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From the 6/11/2021 release of VAERS data:

Found 239 cases where Symptom is Crohn's disease



Case Details

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VAERS ID: 268094 (history)  
Form: Version 1.0  
Age: 72.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2006-10-25
Onset:2006-11-03
   Days after vaccination:9
Submitted: 2006-11-28
   Days after onset:25
Entered: 2006-12-01
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Crohn's disease, Diarrhoea, Hypokalaemia, Laboratory test abnormal, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Hypokalaemia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Combined Diskus, timolol, Advair, Prilosec, Potassium citrate, Multivitamins, Combivent.
Current Illness:
Preexisting Conditions: History of Crohn''s disease
Allergies:
Diagnostic Lab Data: Laboratories results done at the hospital C Diff toxin neg, Feces culture no E coli or salmonella, stool for WBC''s neg, chemistry panel normal, Hemogram + PLT + Autodif + WBC high. Lactate normal.
CDC Split Type: 200603221

Write-up: Initial report received on 22 November 2006 from an investigator participating in the above-mentioned trial. A 72-year-old female subject with history of Crohn''s disease was diagnosed with exacerbation of Crohn''s disease, 9 days after she had received a first dose, right arm, intramuscular injection of Influenza Virus Vaccine USP Trival A & B, High dose, Subvirion-U, lot number not reported, on 25 October 2006. Her medical history also included: osteoarthritis, glaucoma, vascular headaches, vasomotor rhinitis, labile blood pressure, asthma, nephrolithiasis, hyperglycemia, gastroesophageal reflux and dyspepsia, cholecystectomy. Concomitant treatments were Combivent, Advair, Prilosec, Potassium, timolol. On 27 November 2006, two days post-vaccination, the subject experienced diarrhea and nausea that lasted 9 days, until 06 November 2006. On 03 November 2006 the subject experienced hypokalemia that lasted a day, until 04 November 2006. The subject was admitted to the hospital on 03 November 2006 and discharged on 06 November 2006. The subject was treated with Prednisone 40 mg daily, mesalamine 1200mg 4 times a day and IV fluids with potassium chloride. The subject had recovered. Important laboratories results done at the hospital: C-Diff toxin-negative; feces culture- no E.coli or salmonella; stool for WBC''s-negative; chemistry panel-normal, Hemogram + PLT + Autodif + WBC-High; Lactate-normal. The subject continued in the study trial. According to the investigator, the event was related to the study vaccine. Documents held by sender: hospital admission and discharge summaries and laboratory results.


VAERS ID: 271366 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Unknown  
Location: Connecticut  
Vaccinated:2006-11-10
Onset:2006-11-11
   Days after vaccination:1
Submitted: 2007-01-26
   Days after onset:76
Entered: 2007-01-29
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0955F / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Crohn's disease
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Crohn''s disease
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: WAES0701USA03418

Write-up: Information has been received from a physician concerning a patient (age and gender unknown) with Crohn''s disease who on 10-NOV-2006 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil vaccine (yeast) (Lot # 653978/0955F). On 11-NOV-2006 the patient had a flair up of Crohn''s disease after receiving the Gardasil vaccine (yeast). The flair up was so severe that the patient had to be out of school for a month. The patient sought unspecified medical attention. No product quality complaint was involved. At the time of this report, the patient was recovering. The flair up of Crohn''s disease was considered to be disabling. Additional information has been requested.


VAERS ID: 272203 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: California  
Vaccinated:2006-12-01
Onset:2006-12-16
   Days after vaccination:15
Submitted: 2007-02-13
   Days after onset:59
Entered: 2007-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U2220EA / 3 LL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1008F / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Condition aggravated, Crohn's disease, Frequent bowel movements, Haematochezia, Red blood cell sedimentation rate increased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Crohn''s Flare up~Typhoid Vi Polysaccharide (Typhim Vi)~~2.20~Patient
Other Medications: Crohn''s Disease Anti-inflammatory medications- sulfasalazine 5mlx3, Folic Acid 1mlx1
Current Illness: None except Crohn''s Disease in remission.
Preexisting Conditions: Inactive Crohn''s Disease( in remission ) at the time of shots.
Allergies:
Diagnostic Lab Data: After Crohn''s Disease flare up, constant testing and lab reports show classic disease flare up syptoms. High Sed rate, bloody stools, frequent bowel movements and abdminal pain.
CDC Split Type:

Write-up: a)Patient''s Crohn''s Disease is diagnosed in Aug 2005. b)Remission achieved Dec 2005. c) Typhoid short in Jan 2006 before an overseas trip caused minor flare for 3-4 days starting Jan 26. 2006( See VAERS report E-14626 ). d) Dec 1, 2006, Hepatitis A and 2 Flu shots. e) Dec 16: Crohn''s Disease Flared up again. Currently disease is highly active. Follow-up: Crohn''s flare-up is still active. Steroid based treatment and colonoscopy have been prescribed and carried out. Disease is highly active for past 5 months.


VAERS ID: 274547 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Male  
Location: South Dakota  
Vaccinated:1998-06-02
Onset:1999-12-22
   Days after vaccination:568
Submitted: 2007-03-22
   Days after onset:2646
Entered: 2007-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS UNKNOWN / 4 RA / IM

Administered by: Military       Purchased by: Other
Symptoms: Crohn's disease, Diabetic relative
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: none, completely healthy!
Preexisting Conditions: none, healthy
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine given during first batch in 1998. I developed Crohns disease, symptoms first began in 1999-2000. My daughter was born in 1999 and was diagnosed with diabetes in 2002. 06/14/07-spoke with med rec dept they have no record of hospitalizations but clinic notes which will they will mail to my attention. Did provide me with consultant name and number. 6/21/07-records received. PMH:officially diagnosed with Crohn''s disease in January 2004, symptoms started in 1999. He has had two surgeries since, 3 partial bowel resections the first in April 2004, the second surgery September 2005. Gastrointestinal symptoms chronic diarrhea improved with oxycodone. Has not followed through with referrals. Referred to pain management due to increasing narcotic needs. Chronic pain syndrome.


VAERS ID: 281786 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Female  
Location: Michigan  
Vaccinated:1998-08-07
Onset:2006-06-01
   Days after vaccination:2855
Submitted: 2007-05-16
   Days after onset:349
Entered: 2007-05-24
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative, Crohn's disease
SMQs:, Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: serum varicella zoster 10/??/06 negative
CDC Split Type: WAES0611USA04344

Write-up: Information has been received from a physician concerning her daughter with no drug reaction/allergies who on 07-AUG-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There were no concomitant medications. In June 2006, the patient was diagnosed with Crohn''s disease. She has been receiving prednisone and azathioprine sodium (IMURAN) for the treatment of Crohn''s disease. In October 2006, the patient showed a negative varicella zoster virus titer. Unspecified medical attention was sought. There was no product quality compliant. Additional information has been requested.


VAERS ID: 302860 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Connecticut  
Vaccinated:1999-09-23
Onset:0000-00-00
Submitted: 2008-01-16
Entered: 2008-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Amnesia, Antinuclear antibody negative, Arthralgia, Asthenia, Autoimmune disorder, Back pain, Biopsy anus abnormal, Biopsy intestine abnormal, Blood immunoglobulin G normal, Blood immunoglobulin M, Brachial plexus injury, Cognitive disorder, Colitis, Colonoscopy, Condition aggravated, Contusion, Crohn's disease, Diarrhoea, Eczema, Epicondylitis, Flatulence, Gastroenteritis, Gastrointestinal disorder, Gout, Headache, Hypoaesthesia, Ileitis, Immunology test, Influenza like illness, Intestinal functional disorder, Musculoskeletal pain, Nerve injury, Neurological symptom, Osteoarthritis, Pain in extremity, Rash vesicular, Red blood cell sedimentation rate abnormal, Red blood cell sedimentation rate normal, Sciatica, Synovitis, Tendonitis, Tinea infection, X-ray with contrast upper gastrointestinal tract
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Arthritis (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allopurinol
Current Illness: Unknown
Preexisting Conditions: The subject had a 20 to 30 year history of Crohn''s disease. History of "heavy" asbestos exposure; possible seafood allergy (reaction to softshell crab, possible reaction to tuna); finger numbness associated with "heavy physical work"; consuming one alcoholic drink per day. In approximately August 1984, the subject was evaluated for a chief complaint of joint pain in addition to a five to six day history of fever, and was diagnosed with ileitis.
Allergies:
Diagnostic Lab Data: Antinuclear antibody 12Aug2002 negative; Erythrocyte sedimentation rate 22Mar1999 9mm/hr; Erythrocyte sedimentation rate 23Apr2001 7mm/hr; Erythrocyte sedimentation rate 15Apr2003 11mm/hr; Erythrocyte sedimentation rate Nov2003 19mm/hr; Diagnostic results: 10 September 2001: Colonoscopy with ileocecal valve biopsy revealed normal findings; biopsy of colon mucosa at 15 cm showed fragments of hyperplastic colonic mucosa; rectal mucosa biopsy showed granulation tissue and acute inflammatory exudates, consistent with inflammatory bowel disease. 12 August 2002: HLA-DR4 not detected. 04 April 2005: Colonoscopy findings were normal; biopsy of terminal ileum showed chronic active ileitis with ulcer consistent with Crohn''s disease; biopsy of rectum showed d acute and chronic inflammation with granulation tissue. A repeat small bowel series showed involvement of 25 cm of neo-terminal ileum without obstruction. 08 August 2007: Lyme disease IgG and IgM Western Blot results were negative.
CDC Split Type: a0699352a

Write-up: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with Lymerix for prophylaxis. A physician or other health care professional has not verified this report. The following information was received via a statement of injuries forwarded by the subject''s attorney: On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject "suffers and has suffered from joint pain, flu-like symptoms, headaches, gastrointestinal disorders, possible memory loss, and decreased activities of daily life". He also reportedly experienced "rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all caused by vaccination with LYMErix, including but not limited to those set forth above". At the time of reporting the outcome of the events were unspecified. Follow up information was received on 04 December 2007 via medical records. In October 2001, the subject was evaluated by a chiropractor for complaints including low back pain, pinched nerve in low back, pain in buttocks, hips, and leg, and leg numbness. At that time, the patient was 48 to 49 years old. According to billing records, he remained in chiropractic treatment through as recently as June 2007. Follow up information was received on 07 January 2008 via medical records. The subject had a twenty or more year history of Crohn''s disease/Crohn''s colitis, and had undergone two small bowel resections in the 1980s. He also had a history of abnormal liver function tests "for years", gout, remote joint pain, "profound" allergies, and hypertension. On 20 March 1999, the subject was evaluated for right shoulder pain and Crohn''s disease, and on the same date received his first vaccination with LYMErix. The second dose of LYMErix was administered on 19 April 1999 (0.5 mL in the left deltoid). Concurrent medication included allopurinol for uric acid renolithaisis. On 20 July 1999, three months after administration of LYMErix, the subject presented to a podiatrist for acute pain and swelling of the right great toe. Assessment was synovitis of the right first metatarsophalangeal joint, "probable gouty crystalline synovitis". Treatment included corticosteroid infiltration of the affected joint. The third dose of LYMErix was administered on 23 September 1999 (intramuscular, left deltoid). On 01 April 2000, the subject complained of increased right shoulder pain especially with repetitive motion. He was also noted to be experiencing metatarsal pain associated with gout. Diagnoses include 1) "quiet Crohn''s, 2) possible acromioclavicular separation/osteoarthritis, as well as possible ringworm and/or gout. Treatment included Vioxx. On 07 August 2000, the subject was evaluated by an orthopedist for "difficulty" with his right shoulder including pain which sometimes radiated to his elbow and hand. Examination revealed pain and point tenderness in the shoulder area, and the subject also related some transient nerve symptoms. The subject reported that he was an avid sport, clay, and skeet shooter and used to shoot regularly, but at the time of evaluation had decreased shooting to once or twice weekly. Evaluation showed trace intrinsic weakness consistent with recurrent injury to the brachial plexus, and impression was "anterior choricoid pain from direct trauma and brachial plexus irritation or contusion secondary from direct trauma from skeet shooting". Previous treatment with Vioxx had been unsuccessful, and ibuprofen was recommended. In April 2002, the subject reported that he had been treated for sciatica by a chiropractor; at that time, Crohn''s disease was assessed to be stable. On 18 November 2002, the subject was assessed for complaints of left elbow pain which had been aggravated by recent use of a leaf-blower. Assessment was of tendonitis of the extensor tendons, and treatment included Aleve. On 03 March 2003, he complained of gastroenteritis with diarrhea, describing the symptoms as "flu-like" not activation of Crohn''s". On the same date, he received an injection of DepoMedrol in the left lateral epicondyle for a diagnosis of epicondylitis. On 22 July 2005, the subject was evaluated for ongoing Crohn''s colitis, with chronic active ileitis. Medications at that time included Pentasa, allopurinol, and Metamucil, as well as Cozaar. According to a letter dated 14 October 2005, the subject''s digestive disease specialist indicated that the subject was "doing fairly well with occasional loose bowels and some gas but no other symptoms". He was placed on Pentasa, then was switched to Purinethol in an effort to stop the subject''s progression of Crohn''s disease. On 14 June 2007, the subject was evaluated for unspecified knee complaints. Medications at that time included Celebrex and Advil. A note from the subject''s digestive disease specialist dated 10 August 2007 indicated that the subject was receiving Humira and was "doing well". The case was assessed to be medically significant based upon follow up information. In 2000, the subject was evaluated for eczema of the buttocks, possible ringworm, and metatarsal pain attributed to gout. In approximately November 2003, the subject developed increased arthralgias, and approximately five days later was hospitalized on 28 November 2003 with a vesicular rash. He was diagnosed with "most likely first episode" of chicken pox, and was reported to have "no immune deficiencies". He was discharged on 02 December 2003. These were assessed to be incidental findings upon review of medical records.


VAERS ID: 305607 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:2007-08-01
Submitted: 2008-02-14
   Days after onset:197
Entered: 2008-02-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0524U / 3 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Abdominal pain lower, Biopsy colon abnormal, Biopsy small intestine, Chest pain, Colonoscopy abnormal, Computerised tomogram abdomen abnormal, Computerised tomogram abnormal, Congestive cardiomyopathy, Constipation, Crohn's disease, Cyanosis, Decreased appetite, Diarrhoea, Dizziness postural, Gastroenteritis viral, Granuloma, Haematochezia, Ileitis, Malaise, Menorrhagia, Menstruation irregular, Nausea, Ovarian cyst, Pain, Pathology test, Pelvic fluid collection, Serology abnormal, Tenderness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown; atenolol, 50 mg; melatonin, mg
Current Illness: Menstruation irregular; Bleeding menstrual heavy; Non-smoker
Preexisting Conditions: Unknown 3/31/08-records received-Family history of irritable bowel disease. Positive gene for Loey-Dietz syndrome. Chromosomes normal.
Allergies:
Diagnostic Lab Data: Unknown 3/31/08-records received-Echocardiogram normal. Colonoscopy 11/9/07-Crohn''s diagnoses. 12; blood pressure, 108/6 mm Hg; abdominal computed axial, with contrast - suspicion of crohn''s disease; diagnostic pathological 11/02/07, see narrative; computed axial, pelvic - with contrast; colonoscopy, 11/02/07, see narrative; clinical serology test, pattern consistent with IBD and Crohn''s Disease; serum tissue, 14.2 IU/ml
CDC Split Type: WAES0801USA01648

Write-up: Information has been received from a registered nurse concerning her 20 year old daughter with no illness at the time of vaccination who on 22-NOV-2006, 30-JAN-2007 and 10-AUG-2007 was vaccinated with a first, second and third dose of Gardasil (lot# 653735/0688F), (lot# 655165/1425F) and (lot# 658094/0524U) respectively. Concomitant therapy includes atenolol and melatonin. The nurse reported that her daughter was diagnosed with Crohn''s disease in November 2007 after receiving three doses of Gardasil vaccine. The nurse reported that the patient''s symptoms began around August 2007. Medical attention was sought. No further information was provided. Additional information has been requested. 3/31/08-records received-11/8/07-evluation of dilated aortic root. Seen in follow-up. Cyanotic color to nail bed but no central cyanosis. Dizzy on occasion when rising from sitting position. 11/31/07-seen for C/O feeling lousy, Crohn''s symptoms improving. Episode of bloody stool with abdominal pain, lightheaded, passed out. Dizzy. Viral gastroenteritis symptoms last week. Assessment:Crohn''s ileocolitis. 1/7/08- Fatigued, heart racing, palpitations with facial and jaw discomfort. Feeling warm with chills.Assessment: Crohn''s ileocolitis with recent flare. Possibly triggered by dairy intake. Additional information was received from medical records from the physician''s office. The patient had abdominal pain in the right lower quadrant. The patient''s pain on examination is worse in the right lower quadrant and localized better than I suspected based on history. The patient has not had nay symptoms of acute appendicitis. The pain has been fairly chronic. She has had no fevers and the pain wakes and wanes. Because of her long history of menstrual irregularities, as well as heavy menstrual bleeding, the physician is concerned regarding the possibility of cysts or an endometrioses. On 09-OCT-2007 the patient complained of abdominal pain. Overall, the patient noted that she has been having problems for about 3 weeks. The patient cannot define it well. It is usually an achy pain and occasionally sharp. It is occasionally up into the chest area but usually more lower in the abdomen. It is also worse after eating but no particular foods seem to trigger it. The patient noted that she is pretty picky and eats a very bland diet. The patient occasionally was having nausea but has had no vomiting and no diarrhea. The patient has had no real constipation, although she notes she has always had some alteration with bowel movements when some days she has more loose and other days is more constipated but usually goes at least once a day. The patient did not notice some blood in the stool about 1 month ago shortly before these symptoms developed. The patient was not having any perirectal pain or any constipation at that time. The patient''s appetite is down overall but is better some days than others. She has not noticed any changes in the skin. No changes in the perirectal tissue. No fistulas or drainage in the perirectal area. No rashes. No mouth sores. No fevers. Energy level has been a bit low but she has just started school and there is no family history of inflammatory bowel disease of autoimmune disease. The patient notes that her periods have been a little bit more frequent but have not been overly heavy. Some cycles are heavier than others. The patient is not currently taking the oral contraceptive pills to regulate her menses. The patient has a past medical history for a positive of enlargement of the aortic root. The patient has no known drug allergies or drug reactions. Family history includes one aunt had rupture of thoracic aorta from cystic medical necrosis earlier in the year and is surviving postoperatively. Father has a thyroid nodule. Paternal grandfather died of colon cancer. The patient is a non-smoker, no drinks or use of any substances. On 09-OCT-2007 the patient''s blood pressure was 108/60 mm Hg. The patient had a physical examination. The results were as follows. The patient was awake, alert and in no acute distress. Abdomen was soft. The most tenderness was actually in the right lower quadrant going down toward the pelvic area. There is no guarding. No rebound. Bowel sounds were positive through out. The patient is also mildly tender in the left lower quadrant and is nontender in the upper portion of the abdomen. There are no masses palpated. No hepatosplenomegaly. Lower extremities are without edema. On an unspecified date the patient had a CT of the abdomen and pelvis with contrast. The impression was the examination was very suspicious for Crohn''s disease of the distal ileum. Fluid was in the pelvic cul-de-sac may be related to the inflammatory bowel disease. The ovaries showed no masses and contain multiple small follicles. CT scan of the abdomen and pelvis was otherwise unremarkable. On 02-NOV-2007 the patient had a colonoscopy and pathology examination performed. The diagnosis was tissue "A" - ileum terminal biopsy- fragments of small intestinal mucosa with erosion, laceration, exudate, chronic active ileitis, findings consistent with an edge of an ulcer, consistent with Crohn''s. Tissue "B" - colon, right, biopsy - focal chronic active colitis with ill-defines granulomas and giant cells: findings most consistent with Crohn''s. Tissue "C"- Colon left biopsy- focal chronic active colitis with no crypt architectural distortion, findings consistent with inflammatory bowel disease, Crohn''s. At the time of reporting the patient had not recovered. Additional information is not expected.


VAERS ID: 336620 (history)  
Form: Version 1.0  
Age: 36.0  
Sex: Female  
Location: New Jersey  
Vaccinated:1999-03-01
Onset:1999-03-15
   Days after vaccination:14
Submitted: 2009-01-06
   Days after onset:3585
Entered: 2009-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
LYME: LYME (LYMERIX) / GLAXOSMITHKLINE BIOLOGICALS LY120A9 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Arthritis, Autoimmune disorder, Back pain, Blood immunoglobulin G normal, Blood immunoglobulin M, Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, Cognitive disorder, Condition aggravated, Crohn's disease, Eating disorder, Epicondylitis, Fall, Fatigue, Fibromyalgia, Full blood count normal, Gastrointestinal disorder, HLA marker study, Immediate post-injection reaction, Immunology test, Joint sprain, Joint swelling, Lyme disease, Muscle strain, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia, Neck pain, Neurological symptom, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging normal, Oedema peripheral, Osteoarthritis, Pain, Post vaccination syndrome, Rash, Red blood cell sedimentation rate normal, Rheumatoid arthritis, Rheumatoid factor, Rheumatoid factor negative, Sleep disorder, Swelling face, X-ray abnormal, X-ray limb abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal premalignant disorders (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Allergies; Arthritis; Asthma; Depression; Fatigue; Gastroesophageal reflux disease; Joint pain; Kidney stone; Knee derangement; Knee pain; Leg cramps; Low back pain; Lyme disease; Sacral contusion; Smoking; Stress urinary incontinence; Thin hair; Tubal ligation; History of "long-term " treatment of Lyme disease including ZITHROMAX and doxycycline. In approximately 1989, she began experiencing depression, leg cramps, arthralgias, myalgias, and severe fatigue. In December 1989 she was admitted due to a diagnosis of Lyme arthralgia. On 12 February 1993, it was noted that her "more recent" symptoms included arthralgias, fatigue, visual blurring, watery eyes, upper back and neck pain, intermittent rashes, and generalized bruising; symptoms resolved when she resumed antibiotics. She had multiple past tick bites. In September 1993, she reported a diagnosis of Lyme disease and treatment in 1990, with symptoms including tiredness, weakness, numbness, hair loss, blurred vision, hearing loss, ringing in ears, joint pain and swelling, tremors, flu-like symptoms, memory loss, and change in bowel habits. Family history of Lyme disease (parents, brother, sister), possible rheumatoid arthritis (mother).
Allergies:
Diagnostic Lab Data: Antinuclear antibody, 16Mar1999, negative; Antinuclear antibody, 17Jul1999, negative; Antinuclear antibody, 06Oct1999, negative; Antinuclear antibody, 10Mar2008, negative; Erythrocyte sedimentation rate, 16Mar1999, 1mm/hr; Erythrocyte sedimentation rate, 17Jul1999, 2mm/hr; Erythrocyte sedimentation rate, 11Nov2000, 1mm/hr; Erythrocyte sedimentation rate, 11May2004, 4mm/hr; Rheumatoid factor, 16Mar1999, negative; Rheumatoid factor, 06Oct1999, less than 20IU/m. Diagnostic results: 09 September 1998: X-rays of the right knee revealed some probable narrowing of the lateral joint space; patellofemoral joint space appeared to be well-maintained. 16 March 1999: Lyme antibody ELISA 0.24 (normal less than 0.8); Complete blood count normal. 22 July 1999: HLA-DR typing, antigens present: DR1, DR12. 15 January 2000: Correlia burgdorferi negative. Lyme disease IgG and IgM negative. 15 March 2002: Lyme ELISA titer IgG less than 80 (normal); Lyme Western blot IgM and IgG negative: MarDx and Immunetics Western Blot IgG negative; overall interpretation: no evidence of serologic reactivity indicative of infection with B. burgdorferi and no reactivity to native OspA detected. 19 December 2005: Magnetic resonance imaging of the right knee was within normal limits. 05 March 2008: X-rays bilateral hands and wrists showed osteoarthritis in the first carpo-metacarpal joints bilaterally. Bone scan showed osteopenia with accelerated bone loss. 10 March 2008: Lyme disease IgG and IgM, Western Blot, negative. HLA-B27 antigen not detected. 26 March 2008: Magnetic resonance imaging of second and third metacarpal phalangeal joints showed 3 x 4 millimeter erosion involving the third metacarpal head consistent with rheumatoid arthritis.
CDC Split Type: A0730257A

Write-up: This case was reported by a lawyer and described the occurrence of rheumatological symptoms in a female subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX. According to the statement of injuries, at an unspecified time after vaccination with LYMERIX the subject experienced "arthralgias, myalgias, cognitive dysfunction, facial swelling, and fatigue" as well as "rashes, swollen joints, swollen feet, and gastrointestinal problems". The statement of injuries also alleged that the subject experienced "rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism all caused by vaccination with LYMERIX including but not limited to those set forth above", and that she experienced "decreased activities of daily life and decreased ability to participate in recreational activities". At the time of reporting the outcome of the events was unspecified. Follow up information was received on 29 July 2008 via medical records. The subject''s medical history included arthritis, depression, fatigue, joint pain, kidney stone, leg cramps, low back pain and Lyme disease. She also had past subcapsular syndrome treated with hydrocortisone and MARCAINE. She had been hospitalized in the past (1989) for Lyme arthralgia. She received her first dose of LYMERIX on 01 March 1999. on 15 March 1999, she experienced "supposed swelling/ rash, not confirmed" as well as aching. It was noted that the subject "swears she had Lyme disease before getting the vaccine; taken doxycycline for several years for Lyme even though never confirmed". On 10 December 2001, she was evaluated for post-Lyme vaccine syndrome and elbow epicondylitis. She was treated by a "Lyme specialist" and medications included VIOXX and ULTRAM. On 15 March 2002, she reported that "the LYMERIX injections have caused her to have a lot of symptoms". On 27 December 2002, she complained of Lyme signs and symptoms and requested ZITHROMAX. On 01 July 2003, she was seen for follow up of chronic Lyme disease that had been treated with doxycycline. By 03 May 2004, it was noted that her Lyme disease was "fairly well controlled with ZITHROMAX". On 19 December 2005 she was seen by an orthopedist for follow up of a left ankle sprain and chronic right knee pain. Treatment included a corticosteroid injection to the knee as well as application of ice. A progress note dated 24 April 2006 indicated that she had "intermittent Lyme flare-ups relieved with antibiotics". According to a rheumatologist''s summary dated 05 March 2008, the subject had allegedly had Lyme disease approximately ten years prior, and at the time of the notes reported bilateral knee pain treated with oral antibiotics. She had been off and on courses of antibiotics "over the years leading up to now" for "what she claims has been Lyme disease". She noted receiving the Lyme vaccine "about three years after her initial diagnosis" and reported that "immediately following the vaccine she developed polyarticular pain and has had this pain ever since with stiffness in the morning". Rheumatologist''s impression included inflammatory arthritis with secondary fibromyalgia. It was noted that post-Lyme arthritis remained a possibility but "less likely as this is a polyarticular distribution and post-Lyme arthritis is typically mono-arthritic". Prednisone was discontinued, and MEDROL started. In August 2003 she reported fatigue, not eating right, and not sleeping properly but noted that she was "on shift work" and had "a couple of kids that are in trouble, etc.", for which she was prescribed ZYPREXA. On 23 May 2005, she was diagnosed with cervical sprain syndrome. On 17 October 2005, the subject fell down steps and experienced a sprain of the left ankle. On 25 January 2007, she pulled a muscle in her back resulting in back pain. On 28 December 2007 she was involved in an automobile accident resulting in shoulder and arm pain. These were assessed to be incidental findings upon medical record review. Follow up information was received on 06 October 2008 via medical records. The subject had a history of Lyme disease diagnosed as early as October 1989, for which she received long-term treatment. On 15 March 1999, two weeks after her first LYMERIX vaccine, she presented with swelling in her hands and body aches. On 29 March 1999, she was placed on dexamethasone, LASIX, and ATARAX. On 10 December 2001, physician''s notes indicated "she is apparently a victim of the Lyme vaccine post vaccine syndrome". Medications at that time included VIOXX, ULTRAM, CLARITIN, and ATARAX. Assessment included Lyme disease and epicondylitis. In March 2008, radiology findings included osteoarthritis in the first carpo-metacarpal joints bilaterally, and an erosion involving the third metacarpal head consistent with rheumatoid arthritis. She was seronegative for rheumatoid arthritis. She returned for rheumatology follow up on 26 March 2008, and it was reported that x-rays of the hands and wrists were consistent with osteoarthritis. MEDROL was continued and she was placed on vitamin D as well. She was again seen for rheumatology follow up on 30 June 2008, with impression of likely seronegative rheumatoid arthritis. She continued to experience fibromyalgic pain with soreness of the arms. MEDROL was held, ATARAX dose increased, and methotrexate and folate were initiated. Follow up information was received on 03 November 2008 via medical records. On 01 March 2000, a progress note indicated that the subject''s "vaccine symptoms are back?" and diagnoses included Lyme disease and treatment resistant arthritis. On 10 January 2001, the subject complained of swollen joints, body aches, and pain. On 03 February 2001, the subject was diagnosed with post-vaccine arthritis that was non-responsive to treatment, and autoimmune disease. Medications included VIOXX and prednisone. On 15 August 2001 and 19 September 2001, the subject was evaluated for Lyme symptoms/ a flare of Lyme disease with associated joint pain, swelling, and aching "all over". Treatment included doxycycline. Follow up information was received on 05 January 2009 via medical records. On 11 November 2000, the subject presented with a flare-up of "Lyme vaccine symptoms" including swelling, and itching, with treatment including prednisone and ATARAX. The subject was reportedly advised that she had Crohn''s and rheumatoid arthritis "in the past with secondary fibromyalgia, likely from LYMERIX vaccination". In March 2008, rheumatoid factor was within normal limits, and it was noted that in spite of her Crohn''s diagnosis there was no stigmata of Crohn''s arthropathy "although this remains a possibility, but less likely as this is a polyarticular distribution and post-Lyme arthritis is typically mono-arthritic". A progress note dated 24 July 2008 indicated that the subject was diagnosed with "new onset Lyme", had had LYMERIX in the past, and required "long-term" doxycycline therapy.


VAERS ID: 340668 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2007-08-16
Onset:2007-12-01
   Days after vaccination:107
Submitted: 2009-02-23
   Days after onset:450
Entered: 2009-02-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0181U / 1 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Abdominal pain, Crohn's disease, Diarrhoea, Malaise
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None HPV #2 given 10/17/07, LA, 0469U; HPV #3 given 2/20/08, LA, 1287U PMH: environmental allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Abdominal pain, diahrrea, general ill feeling 12/07. Again 8/08 - Diagnosed Crohn''s disease 10/08. 3/9/09 Received PCP vaccine records & medical records of 8/16/07-2/19/2009. FINAL DX: none provided Records reveal patient experienced good health on 8/16/07. Received HPV #1 & also started on BCP for dysmenorrhea. RTC 12/10/07 w/abdominal pain x 4-5 days, diarrhea. Exam revealed decreased bowel sounds & LLQ tenderness. Dx w/possible colitis.


VAERS ID: 345322 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: Ohio  
Vaccinated:2008-02-28
Onset:2008-03-10
   Days after vaccination:11
Submitted: 2009-04-26
   Days after onset:412
Entered: 2009-04-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 9725102 / 2 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1766U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Abdominal pain upper, Crohn's disease, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations: abdominal pain~HPV (Gardasil)~2~15.00~Patient
Other Medications: None at the time of the vaccine
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Crohn''s disease; Upper/lower US; Endoscopy/colonoscopy; Abdominal CT Scan LABS: abdominal US w/right ovarian follicle otherwise WNL.. Urine c/s neg. Upper endoscopy WNL. Colonoscopy abnormal w/ileocecal valve edematous & friable w/pseudopolyp. Upper GI biopsies WNL. Lower GI biopsies abnormal w/chronic colitis & inflammatory polyp. CT enterography abnormal w/inflammatory stricture in terminal ileum.
CDC Split Type:

Write-up: Began with stomach pains, rash on the top and bottom of both feet. Stomach pains were intermittent then became constant. 1 year later 2/09 diagnosed with Crohn''s. I feel the vaccine initiated the Crohn''s. 5/8/09 Received PCP medical records of 2/28/08-4/22/2009. FINAL DX: Crohn''s disease w/terminal ileum inflammation & stricture s/p laparoscopic assisted ileocecal resection/anastamosis Records reveal patient experienced good general health on 2/28/09. RTC 4/29/08 w/increasing abdominal pain x 2-3 wks w/1 episode emesis, urinary frequency over past few days. RTC 5/21/08 w/tinea pedis & cellulitis. RTC 5/30/08 w/dermatitis. RTC 6/13 w/continuation of cellulitis of foot & tinea pedis. RTC 10/16/08 & referred to GI for 4-6 mo hx of abdominal pain & diarrhea w/normal GYN exam & no relief from pepcid. GI consult records of 12/30/08-4/16/09 included & reveal intial dx of non specific colitis. Hospitalized 3/11-16/2009 w/Crohn''s disease. Did not respond to med treatment & re-hospitalized 4/16-4/22/09 for surgery. No further records available.


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