chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Uveitis, Visual acuity reduced
Clinical narrative: Information has been received from an other health care professional author. PURPOSE: In this study, the case of a patient who presented with reactivation of herpes zoster (HZ) keratitis and worsening of neurotrophic keratopathy, keratouveitis, and keratoconjunctivitis sicca after vaccination with live attenuated ZOSTAVAX is described. METHOD: This is a retrospective case review. RESULTS: A 63-year-old man, with a history of HZ and neurotrophic keratopathy that had been quiescent for 3.5 years off medication, presented with keratouveitis 2 weeks after ZOSTAVAX administration. Oral acyclovir and topical prednisolone acetate and cyclopentolate hydrochloride were started, with subsequent improvement in inflammation and visual acuity. However, the patient was unable to be tapered completely off the steroids. CONCLUSIONS: HZ keratouveitis was the result of cell-mediated immunity (CMI) directed toward viral antigens within the eye. The live attenuated ZOSTAVAX, boosts the recipient's CMI to prevent reactivation of HZ. However, patients with a history of HZ keratitis may have persistent viral antigens in their corneas and can develop recurrence of keratouveitis because of the vaccine-induced increase in CMI. Vaccination should be undertaken with caution in patients with a history of HZ ophthalmicus. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Anti-SS-A antibody positive, CD4 lymphocytes decreased, Cell-mediated immune deficiency, Humoral immune defect, Hypogammaglobulinaemia
Clinical narrative: This literature marketed report refers to a 23 years old female patient with a history of CF (delta 508 mutation), complicated by cirrhosis requiring transplant at the age of 18 followed by standard immunosuppressive therapy with steroids, MMF, and tacrolimus. Over the course of the next 3 months, she had reactivation of EBV and VZV with recurrent disseminations; work-up for PTLD was negative. All immunosuppressive were discontinued 7 months after transplant, with the exception of Prednisone, which was discontinued 2 years posttransplant. She developed an Exophiala dermatitidis pulmonary infection, anti-SS-A positive Sjogren's, and seronegative arthritis. A complete immunodeficiency evaluation was initiated. Results: She was diagnosed with humoral and cellular mediated immunodeficiences characterized by hypogammaglobulinemia, specific antibody deficiency with absent response to PNEUMOVAX, significant CD4 lymphopenia, and markedly diminished response to phytohemagglutinin, pokeweed, and Candida. Antiviral therapy was continued, PCP prophylaxis was initiated, and she was started on replacement IVIg. She had done markedly well, with decreased severity and frequency of infections and resolution of the arthritis. To date, she had no evidence of liver transplant rejection despite being off immunosuppressants. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Immunoglobulin therapy, Immunology test abnormal, Lower respiratory tract infection fungal, Lymphopenia, No therapeutic response
Clinical narrative: This literature marketed report refers to a 23 years old female patient with a history of CF (delta 508 mutation), complicated by cirrhosis requiring transplant at the age of 18 followed by standard immunosuppressive therapy with steroids, MMF, and tacrolimus. Over the course of the next 3 months, she had reactivation of EBV and VZV with recurrent disseminations; work-up for PTLD was negative. All immunosuppressive were discontinued 7 months after transplant, with the exception of Prednisone, which was discontinued 2 years posttransplant. She developed an Exophiala dermatitidis pulmonary infection, anti-SS-A positive Sjogren's, and seronegative arthritis. A complete immunodeficiency evaluation was initiated. Results: She was diagnosed with humoral and cellular mediated immunodeficiences characterized by hypogammaglobulinemia, specific antibody deficiency with absent response to PNEUMOVAX, significant CD4 lymphopenia, and markedly diminished response to phytohemagglutinin, pokeweed, and Candida. Antiviral therapy was continued, PCP prophylaxis was initiated, and she was started on replacement IVIg. She had done markedly well, with decreased severity and frequency of infections and resolution of the arthritis. To date, she had no evidence of liver transplant rejection despite being off immunosuppressants. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Seronegative arthritis, Sjogren's syndrome, Therapeutic response decreased
Clinical narrative: This literature marketed report refers to a 23 years old female patient with a history of CF (delta 508 mutation), complicated by cirrhosis requiring transplant at the age of 18 followed by standard immunosuppressive therapy with steroids, MMF, and tacrolimus. Over the course of the next 3 months, she had reactivation of EBV and VZV with recurrent disseminations; work-up for PTLD was negative. All immunosuppressive were discontinued 7 months after transplant, with the exception of Prednisone, which was discontinued 2 years posttransplant. She developed an Exophiala dermatitidis pulmonary infection, anti-SS-A positive Sjogren's, and seronegative arthritis. A complete immunodeficiency evaluation was initiated. Results: She was diagnosed with humoral and cellular mediated immunodeficiences characterized by hypogammaglobulinemia, specific antibody deficiency with absent response to PNEUMOVAX, significant CD4 lymphopenia, and markedly diminished response to phytohemagglutinin, pokeweed, and Candida. Antiviral therapy was continued, PCP prophylaxis was initiated, and she was started on replacement IVIg. She had done markedly well, with decreased severity and frequency of infections and resolution of the arthritis. To date, she had no evidence of liver transplant rejection despite being off immunosuppressants. A copy of the published article is attached as further documentation of the patient's experience. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient. who had been intended to be administered a TB test, was inadvertently administered 0.1 PNEUMOVAX23(lot number reported as H011780, expiration date 16-FEB-2014) intradermally on 27-NOV-2012 due to nursing error. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 76 years old female patient. The patient had no drug reactions or allergies. on 28-NOV-2012, the patient was vaccinated with ZOSTAVAX (lot number reported as 0422AB, expiration date 27-MAR-2013), subcutaneous. No other co-suspects were reported. No concomitant medications were reported. On 30-NOV-2012, the patient developed injection site reaction following vaccination. The patient sought medical attention and contacted the pharmacist. The injection site reaction was described as raised, blotchy, red area about 3/4 of inch in diameter (described as a semicircle with a tail on it) that was sore, but not itchy at the injection site. No treatment information was reported. No laboratories were performed. At the time of the report, the patient's outcome for the events was not recovered/not resolved. This is the first of two report from this reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse. The nurse reports that 3 patients of unknown age respectively were mistakenly vaccinated with (Merck) VARIVAX instead of ZOSTAVAX on 28-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. No adverse effects were reported. The relatedness for vaccinated with VARIVAX instead of ZOSTAVAX was unknown for (Merck) VARIVAX. No further information is available.
Age: 100.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report has been received from a 100 years old female consumer with sulfur allergy. The patient was vaccinated with 1 dose ZOSTAVAX on 30-NOV-2012. No other co-suspects were reported. Concomitant medications included ASPIRIN and VESICARE. On 30-NOV-2012 the patient experienced puffiness around the injection site and redness around the injection site. Caller stated there was no rash, just red and puffy around the area towards the back of the arm. No treatment information was reported. The outcome of puffiness around the injection site and redness around the injection site is unknown. The relatedness for puffiness around the injection site and redness around the injection site was not reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning multiple unspecified patients, who, on an unknown date, were vaccinated with doses of PEDVAXHIB (doses and routes not reported, lot # reported as 1886AA, expiry 02-DEC-2013) that were exposed to 31 F for up to 68 hours. No adverse effects were reported. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash erythematous, Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 14 months old female patient with eczema and no drug reactions or allergies. The patient was vaccinated with a dose of lot # 671848/1797AA; exp date 25-NOV-2013) of VARIVAX (Merck) (dose and route not reported) on 09-OCT-2012. No other co-suspects were reported. Concomitant medications included: an unspecified steroid cream. The physician reported that the patient presented "2 months after VARIVAX vaccination" (in December 2012) with a generalized chicken-pox like rash all over her body accompanied by "a shingles-like rash that consisted of clusters of red vesicles around a dermatome" located on both of the patient's buttocks. The patient sought unspecified medical attention, no treatment was given for the events and no lab diagnostic tests were performed. The outcome of the event was reported as recovering at the time of the report. The relatedness for the reported events was not provided for VARIVAX (Merck). Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 33 years old female patient. The patient was vaccinated with a dose 1 and dose 2 of RECOMBIVAX HB (lot #, dose and route not reported) on 24-JAN-2012 and 16-AUG-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the adult patient received a pediatric dose for her second dose of RECOMBIVAX HB on 16-AUG-2012. No adverse symptoms were reported. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Condition aggravated, Pruritus
Clinical narrative: Exacerbation of asthma symptoms which have not resolved and continue at present time, also itching that continues at present time.
Age: 12.0
Sex: M
Vaccine: FLUX
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Red raised area, tender to touch, hard area.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dizziness, Feeling cold, Feeling hot, Headache, Hyperhidrosis
Clinical narrative: Extreme redness & swelling at injection site of the pneumonia shot which was the right hip. I also had the flu vaccine on my left hip at the same time  On 12/06/12 I felt muscle soreness and slight fever (99.8) I also experienced hot spots on my cheeks, and a bad headache. I went to bed feeling cold and aching all over with a terrible headache. When I finally got warm, I was sweaty.  At 5:30 AM on 12/07/2012 I went to the bathroom and came very close to fainting.  I made it back to my bed but was dripping with sweat (very unusual for me as I am not prone to perspiring much). I was very thirsty but felt nauseated.  My husband gave me ice chips and I began to fell better.  We took my blood pressure which was 109/68 but my heart rate was 114.  We took it an hour later and it was 112/70 and the heart rate was 112.  My temperature was 100.4.  I had hot spots on my cheeks, first the left side, and later in the day my right side. I continued to have very aching muscles. As the day wore on, I began to feel better.  As I write this on 12/08/2012 I am feeling much better.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Nausea, Pain
Clinical narrative: Extreme redness & swelling at injection site of the pneumonia shot which was the right hip. I also had the flu vaccine on my left hip at the same time  On 12/06/12 I felt muscle soreness and slight fever (99.8) I also experienced hot spots on my cheeks, and a bad headache. I went to bed feeling cold and aching all over with a terrible headache. When I finally got warm, I was sweaty.  At 5:30 AM on 12/07/2012 I went to the bathroom and came very close to fainting.  I made it back to my bed but was dripping with sweat (very unusual for me as I am not prone to perspiring much). I was very thirsty but felt nauseated.  My husband gave me ice chips and I began to fell better.  We took my blood pressure which was 109/68 but my heart rate was 114.  We took it an hour later and it was 112/70 and the heart rate was 112.  My temperature was 100.4.  I had hot spots on my cheeks, first the left side, and later in the day my right side. I continued to have very aching muscles. As the day wore on, I began to feel better.  As I write this on 12/08/2012 I am feeling much better.
Age: 69.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Thirst
Clinical narrative: Extreme redness & swelling at injection site of the pneumonia shot which was the right hip. I also had the flu vaccine on my left hip at the same time  On 12/06/12 I felt muscle soreness and slight fever (99.8) I also experienced hot spots on my cheeks, and a bad headache. I went to bed feeling cold and aching all over with a terrible headache. When I finally got warm, I was sweaty.  At 5:30 AM on 12/07/2012 I went to the bathroom and came very close to fainting.  I made it back to my bed but was dripping with sweat (very unusual for me as I am not prone to perspiring much). I was very thirsty but felt nauseated.  My husband gave me ice chips and I began to fell better.  We took my blood pressure which was 109/68 but my heart rate was 114.  We took it an hour later and it was 112/70 and the heart rate was 112.  My temperature was 100.4.  I had hot spots on my cheeks, first the left side, and later in the day my right side. I continued to have very aching muscles. As the day wore on, I began to feel better.  As I write this on 12/08/2012 I am feeling much better.
Age: 62.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Patient initially had small lump at injection site, later developed a small rash less than 1/4 inch red raised area about 1 inch from injection site. Area in tender to touch and complains of an aching in that area of his arm.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: I started to get a really bad headache, then the next day it was worse the pain, then the next day the head pain with dizziness, then the next day the head pain dizziness and throwing up. It got to the point I went to the ER. Its been a week and 2 days and I still have symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash from chest to waist covering breasts an stomach.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Glassy eyes, Lethargy, Ocular hyperaemia, Pyrexia
Clinical narrative: Fever of 102, glassy eyes, redness around the eyes, lethargic at breakfast table.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dehydration, Dizziness, Hypophagia, Immediate post-injection reaction, Palpitations
Clinical narrative: She immediately started feeling dizzy and faint, threw up several times, and felt like her heart was racing.  911 was called and paramedics ultimately determined that she was severely dehydrated and hadn't eaten all day.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: She immediately started feeling dizzy and faint, threw up several times, and felt like her heart was racing.  911 was called and paramedics ultimately determined that she was severely dehydrated and hadn't eaten all day.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Angina pectoris, Crying, Dyspnoea, Dysstasia, Eye movement disorder
Clinical narrative: She immediately started feeling dizzy and faint, threw up several times, and felt like her heart was racing.  911 was called and paramedics ultimately determined that she was severely dehydrated and hadn't eaten all day.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Flushing, Gaze palsy, Hypotension, Pain
Clinical narrative: She immediately started feeling dizzy and faint, threw up several times, and felt like her heart was racing.  911 was called and paramedics ultimately determined that she was severely dehydrated and hadn't eaten all day.
Age: 10.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pallor, Speech disorder, Vertigo, Vomiting
Clinical narrative: She immediately started feeling dizzy and faint, threw up several times, and felt like her heart was racing.  911 was called and paramedics ultimately determined that she was severely dehydrated and hadn't eaten all day.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: High fever, chills, splitting headache from mid-afternoon Tuesday lasting until Friday mid-afternoon, with Wednesday and Thursday being the worst.  Felt like a Mac truck ran me over and could not take enough Advil to get rid of the blinding headache. By Friday evening all signs were gone, but left very weak as though I just had the flu.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Fatigue, Impaired driving ability, Paranasal sinus hypersecretion, Sinus congestion
Clinical narrative: Became tired and drowsy. Could not drive car home; wife drove. Took a nap for 1.25 h starting at about 3:00 PM. Still felt tired after the nap. Mucinex at 6:30 PM, Albuterol HFA (in use from previous condition). In the evening (~7:30 PM), congested sinuses, drainage, coughing. Bedtime at 10:30 PM; salt rinse sinuses, Albuterol HFA for wheezing, Fluticasone, tussin/DMA cough medicine. Retire to bed about 12:30 AM, 2nd dose of cough medicine. Coughing persisted until 12:45 AM then sleep.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Somnolence, Wheezing
Clinical narrative: Became tired and drowsy. Could not drive car home; wife drove. Took a nap for 1.25 h starting at about 3:00 PM. Still felt tired after the nap. Mucinex at 6:30 PM, Albuterol HFA (in use from previous condition). In the evening (~7:30 PM), congested sinuses, drainage, coughing. Bedtime at 10:30 PM; salt rinse sinuses, Albuterol HFA for wheezing, Fluticasone, tussin/DMA cough medicine. Retire to bed about 12:30 AM, 2nd dose of cough medicine. Coughing persisted until 12:45 AM then sleep.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Fever, swelling, hives.
Age: 1.14
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Croup infectious, Decreased appetite, Pyrexia
Clinical narrative: Woke with horrible croupy cough. Fever, loss of appetite, and energy developed 3 days later.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Blood test normal, Electroencephalogram abnormal, Epilepsy, Fear, Grand mal convulsion
Clinical narrative: He starting running a fever on November 16th, that night he woke up screaming several times, his eyes were all glazed over, and he was petrified. I thought they were just nightmares. The morning of November 18th, he was taken by ambulance to the hospital following a grand mal seizure. He went on to have multiple seizures at the hospital, and was transferred to another facility. At first they were calling them febrile seizures until they diagnosed him with epilepsy. The cause of his fever is still unknown, but I believe the vaccines he had on Nov.9 may have caused the fever, and brought on the seizures.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU3, HEPA
Symptoms: Nuclear magnetic resonance imaging abnormal, Pyrexia, Screaming, Staring
Clinical narrative: He starting running a fever on November 16th, that night he woke up screaming several times, his eyes were all glazed over, and he was petrified. I thought they were just nightmares. The morning of November 18th, he was taken by ambulance to the hospital following a grand mal seizure. He went on to have multiple seizures at the hospital, and was transferred to another facility. At first they were calling them febrile seizures until they diagnosed him with epilepsy. The cause of his fever is still unknown, but I believe the vaccines he had on Nov.9 may have caused the fever, and brought on the seizures.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Injection site warmth
Clinical narrative: Patient shows inflammatory reaction in the left arm from the deltoid muscle to the elbow region.  It is warm to touch.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Fatigue, Headache, Nausea
Clinical narrative: Nausea, fatigue, weakness, headache.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal inflammation, Tremor, Vomiting projectile
Clinical narrative: Projectile vomiting, shaking, extreme diarrhea episodes.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Contusion, Headache, Nausea, Oedema peripheral
Clinical narrative: Arm swollen, bruised.  Headache, achy all over, chills, nausea.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Arm swollen, bruised.  Headache, achy all over, chills, nausea.
Age: 11.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Erythema, Induration, Oedema peripheral, Pain in extremity
Clinical narrative: Severe arm pain. Severe swelling, redness, and hardness of shoulder to elbow.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Pain swelling redness rash and heat at injection site.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Patient received PNEUMOVAX in right arm & influenza in left arm. Developed peripheral edema, erythema, tenderness, pain in rt. arm same day. Had been applying ice and taking ibuprofen q 6-8 hours - sent to urgent care on 12/6/12 when she came to clinic.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient has complained about muscle pain and lost mobility post-vaccination.
Age: 27.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 27 years old male patient. The reporter reported that the patient came to receive his third dose of GARDASIL (lot # was unknown) on unknown day. The patient received first two doses of GARDASIL (lot # was unknown) when he was 26 years old but he turned 27 before his third dose was due. No adverse effects reported. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site nodule, Injection site pruritus, Injection site pustule
Clinical narrative: 3 SMALL PUSTULES AT SITE OF INJECTION (TOTAL SIZE: DIME SIZED AREA); ITCHING AT INJECTION SITE WHERE PUSTULES LOCATED; MEMBER WENT TO PCP AND RECEIVED.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal sensation in eye, Headache, Injection site pain, Neck pain, Pain
Clinical narrative: Pain on right side of body to include shoulder, neck, base of head right side, pressure behind right eye. Symptoms began around noon that day and continued until 7:00 pm.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood test, Groin pain, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain/stiffness (1) starting in left groin area then over next 30-45 days, spreading and intensifying (2) to right leg (behind knee and down through calf); (3) to left leg (behind knee and down through calf); (4) to left shoulder and lower arm; (5) to right arm; and (6) to back of neck.  Diagnosed as Polymyalgia Rheumatics (PMR).  Treatment of symptoms: Prednisone, 20 mg daily beginning 12/6/2012.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Polymyalgia rheumatica
Clinical narrative: Pain/stiffness (1) starting in left groin area then over next 30-45 days, spreading and intensifying (2) to right leg (behind knee and down through calf); (3) to left leg (behind knee and down through calf); (4) to left shoulder and lower arm; (5) to right arm; and (6) to back of neck.  Diagnosed as Polymyalgia Rheumatics (PMR).  Treatment of symptoms: Prednisone, 20 mg daily beginning 12/6/2012.
Age: 23.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Discomfort, Erythema, Muscular weakness, Pain
Clinical narrative: I woke up the following day and my arm was sore and I had a red bump smaller than a pea. By 9PM I had a fever (100.1 F), body aches, and general discomfort. I started taking IB Profin (600 mg). My arm was VERY sore, and hurt during even small movements and anytime it was even brushed against. By 9pm the red spot grew to about the size of a quarter. The next morning (Friday 11/30/12) I was still running a fever, my arm still hurt very badly, and the spot was bigger than a golf ball. I called my doctor to inform them of my reaction, but they said it was normal. By noon it was about 2.5 to 3 inches in diameter and I went to my PCP. I started taking Benadryl, while taking IB Profin and Tylenol. By Saturday morning the red spot was about 6 inches long and 4 inches wide, my arm was still very sore, but my fever and body ache symptoms had subsided. My arm in general is still weak and gets sore with extended use (12/9/12), but all redness and bruising is gone. However, it does itch sometimes.
Age: 23.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Pruritus, Pyrexia, Swelling
Clinical narrative: I woke up the following day and my arm was sore and I had a red bump smaller than a pea. By 9PM I had a fever (100.1 F), body aches, and general discomfort. I started taking IB Profin (600 mg). My arm was VERY sore, and hurt during even small movements and anytime it was even brushed against. By 9pm the red spot grew to about the size of a quarter. The next morning (Friday 11/30/12) I was still running a fever, my arm still hurt very badly, and the spot was bigger than a golf ball. I called my doctor to inform them of my reaction, but they said it was normal. By noon it was about 2.5 to 3 inches in diameter and I went to my PCP. I started taking Benadryl, while taking IB Profin and Tylenol. By Saturday morning the red spot was about 6 inches long and 4 inches wide, my arm was still very sore, but my fever and body ache symptoms had subsided. My arm in general is still weak and gets sore with extended use (12/9/12), but all redness and bruising is gone. However, it does itch sometimes.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Blood test normal, Decreased appetite, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Patient was vaccinated in the upper left thigh.  It took a long time for the vaccine "bump" to go away. No illness at the time of vaccine on 06/27/2011, though there was redness/swelling at injection site, and he was tired all day and didn't want to eat.  Those are all things that we're told are "normal" so I wasn't too worried.  06/28/2011 patient awoke in the night screaming that his leg and foot were hurting! I didn't think it had anything to do with the vaccine at that time.  After his pain returned randomly, for a while (almost a year I believe) I took him in for x-rays of his feet and ankles, and I spoke with his pediatrician about possible deficiencies, and arthritic issues, that might have been causing the pain.  Patient had labs done, which came back normal, and there was nothing abnormal on his x-rays.  Dr. suggested shoes with arches.  That did not fix the issue.  Not until patient had his second Hepatitis A vaccine on 06/28/2012 did we (his parents) realize the cause of the pain.  It has been almost 6 months since that final Hepatitis A vaccine was administered, and random occurrences of the injection site swelling correlate to the pain in his leg and foot.  The pain is almost exclusively in the left leg and foot.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash, Injection site swelling, Pain in extremity, Screaming, X-ray limb normal
Clinical narrative: Patient was vaccinated in the upper left thigh.  It took a long time for the vaccine "bump" to go away. No illness at the time of vaccine on 06/27/2011, though there was redness/swelling at injection site, and he was tired all day and didn't want to eat.  Those are all things that we're told are "normal" so I wasn't too worried.  06/28/2011 patient awoke in the night screaming that his leg and foot were hurting! I didn't think it had anything to do with the vaccine at that time.  After his pain returned randomly, for a while (almost a year I believe) I took him in for x-rays of his feet and ankles, and I spoke with his pediatrician about possible deficiencies, and arthritic issues, that might have been causing the pain.  Patient had labs done, which came back normal, and there was nothing abnormal on his x-rays.  Dr. suggested shoes with arches.  That did not fix the issue.  Not until patient had his second Hepatitis A vaccine on 06/28/2012 did we (his parents) realize the cause of the pain.  It has been almost 6 months since that final Hepatitis A vaccine was administered, and random occurrences of the injection site swelling correlate to the pain in his leg and foot.  The pain is almost exclusively in the left leg and foot.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: I experienced the usual soreness in my shoulder for 1-2 days following the shot. (I've received flu shots yearly for 15-20 years) However, this time 1-2 weeks after the shot my shoulder became sore again, no visible inflammation or redness. There was no other injury to the shoulder or arm after the vaccination. I have a pain in the shoulder when lifting the arm, especially to remove clothing over my head or lifting a gallon of milk. Some days it aches at rest and is worse in the morning; it is not painful every day. I have taken Naproxen and applied heat some days when it is especially sore. Today is 5 weeks and it is not improving.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Sensory disturbance
Clinical narrative: Experienced neurological sensory change. Dr. describes these changes as "fleetingall over body stabbing pain."
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Feeling hot, Pain, Paraesthesia
Clinical narrative: Redness, soreness, hot, tingling.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Redness, soreness, hot, tingling.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Convulsion, Electrocardiogram, Hypotension, Rash
Clinical narrative: Severe respiratory distress, tachycardia with dysrhythmia, hypotension, seizure and raised red areas across face, shoulders and sternal area.  Valium, Benadryl, Racemic Epi JN and Morphine given.  Time Course 1850-1930.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Respiratory distress, Tachycardia
Clinical narrative: Severe respiratory distress, tachycardia with dysrhythmia, hypotension, seizure and raised red areas across face, shoulders and sternal area.  Valium, Benadryl, Racemic Epi JN and Morphine given.  Time Course 1850-1930.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient received injection on 12/7/12, approx 1 1/2 days later some swelling and warmth around injection site. 10 x 9 cm. Patient placed ice on area and took some MOTRIN.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Nasal congestion, Pruritus generalised, Rash
Clinical narrative: One hour post injection - rash/body itching severe nasal congestion - tight throat/cough - took a BENADRYL daily to decrease s/s - still has rash - flu s/s now.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: One hour post injection - rash/body itching severe nasal congestion - tight throat/cough - took a BENADRYL daily to decrease s/s - still has rash - flu s/s now.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Skin rash with blisters under skin approximate size 2 inch x 3 inch (deck of cards). Physician advised using Hydrocortisone topically - rash area was reduced to "silver dollar" size when I viewed 12/8/12.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site vesicles
Clinical narrative: Day after vaccine (12/7/12) pt had redness around injection site extending 2 inches around. Day 2 (12/8) pt had redness on the whole back of the arm from elbow up to armpit. Injection site had a blister that started at dime size and grew to size of silver dollar. Sent pt to urgent care and they never saw anything like it. They gave her steroid shot & told her to take BENADRYL. Day 3 (12/9) redness not as bright but blister still silver dollar size.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site vesicles, Pain in extremity
Clinical narrative: Day after vaccine (12/7/12) pt had redness around injection site extending 2 inches around. Day 2 (12/8) pt had redness on the whole back of the arm from elbow up to armpit. Injection site had a blister that started at dime size and grew to size of silver dollar. Sent pt to urgent care and they never saw anything like it. They gave her steroid shot & told her to take BENADRYL. Day 3 (12/9) redness not as bright but blister still silver dollar size.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Dizziness, Eye movement disorder, Heart rate decreased, Pallor
Clinical narrative: At end of administration of Flu vaccine, patient stated felt faint. Patient pale, eyes fluttered slightly, mild tremor to both hands, P-46-48, BP 104/74, BP #2 102/80 Glucose 77, P-59 (15 min after). No loss of consciousness. Near syncopal episode. Reports 3 similar episodes in last year positive family hx valve problem. Discussed with CP - probable vasovagal response.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Presyncope, Tremor
Clinical narrative: At end of administration of Flu vaccine, patient stated felt faint. Patient pale, eyes fluttered slightly, mild tremor to both hands, P-46-48, BP 104/74, BP #2 102/80 Glucose 77, P-59 (15 min after). No loss of consciousness. Near syncopal episode. Reports 3 similar episodes in last year positive family hx valve problem. Discussed with CP - probable vasovagal response.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Swelling
Clinical narrative: Patient reported allergic response requiring visit to ED - swelling, difficulty breathing.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to unspecified patients of unknown age (gender unspecified). On an unknown date, the patients were vaccinated with VAQTA (lot number, expiration and route not reported). No concomitant medications were reported. The nurse stated that her office had improperly stored VAQTA. The reporter stated it was possible that an unspecified number of patients might have been administered with the improperly stored vaccine. No symptoms were reported. This is one of the several report received from the same reporter. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Feeling hot, Headache, Injection site pruritus
Clinical narrative: Case number PHHY2012US110944 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 465138) on 04 Dec 2012. This case refers to 52-year-old female patient. The patient's medical history included diabetes, coronary artery disease and hypertension. Concomitant medications include PLAVIX for stent. The patient was vaccinated with FLUVIRIN (batch number: 1204201) and PNEUMOVAX (batch number: H010515) intramuscularly in left arm on 14 Sep 2012. On 14 Sep 2012, 30 minutes after vaccination, the patient began to feel achiness in the left arm and took ADVIL for it. She then began to feel nausea, chills, throbbing headache on pain level 7 and itchiness at shot site. The patient had to lay down because of the event. The patient also felt heat in the her left arm. During the night of 14 Sep 2012, the patient experienced chills and fever until 3:30 AM. On 15 Sep 2012, the patient was diagnosed with cellulitis. The doctor had prescribed AVELOX for the event. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Case number PHHY2012US110944 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 465138) on 04 Dec 2012. This case refers to 52-year-old female patient. The patient's medical history included diabetes, coronary artery disease and hypertension. Concomitant medications include PLAVIX for stent. The patient was vaccinated with FLUVIRIN (batch number: 1204201) and PNEUMOVAX (batch number: H010515) intramuscularly in left arm on 14 Sep 2012. On 14 Sep 2012, 30 minutes after vaccination, the patient began to feel achiness in the left arm and took ADVIL for it. She then began to feel nausea, chills, throbbing headache on pain level 7 and itchiness at shot site. The patient had to lay down because of the event. The patient also felt heat in the her left arm. During the night of 14 Sep 2012, the patient experienced chills and fever until 3:30 AM. On 15 Sep 2012, the patient was diagnosed with cellulitis. The doctor had prescribed AVELOX for the event. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Chills, Headache, Injection site pruritus, Nausea
Clinical narrative: Case number PHHY2012US110944 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 465138) on 04 Dec 2012. This case refers to 52-year-old female patient. The patient's medical history included diabetes, coronary artery disease and hypertension. Concomitant medications include PLAVIX for stent. The patient was vaccinated with FLUVIRIN (batch number: 1204201) and PNEUMOVAX (batch number: H010515) intramuscularly in left arm on 14 Sep 2012. On 14 Sep 2012, 30 minutes after vaccination, the patient began to feel achiness in the left arm and took ADVIL for it. She then began to feel nausea, chills, throbbing headache on pain level 7 and itchiness at shot site. The patient had to lay down because of the event. The patient also felt heat in the her left arm. During the night of 14 Sep 2012, the patient experienced chills and fever until 3:30 AM. On 15 Sep 2012, the patient was diagnosed with cellulitis. The doctor had prescribed AVELOX for the event. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Case number PHHY2012US110944 is an initial spontaneous report from vaccine adverse event reporting system (VAERS reference number: 465138) on 04 Dec 2012. This case refers to 52-year-old female patient. The patient's medical history included diabetes, coronary artery disease and hypertension. Concomitant medications include PLAVIX for stent. The patient was vaccinated with FLUVIRIN (batch number: 1204201) and PNEUMOVAX (batch number: H010515) intramuscularly in left arm on 14 Sep 2012. On 14 Sep 2012, 30 minutes after vaccination, the patient began to feel achiness in the left arm and took ADVIL for it. She then began to feel nausea, chills, throbbing headache on pain level 7 and itchiness at shot site. The patient had to lay down because of the event. The patient also felt heat in the her left arm. During the night of 14 Sep 2012, the patient experienced chills and fever until 3:30 AM. On 15 Sep 2012, the patient was diagnosed with cellulitis. The doctor had prescribed AVELOX for the event. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Migraine, Oedema peripheral, Skin warm
Clinical narrative: Case number PHHY2012US111006, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 465176) web site on 04 Dec 2012. This report refers to 65 year old male patient. His medical history included Granulomera-red blotches down arms; high Cholesterol; diabetes mellitus; hypertension and high triglyceride. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1203801) into the right arm intramuscularly on 27 Aug 2012 and also vaccinated with PNU-IMUNE (batch number: H010515) into the right arm intramuscularly on 27 Aug 2012. On the same day in the evening, the patient developed migraine, red hot swollen arm. She met the doctor for cellulitis. She was given prednisone and BACTRIM. The event outcome was condition unchanged. Seriousness and causality was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Cellulitis, Erythema, Migraine, Oedema peripheral, Skin warm
Clinical narrative: Case number PHHY2012US111006, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 465176) web site on 04 Dec 2012. This report refers to 65 year old male patient. His medical history included Granulomera-red blotches down arms; high Cholesterol; diabetes mellitus; hypertension and high triglyceride. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1203801) into the right arm intramuscularly on 27 Aug 2012 and also vaccinated with PNU-IMUNE (batch number: H010515) into the right arm intramuscularly on 27 Aug 2012. On the same day in the evening, the patient developed migraine, red hot swollen arm. She met the doctor for cellulitis. She was given prednisone and BACTRIM. The event outcome was condition unchanged. Seriousness and causality was not reported.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abdominal distension, Chest pain, Chills, Muscle spasms, Tremor
Clinical narrative: Case number PHHY2012US111041, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 465266) web site on 04 Dec 2012. This report refers to 71 year old male patient. His medical history included high blood pressure and many medications (unknown). He was vaccinated with FLUVIRIN (batch number: 1204201) into the left arm on 15 Sep 2012. On 16 Sep 2012, the patient experienced severe cramping, shakes, teeth chattering, feeling bloated and slight chest pain. The patient visited to the Doctor for consultation. The outcome of the events was unchanged. Seriousness and causality assessment was not reported.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Injection site swelling, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Case number PHHY2012US111043, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 465270) web site on 04 Dec 2012. This report refers to 12 year old male patient. His medical history and concomitant medications were not reported. On 16 Aug 2012 he was vaccinated with MENVEO (batch number: A11047), in right arm, GARDASIL (batch number: 1745AA) into right arm, HAVRIX (batch number: AHAVB597AA) into left arm and BOOSTRIX (batch number: AC52B063AA) into left arm intramuscularly. On 18 Aug 2012, in the emergency room he was diagnosed with fever, headache, body aches, forehead swollen, right arm, forearm and shoulder swollen. The patient was treated with steroids, antibiotics (unspecified) and BENADRYL. The outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Swelling face
Clinical narrative: Case number PHHY2012US111043, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 465270) web site on 04 Dec 2012. This report refers to 12 year old male patient. His medical history and concomitant medications were not reported. On 16 Aug 2012 he was vaccinated with MENVEO (batch number: A11047), in right arm, GARDASIL (batch number: 1745AA) into right arm, HAVRIX (batch number: AHAVB597AA) into left arm and BOOSTRIX (batch number: AC52B063AA) into left arm intramuscularly. On 18 Aug 2012, in the emergency room he was diagnosed with fever, headache, body aches, forehead swollen, right arm, forearm and shoulder swollen. The patient was treated with steroids, antibiotics (unspecified) and BENADRYL. The outcome of the events was recovered. Seriousness and causality assessment was not reported.
Age: 35.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cellulitis, Headache, Mobility decreased, Swelling, Swelling face
Clinical narrative: Case number PHHY2012US111074, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 465360) web site on 04 Dec 2012. This report refers to 35 year old female patient. Her medical history included allergy to levofloxacin. Concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 1205201) intramuscularly into the left arm on 06 Sep 2012. The patient experienced headache 20 minutes after vaccination. On 07 Sep 2012 the patient experienced cellulitis and KEFLEX was given. The patient could not move arm or neck very well. Swelling of facial area and back. The outcome of the events was unchanged. Seriousness and causality assessment was not reported.
Age: 19.0
Sex: M
Vaccine: FLU3, TDAP, FLU3, TDAP
Symptoms: Convulsion, Pallor
Clinical narrative: Case number PHHY2012US111082, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 465418) web site on 04 Dec 2012. This report refers to a 19 year old male patient. His medical history and concomitant medication was not reported. He was vaccinated with FLUVIRIN (batch number: 1203801) intramuscularly into the right arm and ADACEL (batch number: C4137AA) intramuscularly into left arm on 07 Sep 2012. On the same day the patient experienced seizure affecting arms and legs, patient became very pale. Seizure lasted approximately 15 seconds. The outcome of the events was recovered. Seriousness and causality assessment was not reported.