 3 days post vax, the pt experienced diarrhea, queeziness, nasal discharge and a cough for 2 weeks
Age: 81.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: The pt experienced a headache, fever of 101.9 for 15-20 hours. Fever began 24 hours post vax. The pt took Advil for the fever. The pt also experienced muscular aches. 3 days post vax, the pt experienced diarrhea, queeziness, nasal discharge and a cough for 2 weeks
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Chickenpox breakthrough after vaccine administered on 2/15/1996.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen from shoulder to elbow, red color outer arm to pink noted on inner aspect, hot to touch. No fever. Child alert and happy. Able to move arm well, fingers warm. Recommended cold packs and go to ER/pediatrics if worsens or fever.
Age: 1.8
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis on right thigh, 8cm X 10cm of redness, hot to touch and swelling.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Agitation
Clinical narrative: Baby awakened 1-3 times each night from 1/5/01 to 1/18/01 with high-pitched screaming, difficult to console. Exam normal on 1/22/01.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Pharyngolaryngeal pain, Rash
Clinical narrative: Client received Hep-B #1 (Recombivax) LDT and PPD-TB (Tubersol) in RFA and 10 minutes later, developed rash on neck and a scratchy throat. Went to ER experiencing breathing difficulties. Received Epinephrine and injection of Benadryl and recovered within minutes.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 6cm X 6cm erythema, tenderness and swelling at injection site.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed swelling and redness on left upper arm on 1/14/01 (2 days, post vax). Seen at ER on 1/14/01 and Rx'd with Keflex and Benadryl. Seen by PMD on 1/15/01 and antibiotic changed to Cipro.
Age: 24.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Asthenia, Chills, Disorientation, Dizziness, Dyspnoea
Clinical narrative: Shortness of breath, disorientation, sweats, tingling sensation in hands and feet, chills, weakness, red blotches on face, neck and feet, dizziness and nausea. Treated with Prednisone. (4 weeks recovery, 1st time).
Age: 24.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Hepatic enzyme abnormal, Hyperhidrosis, Nausea, Paraesthesia, Rash macular
Clinical narrative: Shortness of breath, disorientation, sweats, tingling sensation in hands and feet, chills, weakness, red blotches on face, neck and feet, dizziness and nausea. Treated with Prednisone. (4 weeks recovery, 1st time).
Age: 24.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Vaccine positive rechallenge
Clinical narrative: Shortness of breath, disorientation, sweats, tingling sensation in hands and feet, chills, weakness, red blotches on face, neck and feet, dizziness and nausea. Treated with Prednisone. (4 weeks recovery, 1st time).
Age: 24.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Back pain, Fatigue, Liver function test abnormal, Nausea, Neck pain
Clinical narrative: Shortness of breath, disorientation, sweats, tingling sensation in hands and feet, chills, weakness, red blotches on face, neck and feet, dizziness and nausea. Treated with Prednisone. (4 weeks recovery, 1st time).
Age: 24.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Paraesthesia, Rash, Serum sickness, Similar reaction on previous exposure to drug, Vaccine positive rechallenge
Clinical narrative: Shortness of breath, disorientation, sweats, tingling sensation in hands and feet, chills, weakness, red blotches on face, neck and feet, dizziness and nausea. Treated with Prednisone. (4 weeks recovery, 1st time).
Age: 63.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: The symptoms started the following day. Itching, redness, swelling and heat. The swelling kept spreading. Called doctor's office and doctor recommended Benadryl and compresses. Three days later, went to ER and was told that I had a severe allergic reaction. Prescribed Prednisone. Swelling had moved to lower arm.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash on face, neck and legs, less than 24 hours, post vax. Took Benadryl (po).
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Hypersensitivity, Injection site swelling, Joint swelling, Myalgia
Clinical narrative: Severe swelling of affected arm, joint and muscle pain and swelling. Given NSAID therapy with good relief. Questionable serum sickness versus allergy to serum. Phone consult.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pain, Parotid gland enlargement, Swelling face
Clinical narrative: Awoke today fine, took multivitamins, then noted marked edema of left cheek and pain with mild erythema. On exam, left parotid gland is enlarged and mildly tender.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: No data provided.
Age: 26.0
Sex: F
Vaccine: PPV, TD
Symptoms: Cellulitis, Pyrexia
Clinical narrative: Cellulitis, 24 hours, post vax. Pt went to local ER and was treated with Ancef, Rocephin and Augmentin. Temperature 102F. Cellulitis has responded to treatment.
Age: 3.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Ecchymosis, Pallor, Skin discolouration, Swelling face
Clinical narrative: Child awoke the day following his vaccinations, with swollen, purple lips, swollen gums, pale face and a purple rash under the pale skin. Mom reports he felt fine, no fever, no trouble breathing. Rash didn't itch. Symptoms cleared up in 3 days.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Abdominal pain upper, Cough, Epistaxis, Pyrexia, Vomiting
Clinical narrative: High fever at night (parents did not measure), cough at night, vomiting and stomach ache on 1/16/01 and 1/17/01. Epistaxis X3 on 1/18/01. No local reaction. Temperature 101.4F on 1/19/01 at 10:30.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever after 1 day and a rash after 4 days, post vax.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus, Rash erythematous
Clinical narrative: Td booster given per protocol. Pt called on 11/29/00 with complaint of pain and swelling at injection site. Instructed to take Benadryl and ibuprofen per directions on bottle, apply ice pack to site. Called on 12/1/00. Had client come in to clinic. Irregular, red, raised patches on right deltoid, warm to touch. Arm on right 1" larger than left. States better "but still painful, itches and is swollen".
Age: 1.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Extreme erythematous upper left arm, inferior to DTAP injection.
Age: 12.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Father reports that child broke out in hives, post vax, 1st Hep-B on 9/28/00. Mom is a nurse and treated child with Benadryl and the only thing that was different with child on that day, father reported, was Hep-B vaccine. Father reported this on 2nd visit for Hep-B.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Gastritis, Irritability, Lethargy, Oral intake reduced, Pyrexia
Clinical narrative: On 10/11/00 PM, child was fussy, decreased appetite, lethargy and temperature of 99F (rectal). Father called 7 days later, regarding sluggishness and cramps. Seen in ER; weight loss of 4 oz., temperature 98F. PE by MD-WNL. Possible gastritis.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Weight decreased
Clinical narrative: On 10/11/00 PM, child was fussy, decreased appetite, lethargy and temperature of 99F (rectal). Father called 7 days later, regarding sluggishness and cramps. Seen in ER; weight loss of 4 oz., temperature 98F. PE by MD-WNL. Possible gastritis.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Coma, Oral intake reduced, Somnolence, Tachycardia
Clinical narrative: Evening following DTAP, pt became decreasingly alert, decreased appetite and difficult to awaken. Pt was then evaluated in our office, the following day. Mom reported symptoms confirmed and baby was tachycardic. Pt admitted to hospital for observation.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Anaemia, Depressed level of consciousness, Hyperkalaemia, Hypersensitivity, Laboratory test abnormal
Clinical narrative: Evening following DTAP, pt became decreasingly alert, decreased appetite and difficult to awaken. Pt was then evaluated in our office, the following day. Mom reported symptoms confirmed and baby was tachycardic. Pt admitted to hospital for observation.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Lethargy, Listless, Oral intake reduced, Pyrexia, Respiratory rate increased
Clinical narrative: Evening following DTAP, pt became decreasingly alert, decreased appetite and difficult to awaken. Pt was then evaluated in our office, the following day. Mom reported symptoms confirmed and baby was tachycardic. Pt admitted to hospital for observation.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, DTAP, HEP, HIBV, IPV
Symptoms: Staring, Tachycardia, Thrombocythaemia
Clinical narrative: Evening following DTAP, pt became decreasingly alert, decreased appetite and difficult to awaken. Pt was then evaluated in our office, the following day. Mom reported symptoms confirmed and baby was tachycardic. Pt admitted to hospital for observation.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema
Clinical narrative: Developed blanching, erythematous rash on cheeks, neck and upper chest, 15 minutes, post vax. Almost resolved by 45 minutes after vaccine.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, IPV
Symptoms: Screaming
Clinical narrative: Baby received 1st immunization. Mother advised of possible reactions. Baby cried continuously for 5 hours, following IZ. Mom called and was advised to see PMD, immediately. Did not have transportation. Public Health Nurse and Immunization Coordinator went to home. Baby examined and appeared active, alert and in no distress. Temperature normal. Breast feeding.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Angioneurotic oedema, Pruritus, Urticaria
Clinical narrative: Complaining of angioedema and pruritic, urticarial rash off and on, post vax of Hep-A vaccine (which was done for travel reason).
Age: 0.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Coma, Diarrhoea, Hypotonia, Oral intake reduced, Pallor
Clinical narrative: About 18:00 on 1/22/01, she had 1 diaper of severe diarrhea and no more. About 7 or 8 PM, she began vomiting and vomited everything. Mom was finally able to give her a bottle about 23:59. Baby had fever and vomited again at 02:00 on 1/23/01 (temperature was 100.3F). Had Tylenol hours before she vomited and more after. Then baby went limp and turned white as a ghost. Could not wake her up. Went to ER. Stayed with way 2-3 hours. Began responding better at hospital. Color back the next day. Temperature 100.3F (A) at 10:00 and 20:30 was 100.8F. Refused to eat but did take about 8 oz fluid on 1/23/01. Had only 2 wet diapers from 05:00 to 23:00 on 1/23/01. Went to PMD on 1/24/01 with dx of tonsillitis.
Age: 0.6
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Tonsillitis, Vomiting
Clinical narrative: About 18:00 on 1/22/01, she had 1 diaper of severe diarrhea and no more. About 7 or 8 PM, she began vomiting and vomited everything. Mom was finally able to give her a bottle about 23:59. Baby had fever and vomited again at 02:00 on 1/23/01 (temperature was 100.3F). Had Tylenol hours before she vomited and more after. Then baby went limp and turned white as a ghost. Could not wake her up. Went to ER. Stayed with way 2-3 hours. Began responding better at hospital. Color back the next day. Temperature 100.3F (A) at 10:00 and 20:30 was 100.8F. Refused to eat but did take about 8 oz fluid on 1/23/01. Had only 2 wet diapers from 05:00 to 23:00 on 1/23/01. Went to PMD on 1/24/01 with dx of tonsillitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Pyrexia
Clinical narrative: Mother called clinic on 1/24/01 complaining of child having a fever of 102F to 103F and a headache since his fever not relieved by Motrin. Doctor in clinic today, instructed to take child to PMD now for evaluation with copy of shot record including vaccines given on 1/23/01.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Viral infection
Clinical narrative: A male, now 75 years old, reported that he received an influenza virus vaccine a "couple of years ago" and reportedly could not use his arms shortly afterwards. He could no lift them above his head and he reported that "a virus entered my body when I received the flu shot".
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash
Clinical narrative: A female adult reported that she received '98-'99 formula influenza virus and Pneumovax 23 vaccines in 1998 and subsequently, developed a rash on her lower extremities. She was treated with diphenhydramine. She recovered.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion, Sneezing
Clinical narrative: A 47 year old female consumer reported that she received an influenza vaccine on 9/26/00. On 10/4/00, she experienced sneezing and nasal congestion.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Rash maculo-papular
Clinical narrative: A nurse reported approx. 12 pts from a single institution who received injections of Flu-Shield ('00-'01) on 11/6/00 and 11/07/00 developed injection site reactions characterized by redness, swelling and "spots" within a 2" diameter of injection. The reactions abated after 24 hours. The reporter indicated that approx. 12 pts experienced these events; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up information received 01/25/2001 from the original reported revealed all the patients recovered within 48 hours of the events. No patient specific information was provided.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/14/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, swelling, and redness. No further information was available at the date of this report. The reporter indicated that a total of 5 pts from this facility experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Nasopharyngitis, Pharyngolaryngeal pain, Throat tightness
Clinical narrative: A nurse reported a female pt received an injection of influenza virus vaccine on an unspecified date. Subsequent to vaccination, the pt developed a terrible cold with a tight, sore throat and an injection site reaction characterized by redness and pain.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Pain
Clinical narrative: An MA reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/17/00 and subsequently, developed pain down her right side that extends to her toes. She is also having trouble walking.
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal
Clinical narrative: On 11/22/00 the results of the tuberculin test were reportedly positive following the receipt of flu shield.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: A nurse reported that a 42 year old male received an injection of Flu Shield '00-'01 on 11/18/00 and subsequently, developed a fever, hoarseness and a sore throat. On 11/22/00, she was seen by the physician. Follow up information received from the physician on 01/05/2001 indicated the patient recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Neck pain, Necrosis, Paraesthesia
Clinical narrative: A 53 year old female reported that she received an injection of Flu Shield '00-'01 on 10/26/00. Ten days, post vax, she developed an injection site reaction characterized by an indentation, pain, and tingling that radiated down her arm. She also developed neck pain. She was treated with gabapentin and celecoxib. As of 11/27/00, the symptoms persisted. Follow up information was received from an infectious disease specialist on 03/28/2001 who indicated that the patient was diagnosed with fat necrosis at the injection site.
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: A pharmacist reported that a male received an injection of Flu Shield '00-'01 in 11/00 and subsequently, has experienced irritation of his eyes when using contact lens solution containing thimerosal. The reporter indicated that the pt had no previous history of sensitivity to thimerosal. No further information was available at the date of this report.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: A 67 year old female reported that she received an injection of Flu Shield '00-'01 on 11/30/00 and subsequently experienced an increase in pain.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: A 54 year old male reported that he received an injection of Flu Shield '00-'01 on 11/30/00. On 12/1/00, he developed redness and itching over his entire body. He also developed "dime-sized" hives at he injection site. He was treated with methylprednisolone. The hives resolved. As of 12/4/00, the redness and itching persisted. Follow up information received from the physician on 01/05/2001 indicated that the patient recovered.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Ecchymosis, Injection site erythema
Clinical narrative: A nurse reported that a 22 year old pregnant female inadvertently received an intradermal injection of Flu Shield '00-'01 instead of a tuberculin test on 11/30/00. That day, she developed an injection site reaction characterized by redness and a bruise. Follow up from the physician received 02/06/2001 indicated that the injection site reaction resolved.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia
Clinical narrative: A healthcare professional reported that a 49 year old male received an injection of Flu Shield '00-'01 on 11/27/00 and subsequently experienced tingling in his legs and nausea. This is 1 of 2 pts from this facility who experienced this event, post vax, lot #4008185.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, swelling and redness. This is 1 of 5 pts from this office who experienced an adverse event with Flu Shield. No further information was available at the date of this report.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by burning, "severe" pain, redness and swelling. This is 1 of 5 pts from this office who experienced an adverse event with the administrating of Flu Shield. No further information was available at the date of this report.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria, Wheezing
Clinical narrative: A healthcare professional reported that a 61 year old female received an injection of Flu Shield '00-'01 on 12/06/00. Within 24 hours, the pt developed a rash with hives on her forearms, neck, and trunk, pruritus and wheezing. The pt was treated with epinephrine and Benadryl but the rash worsened. The reporter noted that Flovent therapy "may also be the cause" of the events.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A nurse reported that a 32 year old female received Flu Shield '00-'01 on 12/4/00. On 12/5/00, she developed a red and swollen arm and was seen by her rheumatologist. A dx of infection at the injection site was made. The pt was prescribed an antibiotic.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: A nurse reported that a pt received an injection of Flu Shield '00-'01 on 12/4/00 and the next day, the pt developed an injection site reaction characterized by redness, soreness, swelling and itching. The reaction was managed with an unspecified antibiotic.
Sex: U
Vaccine: FLU3
Symptoms: Hypoglycaemia
Clinical narrative: A physician reported that a pt received an injection of Flu Shield '00-'01 and subsequently developed hypoglycemia. The reporter indicated that he did not believe that the pt's experience of hypoglycemia was caused by Flu Shield. Follow up states patient recovered.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Dizziness, Headache, Insomnia
Clinical narrative: A 78 year old female reported she received an injection of '00-'01 of influenza virus vaccine on 11/7/00. Subsequently, she experienced dizziness, headache, insomnia and bone aches. The caller stated that her physician found no evidence of infection.
Sex: U
Vaccine: FLU3
Symptoms: Prothrombin time prolonged
Clinical narrative: A nurse practitioner reported that a pt received an injection of Flu Shield '00-'01. Following the immunization, the pt's INR (international normalized ratio) was increased. No further information was available at the date of this report. The reporter indicated that 2 or 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Paraesthesia
Clinical narrative: A nurse reported that a 20 year old female with a history of asthma received an injection of Flu Shield '00-'01 on 12/12/00. On the morning of 12/13/00, she experienced numbness and tingling in her left arm and left leg. The reporter indicated the physician treated the reaction as an allergic reaction. She recovered.
Sex: M
Vaccine: FLU3
Symptoms: Laboratory test abnormal
Clinical narrative: A nurse reported that a male received injections of Flu Shield '00-'01 and tuberculin, PPD on 11/20/00. On 11/22/00, the results of the pt's tuberculin test were reportedly positive. This is 1 of 2 pts from this facility who developed a positive tuberculin test following receipt of Flu Shield lot 4008183.
Sex: F
Vaccine: FLU3
Symptoms: Mastitis
Clinical narrative: A nurse reported that a female received an injection of Flu Shield '00-'01 and within 24 hour, she developed mastitis in her right breast. She was treated with antibiotics. She recovered. No further information was available at the date of this report.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain
Clinical narrative: A nurse reported that a 34 year old female received an injection of Flu Shield '00-'01 on 11/23/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience, post vax, Flu Shield.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Paraesthesia
Clinical narrative: A healthcare professional reported that a 52 year old female received an injection of Flu Shield '00-'01 on 11/29/00 and subsequently, experienced tingling in her legs and nausea. This is 1 of 2 pts from this facility who experienced this event following receipt of Flu Shield lot 4008185.
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Pain
Clinical narrative: A nurse reported that a female pt received Flu Shield '00-'01 and Pneumovax 23 (MSD) vaccines on 11/13/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Flu Shield.
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Neck pain, Shoulder pain
Clinical narrative: A nurse reported that a female pt received Flu Shield '00-'01 and Pneumovax 23 (MSD) vaccines on 11/13/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Flu Shield.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: The wife of a 45 year old male reported that her husband received an injection of influenza virus vaccine. The next day, he experienced numbness and tingling of his feet extending into the pelvic area. The pt was seen by a physician who sent him to an ER. The pt was also seen by a neurologist.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Hypoaesthesia oral, Lymphadenopathy, Pallor, Tongue oedema
Clinical narrative: A nurse reported that a 33 year old female received an injection of Flu Shield '00-'01 on 11/15/00. Immediately, post vax, she developed a painful knot in her neck. She was treated with ibuprofen and it resolved after 3 hours. Later that day, she developed a swollen tongue and numb lips that "felt like pins and needles". She felt strange and became pale. She was treated with oral diphenhydramine. She recovered on 11/16/00. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Flu Shield '00-'01, lot 4008176.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: A 47 year old female received an injection of Flu Shield '00-'01 on 10/30/00. On 10/31/00, she reportedly developed swelling at the injection site.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: A female reported that she received an injection of Flu Shield '00-'01 on 10/25/00 and subsequently developed redness at the injection site. As of 11/9/00, the redness persisted. No further information was available at the date of this report.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 3 pts experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided. Follow up states additional information received on 01/10/2001 indicated that the patient is a 42-year-old female who developed redness, swelling, and warmth at the injection site. The patient recovered after 3 to 4 days.
Sex: U
Vaccine: FLU3
Symptoms: Injection site reaction
Clinical narrative: A nurse reported that a pt received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction. No further information was available at the date of this report. The reporter indicated that 5 pts  experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: A nurse reported that a pt received an injection of Flu Shield on 11/16/2000 and subsequently developed an injection site reaction characterized by a reddened area.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site mass
Clinical narrative: A pharmacist reported that a 33 year old male pt received Flu Shield '00-'01 and Pneumovax on 11/28/00. On that same date, the pt developed an injection site reaction characterized by a hard knot. The event has since resolved.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: A nurse reported that a 39 year old female received an injection of Flu Shield '00-'01 on 11/16/00. On 11/28/00, she developed soreness at the injection site and pain in her arm with movement. Follow up information received on 01/03/2001 indicated the patient recovered.
Sex: U
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: A pharmacist reported that a pt received an injection of Flu Shield '00-'01 on 12/2/00 and 2 days later, the pt developed an injection site reaction characterized by a "knot at the injection site".
Sex: U
Vaccine: FLU3
Symptoms: Injection site mass
Clinical narrative: A nurse reported a pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by a "hard knot".
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Rash
Clinical narrative: A nurse reported a female pt received an injection of Flu Shield '00-'01 on 11/16/00 and subsequently developed an injection site reaction characterized by swelling. The pt also developed a pin-point rash on her chest. The pt "felt the reaction was due to  the bandaid as she said it went away when she took the bandaid off".
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Urticaria
Clinical narrative: A nurse reported that an 11 year old male received an injection of Flu Shield '00-'01 on 12/15/00. That same day, the pt developed an injection site reaction characterized by pain and hives. Within 48 hours, the hives spread over his entire body. The child was treated with Benadryl and prednisone and the child "seemed to be getting better." Follow up states hives resolved in one week. No residual problems at this time.
Sex: M
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site pain
Clinical narrative: A consumer reported that he received an injection of Flu Shield '00-'01 on 12/14/00 and subsequently developed pain in the shoulder area of his left arm and can not raise his arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: A nurse reported that a 56 year old female received an injection of Flu Shield '00-'01 on 11/15/00 and subsequently developed an injection site reaction characterized by redness, swelling and warmth. She recovered after 2 weeks. This is 1 of 3 pts from this facility who had an adverse experience following receipt of Flu Shield '00-'01, lot 4008176.
Age: 61.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Joint swelling, Oedema peripheral, Rheumatoid arthritis
Clinical narrative: The pt was diagnosed with rheumatoid arthritis six weeks post vax and has developed swelling her hands, shoulders, knees and ankles. The pt sought unspecified medical attention. Upon internal review the pt's rheumatoid arthritis was determined to be an "other medical event". Additional information has been requested. The follow up received on 7/25/03 from an approximately 61 year old female EMT with no significant medical history and no known allergies who was vaccinated IM with a first dose of hep B virus vaccine. Concomitant therapy included methotrexate, folic acid, ibuprofen, Prempro, "Embrel," methylprednisolone (discontinued in approximately September 1999), an unspecified water pill, and an unspecified anxiety medication. The pt reported that after the first dose she experienced swelling of her hand 3-4 days post vaccination. The pt presented to her family physician about six weeks after vaccination with the first dose and was diagnosed with rheumatoid arthritis and has developed swelling in her hands, shoulder, knees and ankles. The pt thought "she got rheumatoid arthritis from vaccination," although her family physician "never heard of it." After vaccination with the second dose in December 1990, on January 3rd (year not specified), the pt presented to a rheumatologist who informed the pt that she "never heard of Recombivax causing rheumatoid arthritis." In 1994, the pt presented to another rheumatologist who said it was very possible that she got rheumatoid arthritis from the vaccine due to the over reaction of T cells. THe pt noted that her rheumatoid factor was presently 741 (October 1999) and that she has been unable to work since "early August" 1999. The consumer felt that her rheuamtoid arthritis was related to the therapy with hep B virus vaccine. Follow up info received on 11/28/01 for this case in litigation from the consumer indicated that she had been told that because the hep B virus vaccine mya have caused her to have rheumatoid arthritis, which is an autoimmune deficiency, that she should  not have any further vaccinations. The consumer was concerned because she would like to get vaccinated against flu, pneumonia and smallpox (if possible). Additional info was received from manufacturer on 7/25/03 concerning the pt who had received injections with hep B virus vaccine on 7/5/97 and 5/17/97. It was noted that at an unspecified time post-immunization, she "developed rheumatoid arthritis and other autoimmune diseases." This info was originally reported by the pt's son. Upon internal review, rheumatoid arthritis and autoimmune diseases were determined to be other important medical events (OMIC). Additional info is not expected.
Age: 61.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Oedema peripheral, Rheumatoid arthritis, Rheumatoid factor
Clinical narrative: The pt was diagnosed with rheumatoid arthritis six weeks post vax and has developed swelling her hands, shoulders, knees and ankles. The pt sought unspecified medical attention. Upon internal review the pt's rheumatoid arthritis was determined to be an "other medical event". Additional information has been requested. The follow up received on 7/25/03 from an approximately 61 year old female EMT with no significant medical history and no known allergies who was vaccinated IM with a first dose of hep B virus vaccine. Concomitant therapy included methotrexate, folic acid, ibuprofen, Prempro, "Embrel," methylprednisolone (discontinued in approximately September 1999), an unspecified water pill, and an unspecified anxiety medication. The pt reported that after the first dose she experienced swelling of her hand 3-4 days post vaccination. The pt presented to her family physician about six weeks after vaccination with the first dose and was diagnosed with rheumatoid arthritis and has developed swelling in her hands, shoulder, knees and ankles. The pt thought "she got rheumatoid arthritis from vaccination," although her family physician "never heard of it." After vaccination with the second dose in December 1990, on January 3rd (year not specified), the pt presented to a rheumatologist who informed the pt that she "never heard of Recombivax causing rheumatoid arthritis." In 1994, the pt presented to another rheumatologist who said it was very possible that she got rheumatoid arthritis from the vaccine due to the over reaction of T cells. THe pt noted that her rheumatoid factor was presently 741 (October 1999) and that she has been unable to work since "early August" 1999. The consumer felt that her rheuamtoid arthritis was related to the therapy with hep B virus vaccine. Follow up info received on 11/28/01 for this case in litigation from the consumer indicated that she had been told that because the hep B virus vaccine mya have caused her to have rheumatoid arthritis, which is an autoimmune deficiency, that she should  not have any further vaccinations. The consumer was concerned because she would like to get vaccinated against flu, pneumonia and smallpox (if possible). Additional info was received from manufacturer on 7/25/03 concerning the pt who had received injections with hep B virus vaccine on 7/5/97 and 5/17/97. It was noted that at an unspecified time post-immunization, she "developed rheumatoid arthritis and other autoimmune diseases." This info was originally reported by the pt's son. Upon internal review, rheumatoid arthritis and autoimmune diseases were determined to be other important medical events (OMIC). Additional info is not expected.
Sex: M
Vaccine: ADEN, MMR, OPV, PPV
Symptoms: Blood disorder, Gastrointestinal disorder, Haematoma, Pneumonia, Skin disorder
Clinical narrative: A few days post vax the pt developed pneumonia. The pt reported that he then developed blood disorders, histiocytosis, severe vasculitis, hematoma's, another bout of pneumonia, skin disease and regurgitation of food shortly after immunization. The pt reported that he has experienced a lasting problem and attributes all of these events to the receipt of adenovirus vaccine type 7. These events are considered "medically important". The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Sex: M
Vaccine: ADEN, MMR, OPV, PPV
Symptoms: Vasculitis
Clinical narrative: A few days post vax the pt developed pneumonia. The pt reported that he then developed blood disorders, histiocytosis, severe vasculitis, hematoma's, another bout of pneumonia, skin disease and regurgitation of food shortly after immunization. The pt reported that he has experienced a lasting problem and attributes all of these events to the receipt of adenovirus vaccine type 7. These events are considered "medically important". The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Age: 0.9
Sex: M
Vaccine: DTP, HEP, HIBV
Symptoms: Autism, Constipation, Dyspepsia, Mental retardation severity unspecified, Pyrexia
Clinical narrative: A mother reported that her 11 month old son received Tri-Immunol, Hib-Titer, and Recombivax-HB (Merck) vaccines on 09/09/93. Subsequently, the infant developed a fever of 99F., excessive mucous secretions, foul body odor, "strong" urine, reflux, heartburn, and "chronic" constipation. He also "stopped learning and had no physical growth". A diagnosis of autism was reportedly made. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes that the preservative thimerosal is related to the development of autism. A copy of this report has been forwarded to Merck, manufacturer of Recombivax-HB.
Age: 0.9
Sex: M
Vaccine: DTP, HEP, HIBV
Symptoms: Rhinorrhoea, Skin odour abnormal, Urine analysis abnormal
Clinical narrative: A mother reported that her 11 month old son received Tri-Immunol, Hib-Titer, and Recombivax-HB (Merck) vaccines on 09/09/93. Subsequently, the infant developed a fever of 99F., excessive mucous secretions, foul body odor, "strong" urine, reflux, heartburn, and "chronic" constipation. He also "stopped learning and had no physical growth". A diagnosis of autism was reportedly made. The mother attributed these events to the vaccines he received since the age of 4 months. She also believes that the preservative thimerosal is related to the development of autism. A copy of this report has been forwarded to Merck, manufacturer of Recombivax-HB.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Pneumonia, Sepsis
Clinical narrative: On 10/12/00, the pt developed pneumococcal sepsis and was hospitalized for 7 days. A blood culture was positive for strep pneumonia penicillin resistant. On an unspecified date the pt recovered. No further information is available.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Pneumonia, Sepsis
Clinical narrative: On 10/12/00, the pt developed pneumococcal sepsis and was hospitalized for 7 days. A blood culture was positive for strep pneumonia penicillin resistant. On an unspecified date the pt recovered. No further information is available.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Eye pain, Headache, Injection site pain, Malaise
Clinical narrative: My arm hurt, then I felt like someone had punched me very hard in the chest. Then pain traveled up to my neck, jaw, teeth, eye and to the top of my head. Which I was in very bad pain all day. Then it hit my sinus and chest and I was very sick. I was ill for 3 weeks, very bad.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain in jaw
Clinical narrative: My arm hurt, then I felt like someone had punched me very hard in the chest. Then pain traveled up to my neck, jaw, teeth, eye and to the top of my head. Which I was in very bad pain all day. Then it hit my sinus and chest and I was very sick. I was ill for 3 weeks, very bad.
Age: 1.08
Sex: M
Vaccine: MMR, PNC, MER, PNC
Symptoms: Cyanosis, Dyspnoea, Hypoventilation, Pyrexia, Wheezing
Clinical narrative: A nurse reported that a 13 month old male received Prevnar and MMR (Merck) vaccines on 12/01/00. Within 2-3 days post immunization, he developed a high fever, wheezing, blue lips, and shallow breathing. He had trouble breathing and was taken to the emergency room. He recovered. Dyspnea is considered medically important. A copy of this report has been forwarded to Merck, manufacturer of MMR.
Age: 37.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Rash, Throat tightness, Wheezing
Clinical narrative: The pt was given the flu vaccine and within 15 minutes experienced a rash, tightening of the throat, wheezing and difficulty breathing. The pt was treated with epinephrine and Benadryl. 911 was called for transport to the hospital. After receiving medications her breathing improved. The pt was reported as having an anaphylactic reaction.
Age: 37.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Rash, Wheezing
Clinical narrative: The pt was given the flu vaccine and within 15 minutes experienced a rash, tightening of the throat, wheezing and difficulty breathing. The pt was treated with epinephrine and Benadryl. 911 was called for transport to the hospital. After receiving medications her breathing improved. The pt was reported as having an anaphylactic reaction.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Hypotension, Urticaria
Clinical narrative: The same day of the vax, the pt developed hives. She was treated with antihistamines. The next day she experienced difficulty swallowing and a drop in her diastolic BP to 60. The pt was admitted to the hospital and treated with prednisone and epinephrine. As of 11/27/00 the pt had been discharged from the hospital. Follow-up information received 12/18/00 indicated that the pt was seen in the ER and then hospitalized for 5 days. Follow-up information also included the state and county of the vaccine administration and the correct phone number of the reporter.
Age: 28.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abortion, Foetal disorder
Clinical narrative: The pt received both vaccines in Mexico. On 11/14/00, the pt had positive pregnancy test with a LMP of 9/29/00 and an estimated due date of 7/6/02. On 12/28/00 an ultrasound revealed a 7.5 week sac without a fetal pole and yolk sac. On 12/27/00 an ultrasound revealed no fetal pole identified. On 12/28/00 the pt had a spontaneous abortion at 13 weeks. On 12/30/00 a pathology revealed no fetal tissue, only placental tissue that is consistent with either a blighted ovum or an abnormally developing pregnancy. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Cerebral haemorrhage, Convulsion, Lethargy, Malaise, Neoplasm
Clinical narrative: The pt became ill and was seen by the MD on 1/3. The pt experienced otitis media, URI, lethargic behavior, had projectile vomiting the night before. The child was hospitalized with possible meningitis, brain tumor or aneurysm. Has since returned home and is on Dilantin. Diagnosis is L frontal cerebral hemorrhage and R superficial femoral artery occlusion. Document no 213382 states that client is still being seen in P. Last MRI, 02/2002. Mother stated next MRI to be done 05/2002, child has recently had chicken pox. He is active, motor skills good. Mother states being told non malignant tumor - decreasing in size not attached to brain, don't feel it is a blood clot and wish to continue to monitor. No medication since 09/2001. The folllow up received on 3/20/01 states on "1/3/01 est 12pm physician visit-s/s unknown at time except projectile vomiting on 1-2. On 1/5/01 pm-child had seizure. Health dept is following up to get more info. I believe you can use 1/3/01 as the onset date."
Age: 0.6
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Otitis media, Peripheral vascular disorder, Upper respiratory tract infection, Vomiting
Clinical narrative: The pt became ill and was seen by the MD on 1/3. The pt experienced otitis media, URI, lethargic behavior, had projectile vomiting the night before. The child was hospitalized with possible meningitis, brain tumor or aneurysm. Has since returned home and is on Dilantin. Diagnosis is L frontal cerebral hemorrhage and R superficial femoral artery occlusion. Document no 213382 states that client is still being seen in P. Last MRI, 02/2002. Mother stated next MRI to be done 05/2002, child has recently had chicken pox. He is active, motor skills good. Mother states being told non malignant tumor - decreasing in size not attached to brain, don't feel it is a blood clot and wish to continue to monitor. No medication since 09/2001. The folllow up received on 3/20/01 states on "1/3/01 est 12pm physician visit-s/s unknown at time except projectile vomiting on 1-2. On 1/5/01 pm-child had seizure. Health dept is following up to get more info. I believe you can use 1/3/01 as the onset date."
Age: 54.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Headache, Joint stiffness, Rheumatoid arthritis
Clinical narrative: The pt experienced stiffening of feet joints, leg joints, severe pain in fingers, brought on by rheumatoid arthritis. The pt is being treated with Celebrex and going to a rheumatologist. 60 day follow-up states the pt had headaches as well as the stiffness in legs and angles. Missing vaccine information not available.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Irritability, Leukocytosis, Pyrexia, Vomiting
Clinical narrative: The pt experienced a fever, emesis, irritability and leukocytosis. Diagnosed with possible reaction to vaccine
Age: 1.0
Sex: F
Vaccine: HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: 24 hours following vaccination the pt spiked a fever up to 106, was not responsive to acetaminophen, ibuprofen, baths. The pt then had a febrile seizure.