chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: White blood cell count decreased
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 23 year old female with PHENERGAN allergy and a history of hypothyroidism, partial thyroidectomy in 2006, total thyroidectomy in 2007 and benign thyroid nodule who on 14-FEB-2007 was vaccinated IM into gluteus maximus with the first dose of GARDASIL (lot # 653978/0955F). Concomitant therapy included LEVOXYL and DEPO-PROVERA. The patient was diagnosed with acute promyelocytic leukemia (APL) on 11-MAR-2007. No family history. Acute onset, no tangible symptoms until roughly 10 days before diagnosis (anemia, fever, night sweats). Consultant records (hematology/oncology) showed diagnosis: APL. The patient was diagnosed with acute promyelocytic leukaemia on 11-MAR-2007 accompanied by mild disseminated intravascular coagulation (DIC). Several office visits for chemotherapy. The patient had received induction, consolidation and maintenance therapy; presently in histologic and molecular remission. The patient underwent several bone marrow aspirations. The patient was being monitored as outpatient. Obstetrics and gynecology records on 05-MAR-2007 showed well woman exam. No health issues documented. Labs/diagnostics in March 2007 included: WBC 0.5 K/mm3 (low), hemoglobin 8.0 g/dL (low), hematocrit 21.4% (low), platelet 10 k/mm3 (low), neutrophil 12% (low), lymphocyte 80% (high), blast 70% (high), AST 87 U/L (high), ALT 149 U/L (high). Bone marrow aspirate: no abnormal myeloid cell population identified. CT of chest, abdomen and pelvis showed pleural effusion with bilateral lower lobe atelectasis vs consolidation; periportal oedema of liver; ascites in pelvis; left adnexal cyst. Numerous additional tests related to monitoring of health condition were performed since diagnosis. The status of the patient was unknown at the time of this report. APL, DIC, several bone marrow aspirations, chemotherapy, anemia, fever and night sweats were considered to be immediately life-threatening by the agency. The original reporting source was not provided. The VAERS ID is 434266. No further information is available. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Bronchiolitis, Chest X-ray normal, Eczema, Erythema, Gastroenteritis
Clinical narrative: This case was reported by a consumer (patient's mother), via Pfizer, Inc., and described the occurrence of gastroenteritis in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Haemophilus influenzae type b vaccine (unknown manufacturer) and PREVNAR (non-gsk). On 19 November 2008 the subject received 1st dose of PEDIARIX (unknown route), 1st dose of Haemophilus influenzae type b vaccine (unknown route) and 1st dose of PREVNAR (unknown route). In November 2008, less than one month after vaccination with Haemophilus influenzae type b vaccine, PEDIARIX and PREVNAR. The subject experienced gastroenteritis, respiratory syncytial viral infection, rash under arm, discharge unspecified ("rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema, bronchiolitis, watering eyes, fever, gastroesophageal reflux disease and immune dysfunction. At the time of the report, the status of therapy with PEDIARIX, Haemophilus influenzae type b vaccine and PREVNAR were unknown. The therapeutic measure taken for gastroesophageal reflux disease included treatment with ranitidine (dose, frequency and duration unknown) and the therapeutic measures taken for the other reported events, if any, were unknown. The subject was hospitalised for 2 days due to the bronchiolitis. Relevant results included blood work done on an unknown date which showed that the consumer had immunological reactions and chest X-ray and test for cystic fibrosis done on unknown dates, the results for which were normal. At the time of reporting the respiratory syncytial viral infection, "rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema bronchiolitis were unresolved and the outcome for watering eyes, fever, gastroesophageal reflux disease and immune dysfunction was unknown.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Gastrooesophageal reflux disease, Immune system disorder, Immunology test abnormal, Laboratory test normal, Lacrimation increased
Clinical narrative: This case was reported by a consumer (patient's mother), via Pfizer, Inc., and described the occurrence of gastroenteritis in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Haemophilus influenzae type b vaccine (unknown manufacturer) and PREVNAR (non-gsk). On 19 November 2008 the subject received 1st dose of PEDIARIX (unknown route), 1st dose of Haemophilus influenzae type b vaccine (unknown route) and 1st dose of PREVNAR (unknown route). In November 2008, less than one month after vaccination with Haemophilus influenzae type b vaccine, PEDIARIX and PREVNAR. The subject experienced gastroenteritis, respiratory syncytial viral infection, rash under arm, discharge unspecified ("rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema, bronchiolitis, watering eyes, fever, gastroesophageal reflux disease and immune dysfunction. At the time of the report, the status of therapy with PEDIARIX, Haemophilus influenzae type b vaccine and PREVNAR were unknown. The therapeutic measure taken for gastroesophageal reflux disease included treatment with ranitidine (dose, frequency and duration unknown) and the therapeutic measures taken for the other reported events, if any, were unknown. The subject was hospitalised for 2 days due to the bronchiolitis. Relevant results included blood work done on an unknown date which showed that the consumer had immunological reactions and chest X-ray and test for cystic fibrosis done on unknown dates, the results for which were normal. At the time of reporting the respiratory syncytial viral infection, "rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema bronchiolitis were unresolved and the outcome for watering eyes, fever, gastroesophageal reflux disease and immune dysfunction was unknown.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash generalised, Rash pustular, Respiratory syncytial virus infection
Clinical narrative: This case was reported by a consumer (patient's mother), via Pfizer, Inc., and described the occurrence of gastroenteritis in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Haemophilus influenzae type b vaccine (unknown manufacturer) and PREVNAR (non-gsk). On 19 November 2008 the subject received 1st dose of PEDIARIX (unknown route), 1st dose of Haemophilus influenzae type b vaccine (unknown route) and 1st dose of PREVNAR (unknown route). In November 2008, less than one month after vaccination with Haemophilus influenzae type b vaccine, PEDIARIX and PREVNAR. The subject experienced gastroenteritis, respiratory syncytial viral infection, rash under arm, discharge unspecified ("rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema, bronchiolitis, watering eyes, fever, gastroesophageal reflux disease and immune dysfunction. At the time of the report, the status of therapy with PEDIARIX, Haemophilus influenzae type b vaccine and PREVNAR were unknown. The therapeutic measure taken for gastroesophageal reflux disease included treatment with ranitidine (dose, frequency and duration unknown) and the therapeutic measures taken for the other reported events, if any, were unknown. The subject was hospitalised for 2 days due to the bronchiolitis. Relevant results included blood work done on an unknown date which showed that the consumer had immunological reactions and chest X-ray and test for cystic fibrosis done on unknown dates, the results for which were normal. At the time of reporting the respiratory syncytial viral infection, "rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema bronchiolitis were unresolved and the outcome for watering eyes, fever, gastroesophageal reflux disease and immune dysfunction was unknown.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Blood test abnormal, Bronchiolitis, Chest X-ray normal, Eczema, Erythema
Clinical narrative: This case was reported by a consumer (patient's mother), via Pfizer, Inc., and described the occurrence of gastroenteritis in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Haemophilus influenzae type b vaccine (unknown manufacturer) and PREVNAR (non-gsk). On 19 November 2008 the subject received 1st dose of PEDIARIX (unknown route), 1st dose of Haemophilus influenzae type b vaccine (unknown route) and 1st dose of PREVNAR (unknown route). In November 2008, less than one month after vaccination with Haemophilus influenzae type b vaccine, PEDIARIX and PREVNAR. The subject experienced gastroenteritis, respiratory syncytial viral infection, rash under arm, discharge unspecified ("rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema, bronchiolitis, watering eyes, fever, gastroesophageal reflux disease and immune dysfunction. At the time of the report, the status of therapy with PEDIARIX, Haemophilus influenzae type b vaccine and PREVNAR were unknown. The therapeutic measure taken for gastroesophageal reflux disease included treatment with ranitidine (dose, frequency and duration unknown) and the therapeutic measures taken for the other reported events, if any, were unknown. The subject was hospitalised for 2 days due to the bronchiolitis. Relevant results included blood work done on an unknown date which showed that the consumer had immunological reactions and chest X-ray and test for cystic fibrosis done on unknown dates, the results for which were normal. At the time of reporting the respiratory syncytial viral infection, "rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema bronchiolitis were unresolved and the outcome for watering eyes, fever, gastroesophageal reflux disease and immune dysfunction was unknown.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Gastroenteritis, Gastrooesophageal reflux disease, Immune system disorder, Lacrimation increased, Purulent discharge
Clinical narrative: This case was reported by a consumer (patient's mother), via Pfizer, Inc., and described the occurrence of gastroenteritis in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Haemophilus influenzae type b vaccine (unknown manufacturer) and PREVNAR (non-gsk). On 19 November 2008 the subject received 1st dose of PEDIARIX (unknown route), 1st dose of Haemophilus influenzae type b vaccine (unknown route) and 1st dose of PREVNAR (unknown route). In November 2008, less than one month after vaccination with Haemophilus influenzae type b vaccine, PEDIARIX and PREVNAR. The subject experienced gastroenteritis, respiratory syncytial viral infection, rash under arm, discharge unspecified ("rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema, bronchiolitis, watering eyes, fever, gastroesophageal reflux disease and immune dysfunction. At the time of the report, the status of therapy with PEDIARIX, Haemophilus influenzae type b vaccine and PREVNAR were unknown. The therapeutic measure taken for gastroesophageal reflux disease included treatment with ranitidine (dose, frequency and duration unknown) and the therapeutic measures taken for the other reported events, if any, were unknown. The subject was hospitalised for 2 days due to the bronchiolitis. Relevant results included blood work done on an unknown date which showed that the consumer had immunological reactions and chest X-ray and test for cystic fibrosis done on unknown dates, the results for which were normal. At the time of reporting the respiratory syncytial viral infection, "rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema bronchiolitis were unresolved and the outcome for watering eyes, fever, gastroesophageal reflux disease and immune dysfunction was unknown.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Rash generalised, Respiratory syncytial virus infection, Type IV hypersensitivity reaction
Clinical narrative: This case was reported by a consumer (patient's mother), via Pfizer, Inc., and described the occurrence of gastroenteritis in a 1-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Haemophilus influenzae type b vaccine (unknown manufacturer) and PREVNAR (non-gsk). On 19 November 2008 the subject received 1st dose of PEDIARIX (unknown route), 1st dose of Haemophilus influenzae type b vaccine (unknown route) and 1st dose of PREVNAR (unknown route). In November 2008, less than one month after vaccination with Haemophilus influenzae type b vaccine, PEDIARIX and PREVNAR. The subject experienced gastroenteritis, respiratory syncytial viral infection, rash under arm, discharge unspecified ("rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema, bronchiolitis, watering eyes, fever, gastroesophageal reflux disease and immune dysfunction. At the time of the report, the status of therapy with PEDIARIX, Haemophilus influenzae type b vaccine and PREVNAR were unknown. The therapeutic measure taken for gastroesophageal reflux disease included treatment with ranitidine (dose, frequency and duration unknown) and the therapeutic measures taken for the other reported events, if any, were unknown. The subject was hospitalised for 2 days due to the bronchiolitis. Relevant results included blood work done on an unknown date which showed that the consumer had immunological reactions and chest X-ray and test for cystic fibrosis done on unknown dates, the results for which were normal. At the time of reporting the respiratory syncytial viral infection, "rash protruding under arm with white cheesy discharge coming out", immunological reaction, "all over" body rash, erythema, "extensive" eczema bronchiolitis were unresolved and the outcome for watering eyes, fever, gastroesophageal reflux disease and immune dysfunction was unknown.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Blood test, Constipation, Decreased appetite, Dysgeusia
Clinical narrative: MY DAUGHTER WAS ADMINISTERED THE HPV VAC SEPT. 23RD WITH A FLU SHOT AND THEN WAS GIVEN THE DEPO AND ANOTHER HPV VACCINATION 1 WEEK LATER, OCT. 10TH. PATIENT FAINTED AFTER DRIVING HERSELF TO WORK AND IS HAVING DIFFERENT SIDE EFFECTS. TROUBLE WITH RIGHT EYE, BLURRY VISION, EYELID NOT OPENING, MIGRAINES, CONSTIPATION, WEIGHT LOSS, LOSS OF APPETITE, CHEMICAL/BLEACH TASTE IN MOUTH, RASH ON FACE, HAIR LOSS, FATIGUE. PATIENT IS VERY PETITE AND ONLY WEIGHED 90LBS TO START AND NOW WEIGHS 85LBS. PATIENT WAS NOT SUPPOSE TO BE GIVEN THE HPV/GARDISIL VAC. HER DR. IS NOW DENYING THE 2ND WAS GIVEN TO HER, BUT PATIENT WAS GIVEN A SHOT IN EACH ARM AND OUR INSURANCE WAS BILLED. HELP!
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Eyelid function disorder, Fatigue, Inappropriate schedule of drug administration, Migraine, Nuclear magnetic resonance imaging
Clinical narrative: MY DAUGHTER WAS ADMINISTERED THE HPV VAC SEPT. 23RD WITH A FLU SHOT AND THEN WAS GIVEN THE DEPO AND ANOTHER HPV VACCINATION 1 WEEK LATER, OCT. 10TH. PATIENT FAINTED AFTER DRIVING HERSELF TO WORK AND IS HAVING DIFFERENT SIDE EFFECTS. TROUBLE WITH RIGHT EYE, BLURRY VISION, EYELID NOT OPENING, MIGRAINES, CONSTIPATION, WEIGHT LOSS, LOSS OF APPETITE, CHEMICAL/BLEACH TASTE IN MOUTH, RASH ON FACE, HAIR LOSS, FATIGUE. PATIENT IS VERY PETITE AND ONLY WEIGHED 90LBS TO START AND NOW WEIGHS 85LBS. PATIENT WAS NOT SUPPOSE TO BE GIVEN THE HPV/GARDISIL VAC. HER DR. IS NOW DENYING THE 2ND WAS GIVEN TO HER, BUT PATIENT WAS GIVEN A SHOT IN EACH ARM AND OUR INSURANCE WAS BILLED. HELP!
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Syncope, Vision blurred, Weight decreased
Clinical narrative: MY DAUGHTER WAS ADMINISTERED THE HPV VAC SEPT. 23RD WITH A FLU SHOT AND THEN WAS GIVEN THE DEPO AND ANOTHER HPV VACCINATION 1 WEEK LATER, OCT. 10TH. PATIENT FAINTED AFTER DRIVING HERSELF TO WORK AND IS HAVING DIFFERENT SIDE EFFECTS. TROUBLE WITH RIGHT EYE, BLURRY VISION, EYELID NOT OPENING, MIGRAINES, CONSTIPATION, WEIGHT LOSS, LOSS OF APPETITE, CHEMICAL/BLEACH TASTE IN MOUTH, RASH ON FACE, HAIR LOSS, FATIGUE. PATIENT IS VERY PETITE AND ONLY WEIGHED 90LBS TO START AND NOW WEIGHS 85LBS. PATIENT WAS NOT SUPPOSE TO BE GIVEN THE HPV/GARDISIL VAC. HER DR. IS NOW DENYING THE 2ND WAS GIVEN TO HER, BUT PATIENT WAS GIVEN A SHOT IN EACH ARM AND OUR INSURANCE WAS BILLED. HELP!
Age: 43.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal sensation in eye, Axillary pain, Back pain, Disorientation, Full blood count
Clinical narrative: Fever of 103 Degrees, Severe pain in vaccine inject under arm/inflammed gland in under arm. Adverse reaction in injection site, raised and sore. Back spasm and seizures in muscles of back. Disorientation and incoherant speech. Headaches and eye pressure. Treated with Ice and cold compressess to effected injection site and under arm glands to reduce pain and lymphnodes. Fever and back pain being treated with Ibuprofe and cold compresses.
Age: 43.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Incoherent, Inflammation, Injection site pain, Injection site swelling
Clinical narrative: Fever of 103 Degrees, Severe pain in vaccine inject under arm/inflammed gland in under arm. Adverse reaction in injection site, raised and sore. Back spasm and seizures in muscles of back. Disorientation and incoherant speech. Headaches and eye pressure. Treated with Ice and cold compressess to effected injection site and under arm glands to reduce pain and lymphnodes. Fever and back pain being treated with Ibuprofe and cold compresses.
Age: 43.0
Sex: M
Vaccine: DTAP
Symptoms: Lymphadenopathy, Muscle spasms, Pyrexia, Urine analysis
Clinical narrative: Fever of 103 Degrees, Severe pain in vaccine inject under arm/inflammed gland in under arm. Adverse reaction in injection site, raised and sore. Back spasm and seizures in muscles of back. Disorientation and incoherant speech. Headaches and eye pressure. Treated with Ice and cold compressess to effected injection site and under arm glands to reduce pain and lymphnodes. Fever and back pain being treated with Ibuprofe and cold compresses.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Tendon disorder
Clinical narrative: Started with a sore shoulder which continued to get worse, eventually affecting arm, hand, neck, and pain in entire shoulder area.  Had an MRI of left shoulder and it shows rotator cuff tendinosis.  Severe pain.  Going back to the dr on December 22 to discuss results of MRI.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: 12/13/11 10:52 Patient called advice line: states had a tetanus shot in her right arm 12/8/11. States there is swelling under the arm & at the injection site.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood thyroid stimulating hormone, Computerised tomogram head, Full blood count, Metabolic function test, Syncope
Clinical narrative: Patient had & has been having syncope episodes since the first HPV vaccine given. HPV 8-10-2007, 9-13-2011, 10-20-2011.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Rash, Rash macular
Clinical narrative: C/O burning pain & itching with blotchy rash to (R) leg & (R) buttocks. Dx with shingles by primary care MD 11/3/11.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Nuclear magnetic resonance imaging normal, VIIth nerve paralysis
Clinical narrative: Bell's palsy. Facial droop on 11/2/11. Seen at hospital. MRI negative.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 60 year old female patient with diabetes and no drug reactions or allergies, who on 01-DEC-2011 was vaccinated intramuscularly in her left arm, with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 671176/0985AA, Exp. Date: March 2013). There was no concomitant medication. The doctor of pharmacy reported that "after receiving PNEUMOVAX 23", on approximately 01-DEC-2011, the patient experienced severe arm pain. The pain was from the injection site down to her elbow. There was no redness or swelling. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by making a phone call to doctor of pharmacy. Severe arm pain and the injection site pain down to the elbow were considered to be disabling by the doctor of pharmacy since the patient could not lift her arm. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypersensitivity, Muscle injury, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Vaccination complication
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 60 year old female patient with diabetes and no drug reactions or allergies, who on 01-DEC-2011 was vaccinated intramuscularly in her left arm, with a 0.5 ml dose of PNEUMOVAX 23 (Lot number 671176/0985AA, Exp. Date: March 2013). There was no concomitant medication. The doctor of pharmacy reported that "after receiving PNEUMOVAX 23", on approximately 01-DEC-2011, the patient experienced severe arm pain. The pain was from the injection site down to her elbow. There was no redness or swelling. No lab diagnostics studies were performed. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by making a phone call to doctor of pharmacy. Severe arm pain and the injection site pain down to the elbow were considered to be disabling by the doctor of pharmacy since the patient could not lift her arm. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Delirium, Laboratory test normal, Unresponsive to stimuli
Clinical narrative: Woke up delirious.  Then went back to sleep, it happened three times.  Then Saturday morning was totally unresponsive and brought to hospital.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient says she still has pain in left arm.
Age: 1.62
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Parent brought child in 12-7-11 right thigh red area 8 x 7 1/2 cm. Warm. 12-8-11. resolving.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Hyperhidrosis, Malaise, Muscle rigidity, Pallor, Posture abnormal
Clinical narrative: Pt c/o not feeling well - head dropped, color was pale, was sweaty and arms became rigid for short time (syncopal episode).
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Pt c/o not feeling well - head dropped, color was pale, was sweaty and arms became rigid for short time (syncopal episode).
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Upper respiratory tract infection, Varicella post vaccine
Clinical narrative: 15 scattered chicken pox vesicles mostly on anterior trunk; some fresh others resolving; no frank scabs; also with URI sxs exposed 2 wks prior to cousin w/ chicken pox.
Age: 36.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Chills, Injection site erythema, Pyrexia
Clinical narrative: Fevers, chills, erythema at injection site. Dx: cellulitis. Tx - KEFLEX 500mg PO 4 caps x10d.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash, Injection site swelling, Pain
Clinical narrative: Patient said she felt the pain right after she had the shot, but a rash occurred right after next day. The rash is on the left are where the injection was done. It is about one inch below the site. It is also red & swelling.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain
Clinical narrative: Experienced shingles episodes approximately yearly from age 50-58. No recurrence until approximately one week after shingles vaccine. Most current episode was most intense pain of all previous episodes
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint stiffness, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Patient's husband came to pharmacy asking about getting the flu from taking the flu shot. He said patient woke up this morning with a sore throat, aching, feeling weak, and joints were stiff. He said she is pretty tough and it is unusual for anything to get her down like this, but she is really sick. I explained to him that the vaccine is a killed virus and unlikely to cause the flu. I suggested that she to to the doctor and get checked.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: 1 hr. after GARDASIL shot was given - patient became dizzy, nausea & weak. 2 hrs. later - headache w/ extreme exhaustion - fell asleep & woke up 1 hr. later, not remembering anything after shot was given! She experienced headache, nausea & tingling & numbness of the fingers/hands 2 days later. She will not be getting the 2nd or 3rd vaccine of GARDASIL!!! (Fri) 10-28-11 - patient had a sudden dizzy spell in school, lost feeling in finger & hands, headache.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Paraesthesia
Clinical narrative: 1 hr. after GARDASIL shot was given - patient became dizzy, nausea & weak. 2 hrs. later - headache w/ extreme exhaustion - fell asleep & woke up 1 hr. later, not remembering anything after shot was given! She experienced headache, nausea & tingling & numbness of the fingers/hands 2 days later. She will not be getting the 2nd or 3rd vaccine of GARDASIL!!! (Fri) 10-28-11 - patient had a sudden dizzy spell in school, lost feeling in finger & hands, headache.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Nausea, Vomiting
Clinical narrative: 14 hours after receiving MENVEO, patient vomited once & has been nauseated. No fever. I talked to the patient & she said she's nauseated but able to tolerate toast the ff. morning.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Laboratory test
Clinical narrative: Pt. here for lab work. Has red, painful upper (L) arm - hot. No evidence of abscess. Last tetanus in childhood. Advised ice pack. To RTC if not better in 3-5 days.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site reaction, Oedema peripheral, Rash erythematous
Clinical narrative: On 8/30/11 pt given TDAP vaccine on 9/1/11 pt seen in office for localized swelling of arm -> treated with antibiotics & steroids -> no hospitalization. Now on 12/6/11 mom c/o (L) upper arm occasional red bumps appearing.
Age: 0.76
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: Problem breathing, threw up, chills, fever.
Age: 77.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Arthralgia, Chills, Diarrhoea, Erythema, Nausea
Clinical narrative: Symptoms: Symptoms: 1. Arthralgia, 2. Diarrhea, 3. Nausea Vomiting, 4. Chills, erythema. Treatment Drugs Used: 1 - INFLUENZA Dose: Units: Freq: Route:.
Age: 77.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Vomiting
Clinical narrative: Symptoms: Symptoms: 1. Arthralgia, 2. Diarrhea, 3. Nausea Vomiting, 4. Chills, erythema. Treatment Drugs Used: 1 - INFLUENZA Dose: Units: Freq: Route:.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chills, Dyspnoea, Injection site discomfort, Pyrexia
Clinical narrative: Patient received Influenza vaccine at 0730 on 12/07/2011. The injection was place in right deltoid. Patient was advised to take a dose of Acetaminophen 325mg to help with the injection site discomfort. Prior to the injection. Patient was asked if she was allergic to eggs -NO-,  Fever or Cough -NO-, Prior reaction to influenza -NO-, patient  stated this was the first flu shot she has ever received. 12/07/2011 at 1330 patient called to state she woke with high fever, chills, shortness of breath and back pain. I advised her to take dose of acetaminophen. I asked if she had any BENADRYL and if she did to take one immediately. I also advised her to go to the ER if her symptoms progressed. Information on Vaccine Product: FLUZONE Man: Sanofi-Pasteur Lot# UH453AA Exp. 30June12.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Oedema peripheral, Pain, X-ray limb normal
Clinical narrative: Patient has has influenza immunization (FLUZONE HD) on 9/22/11. Started to complain about symptom: constant painful upon movement of shoulder, swollen and limited range of motion. Feels like there is something constantly poking inside shoulder.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Influenza like illness, Myalgia, Tremor
Clinical narrative: Pt reported flu like symptoms 90 minutes after receiving immunization; temp 102 muscular pain, uncontrolled tremors and shaking.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration
Clinical narrative: 2-3 cm induration at site flu vaccine - left deltoid.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: Given pneumonia shot and had serious allergic reaction. Doctor could not tell me what was in injection.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure abnormal, Loss of consciousness, Vomiting
Clinical narrative: Had first GARDASIL shot. Passed out and had seizure for approximately sixty seconds. When awoke blood pressure low 60/45. Vomited. After thirty minutes blood pressure back up to 65/50. Ten minutes after that BP was 70/50. Shot was done at MD office by RN. No issue during shot or immediately after. Walked back to waiting room sat down and passed out a few minutes later. Normal blood pressure is 110/80.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Inflammation, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 40 yo presented to Emergency Room with tetanus vaccine ADR. Inflammatory response due to tetanus vaccine: Received tetanus vax in Rt shoulder 4 days ago - on 10/6/2011 - 3 days - 10/7/2011 - ago developed pain, swelling, redness near immunization site along with chills and nausea. Discharged from ED with rxs for cephalexin and prednisone.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: 40 yo presented to Emergency Room with tetanus vaccine ADR. Inflammatory response due to tetanus vaccine: Received tetanus vax in Rt shoulder 4 days ago - on 10/6/2011 - 3 days - 10/7/2011 - ago developed pain, swelling, redness near immunization site along with chills and nausea. Discharged from ED with rxs for cephalexin and prednisone.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site erythema, Injection site swelling, Rash papular
Clinical narrative: See attached.
Age: 0.9
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Type of practice: Community Health Office Name of products involved: KINRIX, 0.5ml given to 11-month-old child for the second set of immunizations of DTaP, IPV and (should have been) HIB. Child should have been given PENTACEL. At 0905: 11-month-old child given KINRIX instead of PENTACEL. KINRIX is not licensed for this age group. Child monitored for 30 minutes with no signs of reaction. This error was identified at 0910, after administration of KINRIX vaccine. The nurse identified the error upon entering the lot number information onto the immunization record. At 0910: Family notified of error in person at community health office. Family gives verbal consent for error to be reported to child's doctor via telephone. At 0915: Family's doctor notified of error. At 1345: Doctor instructed community health nurse to contact the Department of Health for further instruction. CDC contacted for further guidance. (3 days after): CDC (nurse educator with the CDC) confirms that doses do NOT need to be repeated. At 1415 Left voicemail with family informing them doses do not need to be repeated and asked them to call office to schedule next set of immunizations. Plan to schedule next set of immunizations per policy (4 weeks from this set of immunizations given). Variables contributing to error: Vial was checked two times prior to administration, not three. PENTACEL and KINRIX baskets set near each other in the med fridge. Plan of correction: KINRIX and PENTACEL baskets moved to opposite shelves to create more distance between them. Color-coded labels placed on both KINRIX and PENTACEL better identifying their intended age group. Color-coded labels also placed on the front of the med fridge. Reviewed the policy and correct vaccine administration practices emphasizing verifying medications three times before administration.
Age: 25.0
Sex: M
Vaccine: FLUX, SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 30 November 2011. A 25-year-old male subject received the following vaccinations: On 14 October 2011 an injection of ACAM2000 (lot number not reported) and INFLUENZA, INTRANASAL (manufacturer and lot number not reported); On 05 October 2011 an injection of anthrax (manufacturer and lot number not reported), an injection of hepatitis A and hepatitis B vaccines (manufacturer and lot number not reported) and TYPHIM Vi, sanofi pasteur SA lot number not reported. The subject has no significant medical history. On 25 October 2011, the subject had an abnormal Troponin I of 14.04 and abnormal electrocardiogram (ECG). On 26 October 2011, the subject had a normal echocardiogram. On 31 October 2011, the subject was diagnosed acute pericarditis, unspecified. The outcome was not reported. Note: There is not reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient had vaccine administered on 12-14-11 at 0900 am. Experienced (L) arm pain around injection site to axillary area, radiating to (L) breast, and down (L) arm to fingers. No swelling. Took ALEVE did not help. Pain 7 out of 10. Next day better but still a pain primarily on posterior upper arm and into palm. But was getting better.
Sex: U
Vaccine: FLU3
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: In a local health department on XX/X/11, child, should have received influenza vaccine Lot# UT471AA, by Sanofi Pasteur for children 6mo to 35 months. Instead, child received FLUZONE HIGH-DOSE Lot # UH457AA, manufactured by Sanofi Pasteur for 65 yrs and older. This dose is 8 times more potent than the children's dose. Patient's doctor and head of state immunization program were called, along with patient's mother on day of immunization. Possible side effects were explained and mother was advised to call family physician and health department with any adverse reactions. Called mother back on XX/X/11 (3 days later). Child had slight fever night of immunization (101 F), was given TYLENOL x 1. No other doses needed. Child did not have any other symptoms, including no local redness, swelling or pain observed by mother. Area in refrigerator where flu vaccine was held was rearranged. Color coding of labels on baskets used to hold vaccine and vaccine permission slips were already used. Vaccine lot numbers will be reviewed x 3 before administering any vaccine per protocol. Medication administered to or used by the patient: No. Outcome: Child had slight fever night of immunization (101 F), was given TYLENOL x 1. No other doses needed. Child did not have any other symptoms, including no local redness, swelling or pain observed by mother. Where did the error occur. Local Health Department. Patient counseling provided: Unknown. Reporter's recommendations: Area in refrigerator where flu vaccine was held was rearranged. Color coding of labels on baskets used to hold vaccine and vaccine permission slips were already used. Vaccine lot numbers will be reviewed x 3 before administering any vaccine per protocol. Relevant materials provided: None.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Diarrhoea, Hot flush, Irritability, Skin burning sensation
Clinical narrative: Irritability, shivering, vomiting, diarrhea, hot flashes, vertigo, feeling of "burning" all over skin.  This lasted 3 days.
Age: 33.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo, Vomiting
Clinical narrative: Irritability, shivering, vomiting, diarrhea, hot flashes, vertigo, feeling of "burning" all over skin.  This lasted 3 days.
Age: 1.05
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever.
Age: 10.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Erythema multiforme, Oedema peripheral, Rash
Clinical narrative: Rash on chest, arms, thighs. He also had swelling in right arm the day after immunization.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pain in right arm. Very sore. Went to Dr. Dr said to take Advil. She can only take Tylenol. Dr said it may take up to 3 months to heal.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Erythema, Injection site cellulitis, Injection site pruritus, Pain in extremity, Vaccination site erythema
Clinical narrative: Had VZV and HPV vaccine in the right arm, VZV given SC in the right mid lateral arm, HPV given IM/RD on 12-13-2011.  Right arm started hurting after the vaccine, was a little red in the evening of the 13th.  Morning of the 14th started to swell at the VZV site. Was seen for an OV 12-15-2011 when mom indicated that the swelling at the VZV site was improved, but that the site itched and the redness had gotten larger.  The VZV site is hot to touch and painful. There is a 10 cm x 7.5 cm area of erythema, induration, tenderness to palpation at the VZV injection site.  She has full ROM right shoulder. The circumference of the right mid upper arm is 15 inches with the circumference of the left mid upper arm at 14 inches.  Diagnosed with cellulitis of the right upper arm.  Loratadine 10 mg,daily, and Keflex 500 mg, one TID x 10 days ordered 12-15-11.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4, VARCEL
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Had VZV and HPV vaccine in the right arm, VZV given SC in the right mid lateral arm, HPV given IM/RD on 12-13-2011.  Right arm started hurting after the vaccine, was a little red in the evening of the 13th.  Morning of the 14th started to swell at the VZV site. Was seen for an OV 12-15-2011 when mom indicated that the swelling at the VZV site was improved, but that the site itched and the redness had gotten larger.  The VZV site is hot to touch and painful. There is a 10 cm x 7.5 cm area of erythema, induration, tenderness to palpation at the VZV injection site.  She has full ROM right shoulder. The circumference of the right mid upper arm is 15 inches with the circumference of the left mid upper arm at 14 inches.  Diagnosed with cellulitis of the right upper arm.  Loratadine 10 mg,daily, and Keflex 500 mg, one TID x 10 days ordered 12-15-11.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Left arm pain and weakness.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Blister, Dysphonia, Lip blister, Lip swelling, Oral pain
Clinical narrative: Lips itchy; throat hoarse by 12/15 face and lips swollen with rows of blisters on each lip; mouth extremely tender and sore; blisters on face and below nose; doctor took picture.  Consider this reaction in conjunction with Patient's daily dose of 15 mg. of prednisone.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pruritus, Swelling face
Clinical narrative: Lips itchy; throat hoarse by 12/15 face and lips swollen with rows of blisters on each lip; mouth extremely tender and sore; blisters on face and below nose; doctor took picture.  Consider this reaction in conjunction with Patient's daily dose of 15 mg. of prednisone.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Skin lesion
Clinical narrative: Hard, swollen, red, itchy lesion to site of administration.
Age: 0.51
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13, RV5
Symptoms: Radioallergosorbent test negative, Urticaria
Clinical narrative: Pt developed hives all over body approximately 11 hours after receiving 6 mo vaccines. Pt received Daptacel, Act Hib, PCV 13, Rotateq, and .25ml Fluzone. All vaccines patient has had before without incident except for the Flu Vaccine; this was the first dose.
Age: 0.6
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: County Health Department Imm clinic about 11 am, I reviewed child's imm needs on schedule in records noted that he needed hep B as well as DTP HIB polio flu and roto. I substituted pediatric hep A, HAVRIX .5 ml GSK by mistake for the hep B. Child was 6 mo 11 days, given in right thigh. Contacted CDC next day as soon as I was made aware of wrong imm given, found on vacc error report (call/31-129830289) spoke with, advised min age for pediatric hep A 12 mo. Early dose off label therefore no info on adverse events because hasn't tested on this age group. Child does need to be revaccinated for hep A at appropriate age and still needs hep B. Contacted parent by phone 1:45 pm advised pt of above, she expressed understanding that hep A was given too early and the it would need to be repeated at appropriate age, and that child needs hep B. She will bring the child in the next few wks for hep B and pneumo. Patent states child is well and will observe for any adverse reaction to hep A and other vac given. Parent states child is well and will observe for any adverse reaction to hep A and other vacc given.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Pain, Pyrexia, Swelling
Clinical narrative: Left arm injected 11:15 AM (12-01-11), fever 101 degrees 8PM; severe swelling inflammation; pain; 1 inch below inj site to above elbow; called RPh; took BENADRYL for allergy; called personal doctor; advised to E.R.; Z-PAK, ZYRTEC & ADVIL; compresses 4x day - 4-7 days.
Age: 13.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Testicular pain, Vaccination complication
Clinical narrative: Testicular pain x 1 day on 12/11/11 which resolved. Mother concerned this is an HPV side effect. PE No swelling, NT, normal exam on 12/12/11.
Age: 0.78
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient's mother called our office on 12/14/11 stating that patient's (L) thigh was red & swollen 3x larger than normal & fever 103-104 degrees. Has been giving TYLENOL p.o. Fever responds well. Has been using cold compresses to leg. 12/15/11 mother states thigh is normal size, no fever.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Blood culture negative, CSF culture negative, Culture urine negative, Influenza virus test negative, Pyrexia
Clinical narrative: Initial report was received on 01 December 2011 from another manufacturer (manufacturer report number A0953777A). The following is verbatim from the report: "This case was reported by a physician, via a GSK sales representative, and described the occurrence of fever in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX, HIB (non-gsk) and (non-gsk) PREVNAR. Concurrent medical conditions included pineal cyst. On 18 October 2011 the subject received 1st dose of PEDIARIX (.5ml, unknown route, left thigh), 1st dose of ROTARIX (details unknown), 1st dose of HIB (Non-GSK) (details unknown), 1st dose of PREVNAR (details unknown). On 19 October 2011, 1 day after vaccination with PEDIARIX, ROTARIX, HIB (Non-GSK) and PREVNAR, the subject experienced fever. The subject's parents reported the fever as high as 103 to 104 degrees Fahrenheit. The fever was only confirmed as high as 101.2 degrees Fahrenheit. The subject was hospitalised. The subject was treated with antibiotics. Relevant test results included negative results for urine culture, blood culture, cerebrospinal fluid culture, influenza virus test and respiratory syncytial virus test. On 22 October 2011, the event was resolved. The subject was discharged without fever after 3 days of hospitalization. The physician considered the event was possibly related to vaccination with PEDIARIX, ROTARIX, HIB (Non-GSK) and PREVNAR. Note: the ACTHIB, lot number OH289AA (invalid lot number) was reported by the other manufacturer as a sanofi pasteur product. Documents held by sender: none.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Respiratory syncytial virus test negative
Clinical narrative: Initial report was received on 01 December 2011 from another manufacturer (manufacturer report number A0953777A). The following is verbatim from the report: "This case was reported by a physician, via a GSK sales representative, and described the occurrence of fever in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTARIX, HIB (non-gsk) and (non-gsk) PREVNAR. Concurrent medical conditions included pineal cyst. On 18 October 2011 the subject received 1st dose of PEDIARIX (.5ml, unknown route, left thigh), 1st dose of ROTARIX (details unknown), 1st dose of HIB (Non-GSK) (details unknown), 1st dose of PREVNAR (details unknown). On 19 October 2011, 1 day after vaccination with PEDIARIX, ROTARIX, HIB (Non-GSK) and PREVNAR, the subject experienced fever. The subject's parents reported the fever as high as 103 to 104 degrees Fahrenheit. The fever was only confirmed as high as 101.2 degrees Fahrenheit. The subject was hospitalised. The subject was treated with antibiotics. Relevant test results included negative results for urine culture, blood culture, cerebrospinal fluid culture, influenza virus test and respiratory syncytial virus test. On 22 October 2011, the event was resolved. The subject was discharged without fever after 3 days of hospitalization. The physician considered the event was possibly related to vaccination with PEDIARIX, ROTARIX, HIB (Non-GSK) and PREVNAR. Note: the ACTHIB, lot number OH289AA (invalid lot number) was reported by the other manufacturer as a sanofi pasteur product. Documents held by sender: none.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site anaesthesia, Injection site nodule, Injection site pain, Rash
Clinical narrative: Reports that after his Td shot on Sept 22 the site of the injection still numb and with a knot that bothers him to raise his arm. He also report breaking down in a rash. He reports that he has taken tetanus shots before and had never cause him any problems. He said that the rash has subsided and gone but his (RT) deltoid area is sore. Denies any fever or chills.