chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Convulsion, Decreased appetite, Feeling hot, Full blood count normal, Lethargy
Clinical narrative: Awoke at 7 AM the morning after with severe leg pain, lethargy, loss of appetite but still willing to go to Kindergarten orientation; all morning (by report) was "sleepy" (normally a very social child) and not hungry.   Was carried to nurse's office at school to lie down shortly before 11:00 AM (time of school dismissal).  At 11:00 AM, was found by mother to be unattended and non-responsive. EMS was called. Oxygen saturation 84%, began seizing. Finger stick glucose normal. IV started. Was transported to hospital by ambulance. Continued seizing after arrival even with diazepam administration en route. Lorazepam was administered shortly after arrival in emergency department. Maintained on 8 litre flow of oxygen. Pediatric neurology consult. Remained in ED approximately 5 hours until awake. Temperature in ED was reported to be normai shortly after arrival but before dismissal child complained of leg pain and nurse commented "felt warm" so ibuprofen was administered before discharge. Behavior was improving but not typical the rest of the evening.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Pain in extremity, Somnolence, Unresponsive to stimuli
Clinical narrative: Awoke at 7 AM the morning after with severe leg pain, lethargy, loss of appetite but still willing to go to Kindergarten orientation; all morning (by report) was "sleepy" (normally a very social child) and not hungry.   Was carried to nurse's office at school to lie down shortly before 11:00 AM (time of school dismissal).  At 11:00 AM, was found by mother to be unattended and non-responsive. EMS was called. Oxygen saturation 84%, began seizing. Finger stick glucose normal. IV started. Was transported to hospital by ambulance. Continued seizing after arrival even with diazepam administration en route. Lorazepam was administered shortly after arrival in emergency department. Maintained on 8 litre flow of oxygen. Pediatric neurology consult. Remained in ED approximately 5 hours until awake. Temperature in ED was reported to be normai shortly after arrival but before dismissal child complained of leg pain and nurse commented "felt warm" so ibuprofen was administered before discharge. Behavior was improving but not typical the rest of the evening.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red and swollen LT after Varicella vaccine. RT red and swollen after MMR vaccine.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: MD noticed erythematous swelling at injection site and asked patient to return to pharmacy MD gave preventative sulfa drug.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth, Laboratory test, Pain in extremity
Clinical narrative: (L) arm was sore to lay on the day vacc. was given (8-19-11). On Sunday, 8-21-11, arm became red, warm to the touch at injection site. Soreness is improved Mon. 8-22-11, but redness is still present.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site vesicles, Pyrexia
Clinical narrative: Pts mom called & stated that pts RA was red & had a blister where SQ was given, ran a fever of 101 degrees F & had a knot on deltoid.
Age: 14.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Vaccine given on 8/17/11. On Friday 8/18/11 had redness & swelling used ice pack only. On Saturday 8/19/11 had blisters parents state they applied anti-itch cream 2% to area.
Age: 14.0
Sex: M
Vaccine: HPV4, MMR
Symptoms: Syncope
Clinical narrative: Patient fainted, recovered shortly. No lasting effects.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Prolonged rash after MMR/HepA/Varicella/PREVNAR 13.  Fever/rash onset 13d after vaccines. Rash persisted x 4-6 wks.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Abasia, Balance disorder, Pain
Clinical narrative: Unable to walk. Unsteady for 48 hours following vaccines. In pain.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Large area deltoids about 4 x 4 inches right and left erythema, warmth and tenderness.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Nodule
Clinical narrative: Firm, erythemic nodule, approx size of silver dollar. 8/22/11 mother states symptoms have decreased has bad reactions due to allergies from insect bites, stings etc.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Had large local reaction to right arm 7 inches in length totally surrounds arm width.
Age: 5.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Injection site warmth, Pyrexia, Vomiting
Clinical narrative: Received DTaP, VARIVAX to (L) arm on 8/18/11. On 8/20/11 pt with erythema (approximately 8cm x 6cm) to (L) arm with bruising (approximately 0.5cm x 2 bruises). Positive warmth. SUTTP. MAEE. Positive distal grip positive 2+ radial pulse. Also had fever Tmax 101 & emesis x 1 on 8/19/11.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Epistaxis, Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: Patients mother reported at least 10 nose bleeds within the first 24hrs of receiving the shot. Patient also developed flu like symptoms with nausea, vomiting and fever.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Right upper arm - redness and swelling 13cm x 11cm above redness bruise 2cm x 1cm, mild tenderness. Left upper arm - erythema, 15cm x 12cm, mild tenderness. Bilateral normal strength, ROM, and sensation. Tx MOTRIN, cool compresses.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Redness, hardness; red hard lump by injection site also on face & possibly back. Went to clinic 8/22/11; vomiting, chills. Possibly fever (very warm) sweating.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site mass, Pyrexia, Vomiting
Clinical narrative: Redness, hardness; red hard lump by injection site also on face & possibly back. Went to clinic 8/22/11; vomiting, chills. Possibly fever (very warm) sweating.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Anger, Dizziness, Dysgeusia, Feeling abnormal
Clinical narrative: 2pm Tdap LD. 2:10 c/o arm hurting, acting giddy, 2:20 moody -> anger, didn't want to talk to father, ran off into forest. 4pm approx went to older sister's house, didn't want parents told. 7pm Mom arrived at daughter's house. Patient moody, angry and couldn't sit still. fidgeted with empty plastic water bottle, crushing, crackling it. Son stated felt weird, different. Mom lightly stroked (L) arm. Son stated at 5 minutes and 1/2 hour later could still feel where she stroked. Continued to feel strange. Went to bed 2 am, slept 12 hrs. Ate food night of vaccination stated it tasted different. Awakened feeling different but unable to explain how. Took shower - felt normal on skin. 4 pm 8/18/11 calm and doing normal activities but still felt different. Father stated did not receive VIS form prior to vaccination. Accidentally handed back to LVN who returned after the shot. Stated if had rec'd VIS form for adverse reactions probably would not have allowed the shot. Our error, not allowing time to read VIS.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Mood altered, Pain in extremity, Restlessness, Sensory disturbance
Clinical narrative: 2pm Tdap LD. 2:10 c/o arm hurting, acting giddy, 2:20 moody -> anger, didn't want to talk to father, ran off into forest. 4pm approx went to older sister's house, didn't want parents told. 7pm Mom arrived at daughter's house. Patient moody, angry and couldn't sit still. fidgeted with empty plastic water bottle, crushing, crackling it. Son stated felt weird, different. Mom lightly stroked (L) arm. Son stated at 5 minutes and 1/2 hour later could still feel where she stroked. Continued to feel strange. Went to bed 2 am, slept 12 hrs. Ate food night of vaccination stated it tasted different. Awakened feeling different but unable to explain how. Took shower - felt normal on skin. 4 pm 8/18/11 calm and doing normal activities but still felt different. Father stated did not receive VIS form prior to vaccination. Accidentally handed back to LVN who returned after the shot. Stated if had rec'd VIS form for adverse reactions probably would not have allowed the shot. Our error, not allowing time to read VIS.
Age: 78.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Local reaction
Clinical narrative: 23 x 9 cm wheal (L) upper arm, diffuse local reaction, no systemic symptoms.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Swelling to left arm at injection site within 24hrs. (+) erythema that involved entire length of arm. No fever, mild tenderness.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: About 5 min after getting 1 dose of BOOSTRIX, pt feels itching on her left wrist, elbow and back upper thigh. No breathing problem, no swelling, no wheezing, no severe allergic reaction is noticed. After pt takes 25mg of WAL-DRYL, the itching stop within 5 minutes. Then pt feels OK afterward.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Adverse reaction, Malaise
Clinical narrative: Patient had side effects, general malaise.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local reaction, Local swelling, Pain
Clinical narrative: Local immunization reaction (local pain/swelling/redness).
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema over site of shot administration measuring 9x10cm day after immunization. Treated with BENADRYL.
Age: 28.0
Sex: F
Vaccine: TD
Symptoms: Headache, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Headache 8/17 -> 8/19 worsened; 8/20 -> 8/22 subsided but still present. Rash on upper (R) arm spreading, warm to the touch, swollen.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt woke with redness, warm to touch, swelling on(L) deltoid area on 8/18/11. Advised Ice & TYLENOL if needed. 8.8 x 6cm. Pt able to move arm.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Bacterial test negative, Blister infected, Injection site cellulitis, Injection site vesicles, Polymerase chain reaction
Clinical narrative: Developed blisters on legs 4 days post-vaccination. Patient had high-grade fever (103F) on day 2 of rash. She developed cellulitis secondary to infected blister on her (L) leg. Placed on Clindamycin from the start. Developed smaller lesions on forehead started ZOVIRAX on day 4.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Skin lesion, Varicella virus test negative
Clinical narrative: Developed blisters on legs 4 days post-vaccination. Patient had high-grade fever (103F) on day 2 of rash. She developed cellulitis secondary to infected blister on her (L) leg. Placed on Clindamycin from the start. Developed smaller lesions on forehead started ZOVIRAX on day 4.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Decreased appetite, Influenza like illness, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: On 6-15-11 pt's father reported that son's left arm had a red rah around injection site. Deltoid had red, swollen, warm to the touch. Developed "flu like symptoms" fever, malaise, decreased appetite. Symptoms lasted five days.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Malaise, Pyrexia, Rash erythematous
Clinical narrative: On 6-15-11 pt's father reported that son's left arm had a red rah around injection site. Deltoid had red, swollen, warm to the touch. Developed "flu like symptoms" fever, malaise, decreased appetite. Symptoms lasted five days.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema
Clinical narrative: Bilateral localized erythema at site of injection.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Eye pain, Ocular hyperaemia
Clinical narrative: On 18Aug11 pt. started having redness & pain in right eye.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Incontinence, Movement disorder, Tremor
Clinical narrative: Pt mentioned she was very afraid of needles/shot & usually passed out. After receiving the shot, pt seemed fine. But about 30 secs later pt said that she's scared & began to shake & had convulsion like symptoms. Pt experienced involuntary incontinence sxs. Pt's mother was holding her & comforting her & pt recovered. Pt rested for about 5-10 min, had some water & left the pharmacy. Called pt's home at 3:20pm. Mom states pt is fine.
Age: 1.26
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Rash consistent with varicella - no fever - 20 eruptions total on upper extremities & upper torso no fever.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Mother reported swelling at site of injection and fever. Dr then recommend ice for arm and MOTRIN for fever.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Shoulder swelled, was the circumference of a baseball. It also felt hard & warm to the touch.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anti-insulin antibody positive, Anti-thyroid antibody positive, Cyst, Infection, Type 1 diabetes mellitus
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 06-AUG-2009 and 18-NOV-2010, a female patient with only minor allergy to cats, vocal cord spasm/dyspnea and no pre-existent illnesses was vaccinated with the first and second doses of GARDASIL, respectively. On 14-FEB-2011, the 14 year old female patient was vaccinated with the third dose of GARDASIL (Lot # 666597/0768Z). There were no concomitant medications. On 27-MAY-2011, the patient presented with a large cyst in her left buttock (infection, not at the shot site) within days after the third dose of GARDASIL which could indicate high blood sugar. Per dermatology consultation, she was diagnosed with inflamed cyst in her left buttock and pruritus. The patient was given triamcinolone/xylocaine injection and oral antibiotics. During the 2 to 3 weeks after the third dose, the patient was diagnosed with Type 1 diabetes mellitus "however, the onset probably happened earlier" and was noted to have a 14 pound weight loss. The patient presented with elevated blood sugars, increased urination, 14 pound weight loss, new onset type 1 diabetes mellitus: uncontrolled, urinary urgency, polyuria, nocturia, she was dizzy, drinking more than usual and had blurred vision and thirst. The patient was diagnosed with antibodies against the pancreatic/insulin function and also antibodies against the thyroid. Diagnostic laboratory tests included HgB A1C: 9.7%; glucose: 226 mg/dl; urinalysis: 100 dl gluc; ketones: 40 mg/dl; blood glucose: 230 mg/dl. Insulin was administered and the patient was given education. She was discharged in good condition. The patient required hospitalization and ER visit. The listing indicated that one or more of the events of diagnosed with type 1 diabetes, 14 pound weight loss, had a large cyst/inflamed cyst left buttock, infection (not at the shot site), high blood sugar/elevated blood sugar, increased urination, thirst, pruritus, dizzy, polyuria, nocturia, urinary urgency and drinking more than usual were considered to be life threatening and disabling events and required hospitalization. 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 # was 424767. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Weight 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 06-AUG-2009 and 18-NOV-2010, a female patient with only minor allergy to cats, vocal cord spasm/dyspnea and no pre-existent illnesses was vaccinated with the first and second doses of GARDASIL, respectively. On 14-FEB-2011, the 14 year old female patient was vaccinated with the third dose of GARDASIL (Lot # 666597/0768Z). There were no concomitant medications. On 27-MAY-2011, the patient presented with a large cyst in her left buttock (infection, not at the shot site) within days after the third dose of GARDASIL which could indicate high blood sugar. Per dermatology consultation, she was diagnosed with inflamed cyst in her left buttock and pruritus. The patient was given triamcinolone/xylocaine injection and oral antibiotics. During the 2 to 3 weeks after the third dose, the patient was diagnosed with Type 1 diabetes mellitus "however, the onset probably happened earlier" and was noted to have a 14 pound weight loss. The patient presented with elevated blood sugars, increased urination, 14 pound weight loss, new onset type 1 diabetes mellitus: uncontrolled, urinary urgency, polyuria, nocturia, she was dizzy, drinking more than usual and had blurred vision and thirst. The patient was diagnosed with antibodies against the pancreatic/insulin function and also antibodies against the thyroid. Diagnostic laboratory tests included HgB A1C: 9.7%; glucose: 226 mg/dl; urinalysis: 100 dl gluc; ketones: 40 mg/dl; blood glucose: 230 mg/dl. Insulin was administered and the patient was given education. She was discharged in good condition. The patient required hospitalization and ER visit. The listing indicated that one or more of the events of diagnosed with type 1 diabetes, 14 pound weight loss, had a large cyst/inflamed cyst left buttock, infection (not at the shot site), high blood sugar/elevated blood sugar, increased urination, thirst, pruritus, dizzy, polyuria, nocturia, urinary urgency and drinking more than usual were considered to be life threatening and disabling events and required hospitalization. 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 # was 424767. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anti-insulin antibody positive, Anti-islet cell antibody positive, Anti-thyroid antibody positive, Blood glucose abnormal, Blood glucose 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 06-AUG-2009 and 18-NOV-2010, a female patient with only minor allergy to cats, vocal cord spasm/dyspnea and no pre-existent illnesses was vaccinated with the first and second doses of GARDASIL, respectively. On 14-FEB-2011, the 14 year old female patient was vaccinated with the third dose of GARDASIL (Lot # 666597/0768Z). There were no concomitant medications. On 27-MAY-2011, the patient presented with a large cyst in her left buttock (infection, not at the shot site) within days after the third dose of GARDASIL which could indicate high blood sugar. Per dermatology consultation, she was diagnosed with inflamed cyst in her left buttock and pruritus. The patient was given triamcinolone/xylocaine injection and oral antibiotics. During the 2 to 3 weeks after the third dose, the patient was diagnosed with Type 1 diabetes mellitus "however, the onset probably happened earlier" and was noted to have a 14 pound weight loss. The patient presented with elevated blood sugars, increased urination, 14 pound weight loss, new onset type 1 diabetes mellitus: uncontrolled, urinary urgency, polyuria, nocturia, she was dizzy, drinking more than usual and had blurred vision and thirst. The patient was diagnosed with antibodies against the pancreatic/insulin function and also antibodies against the thyroid. Diagnostic laboratory tests included HgB A1C: 9.7%; glucose: 226 mg/dl; urinalysis: 100 dl gluc; ketones: 40 mg/dl; blood glucose: 230 mg/dl. Insulin was administered and the patient was given education. She was discharged in good condition. The patient required hospitalization and ER visit. The listing indicated that one or more of the events of diagnosed with type 1 diabetes, 14 pound weight loss, had a large cyst/inflamed cyst left buttock, infection (not at the shot site), high blood sugar/elevated blood sugar, increased urination, thirst, pruritus, dizzy, polyuria, nocturia, urinary urgency and drinking more than usual were considered to be life threatening and disabling events and required hospitalization. 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 # was 424767. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Cyst, Diabetes mellitus inadequate control, Dizziness, Glucose urine present, Glycosylated haemoglobin 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 06-AUG-2009 and 18-NOV-2010, a female patient with only minor allergy to cats, vocal cord spasm/dyspnea and no pre-existent illnesses was vaccinated with the first and second doses of GARDASIL, respectively. On 14-FEB-2011, the 14 year old female patient was vaccinated with the third dose of GARDASIL (Lot # 666597/0768Z). There were no concomitant medications. On 27-MAY-2011, the patient presented with a large cyst in her left buttock (infection, not at the shot site) within days after the third dose of GARDASIL which could indicate high blood sugar. Per dermatology consultation, she was diagnosed with inflamed cyst in her left buttock and pruritus. The patient was given triamcinolone/xylocaine injection and oral antibiotics. During the 2 to 3 weeks after the third dose, the patient was diagnosed with Type 1 diabetes mellitus "however, the onset probably happened earlier" and was noted to have a 14 pound weight loss. The patient presented with elevated blood sugars, increased urination, 14 pound weight loss, new onset type 1 diabetes mellitus: uncontrolled, urinary urgency, polyuria, nocturia, she was dizzy, drinking more than usual and had blurred vision and thirst. The patient was diagnosed with antibodies against the pancreatic/insulin function and also antibodies against the thyroid. Diagnostic laboratory tests included HgB A1C: 9.7%; glucose: 226 mg/dl; urinalysis: 100 dl gluc; ketones: 40 mg/dl; blood glucose: 230 mg/dl. Insulin was administered and the patient was given education. She was discharged in good condition. The patient required hospitalization and ER visit. The listing indicated that one or more of the events of diagnosed with type 1 diabetes, 14 pound weight loss, had a large cyst/inflamed cyst left buttock, infection (not at the shot site), high blood sugar/elevated blood sugar, increased urination, thirst, pruritus, dizzy, polyuria, nocturia, urinary urgency and drinking more than usual were considered to be life threatening and disabling events and required hospitalization. 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 # was 424767. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haemoglobin, Infection, Inflammation, Micturition urgency, Nocturia
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 06-AUG-2009 and 18-NOV-2010, a female patient with only minor allergy to cats, vocal cord spasm/dyspnea and no pre-existent illnesses was vaccinated with the first and second doses of GARDASIL, respectively. On 14-FEB-2011, the 14 year old female patient was vaccinated with the third dose of GARDASIL (Lot # 666597/0768Z). There were no concomitant medications. On 27-MAY-2011, the patient presented with a large cyst in her left buttock (infection, not at the shot site) within days after the third dose of GARDASIL which could indicate high blood sugar. Per dermatology consultation, she was diagnosed with inflamed cyst in her left buttock and pruritus. The patient was given triamcinolone/xylocaine injection and oral antibiotics. During the 2 to 3 weeks after the third dose, the patient was diagnosed with Type 1 diabetes mellitus "however, the onset probably happened earlier" and was noted to have a 14 pound weight loss. The patient presented with elevated blood sugars, increased urination, 14 pound weight loss, new onset type 1 diabetes mellitus: uncontrolled, urinary urgency, polyuria, nocturia, she was dizzy, drinking more than usual and had blurred vision and thirst. The patient was diagnosed with antibodies against the pancreatic/insulin function and also antibodies against the thyroid. Diagnostic laboratory tests included HgB A1C: 9.7%; glucose: 226 mg/dl; urinalysis: 100 dl gluc; ketones: 40 mg/dl; blood glucose: 230 mg/dl. Insulin was administered and the patient was given education. She was discharged in good condition. The patient required hospitalization and ER visit. The listing indicated that one or more of the events of diagnosed with type 1 diabetes, 14 pound weight loss, had a large cyst/inflamed cyst left buttock, infection (not at the shot site), high blood sugar/elevated blood sugar, increased urination, thirst, pruritus, dizzy, polyuria, nocturia, urinary urgency and drinking more than usual were considered to be life threatening and disabling events and required hospitalization. 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 # was 424767. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pollakiuria, Polydipsia, Polyuria, Pruritus, Thirst
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 06-AUG-2009 and 18-NOV-2010, a female patient with only minor allergy to cats, vocal cord spasm/dyspnea and no pre-existent illnesses was vaccinated with the first and second doses of GARDASIL, respectively. On 14-FEB-2011, the 14 year old female patient was vaccinated with the third dose of GARDASIL (Lot # 666597/0768Z). There were no concomitant medications. On 27-MAY-2011, the patient presented with a large cyst in her left buttock (infection, not at the shot site) within days after the third dose of GARDASIL which could indicate high blood sugar. Per dermatology consultation, she was diagnosed with inflamed cyst in her left buttock and pruritus. The patient was given triamcinolone/xylocaine injection and oral antibiotics. During the 2 to 3 weeks after the third dose, the patient was diagnosed with Type 1 diabetes mellitus "however, the onset probably happened earlier" and was noted to have a 14 pound weight loss. The patient presented with elevated blood sugars, increased urination, 14 pound weight loss, new onset type 1 diabetes mellitus: uncontrolled, urinary urgency, polyuria, nocturia, she was dizzy, drinking more than usual and had blurred vision and thirst. The patient was diagnosed with antibodies against the pancreatic/insulin function and also antibodies against the thyroid. Diagnostic laboratory tests included HgB A1C: 9.7%; glucose: 226 mg/dl; urinalysis: 100 dl gluc; ketones: 40 mg/dl; blood glucose: 230 mg/dl. Insulin was administered and the patient was given education. She was discharged in good condition. The patient required hospitalization and ER visit. The listing indicated that one or more of the events of diagnosed with type 1 diabetes, 14 pound weight loss, had a large cyst/inflamed cyst left buttock, infection (not at the shot site), high blood sugar/elevated blood sugar, increased urination, thirst, pruritus, dizzy, polyuria, nocturia, urinary urgency and drinking more than usual were considered to be life threatening and disabling events and required hospitalization. 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 # was 424767. No further information is available.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urine ketone body present, Vision blurred, Weight 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 06-AUG-2009 and 18-NOV-2010, a female patient with only minor allergy to cats, vocal cord spasm/dyspnea and no pre-existent illnesses was vaccinated with the first and second doses of GARDASIL, respectively. On 14-FEB-2011, the 14 year old female patient was vaccinated with the third dose of GARDASIL (Lot # 666597/0768Z). There were no concomitant medications. On 27-MAY-2011, the patient presented with a large cyst in her left buttock (infection, not at the shot site) within days after the third dose of GARDASIL which could indicate high blood sugar. Per dermatology consultation, she was diagnosed with inflamed cyst in her left buttock and pruritus. The patient was given triamcinolone/xylocaine injection and oral antibiotics. During the 2 to 3 weeks after the third dose, the patient was diagnosed with Type 1 diabetes mellitus "however, the onset probably happened earlier" and was noted to have a 14 pound weight loss. The patient presented with elevated blood sugars, increased urination, 14 pound weight loss, new onset type 1 diabetes mellitus: uncontrolled, urinary urgency, polyuria, nocturia, she was dizzy, drinking more than usual and had blurred vision and thirst. The patient was diagnosed with antibodies against the pancreatic/insulin function and also antibodies against the thyroid. Diagnostic laboratory tests included HgB A1C: 9.7%; glucose: 226 mg/dl; urinalysis: 100 dl gluc; ketones: 40 mg/dl; blood glucose: 230 mg/dl. Insulin was administered and the patient was given education. She was discharged in good condition. The patient required hospitalization and ER visit. The listing indicated that one or more of the events of diagnosed with type 1 diabetes, 14 pound weight loss, had a large cyst/inflamed cyst left buttock, infection (not at the shot site), high blood sugar/elevated blood sugar, increased urination, thirst, pruritus, dizzy, polyuria, nocturia, urinary urgency and drinking more than usual were considered to be life threatening and disabling events and required hospitalization. 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 # was 424767. No further information is available.
Age: 1.35
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Breath sounds abnormal, Drug screen negative, Endotracheal intubation, Gaze palsy, Postictal state
Clinical narrative: She was laying down with the patient taking a nap this afternoon when she was awakened by, what she described as a gurgling noise.  She turned to find the patient with eyes rolled up and both upper extremities shaking.  She called 9-1-1 and the patient was transported via ambulance to Hospital.  The EMS stated that they gave the patient rectal Valium, and they did not notice any seizure activity en route to the hospital.  In the emergency room, the patient was described as being postictal, but then began to have generalized tonic clonic activity.  She received Ativan with no result.  She then received a dose of Valium and continued to have seizure activities, so the patient was given a neuromuscular blockade and was intubated at that time.  She was then loaded with 20 mg/kg of fosphenytoin.
Age: 1.35
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Seizure like phenomena, Tonic clonic movements, Tremor
Clinical narrative: She was laying down with the patient taking a nap this afternoon when she was awakened by, what she described as a gurgling noise.  She turned to find the patient with eyes rolled up and both upper extremities shaking.  She called 9-1-1 and the patient was transported via ambulance to Hospital.  The EMS stated that they gave the patient rectal Valium, and they did not notice any seizure activity en route to the hospital.  In the emergency room, the patient was described as being postictal, but then began to have generalized tonic clonic activity.  She received Ativan with no result.  She then received a dose of Valium and continued to have seizure activities, so the patient was given a neuromuscular blockade and was intubated at that time.  She was then loaded with 20 mg/kg of fosphenytoin.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ocular discomfort, Pain, Skin discomfort
Clinical narrative: Information has been received from a physician concerning a 66 year old female patient who on 19-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669589/1453Z, expiration not reported). Physician reported that on 05-MAY-2011 after vaccination with ZOSTAVAX (Merck) the patient developed shingles. It was unspecified if the patient sought medical attention. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician via a complete Herpes Zoster Questionnaire concerning the female patient with glaucoma, hyperlipidaemia, hypertension, hypothyroidism, tobacco user, osteopenia with no illness at time of vaccination with unknown history of chickenpox and with no recent exposure to chickenpox or Herpes Zoster, who on 19-JAN-2011 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 669589/1453Z), left deltoid. It was reported that no rash occurred at the site of injection or elsewhere within 42 days of the vaccination. On 05-MAY-2011 the patient developed shingles (severe outbreak) distributed in V1 branch of trigeminal nerve with a maximum temperature of 97.6. The patient systemic symptoms included pain in a grade of 9 (scale 0 to 10), ocular irritation. No direct fluorescent antibody test and PCR test were done. There were no relevant diagnostics test and laboratory data. In July 2011, the patient recovered from shingles (severe outbreak) which was also reported by the physician that the patient still had same residual discomfort in dermatomal distribution and pain, (conflicting information). Shingles (severe outbreak) was considered to be disabling by the physician. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Paralysis, Tremor
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who in March 2011, was vaccinated with ZOSTAVAX (Merck) (lot#, dose, and route were not specified). The pharmacist reported that a female patient developed "palsy of her head" after receiving ZOSTAVAX (Merck) in March 2011. The patient reported that her head started shaking "shortly after" receiving the vaccine. The patient stated that the shaking was a nuisance and would like it to stop. It was unspecified if the patient sought medical attention. At the time of the report, the patient's events persisted. Upon internal review, "palsy of her head" was determined to be an other important medical event. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from the authors in a published literature article concerning a child patient who on an unspecified date was vaccinated with the three doses of ROTATEQ. On an unknown date, the patient experienced rotavirus and was hospitalized. At the time of the report the outcome of the patient was not reported. The article also discussed the experience of another child patients while on therapy with ROTATEQ (WAES # 1108USA01482, WAES # 1108USA02150, WAES # 1108USA02151, WAES # 1108USA02152 and WAES # 1108USA02153). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from the authors in a published literature article concerning a child patient who on an unspecified date was vaccinated with the three doses of ROTATEQ. On an unknown date, the patient experienced rotavirus and was hospitalized. At the time of the report the outcome of the patient was not reported. The article also discussed the experience of another child patients while on therapy with ROTATEQ (WAES # 1108USA01482, WAES # 1108USA02151, WAES # 1108USA02152, WAES # 1108USA02153 and WAES # 1108USA02154). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Gastroenteritis rotavirus.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from the authors in a published literature article concerning a child patient who on an unspecified date was vaccinated with the three doses of ROTATEQ. On an unknown date, the patient experienced rotavirus and was hospitalized. At the time of the report the outcome of the patient was not reported. The article also discussed the experience of another child patients while on therapy with ROTATEQ (WAES # 1108USA01482, WAES # 1108USA02150, WAES # 1108USA02151, WAES # 1108USA02153 and WAES # 1108USA02154). Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Information has been received from the authors in a published literature article concerning a child patient who on an unspecified date was vaccinated with the three doses of ROTATEQ. On an unknown date, the patient experienced rotavirus and was hospitalized. At the time of the report the outcome of the patient was not reported. The article also discussed the experience of another child patients while on therapy with ROTATEQ (WAES # 1108USA01482, 1108USA02150, 1108USA02151, 1108USA02152 and 1108USA02154). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse reaction, Arthralgia, Asthenia, Dysphagia, Injection site swelling
Clinical narrative: Injection site swelling, painful joints, difficulty swallowing, nausea, weakness, pyrogenic reaction, I.e. Favera
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea
Clinical narrative: Injection site swelling, painful joints, difficulty swallowing, nausea, weakness, pyrogenic reaction, I.e. Favera
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives appeared on inner thighs then spread to chest, stomach, arms, legs, neck, back, and face over the course of 1 month
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia, Sinus congestion
Clinical narrative: Flu like symptoms with low grade fever, sinus congestion, myalgias and fatigue lasting for at least 12 days.
Age: 22.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Activities of daily living impaired, Impaired work ability, Injection site discomfort, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: During injection it felt as if my shoulder needed to pop very badly. It felt like I was injected in my joint, not my muscle. Hours later, I could only move my arm a few inches in either direction.  Extreme pain if I try to lift my arm or use great strength from shoulder.  I couldn't undress myself, I couldn't do my hair, and now I will probably lose my job, because my job involves lifting children all day long.
Age: 22.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain
Clinical narrative: During injection it felt as if my shoulder needed to pop very badly. It felt like I was injected in my joint, not my muscle. Hours later, I could only move my arm a few inches in either direction.  Extreme pain if I try to lift my arm or use great strength from shoulder.  I couldn't undress myself, I couldn't do my hair, and now I will probably lose my job, because my job involves lifting children all day long.
Age: 22.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: During injection it felt as if my shoulder needed to pop very badly. It felt like I was injected in my joint, not my muscle. Hours later, I could only move my arm a few inches in either direction.  Extreme pain if I try to lift my arm or use great strength from shoulder.  I couldn't undress myself, I couldn't do my hair, and now I will probably lose my job, because my job involves lifting children all day long.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Fall
Clinical narrative: The client and her mother were in the office, so patient could get Hepatitis A and Meningococcal immunizations. Following the immunizations and follow-up discussion about the next Hepatitis A, they went to the waiting area. Patient got up and was walking back to the immunization room, 9:35 AM. I met her in the hall and she asked for a cold pack. I asked what she needed it for and before she could answer, she started to go down. I held her and her mother came and held her from the back and we lowered her to the floor. By the time she was on the floor, she looked at us and asked if she had fainted. She had no complaints. There was no injury. At 9:40 AM her blood pressure was 98/62 and pulse was 68. She was then alert and talkative. We let her lay on the floor until she was comfortable to sit up and then stand up. She then went and sat in the waiting area and drank some water and at 9:55 AM, she and her mother left the office.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Chest pain, Dizziness, Swelling face
Clinical narrative: TC from father who said that he was driving home when he noticed that his son's face was swollen.  Says his son says his chest hurts and he is dizzy.  No difficulty breathing.  Advised him to take his son to the nearest Emergency Department at the closest hospital for evaluation. After receiving vaccines they had gone to the mall for a while before driving home. Father said he was going to check with mom before he took him any where.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site pain, Nausea, Syncope
Clinical narrative: Syncope, nausea, pain at injection site.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Rash starting at injestion site spreading to chest and scalp as well as back.  Was seen by clinic physician.  Given Benadryl 50 MG PO.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: hives all over body, swelling of face
Sex: F
Vaccine: HEP, TDAP
Symptoms: Vaccination error
Clinical narrative: Tdap vaccine given in error.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Injection site anaesthesia, Injection site reaction, Pain in extremity, Paraesthesia
Clinical narrative: Pt. had received last postexposure rabies shot Left deltoid on 08/19/11 @ 9AM. While pt. was in facility's driveway she felt some tingling/numbness over Left upper arm. Escorted her back to the clinic- vitals checked BP 160/78, pt. anxious observed for 15 mins. Numbness still present but not worse-she went home. 3:45pm- Called pt. @ home she stated numbness/tingling is gone and arm just feels sore.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red sore area that is hot to touch started one day after injection was given.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Chills, Diarrhoea, Feeling abnormal
Clinical narrative: Chills, fever, weak, diarrhea next day and today, weak, cramps, feeling poor, unable to go out
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Muscle spasms, Pyrexia
Clinical narrative: Chills, fever, weak, diarrhea next day and today, weak, cramps, feeling poor, unable to go out
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Circular erythematous blistering rash developed at the site of the injection about 2 cm in diameter
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary mass, Condition aggravated, Fibromyalgia, Injection site erythema, Injection site pain
Clinical narrative: Pain at injection site, redness at site, swelling in axillary area, increase in baseline of fibromyalgia pain
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Arrhythmia, Autopsy, Blood culture positive, Body fluid analysis, Cardiac failure
Clinical narrative: Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Cardiomyopathy, Death, Drug screen negative, Microscopy, Streptococcus test positive
Clinical narrative: Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, FLU3, HPV4
Symptoms: Sudden cardiac death
Clinical narrative: Found dead in bed in a.m. by family.  Pathologist stated cause of death as consistent with cardiac insufficiency, due to cardiac arrhythmia, due to probable early cardiomyopathy.  Child Death Review Team felt this death was consistent with a diagnosis of sudden cardiac death.