chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash pruritic, Rash vesicular, Respiratory rate, Secondary transmission, Ultrasound Doppler abnormal
Clinical narrative: Information has been received from a physician concerning a 14-year-old female with a history of a bone marrow transplant in 2004 who on an unknown date was vaccinated with a third dose of VARIVAX. On an unspecified date it was reported that patient had "transmission from varicella virus vaccine live". It was noted the patient was sitting next to a child with a rash. The patient is now hospitalized with a varicella rash. The physician also reports that he does not know if there was an adverse experience, he wants to "know if it is a vaccine strain or infection". At the time of the report the patient's status was unknown. A product quality complaint was not involved. The physician indicated that he received the VZVIP questionnaire and he would be sending in a sample collected from a scraping of a "varicella rash". This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 14-year-old female with a history of a bone marrow transplant in 2004 who on an unknown date was vaccinated with a third dose of VARIVAX. On an unspecified date it was reported that patient had "transmission from varicella virus vaccine live". It was noted the patient was sitting next to a child with a rash. The patient is now hospitalized with a varicella rash. The physician also reports that he does not know if there was an adverse experience, he wants to "know if it is a vaccine strain or infection". At the time of the report the patient's status was unknown. A product quality complaint was not involved. The physician indicated that he received the VZVIP questionnaire and he would be sending in a sample collected from a scraping of a "varicella rash". This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash, Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning a 14-year-old female with a history of a bone marrow transplant in 2004 who on an unknown date was vaccinated with a third dose of VARIVAX. On an unspecified date it was reported that patient had "transmission from varicella virus vaccine live". It was noted the patient was sitting next to a child with a rash. The patient is now hospitalized with a varicella rash. The physician also reports that he does not know if there was an adverse experience, he wants to "know if it is a vaccine strain or infection". At the time of the report the patient's status was unknown. A product quality complaint was not involved. The physician indicated that he received the VZVIP questionnaire and he would be sending in a sample collected from a scraping of a "varicella rash". This is one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Chest pain, Computerised tomogram normal, Electrocardiogram normal, Eye pain, Head injury
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 10-JUL-2007 was vaccinated with a second SC dose of VARIVAX (Oka/Merck) (Lot# 657620/0536U).  In July 2007, the patient developed an injection site reaction that was hard, swollen, red, and feverish to the touch.  The reaction had been of "softball-size."  Unspecified medical attention was sought.  Physician suggested BENADRYL for treatment of the injection site reaction.  Subsequently, the patient recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Headache, Neck pain, Pain, Paraesthesia, Syncope
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 10-JUL-2007 was vaccinated with a second SC dose of VARIVAX (Oka/Merck) (Lot# 657620/0536U).  In July 2007, the patient developed an injection site reaction that was hard, swollen, red, and feverish to the touch.  The reaction had been of "softball-size."  Unspecified medical attention was sought.  Physician suggested BENADRYL for treatment of the injection site reaction.  Subsequently, the patient recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 10-JUL-2007 was vaccinated with a second SC dose of VARIVAX (Oka/Merck) (Lot# 657620/0536U).  In July 2007, the patient developed an injection site reaction that was hard, swollen, red, and feverish to the touch.  The reaction had been of "softball-size."  Unspecified medical attention was sought.  Physician suggested BENADRYL for treatment of the injection site reaction.  Subsequently, the patient recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Crying, Dizziness
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 10-JUL-2007 was vaccinated with a second SC dose of VARIVAX (Oka/Merck) (Lot# 657620/0536U).  In July 2007, the patient developed an injection site reaction that was hard, swollen, red, and feverish to the touch.  The reaction had been of "softball-size."  Unspecified medical attention was sought.  Physician suggested BENADRYL for treatment of the injection site reaction.  Subsequently, the patient recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Eye movement disorder, Eye pain, Fall, Fatigue, Headache
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 10-JUL-2007 was vaccinated with a second SC dose of VARIVAX (Oka/Merck) (Lot# 657620/0536U).  In July 2007, the patient developed an injection site reaction that was hard, swollen, red, and feverish to the touch.  The reaction had been of "softball-size."  Unspecified medical attention was sought.  Physician suggested BENADRYL for treatment of the injection site reaction.  Subsequently, the patient recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Laboratory test normal, Musculoskeletal chest pain, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 10-JUL-2007 was vaccinated with a second SC dose of VARIVAX (Oka/Merck) (Lot# 657620/0536U).  In July 2007, the patient developed an injection site reaction that was hard, swollen, red, and feverish to the touch.  The reaction had been of "softball-size."  Unspecified medical attention was sought.  Physician suggested BENADRYL for treatment of the injection site reaction.  Subsequently, the patient recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, MNQ
Symptoms: Sensory disturbance, Syncope
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 10-JUL-2007 was vaccinated with a second SC dose of VARIVAX (Oka/Merck) (Lot# 657620/0536U).  In July 2007, the patient developed an injection site reaction that was hard, swollen, red, and feverish to the touch.  The reaction had been of "softball-size."  Unspecified medical attention was sought.  Physician suggested BENADRYL for treatment of the injection site reaction.  Subsequently, the patient recovered.  No product quality complaint reported.  Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5, RV5
Symptoms: Culture stool positive, Dehydration, Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 14 month old white female who on 21-MAR-2007 was vaccinated with ROTATEQ first dose (LOT# 656191/1365F) at the age of 2 months. Subsequent doses of ROTATEQ were given on 11-OCT-2008  (LOT 656383/0235U)  at age 4 months on 11-OCT-2008 and third dose on 30-OCT-2008 LOT # 656705/0241U at age 6 months. There was no concomitant medication. On 18-APR-2008 the patient developed diarrhea and dehydration and was hospitalized. The patient was hospitalized for three days. The patient had a stool culture which was positive on 19-APR-2008 for rotavirus antigen. On 20-APR-2008 the patient had recovered. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5, RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus test positive
Clinical narrative: Information has been received from a physician concerning a 14 month old white female who on 21-MAR-2007 was vaccinated with ROTATEQ first dose (LOT# 656191/1365F) at the age of 2 months. Subsequent doses of ROTATEQ were given on 11-OCT-2008  (LOT 656383/0235U)  at age 4 months on 11-OCT-2008 and third dose on 30-OCT-2008 LOT # 656705/0241U at age 6 months. There was no concomitant medication. On 18-APR-2008 the patient developed diarrhea and dehydration and was hospitalized. The patient was hospitalized for three days. The patient had a stool culture which was positive on 19-APR-2008 for rotavirus antigen. On 20-APR-2008 the patient had recovered. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram normal, Laboratory test, Paraesthesia, X-ray
Clinical narrative: Initial report was received 12 May 2008 from a health care professional.  A 23-year-old female patient with a history of penicillin allergy, had received a right deltoid injection of FLUZONE SV 2007-2008, lot number U2465AA (route not reported), and one day later, she complained of tingling in her right arm and fingers.  The tingling progressed to her left arm and fingers over several weeks, and then progressed to her legs in December 2007.  She was seen by her primary care provider on 03 January 2008 for these same symptoms.  On approximately 17 January 2008, laboratory testing was performed with normal results (specific lab tests not reported).  A "temperomandibular" joint x-ray had been performed on 28 January 2008 with negative results.  On 01 April 2008, the symptoms of tingling had not resolved and the patient had an additional symptom of tingling on the right side of her face so she went to the emergency room.  A CT Scan was performed at that time with negative results (site assessed not reported).  The patient had no illness and had not been taking any medications at the time of vaccination.  She was evaluated by a neurologist on 23 April 2008 and her neurological work-up continued at the time of the report.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Computerised tomogram normal, Laboratory test normal, Paraesthesia, X-ray normal
Clinical narrative: Initial report was received 12 May 2008 from a health care professional.  A 23-year-old female patient with a history of penicillin allergy, had received a right deltoid injection of FLUZONE SV 2007-2008, lot number U2465AA (route not reported), and one day later, she complained of tingling in her right arm and fingers.  The tingling progressed to her left arm and fingers over several weeks, and then progressed to her legs in December 2007.  She was seen by her primary care provider on 03 January 2008 for these same symptoms.  On approximately 17 January 2008, laboratory testing was performed with normal results (specific lab tests not reported).  A "temperomandibular" joint x-ray had been performed on 28 January 2008 with negative results.  On 01 April 2008, the symptoms of tingling had not resolved and the patient had an additional symptom of tingling on the right side of her face so she went to the emergency room.  A CT Scan was performed at that time with negative results (site assessed not reported).  The patient had no illness and had not been taking any medications at the time of vaccination.  She was evaluated by a neurologist on 23 April 2008 and her neurological work-up continued at the time of the report.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Awoke at 1230 am on 5/7/08 with severe pruritus. By 0800 am, hives covered entire body from head to ankles. Went to ER 5/8/08. Returned to family doctor on 5/12/08. Hives still present on 5/14/08.
Age: 41.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Extrasystoles
Clinical narrative: Information has been received from a registered nurse concerning a 41-year-old male with no pre-existing allergies, birth defects or medical conditions who on 05-NOV-2007 around 15:00 pm was vaccinated subcutaneously in the left deltoid with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658407/1176U). Secondary suspect vaccination given on the same day included a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 656529/0287U) given subcutaneously in the left deltoid. There was no illness at the time of vaccination. On 06-NOV-2007 between 08:30 and 09:00 am, the patients heart began to skip beats. It was reported that his heart skipped beats 1-3 times/day, lasting 5-10 seconds from 06-NOV-2007 until 14-NOV-2007. No symptoms of heart beat skipping were reported on 15-NOV-2007. The R.N. instructed the client to call his physician to let him know about his symptoms. At the time of this report, no relevant diagnostic tests or laboratory tests were performed. Additional information tests were performed. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL, DTAPHEPBIP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 3x4" redness R thigh. Swollen 1/2" larger than other leg. Induration, warmth, painful to touch.
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL, DTAPHEPBIP, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: 3x4" redness R thigh. Swollen 1/2" larger than other leg. Induration, warmth, painful to touch.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: pt has swollen reddened area on L thigh.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Hypokinesia, Muscle spasms, Musculoskeletal pain, Neck injury, Torticollis
Clinical narrative: Initial and follow up information has been received from a physician and emergency room records concerning a 17 year old female student who at 3:45PM on 07-APR-2008, was vaccinated into the right arm with her second dose of GARDASIL (lot# 659964/1978U).  The patient had an upper respiratory infection at the time of vaccination.  On 08-APR-2008 (reported as 2:00PM and also as "in the AM") the patient experienced severe pain in the left shoulder and had a hard time moving her neck.  She was sent to the ER where she received IV fluids.  Follow up information from the physician indicated that the patient woke up in the AM on 08-APR-2008 with a severe spasm of her left neck and left shoulder.  The emergency room records indicated that the patient presented at 14:45 with right side neck spasm which had progressively worsened through out the day.  Torticollis along with palpable muscle spasms were noted in the emergency room evaluation.  There was no known trauma or abnormal activities.  The patient had pain with movement and no systemic symptoms, no fever, no nausea, vomiting or diarrhea.  She denied paresthesia/weakness.  She was reported to have tried heat and BENGAY with relief.  Emergency room diagnosis was neck strain.  The patient was treated with one shot of TORADOL, 30 mg IV and VALIUM, 20 mg IV.  She was discharged to home with instructions to take either ibuprofen or TORADOL, apply heat and follow up with primary physician.  The reporting physician also indicated that patient stayed on TORADOL for a few days and did well.  Further information is not expected. 5/29/08-records received for DOS 4/8/08-DX: Neck strain. ER visit with C/O right side neck pain began morning of ER visit and worsened throughout day. Now with Torticollis. Pain with movement. Denies paresthesia and weakness. URI symptoms recently.  PE: yellow discharge from nose. Palpable muscle spasm neck left neck.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Emotional distress, Syncope, Syncope vasovagal
Clinical narrative: Information has been received from a health professional concerning a 16 year old female who on approximately 25-MAR-2008 was vaccinated with her first dose of Gardasil vaccine (lot# not reported). The patient fainted twice after receiving the vaccine. She was at the clinic when this occurred. She was taken to the ER where she was treated and released for vasovagal response to the immunization. The patient's mother reported that her daughter ate very little that day and was also emotionally upset that day. Her outcome was not reported. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 10 year old female with a history of fainting when receiving shots, who on 08-APR-2008 was vaccinated with the first dose of Gardasil vaccine. After receiving the vaccination the patient fainted. Also, the patient had a history of disliking shots and she had fainted before and after receiving vaccinations, unknown medical attention was sought. The patient was recovered. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, C-reactive protein increased, Joint effusion, Joint swelling, Oedema
Clinical narrative: Symptoms began 1-2 weeks after vaccine administered with some bilateral knee pain and swelling.  She took 2 ibuprofen TID.  She was seen 3/5/08 by me; obvious edema and knee effusion was noted.  She was treated with MEDROL DOSE PACK, 1/2 ayazide x 1 week.  Her CRP was 24.5, ESR was 6.5.  Symptoms resolved; a followup with rheumatologist suggested no other cause except for the vaccine because of proximity to symptoms.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Symptoms began 1-2 weeks after vaccine administered with some bilateral knee pain and swelling.  She took 2 ibuprofen TID.  She was seen 3/5/08 by me; obvious edema and knee effusion was noted.  She was treated with MEDROL DOSE PACK, 1/2 ayazide x 1 week.  Her CRP was 24.5, ESR was 6.5.  Symptoms resolved; a followup with rheumatologist suggested no other cause except for the vaccine because of proximity to symptoms.
Age: 6.0
Sex: M
Vaccine: MMRV, VARCEL, VARCEL
Symptoms: Blister, Rash pruritic, Scab, Skin lesion
Clinical narrative: Rash began 6 days ago, very itchy, rash mostly on legs, abdomen and face.  Crusted lesions, vesicles on red base.  BENADRYL - CALAMINE.
Age: 6.0
Sex: M
Vaccine: MMRV, VARCEL, VARCEL
Symptoms: Chest pain, Impetigo
Clinical narrative: Rash began 6 days ago, very itchy, rash mostly on legs, abdomen and face.  Crusted lesions, vesicles on red base.  BENADRYL - CALAMINE.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever x3d, pain x3d, erythema x2d, swelling x2d, warm at site x2d, 45mm x 80mm erythema & edema.
Age: 16.0
Sex: F
Vaccine: HPV4, TYP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 1 inch red, indurated area at site of varicella injection.  No systemic symptoms.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Varicella zoster serology negative
Clinical narrative: Slight rash around nose and chest on 5-13-08. More rash on forehead and chin on 5-15-08. Doctor prescribed VALTREX for 7 days.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis.  AUGMENTIN 400mg BID x10d.
Age: 45.0
Sex: U
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Patient reports a swollen gland in her neck 3 days after Tdap injection. Reassured of minor reaction.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood pressure decreased, Feeling abnormal, Head injury, Syncope
Clinical narrative: 10 hours after vaccine when walking out, fainted, hit head on carpet - was dazed for 10 minutes. Decreased BP, glucose was ok.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site mass, Injection site pain
Clinical narrative: 1 month after vaccine, patient still has soreness and knot at site of administration.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site swelling, Rash pustular
Clinical narrative: Pt with c/o redness, swelling to injection site 8 d after injection. No fever - seen in office 4/11 2 hours increasing gin size - had 4x2cm eryth papule to (L) lateral thigh with central pustule and induration; Duricef/Bactroban.
Age: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Death, Dizziness, Herpes zoster, Myocardial infarction, Nausea
Clinical narrative: This case was received from a consumer on 13 May 2008. A consumer reported that his 92-year-old mother received an injection of Influenza Vaccine (manufacturer and lot number not reported) on 29 November 2007. At the time of vaccination, the subject had high blood pressure. Two days after vaccination, on 01 December 2007, the patient began experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and admitted to the hospital for 14 days. She later developed shingles on her forehead. She died on 12 January 2008; cause of death on the death certificate was "heart attack" according to the patient's son. No autopsy was performed. 6/16/08-records received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp, gurgling and wheezing, falling towards left side. Appeared to improved but had sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation. Assessment viral versus bacterial community acquired pneumonia.  7/18/08-records received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema. Presented to ED less responsive than baseline. PE:rales.  9/24/08-records receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration.
Age: 92.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: This case was received from a consumer on 13 May 2008. A consumer reported that his 92-year-old mother received an injection of Influenza Vaccine (manufacturer and lot number not reported) on 29 November 2007. At the time of vaccination, the subject had high blood pressure. Two days after vaccination, on 01 December 2007, the patient began experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and admitted to the hospital for 14 days. She later developed shingles on her forehead. She died on 12 January 2008; cause of death on the death certificate was "heart attack" according to the patient's son. No autopsy was performed. 6/16/08-records received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp, gurgling and wheezing, falling towards left side. Appeared to improved but had sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation. Assessment viral versus bacterial community acquired pneumonia.  7/18/08-records received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema. Presented to ED less responsive than baseline. PE:rales.  9/24/08-records receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Lt upper thigh at injection site, redness, and slightly raised area, 8 cm around. Slightly warm to touch. No s/s of pain. Instructed pt's mom to apply cool compress and notify us/MD immediately if it gets worse.
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Erythema, Pyrexia, Rash maculovesicular
Clinical narrative: Pt. presents in office 5/16/08 with low grade fever, <15 erythematous maculovesicular lesions on post neck & face.  Vaccinated with VARIVAX on 5/6/08.  Rx BENADRYL, calamine & AVEENO baths.
Age: 9.0
Sex: M
Vaccine: TYP, VARCEL
Symptoms: Erythema, Local reaction, Pain, Rash pruritic
Clinical narrative: Local reaction where VARIVAX immunization administered 5 x 5.4 cm area-red, raised and pruritic/painful afebrile; no systemic symptoms. Treated with BENADRYL and cool compresses. Symptoms resolved after a few days
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness, swelling. Ice pack, Benadryl tablets 25 mg every 8 hrs for 1 week.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received vaccines on 5/12/08. Came in 5/14/08 with swelling and redness where vaccines given. Placed on antibiotic treatment
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received vaccinations on 5/12/08. On 5/14/08 evaluated in clinic for swelling, redness, and tenderness at 2 of the sites where injections were given. He was instructed to start on antibiotic treatment. Affected sites were LD and RA.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Arthralgia, Arthritis reactive, Asthenia
Clinical narrative: Initial and follow up information has been received from a physician and by telephone call from the healthcare professional concerning a 22 year old female patient with family history of rheumatoid arthritis and autoimmune disease who on 03-APR-2008 was vaccinated IM with a dose of GARDASIL (lot # not available).  The physician reported that the patient experienced serum sickness, full body rash, and severe arthritis and joint pain.  She was taken to the emergency room and was admitted to the hospital.  In follow up telephone call the health care professional reported that on 04-APR-2008 patient developed fatigue, temperature of 102, weakness, near syncope episode at work, blanchable rash all over body, very achy joints hands, knees and ankles, and had trouble walking.  She went to the emergency room (E.R.) on 04-APR-2008 and was sent home.  On 05-APR-2008, she went to the ER and was told she had chicken pox and was sent home.  On 08-APR-2008 the patient went to the ER and was sent home.  On 09-APR-2008 the patient was admitted to the hospital.  The patient's final diagnosis was reactive arthritis, possible reaction to GARDASIL, urticaria associated with reactive arthritis, abnormal liver function test (LFT's) possibly related to fatty liver or polycystic ovary syndrome or possibly related to reactive arthritis.  Her hepatitis A, hepatitis B and hepatitis C, Lyme, Rocky Mountain fever, serum antinuclear antibodies (ANA), serum antineutrophil cytoplasmic antibody (ANCA) test was normal.  Her Rheumatoid factor tests were all normal and her sed rate was slightly elevated.  Serum C Reactive protein test was 29.9.  The patient was treated with intravenous (IV) steroids and improved.  She was in the hospital for four days.  On 21-APR-2008, the patient was seen in the office and it was noted that she was "remarkably better".  Skin rash was resolved, ache in joints/stiffness still there especially after sleeping.  Fever was gone.  The patient was recovering.  Additional information has been requested.  06/04/2008 MR received from DOS 4/09-11/2008 with D/C DX: Reactive Arthritis: Possible reaction to Gardasil vaccine (symptoms began 3 days after the injection and peaked at ~7-8 days after the injection). Urticaria associated with Reactive Arthritis.  Abnormal LFTs: possibly related to fatty liver or polycystic ovary syndrome or reactive arthritis.  Hx of polycystic ovarain syndrome-on Provera for menses. Pt presented with c/o fatigue, fever, a near syncopal episode, weakness, joint pain, macular rash and difficulty walking x 6-7 days.  PE (+) for mouth ulcerations, abdominal tenderness, macular erythematous rash and marked swelling of the PIP, DIP and MTP joints of the hands and ankles, with associated tenderness. Swelling also noted at wrists with tenderness and limited ROM. (+) warmth of the joints.  LFTs markedly abnormal. Txd with Solumedrol then Medrol dosepack with partial resolution of sx.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Borrelia burgdorferi serology negative, C-reactive protein increased, Fatigue, Gait disturbance
Clinical narrative: Initial and follow up information has been received from a physician and by telephone call from the healthcare professional concerning a 22 year old female patient with family history of rheumatoid arthritis and autoimmune disease who on 03-APR-2008 was vaccinated IM with a dose of GARDASIL (lot # not available).  The physician reported that the patient experienced serum sickness, full body rash, and severe arthritis and joint pain.  She was taken to the emergency room and was admitted to the hospital.  In follow up telephone call the health care professional reported that on 04-APR-2008 patient developed fatigue, temperature of 102, weakness, near syncope episode at work, blanchable rash all over body, very achy joints hands, knees and ankles, and had trouble walking.  She went to the emergency room (E.R.) on 04-APR-2008 and was sent home.  On 05-APR-2008, she went to the ER and was told she had chicken pox and was sent home.  On 08-APR-2008 the patient went to the ER and was sent home.  On 09-APR-2008 the patient was admitted to the hospital.  The patient's final diagnosis was reactive arthritis, possible reaction to GARDASIL, urticaria associated with reactive arthritis, abnormal liver function test (LFT's) possibly related to fatty liver or polycystic ovary syndrome or possibly related to reactive arthritis.  Her hepatitis A, hepatitis B and hepatitis C, Lyme, Rocky Mountain fever, serum antinuclear antibodies (ANA), serum antineutrophil cytoplasmic antibody (ANCA) test was normal.  Her Rheumatoid factor tests were all normal and her sed rate was slightly elevated.  Serum C Reactive protein test was 29.9.  The patient was treated with intravenous (IV) steroids and improved.  She was in the hospital for four days.  On 21-APR-2008, the patient was seen in the office and it was noted that she was "remarkably better".  Skin rash was resolved, ache in joints/stiffness still there especially after sleeping.  Fever was gone.  The patient was recovering.  Additional information has been requested.  06/04/2008 MR received from DOS 4/09-11/2008 with D/C DX: Reactive Arthritis: Possible reaction to Gardasil vaccine (symptoms began 3 days after the injection and peaked at ~7-8 days after the injection). Urticaria associated with Reactive Arthritis.  Abnormal LFTs: possibly related to fatty liver or polycystic ovary syndrome or reactive arthritis.  Hx of polycystic ovarain syndrome-on Provera for menses. Pt presented with c/o fatigue, fever, a near syncopal episode, weakness, joint pain, macular rash and difficulty walking x 6-7 days.  PE (+) for mouth ulcerations, abdominal tenderness, macular erythematous rash and marked swelling of the PIP, DIP and MTP joints of the hands and ankles, with associated tenderness. Swelling also noted at wrists with tenderness and limited ROM. (+) warmth of the joints.  LFTs markedly abnormal. Txd with Solumedrol then Medrol dosepack with partial resolution of sx.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hepatitis A virus, Hepatitis B test negative, Hepatitis C test negative, Liver function test abnormal, Presyncope
Clinical narrative: Initial and follow up information has been received from a physician and by telephone call from the healthcare professional concerning a 22 year old female patient with family history of rheumatoid arthritis and autoimmune disease who on 03-APR-2008 was vaccinated IM with a dose of GARDASIL (lot # not available).  The physician reported that the patient experienced serum sickness, full body rash, and severe arthritis and joint pain.  She was taken to the emergency room and was admitted to the hospital.  In follow up telephone call the health care professional reported that on 04-APR-2008 patient developed fatigue, temperature of 102, weakness, near syncope episode at work, blanchable rash all over body, very achy joints hands, knees and ankles, and had trouble walking.  She went to the emergency room (E.R.) on 04-APR-2008 and was sent home.  On 05-APR-2008, she went to the ER and was told she had chicken pox and was sent home.  On 08-APR-2008 the patient went to the ER and was sent home.  On 09-APR-2008 the patient was admitted to the hospital.  The patient's final diagnosis was reactive arthritis, possible reaction to GARDASIL, urticaria associated with reactive arthritis, abnormal liver function test (LFT's) possibly related to fatty liver or polycystic ovary syndrome or possibly related to reactive arthritis.  Her hepatitis A, hepatitis B and hepatitis C, Lyme, Rocky Mountain fever, serum antinuclear antibodies (ANA), serum antineutrophil cytoplasmic antibody (ANCA) test was normal.  Her Rheumatoid factor tests were all normal and her sed rate was slightly elevated.  Serum C Reactive protein test was 29.9.  The patient was treated with intravenous (IV) steroids and improved.  She was in the hospital for four days.  On 21-APR-2008, the patient was seen in the office and it was noted that she was "remarkably better".  Skin rash was resolved, ache in joints/stiffness still there especially after sleeping.  Fever was gone.  The patient was recovering.  Additional information has been requested.  06/04/2008 MR received from DOS 4/09-11/2008 with D/C DX: Reactive Arthritis: Possible reaction to Gardasil vaccine (symptoms began 3 days after the injection and peaked at ~7-8 days after the injection). Urticaria associated with Reactive Arthritis.  Abnormal LFTs: possibly related to fatty liver or polycystic ovary syndrome or reactive arthritis.  Hx of polycystic ovarain syndrome-on Provera for menses. Pt presented with c/o fatigue, fever, a near syncopal episode, weakness, joint pain, macular rash and difficulty walking x 6-7 days.  PE (+) for mouth ulcerations, abdominal tenderness, macular erythematous rash and marked swelling of the PIP, DIP and MTP joints of the hands and ankles, with associated tenderness. Swelling also noted at wrists with tenderness and limited ROM. (+) warmth of the joints.  LFTs markedly abnormal. Txd with Solumedrol then Medrol dosepack with partial resolution of sx.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Serology normal, Serum sickness
Clinical narrative: Initial and follow up information has been received from a physician and by telephone call from the healthcare professional concerning a 22 year old female patient with family history of rheumatoid arthritis and autoimmune disease who on 03-APR-2008 was vaccinated IM with a dose of GARDASIL (lot # not available).  The physician reported that the patient experienced serum sickness, full body rash, and severe arthritis and joint pain.  She was taken to the emergency room and was admitted to the hospital.  In follow up telephone call the health care professional reported that on 04-APR-2008 patient developed fatigue, temperature of 102, weakness, near syncope episode at work, blanchable rash all over body, very achy joints hands, knees and ankles, and had trouble walking.  She went to the emergency room (E.R.) on 04-APR-2008 and was sent home.  On 05-APR-2008, she went to the ER and was told she had chicken pox and was sent home.  On 08-APR-2008 the patient went to the ER and was sent home.  On 09-APR-2008 the patient was admitted to the hospital.  The patient's final diagnosis was reactive arthritis, possible reaction to GARDASIL, urticaria associated with reactive arthritis, abnormal liver function test (LFT's) possibly related to fatty liver or polycystic ovary syndrome or possibly related to reactive arthritis.  Her hepatitis A, hepatitis B and hepatitis C, Lyme, Rocky Mountain fever, serum antinuclear antibodies (ANA), serum antineutrophil cytoplasmic antibody (ANCA) test was normal.  Her Rheumatoid factor tests were all normal and her sed rate was slightly elevated.  Serum C Reactive protein test was 29.9.  The patient was treated with intravenous (IV) steroids and improved.  She was in the hospital for four days.  On 21-APR-2008, the patient was seen in the office and it was noted that she was "remarkably better".  Skin rash was resolved, ache in joints/stiffness still there especially after sleeping.  Fever was gone.  The patient was recovering.  Additional information has been requested.  06/04/2008 MR received from DOS 4/09-11/2008 with D/C DX: Reactive Arthritis: Possible reaction to Gardasil vaccine (symptoms began 3 days after the injection and peaked at ~7-8 days after the injection). Urticaria associated with Reactive Arthritis.  Abnormal LFTs: possibly related to fatty liver or polycystic ovary syndrome or reactive arthritis.  Hx of polycystic ovarain syndrome-on Provera for menses. Pt presented with c/o fatigue, fever, a near syncopal episode, weakness, joint pain, macular rash and difficulty walking x 6-7 days.  PE (+) for mouth ulcerations, abdominal tenderness, macular erythematous rash and marked swelling of the PIP, DIP and MTP joints of the hands and ankles, with associated tenderness. Swelling also noted at wrists with tenderness and limited ROM. (+) warmth of the joints.  LFTs markedly abnormal. Txd with Solumedrol then Medrol dosepack with partial resolution of sx.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Initial and follow up information has been received from a physician and by telephone call from the healthcare professional concerning a 22 year old female patient with family history of rheumatoid arthritis and autoimmune disease who on 03-APR-2008 was vaccinated IM with a dose of GARDASIL (lot # not available).  The physician reported that the patient experienced serum sickness, full body rash, and severe arthritis and joint pain.  She was taken to the emergency room and was admitted to the hospital.  In follow up telephone call the health care professional reported that on 04-APR-2008 patient developed fatigue, temperature of 102, weakness, near syncope episode at work, blanchable rash all over body, very achy joints hands, knees and ankles, and had trouble walking.  She went to the emergency room (E.R.) on 04-APR-2008 and was sent home.  On 05-APR-2008, she went to the ER and was told she had chicken pox and was sent home.  On 08-APR-2008 the patient went to the ER and was sent home.  On 09-APR-2008 the patient was admitted to the hospital.  The patient's final diagnosis was reactive arthritis, possible reaction to GARDASIL, urticaria associated with reactive arthritis, abnormal liver function test (LFT's) possibly related to fatty liver or polycystic ovary syndrome or possibly related to reactive arthritis.  Her hepatitis A, hepatitis B and hepatitis C, Lyme, Rocky Mountain fever, serum antinuclear antibodies (ANA), serum antineutrophil cytoplasmic antibody (ANCA) test was normal.  Her Rheumatoid factor tests were all normal and her sed rate was slightly elevated.  Serum C Reactive protein test was 29.9.  The patient was treated with intravenous (IV) steroids and improved.  She was in the hospital for four days.  On 21-APR-2008, the patient was seen in the office and it was noted that she was "remarkably better".  Skin rash was resolved, ache in joints/stiffness still there especially after sleeping.  Fever was gone.  The patient was recovering.  Additional information has been requested.  06/04/2008 MR received from DOS 4/09-11/2008 with D/C DX: Reactive Arthritis: Possible reaction to Gardasil vaccine (symptoms began 3 days after the injection and peaked at ~7-8 days after the injection). Urticaria associated with Reactive Arthritis.  Abnormal LFTs: possibly related to fatty liver or polycystic ovary syndrome or reactive arthritis.  Hx of polycystic ovarain syndrome-on Provera for menses. Pt presented with c/o fatigue, fever, a near syncopal episode, weakness, joint pain, macular rash and difficulty walking x 6-7 days.  PE (+) for mouth ulcerations, abdominal tenderness, macular erythematous rash and marked swelling of the PIP, DIP and MTP joints of the hands and ankles, with associated tenderness. Swelling also noted at wrists with tenderness and limited ROM. (+) warmth of the joints.  LFTs markedly abnormal. Txd with Solumedrol then Medrol dosepack with partial resolution of sx.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Information has been received from a Registered Nurse (R.N.) and by telephone concerning a 22 year old female patient with a history of seizure for which she was on therapy.  On 23-MAY-2007 patient was vaccinated with a first dose of GARDASIL and on 23-JUL-2007 she was vaccinated with a second dose of GARDASIL in another doctor's office.  No lot number was provided.  Concomitant therapy included TEGRETOL, DIAMOX and YAZ.  The nurse reported that on 29-JUL-2007, patient had a seizure type episode six days after she received her second dose of GARDASIL.  The patient sought unspecified medical attention.  She reported that patient had no seizures since this incident.  No further information was provided.  Upon internal review seizure was determined to be an other important medical event.  Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 39 year old male, who on 06-MAY-2008 (previously reported as 12-MAY-2008) was vaccinated SQ with a dose of PNEUMOVAX 23 (Lot# 661039/0248X).  It was reported that at the time of the injection the patient was hospitalized (05-MAY-2008) for alcohol withdrawal, hypertension, and hepatitis C.  On 08-MAY-2008 the patient complained of pain at the elbow in the arm where the vaccination was received.  The patient was treated with ANCEF, 1 gram intravenously and ice was applied to the affected area.  The affected area was 2 inches below the elbow to the mid upper arm.  Later in the day on 08-MAY-2008 the patient was examined by the physician and it was reported that the patient's arm was reddened with edema.  It was also reported that on 12-MAY-2008 the patient developed severe redness, hotness, and swelling at the injection site.  The patient also experienced itching.  The patient was treated with vancomycin, 1 gram intravenously.  On 12-MAY-2008 the patient was discharged.  The patient's discharge diagnoses were vaccine reaction, alcohol withdrawal, hypertension, and hepatitis C.  The patient recovered from the PNEUMOVAX 23 reaction on an unspecified date.  The events prolonged hospitalization.  Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 39 year old male, who on 06-MAY-2008 (previously reported as 12-MAY-2008) was vaccinated SQ with a dose of PNEUMOVAX 23 (Lot# 661039/0248X).  It was reported that at the time of the injection the patient was hospitalized (05-MAY-2008) for alcohol withdrawal, hypertension, and hepatitis C.  On 08-MAY-2008 the patient complained of pain at the elbow in the arm where the vaccination was received.  The patient was treated with ANCEF, 1 gram intravenously and ice was applied to the affected area.  The affected area was 2 inches below the elbow to the mid upper arm.  Later in the day on 08-MAY-2008 the patient was examined by the physician and it was reported that the patient's arm was reddened with edema.  It was also reported that on 12-MAY-2008 the patient developed severe redness, hotness, and swelling at the injection site.  The patient also experienced itching.  The patient was treated with vancomycin, 1 gram intravenously.  On 12-MAY-2008 the patient was discharged.  The patient's discharge diagnoses were vaccine reaction, alcohol withdrawal, hypertension, and hepatitis C.  The patient recovered from the PNEUMOVAX 23 reaction on an unspecified date.  The events prolonged hospitalization.  Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Hypersensitivity, Swelling
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old male who on 27-NOV-2006 was vaccinated with a dose of PNEUMOVAX 23. Concomitant medication was not reported. On 27-NOV-2006 after receiving the PNEUMOVAX 23 vaccine, the patient had an allergic reaction. The patient swelled up and went to the emergency room. Subsequently, the patient recovered from the events and was release after his recovery. The reporting pharmacist felt that allergic reaction and swelled up were related to therapy with PNEUMOVAX 23 vaccine. No product quality complaint was involved. Allergic reaction and swelled up were considered to be immediately life-threatening. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Laboratory test
Clinical narrative: Information has been received from a pharmacist concerning his 6 year old son with no pertinent medical history or drug allergies who on an unspecified date and on approximately 01-MAR-2005 was vaccinated with his first and second dose of MMR II. There was no concomitant medication. At that same time, the patient was diagnosed with autism. The pharmacist mentioned there were "signs before vaccination" and that "things were not getting better." The patient was seen by a psychologist who performed "a battery of tests." The pharmacist also mentioned he does not feel that MMR II was related to his son's autism. There was no product quality complaint. No further information is available. Autism was also considered to be disabling by the reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning a patient who on 06-MAY-2008 was vaccinated PO with the second dose of ROTATEQ. In May 2008, after vaccination the patient experienced "hematochezia." It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information was provided. Upon internal review, hematochezia was determined to be an other important medical event. Additional information has been requested.
Age: 34.0
Sex: M
Vaccine: TDAP, TYP, YF
Symptoms: Chills, Disorientation, Headache, Pyrexia
Clinical narrative: Sxs of fever, chills, disorientation, headache.  Sxs started approximately 4days after vaccine administration.  Went to ER, admitted to hospital for observation. 10/27/08-records received for DOS 5/13-5/18/08-DC DX: Neck pain and headache likely viral syndrome with post lumbar puncture headache with possible adverse reaction of headache and fever secondary to immunizations. Presented with intractable headache and neck pain and fever. Temperature 101. Arthralgias, fevers chills and mild confusion 4-5 days prior to admission. One day of discharge C/O tunneling vision, blurry vision increased confusion with position changes. Transferred. 12/19/08-records received for DOS 5/18-5/20/08-DC DX: Headache. Possibly post LP. Febrile illness post immunization. Intractable headache times 1 week exacerbated following LP times 2 at outside hospital. Chills and fever. Anxiety and stress may have contributed to persisting headache.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Crying
Clinical narrative: crying