chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus, Swelling face, Vulvovaginal pruritus
Clinical narrative: Patient stated that face, hands swelled and was itchy. Patient also states that vaginal area was also itchy.
Age: 0.49
Sex: F
Vaccine: DTAP, IPV, RV5
Symptoms: Dermatitis diaper, Irritability, Scab, Skin ulcer, Urticaria
Clinical narrative: Diaper changed immediately prior to exam, vaccine followed exam.  Baby was fussy and diaper change between 1 and 2 hours following the shot showed hives on the diaper area.  Hives turned into sores and diaper rash within 1 hour.  Scabbed over sores and rash lasted 3-5 days.  The nurse was contacted regarding this and asked which leg the vaccine was in.  I reported that both vaccines were given in the right leg.  I was then told that couldn't be possible, but I watched the vaccination and was looking at two bandages on the baby's leg.  The nurse assured me she would discuss this with the doctor, but never did.  I asked to have this noted in the child's chart, also, and she did not do that either.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Injection site pain, Periarthritis, Pyrexia, X-ray limb normal
Clinical narrative: Had fever the evening of the shot, had chills and shoulder where shot was given was sore, has ongoing pain in right shoulder, has been diagnosed with frozen shoulder and been going to PT.
Age: 22.0
Sex: M
Vaccine: FLUX
Symptoms: Arthralgia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Severe shoulder pain could not sleep on it- now severe joint pain at AJ joint with decreased ROM of RUE.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Asthenia, Convulsion, Headache, Pain
Clinical narrative: Information has been received from a newspaper which indicated that a mother reported that her 16 year old daughter who 3 years ago (in November 2008), was vaccinated with GARDASIL vaccine (dose and lot # not reported). Subsequently the patient had been debilitated by headache, pains and seizure brought on by the vaccine and could no longer attend school.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Received shot high in shoulder area and had pain at the onset. A week later pain and weakness in hand and arm were still present. Went to doctor and he referred him to another specialist with possible MRI.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, RVX
Symptoms: Crying
Clinical narrative: Non-stop crying for a few hours, tried Acetaminophen.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Initial symptoms were mild, sporadic, and infrequent (i.e. tingling in my feet only when I biked). Symtoms were limited to my feet and then over a month's time migrated to include tingling in my hands, and eventually to tingling throughout my body, and now, two months after the vaccine, I have full body nerve pain and began taking Neurontin. I have not officially been diagnosed with MS, but the symptoms are classic to MS.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Back pain, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Severe pain in upper back and upper left arm. Ibuprofen and naproxen sodium had no effect. Cyclobenzaprine and Lortab controlled pain used for one week until pain was reduced to moderate pain.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Mild Fever, sore throat, cough - cold flu like symptoms. Chest congestion. Arm at injection sight became red, warm, swollen and very red from 4hrs after shot through 3 days. Still some redness today. Cold and flu symptoms seem to be related to shot.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Mild Fever, sore throat, cough - cold flu like symptoms. Chest congestion. Arm at injection sight became red, warm, swollen and very red from 4hrs after shot through 3 days. Still some redness today. Cold and flu symptoms seem to be related to shot.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Back pain, Chills, Dyspepsia, Flank pain, Headache
Clinical narrative: I noticed to normal reactions within 24 hours such as backache, chills, soreness in the arm.  Within the following days I felt sluggish, backache, chills for approximately 1 week that I just could not seem to shake. Pain in side with chills and then total body soreness and aches.  Now my legs and especially my feet are sore to the touch and painful for approximately 2 days.  Two and 1/2 weeks and I wish I had never taken the flu vaccine.  I would rather take my chances of getting the flu.  I feel chilled, body aches, soreness and pains in my arm(s), back, legs, feet.  I also had a severe headache for approximately 2 days and some nausea and digestive problems for a week.  Over all I have felt "ill" since the vaccine was given and there does not seem to be an end.  I worry that each day I will continue to get worse, not better. I will see the doctor this week if not better soon.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Malaise, Nausea, Pain, Pain in extremity, Sluggishness
Clinical narrative: I noticed to normal reactions within 24 hours such as backache, chills, soreness in the arm.  Within the following days I felt sluggish, backache, chills for approximately 1 week that I just could not seem to shake. Pain in side with chills and then total body soreness and aches.  Now my legs and especially my feet are sore to the touch and painful for approximately 2 days.  Two and 1/2 weeks and I wish I had never taken the flu vaccine.  I would rather take my chances of getting the flu.  I feel chilled, body aches, soreness and pains in my arm(s), back, legs, feet.  I also had a severe headache for approximately 2 days and some nausea and digestive problems for a week.  Over all I have felt "ill" since the vaccine was given and there does not seem to be an end.  I worry that each day I will continue to get worse, not better. I will see the doctor this week if not better soon.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Tenderness
Clinical narrative: I noticed to normal reactions within 24 hours such as backache, chills, soreness in the arm.  Within the following days I felt sluggish, backache, chills for approximately 1 week that I just could not seem to shake. Pain in side with chills and then total body soreness and aches.  Now my legs and especially my feet are sore to the touch and painful for approximately 2 days.  Two and 1/2 weeks and I wish I had never taken the flu vaccine.  I would rather take my chances of getting the flu.  I feel chilled, body aches, soreness and pains in my arm(s), back, legs, feet.  I also had a severe headache for approximately 2 days and some nausea and digestive problems for a week.  Over all I have felt "ill" since the vaccine was given and there does not seem to be an end.  I worry that each day I will continue to get worse, not better. I will see the doctor this week if not better soon.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac disorder
Clinical narrative: Described by patient as "heart attack like symptoms".
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives all over the body especially on upper and lower extremities.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time shortened, Albumin urine, Anion gap normal, Anticonvulsant drug level decreased
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Bacterial test negative, Bilirubin urine, Blood calcium decreased, Blood chloride normal, Blood creatinine normal
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose increased, Blood magnesium normal, Blood phosphorus normal, Blood potassium normal, Blood sodium normal
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Blood urea decreased, Blood urine absent, Carbon dioxide abnormal, Chromaturia, Dysuria
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Ehrlichia test, Gait disturbance, Glomerular filtration rate, Glucose urine absent, Haematocrit decreased
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Haemoglobin decreased, International normalised ratio normal, Laboratory test, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Mean cell volume normal, Nitrite urine absent, Platelet count decreased, Protein urine, Prothrombin time prolonged
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Red blood cell count decreased, Red blood cells urine negative, Red cell distribution width increased, Specific gravity urine normal, Urinary sediment present
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urine ketone body present, Urine leukocyte esterase, Urobilinogen urine decreased, White blood cell count increased, White blood cells urine negative
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: pH urine, pH urine normal
Clinical narrative: h/o developmental delay, DM type 2, HTN, HLD, anemia, past h/o provoked PE (2000) with a h/o lower extremity numbness and weakness. She is experiencing difficulty walking, having difficulty with urination (has urge but difficulty voiding) for the past 3 days. She has no recent fever, diarrhea, respiratory illness. She had a flu shot a month ago.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Oedema peripheral
Clinical narrative: CIRCUMFERENTIAL SWELLING OF INJECTED ARM,  General Appearance: alert and oriented, well nourished and hydrated, NAD.  Skin  L upper arm w large IZ reaction- 7-8 inches diameter of red, raised generalized swelling, a few blisters at the IZ site.  HEENT: TM's normal, nose clear, pharynx and tonsils normal.  Neck, Thyroid : no thyromegaly, no lymphadenopathy.  Heart: Regular rate and rhythm, no murmurs.  Judging by the site of the blisters, appears to be site of the Varicella vaccine.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Computerised tomogram normal, Convulsion, Echocardiogram normal, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Headache, nausea, left side weakness, pain, seizures on 11/5, 11/6, 11/7, 11/11, 11/16. Hospitalized 11/7- 11/9.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Headache, Hemiparesis, Laboratory test normal, Nausea, Nuclear magnetic resonance imaging normal
Clinical narrative: Headache, nausea, left side weakness, pain, seizures on 11/5, 11/6, 11/7, 11/11, 11/16. Hospitalized 11/7- 11/9.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Pain, Urine analysis normal
Clinical narrative: Headache, nausea, left side weakness, pain, seizures on 11/5, 11/6, 11/7, 11/11, 11/16. Hospitalized 11/7- 11/9.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Increased frequency & severity of zoster outbreaks after vaccine.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Patient began itching in about 4 hours. She broke out all over from head to toe. Took BENADRYL and rash went away.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt had large red swollen area around injection site. Was given BACTRIM Bid x 7 days.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Pain in extremity, Pyrexia
Clinical narrative: Received flu shot at about 10:22 a.m. Then around 6 pm she had arm pain and fever. The next day her arm was fine but the fever persisted feeling clammy & feverish. Patient has been taking MOTRIN for the fever with minor relief.
Age: 25.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 64.0
Sex: M
Vaccine: FLU3, HEPAB, VARZOS
Symptoms: Erythema, Induration, Pruritus, Skin irritation
Clinical narrative: Localized irritation, itchiness, induration and redness on LU extremity. 24hrs. of administration.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Day after immunizations left thigh slightly swollen, red at injection site of DTaP & IPV. 3rd day after immunizations 4" diameter red blotchy, more swollen, painful to touch. BENADRYL 1 tsp q 6 hour.
Age: 67.0
Sex: M
Vaccine: YF
Symptoms: Condition aggravated, Pericardial effusion, Pericarditis
Clinical narrative: Developed pericarditis/pericardial effusion 1 wk after. Does have a previous h/o pericardial effusion.
Age: 0.78
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Faecal incontinence, Pallor, Unresponsive to stimuli, Vomiting
Clinical narrative: Turned pale & vomited & had BM 4 hrs after receiving. Became unresponsive PENTACEL & PREVNAR & Rotavirus vaccine on 11/22/11.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Client reports getting the high dose Flu vaccine about (4) weeks ago. The day after she experienced left arm pain & then the area of the injection became somewhat swollen & hot to touch. Developed a fever as well (? not taken). Arm remains tender to touch & she is in PT to resolve problem. Does have hx of tendon problem for same area.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: The employee developed a 10mm raised area on the left deltoid. Dime size area circumference with fluid-filled area. Tender, red & sore to touch.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Dizziness
Clinical narrative: Administered HPV vaccine then administered varicella vaccine noticed patient head dropping forward. Called out for help. HM3 brought over ammonia. Patient responded quickly to ammonia. Patient transferred into gurney with feet elevated & head down. 1600 - BP 101/60, HR 77, RR 16, 100% O2 sat. Patient still feeling dizzy, gave water to drink. 1615 - BP 107/63, HR 75, RR 16, 100% O2 sat. Assessed by Dr. 1615 - Patient states feeling OK.  Per MD to discharge.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dry mouth, Dyspnoea, Nausea, Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a physician concerning a 24 year old female with latex allergy who on 10-NOV-2011 in the mid-afternoon was vaccinated with the first dose of GARDASIL (Lot# 669285/0691AA, exp 17-AUG-2013) (route not reported). Concomitant therapy included LO SEASONIQUE from October 2011. On 10-NOV-2011, within several hours after the vaccine, the patient called the physician's office reporting that she was experiencing "itchiness all over." The physician told her to take some BENADRYL when she got home, but her condition progressed to nausea and dry mouth. When the patient developed shortness of breath, she was taken to an Emergency Room where she received IV BENADRYL and unspecified steroid intravenously. The emergency room staff noted that the patient had some hives on her back. She was released that same evening and was prescribed a tapering dose of an unspecified steroid. The physician reported that the patient was recovering and that she had instructed her patient to not received any additional doses of GARDASIL. Therapy with GARDASIL would not be reintroduced. Upon internal review, the patient itchiness all over, nausea and dry mouth, shortness of breath and hives on her back which required IV BENADRYL and unspecified steroid intravenously were considered to be other important medical events. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Herpes zoster, Injection site reaction, Polymerase chain reaction, Rash vesicular, Varicella virus test positive
Clinical narrative: 1 day after receiving MMR in (R) thigh & dTAP #5 in (L) thigh pt developed a vesicular eruption on (L) thigh which was later proven to be herpes zoster by PCR. Patient had 1 varicella immunization 11/11/08.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Neuralgia, Rash
Clinical narrative: Patient complains of a rash on shoulder and back with nerve involvement pain and weakness after the ZOSTAVAX vaccine was administered.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient called to inform that she has swelling at the injection site with itching. Suggested to take BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHEH2011US07069 is an initial spontaneous report received from a pharmacist on 12 Oct 2011 with the follow up received from a nurse on 16 Nov 2011. This case refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: A10058) at a dose of 0.5ml intramuscularly into his right deltoid on 10 Oct 2011. On the same day he was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC528074AA) at a dose of 0.5ml intramuscularly. On 11 Oct 2011, he developed cellulitis at the injection site (6x8 inches area). He required treatment with steroids. The outcome of the event was reported as recovered. Follow up information received from a nurse on 16 Nov 2011: Updated patient details (previously reported as multiple patients), suspect vaccine, adverse event experienced by the patient, treatment received and the outcome.
Age: 0.38
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Erythema, Pyrexia, Rash generalised
Clinical narrative: Very high fever, redness on a side of injection and general rash.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Dizziness, Local reaction
Clinical narrative: 11/4/11 - Presented to ED for dizziness. 11/9/11 - Seen in clinic. Local reaction R thigh where IPO given.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyspnoea, Pruritus, Swelling face, Swollen tongue
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 20 year old female with allergy (citrus caused swelling) and previous medical history of anxiety attacks and no illness at the time of vaccination on 26-AUG-2011 was vaccinated IM with the second dose of GARDASIL (dose not reported, lot # 1511Z) into her left arm. There was not concomitant medication. On 26-AUG-2011 after 2-3 hours following injection, the patient had diffuse pruritus, facial swelling, tongue swelling and difficulty breathing. The patient reported Emergency Department (ED) and received SOLUMEDROL IV and BENADRYL. The following information was obtained through follow-up and/or provided by the government. On 31-AUG-2011 received Emergency Room (ER) medical records for DOS 8/26/2011. Final diagnosis was allergic reaction records reveal patient experienced tingling of face & tongue, legs feeling numb & heavy, anxiety, diffuse pruritus, tongue swelling, short of breath (SOB). Patient was treated with BENADRYL and with steroids in ER. The patient improved & was discharged to home. The listing indicated that one or more of the events was considered to be immediately life-threatening. 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. The original reporting source was not provided. The VAERS ID# is 432210.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anxiety, Dyspnoea, Hypersensitivity, Hypoaesthesia, Paraesthesia
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 20 year old female with allergy (citrus caused swelling) and previous medical history of anxiety attacks and no illness at the time of vaccination on 26-AUG-2011 was vaccinated IM with the second dose of GARDASIL (dose not reported, lot # 1511Z) into her left arm. There was not concomitant medication. On 26-AUG-2011 after 2-3 hours following injection, the patient had diffuse pruritus, facial swelling, tongue swelling and difficulty breathing. The patient reported Emergency Department (ED) and received SOLUMEDROL IV and BENADRYL. The following information was obtained through follow-up and/or provided by the government. On 31-AUG-2011 received Emergency Room (ER) medical records for DOS 8/26/2011. Final diagnosis was allergic reaction records reveal patient experienced tingling of face & tongue, legs feeling numb & heavy, anxiety, diffuse pruritus, tongue swelling, short of breath (SOB). Patient was treated with BENADRYL and with steroids in ER. The patient improved & was discharged to home. The listing indicated that one or more of the events was considered to be immediately life-threatening. 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. The original reporting source was not provided. The VAERS ID# is 432210.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia oral, Pruritus, Sensation of heaviness, Swelling face, Swollen tongue
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 20 year old female with allergy (citrus caused swelling) and previous medical history of anxiety attacks and no illness at the time of vaccination on 26-AUG-2011 was vaccinated IM with the second dose of GARDASIL (dose not reported, lot # 1511Z) into her left arm. There was not concomitant medication. On 26-AUG-2011 after 2-3 hours following injection, the patient had diffuse pruritus, facial swelling, tongue swelling and difficulty breathing. The patient reported Emergency Department (ED) and received SOLUMEDROL IV and BENADRYL. The following information was obtained through follow-up and/or provided by the government. On 31-AUG-2011 received Emergency Room (ER) medical records for DOS 8/26/2011. Final diagnosis was allergic reaction records reveal patient experienced tingling of face & tongue, legs feeling numb & heavy, anxiety, diffuse pruritus, tongue swelling, short of breath (SOB). Patient was treated with BENADRYL and with steroids in ER. The patient improved & was discharged to home. The listing indicated that one or more of the events was considered to be immediately life-threatening. 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. The original reporting source was not provided. The VAERS ID# is 432210.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Dizziness, Feeling abnormal, Flushing, Hypoaesthesia
Clinical narrative: Numbness, tingling and burning sensation throughout body and head. Weakness.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Numbness, tingling and burning sensation throughout body and head. Weakness.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Borrelia test negative, Burning sensation, HIV test negative, Hypoaesthesia
Clinical narrative: Numbness, tingling and burning sensation throughout body and head. Weakness.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Neuropathy peripheral, Paraesthesia, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: Numbness, tingling and burning sensation throughout body and head. Weakness.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Acute myeloid leukaemia
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. On 28-APR-2009 a 24 year old female patient with childhood asthma, azithromycin allergy and high blood pressure was vaccinated with the third dose of GARDASIL (lot number 658271/0558X). The patient had no previous problems with the prior GARDASIL injection. On 15-SEP-2010 the patient had Acute Myeloid Leukemia, 6 months of chemotherapy. The following information was obtained through follow up and/or provided by the government. On 19-SEP-2011 other correspondence, unremarkable. On 28-SEP-2011 hospital records DOS 20-OCT-2010 to 19-NOV-2010; 29-NOV-2010; 04-DEC-2010; 17-DEC-2010; 03-JAN-2011 to August 2011; 12-MAR-2011. Diagnosis: Acute Myeloid Leukemia, rash, anaemia secondary to cancer, pancytopaenia, due to chemotherapy, abdominal pain, epigastric, asthma. Concomitant condition: transferred from another facility; one month history of increasing fatigue; easy bruising; dyspnoea on exertion; lightheadedness; productive cough; vaginal bleeding; medical workup showed severe anaemia; thrombocytopaenia et blasts. Extended stay in hospital complicated by severe neutropaenia, persistent cough, generalized rash. The patient started on chemotherapy. The patient was discharged in stable condition to follow up contact with primary care professional, oncologist. Subsequent readmissions for chemotherapy et management of complications due to chemotherapy. Lad data: On 28-SEP-2011 hospital records: HSV 1, IgG: positive, WBC 0.6 K/mm3 (L), Hgb 8.5 g/ddL (L), HCT 25% (L), PLT 50 K/mm3 (L), ABS lymphs 100/mm3 (L), D-dimer 247 ng/ml (H), fibrinogen 477 mg/dl (H). On 28-SEP-2011 stool occult blood positive. The patient required emergency room visit. The reporter considered all the adverse events as serious due to hospitalization, extended hospital stay and life threatening. The original reporting source was not provided. The VAERS ID # 434411. Additional information is not expected. 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: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain upper, Acute myeloid leukaemia, Anaemia of malignant disease, Blood fibrinogen increased, Blood immunoglobulin G increased
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. On 28-APR-2009 a 24 year old female patient with childhood asthma, azithromycin allergy and high blood pressure was vaccinated with the third dose of GARDASIL (lot number 658271/0558X). The patient had no previous problems with the prior GARDASIL injection. On 15-SEP-2010 the patient had Acute Myeloid Leukemia, 6 months of chemotherapy. The following information was obtained through follow up and/or provided by the government. On 19-SEP-2011 other correspondence, unremarkable. On 28-SEP-2011 hospital records DOS 20-OCT-2010 to 19-NOV-2010; 29-NOV-2010; 04-DEC-2010; 17-DEC-2010; 03-JAN-2011 to August 2011; 12-MAR-2011. Diagnosis: Acute Myeloid Leukemia, rash, anaemia secondary to cancer, pancytopaenia, due to chemotherapy, abdominal pain, epigastric, asthma. Concomitant condition: transferred from another facility; one month history of increasing fatigue; easy bruising; dyspnoea on exertion; lightheadedness; productive cough; vaginal bleeding; medical workup showed severe anaemia; thrombocytopaenia et blasts. Extended stay in hospital complicated by severe neutropaenia, persistent cough, generalized rash. The patient started on chemotherapy. The patient was discharged in stable condition to follow up contact with primary care professional, oncologist. Subsequent readmissions for chemotherapy et management of complications due to chemotherapy. Lad data: On 28-SEP-2011 hospital records: HSV 1, IgG: positive, WBC 0.6 K/mm3 (L), Hgb 8.5 g/ddL (L), HCT 25% (L), PLT 50 K/mm3 (L), ABS lymphs 100/mm3 (L), D-dimer 247 ng/ml (H), fibrinogen 477 mg/dl (H). On 28-SEP-2011 stool occult blood positive. The patient required emergency room visit. The reporter considered all the adverse events as serious due to hospitalization, extended hospital stay and life threatening. The original reporting source was not provided. The VAERS ID # 434411. Additional information is not expected. 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: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Chemotherapy, Cough, Dizziness, Dyspnoea exertional, Fatigue
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. On 28-APR-2009 a 24 year old female patient with childhood asthma, azithromycin allergy and high blood pressure was vaccinated with the third dose of GARDASIL (lot number 658271/0558X). The patient had no previous problems with the prior GARDASIL injection. On 15-SEP-2010 the patient had Acute Myeloid Leukemia, 6 months of chemotherapy. The following information was obtained through follow up and/or provided by the government. On 19-SEP-2011 other correspondence, unremarkable. On 28-SEP-2011 hospital records DOS 20-OCT-2010 to 19-NOV-2010; 29-NOV-2010; 04-DEC-2010; 17-DEC-2010; 03-JAN-2011 to August 2011; 12-MAR-2011. Diagnosis: Acute Myeloid Leukemia, rash, anaemia secondary to cancer, pancytopaenia, due to chemotherapy, abdominal pain, epigastric, asthma. Concomitant condition: transferred from another facility; one month history of increasing fatigue; easy bruising; dyspnoea on exertion; lightheadedness; productive cough; vaginal bleeding; medical workup showed severe anaemia; thrombocytopaenia et blasts. Extended stay in hospital complicated by severe neutropaenia, persistent cough, generalized rash. The patient started on chemotherapy. The patient was discharged in stable condition to follow up contact with primary care professional, oncologist. Subsequent readmissions for chemotherapy et management of complications due to chemotherapy. Lad data: On 28-SEP-2011 hospital records: HSV 1, IgG: positive, WBC 0.6 K/mm3 (L), Hgb 8.5 g/ddL (L), HCT 25% (L), PLT 50 K/mm3 (L), ABS lymphs 100/mm3 (L), D-dimer 247 ng/ml (H), fibrinogen 477 mg/dl (H). On 28-SEP-2011 stool occult blood positive. The patient required emergency room visit. The reporter considered all the adverse events as serious due to hospitalization, extended hospital stay and life threatening. The original reporting source was not provided. The VAERS ID # 434411. Additional information is not expected. 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: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Fibrin D dimer decreased, Haematocrit decreased, Haemoglobin decreased, Herpes simplex serology positive, Increased tendency to bruise
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. On 28-APR-2009 a 24 year old female patient with childhood asthma, azithromycin allergy and high blood pressure was vaccinated with the third dose of GARDASIL (lot number 658271/0558X). The patient had no previous problems with the prior GARDASIL injection. On 15-SEP-2010 the patient had Acute Myeloid Leukemia, 6 months of chemotherapy. The following information was obtained through follow up and/or provided by the government. On 19-SEP-2011 other correspondence, unremarkable. On 28-SEP-2011 hospital records DOS 20-OCT-2010 to 19-NOV-2010; 29-NOV-2010; 04-DEC-2010; 17-DEC-2010; 03-JAN-2011 to August 2011; 12-MAR-2011. Diagnosis: Acute Myeloid Leukemia, rash, anaemia secondary to cancer, pancytopaenia, due to chemotherapy, abdominal pain, epigastric, asthma. Concomitant condition: transferred from another facility; one month history of increasing fatigue; easy bruising; dyspnoea on exertion; lightheadedness; productive cough; vaginal bleeding; medical workup showed severe anaemia; thrombocytopaenia et blasts. Extended stay in hospital complicated by severe neutropaenia, persistent cough, generalized rash. The patient started on chemotherapy. The patient was discharged in stable condition to follow up contact with primary care professional, oncologist. Subsequent readmissions for chemotherapy et management of complications due to chemotherapy. Lad data: On 28-SEP-2011 hospital records: HSV 1, IgG: positive, WBC 0.6 K/mm3 (L), Hgb 8.5 g/ddL (L), HCT 25% (L), PLT 50 K/mm3 (L), ABS lymphs 100/mm3 (L), D-dimer 247 ng/ml (H), fibrinogen 477 mg/dl (H). On 28-SEP-2011 stool occult blood positive. The patient required emergency room visit. The reporter considered all the adverse events as serious due to hospitalization, extended hospital stay and life threatening. The original reporting source was not provided. The VAERS ID # 434411. Additional information is not expected. 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: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Lymphocyte count decreased, Neutropenia, Occult blood positive, Pancytopenia, Platelet 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. On 28-APR-2009 a 24 year old female patient with childhood asthma, azithromycin allergy and high blood pressure was vaccinated with the third dose of GARDASIL (lot number 658271/0558X). The patient had no previous problems with the prior GARDASIL injection. On 15-SEP-2010 the patient had Acute Myeloid Leukemia, 6 months of chemotherapy. The following information was obtained through follow up and/or provided by the government. On 19-SEP-2011 other correspondence, unremarkable. On 28-SEP-2011 hospital records DOS 20-OCT-2010 to 19-NOV-2010; 29-NOV-2010; 04-DEC-2010; 17-DEC-2010; 03-JAN-2011 to August 2011; 12-MAR-2011. Diagnosis: Acute Myeloid Leukemia, rash, anaemia secondary to cancer, pancytopaenia, due to chemotherapy, abdominal pain, epigastric, asthma. Concomitant condition: transferred from another facility; one month history of increasing fatigue; easy bruising; dyspnoea on exertion; lightheadedness; productive cough; vaginal bleeding; medical workup showed severe anaemia; thrombocytopaenia et blasts. Extended stay in hospital complicated by severe neutropaenia, persistent cough, generalized rash. The patient started on chemotherapy. The patient was discharged in stable condition to follow up contact with primary care professional, oncologist. Subsequent readmissions for chemotherapy et management of complications due to chemotherapy. Lad data: On 28-SEP-2011 hospital records: HSV 1, IgG: positive, WBC 0.6 K/mm3 (L), Hgb 8.5 g/ddL (L), HCT 25% (L), PLT 50 K/mm3 (L), ABS lymphs 100/mm3 (L), D-dimer 247 ng/ml (H), fibrinogen 477 mg/dl (H). On 28-SEP-2011 stool occult blood positive. The patient required emergency room visit. The reporter considered all the adverse events as serious due to hospitalization, extended hospital stay and life threatening. The original reporting source was not provided. The VAERS ID # 434411. Additional information is not expected. 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: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Productive cough, Rash generalised, Thrombocytopenia, Vaginal haemorrhage, 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. On 28-APR-2009 a 24 year old female patient with childhood asthma, azithromycin allergy and high blood pressure was vaccinated with the third dose of GARDASIL (lot number 658271/0558X). The patient had no previous problems with the prior GARDASIL injection. On 15-SEP-2010 the patient had Acute Myeloid Leukemia, 6 months of chemotherapy. The following information was obtained through follow up and/or provided by the government. On 19-SEP-2011 other correspondence, unremarkable. On 28-SEP-2011 hospital records DOS 20-OCT-2010 to 19-NOV-2010; 29-NOV-2010; 04-DEC-2010; 17-DEC-2010; 03-JAN-2011 to August 2011; 12-MAR-2011. Diagnosis: Acute Myeloid Leukemia, rash, anaemia secondary to cancer, pancytopaenia, due to chemotherapy, abdominal pain, epigastric, asthma. Concomitant condition: transferred from another facility; one month history of increasing fatigue; easy bruising; dyspnoea on exertion; lightheadedness; productive cough; vaginal bleeding; medical workup showed severe anaemia; thrombocytopaenia et blasts. Extended stay in hospital complicated by severe neutropaenia, persistent cough, generalized rash. The patient started on chemotherapy. The patient was discharged in stable condition to follow up contact with primary care professional, oncologist. Subsequent readmissions for chemotherapy et management of complications due to chemotherapy. Lad data: On 28-SEP-2011 hospital records: HSV 1, IgG: positive, WBC 0.6 K/mm3 (L), Hgb 8.5 g/ddL (L), HCT 25% (L), PLT 50 K/mm3 (L), ABS lymphs 100/mm3 (L), D-dimer 247 ng/ml (H), fibrinogen 477 mg/dl (H). On 28-SEP-2011 stool occult blood positive. The patient required emergency room visit. The reporter considered all the adverse events as serious due to hospitalization, extended hospital stay and life threatening. The original reporting source was not provided. The VAERS ID # 434411. Additional information is not expected. 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: 83.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pruritus, Swelling face
Clinical narrative: Case number PHHY2011US102754 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 434821) website on 24 Nov 2011. This report refers to 83-year-old male patient. Medical history included egg allergy on VAR, but he had flu shot in past. He was vaccinated with FLUVIRIN (batch number: 1100201) in to left arm intramuscularly on 17 Sep 2011. He came back on 19 Sep 2011, complaining of itching and swelling in facial area. He was treated with BENADRYL. The final outcome reported as not recovered at the time reporting on 19 Sep 2011.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Consciousness fluctuating, Loss of consciousness
Clinical narrative: Case number PHHY2011US102966 is an initial report received from the Vaccine Adverse Event Reporting System (VAERS ref: 435854) website on 24 Nov 2011. This report refers to a 67-year-old female patient. Her concomitant medications are LYRICA, tramadol, losartan potassium hydrochlorothiazide, clonazepam, trazodone and SYMBICORT. She was vaccinated with FLUVIRIN (batch number: 1100201) intramuscularly into left arm on 16 Sep 2011 and also vaccinated with PPV vaccine (other manufacturers, batch number: 0933Z) intramuscularly into left arm on 16 Sep 2011. After vaccination she stated, she passed out and drifted in and out of consciousness until 4-pm till next day. At that time she called an ambulance, checked her out but did not take her to hospital and she is better now. The event outcome reported as recovered.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myocardial infarction
Clinical narrative: Received flu vaccine. Initially he felt ok but at about 5 pm developed severe back pain, severe nausea and chest pain. He called paramedic & was transported to hospital ER & was admitted.
Age: 72.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Back pain, Chest pain, Nausea
Clinical narrative: Received flu vaccine. Initially he felt ok but at about 5 pm developed severe back pain, severe nausea and chest pain. He called paramedic & was transported to hospital ER & was admitted.
Age: 15.0
Sex: F
Vaccine: FLUX, HPVX, FLUN3, HPV4
Symptoms: Cellulitis, Erythema, Local swelling, Pruritus
Clinical narrative: Pt received Gardasil HPV vaccine in her left deltoid on 11/08/11 and experienced itching at the injection site three hours later.  The area became painful and warm.  Pt previously received a dose of the HPV vaccine (in 2009) and did not have a reaction.  Pt was instructed by a pharmacy employee to take OTC hydrocortisone and Benadryl.  No relief of symptoms.  Pt's mother brought her to the ED on 11/12/11.  Symptoms were still apparent on presentation to the ED.  Pt's BP was 122/77, pulse was 84, resp rate was 16, temp was 36.0, oxygen sat was 99% on room air.  Pt had no trouble breathing.  She was diagnosed with a mild cellulitis at the injection site.  Pt was prescribed Keflex 500 mg by mouth three times daily x 10 days and Benadryl prn.  Pt's mother states that symptoms have improved.
Age: 15.0
Sex: F
Vaccine: FLUX, HPVX, FLUN3, HPV4
Symptoms: Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received Gardasil HPV vaccine in her left deltoid on 11/08/11 and experienced itching at the injection site three hours later.  The area became painful and warm.  Pt previously received a dose of the HPV vaccine (in 2009) and did not have a reaction.  Pt was instructed by a pharmacy employee to take OTC hydrocortisone and Benadryl.  No relief of symptoms.  Pt's mother brought her to the ED on 11/12/11.  Symptoms were still apparent on presentation to the ED.  Pt's BP was 122/77, pulse was 84, resp rate was 16, temp was 36.0, oxygen sat was 99% on room air.  Pt had no trouble breathing.  She was diagnosed with a mild cellulitis at the injection site.  Pt was prescribed Keflex 500 mg by mouth three times daily x 10 days and Benadryl prn.  Pt's mother states that symptoms have improved.
Age: 54.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood culture negative, Cellulitis, Erythema, Full blood count, Incorrect route of drug administration
Clinical narrative: Initial report was received on 31 October 2011 from a health care professional, which also involves a case of misuse. A 54 year-old female patient who had no illness at the time of vaccination had received on 31 October 2011 a 0.25 ml intradermal right forearm injection of ADACEL, lot number U4103AA (sanofi pasteur ltd lot number C3971) and an intradermal left forearm injection of TUBERSOL, lot number C3630AB and six hours later the patient reported the right forearm to be swollen and blotchy. According to the initial reporter, they administered ADACEL intradermally with a 25g 5/8 inch needle "by mistake and then they squeezed the liquid out until the site bled". No further information was available at the time of the report. The patient's outcome was reported as not recovered. Follow-up information was received on 17 November 2011 from a health care professional. Based upon new information received, it was determined this case now meets seriousness criteria and has been upgraded from non-serious to serious. According to the report, the TUBERSOL was administer intramuscularly in the deltoid (previously reported as intradermal in the left forearm). The patient was hospitalized for draining of a red, swollen, blistered open wound. The reporter stated that the wound was closed and healing. Treatment included IV (intravenous) antibiotics. No further information was available at the time of the report. The patient's outcome was reported as not recovered. Documents held by sender: none.