chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Asthenia, Hypotension, Loss of consciousness, Nausea, Pallor
Clinical narrative: Case number PHHY2012US099136 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 463497) web site on 01 Nov 2012 with the follow-up received from Quality Assurance Department (reference number: 209191) on 09 May 2013. This report refers to a 17 year old female patient. Her medical history and concomitant medications were not reported. On 28 Aug 2012, she was vaccinated with MENVEO (batch number: A10130), intramuscular into the right arm, GARDASIL (batch number: 0022AE) IM into right arm, IPOL (batch number: H1340), IM into left arm, MMR II (batch number: 1026AA) SC left arm, BOOSTRIX (batch number: AC52B085BA) IM into left arm and VARIVAX (batch number: 0316AE), SC into the right arm. One the same day at 12:50 the patient became pale and lost consciousness briefly did not fall and was able to walk to the bed. At 12:55 blood pressure was 90/70, at 1:30 BP was 100/70. Awake oriented, but continued to feel weak and nauseous. The patient was moved to the hospital at 13:10. The final outcome of the event was recovered. Seriousness and causality assessment was not reported. Batch review report concluded that, based on the document review, it was stated that, the concerned MENVEO (batch number: A10130), was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up received from Quality Assurance Department on 09 May 2013: Updated batch review report.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Clumsiness, Decreased appetite, Discomfort, Dyspepsia
Clinical narrative: Flu like symptoms began to develop with a dull headache; left arm from shoulder to wrist had begun to ache; by morning of 05/09/2013 (5:00 AM) all joints in left side from hip to shoulder ached and felt tender, dull headache continued; by 12:00 PM on 05/09/2013 all joints right and left side ached.  By evening of 05/09/2013 and through most of 05/10/2013 the joint aches had spread to my ankles and feet. While not completely debilitating, the discomfort was distracting and I felt clumsy. My appetite was diminished; I experienced flatulence, heartburn, excessive burping. My spouse reported that I was feverish throughout the night of 05/09/2013 and 05/10/2013; I awoke both nights drenched in perspiration.  Flu like symptoms and dull headache continued until about mid-day on 05/11/2013.  The injection site remains sore (05/12/2013 at 7:00 AM, much like a bruise that is a day or so old.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Eructation, Flatulence, Headache, Influenza like illness, Injection site pain
Clinical narrative: Flu like symptoms began to develop with a dull headache; left arm from shoulder to wrist had begun to ache; by morning of 05/09/2013 (5:00 AM) all joints in left side from hip to shoulder ached and felt tender, dull headache continued; by 12:00 PM on 05/09/2013 all joints right and left side ached.  By evening of 05/09/2013 and through most of 05/10/2013 the joint aches had spread to my ankles and feet. While not completely debilitating, the discomfort was distracting and I felt clumsy. My appetite was diminished; I experienced flatulence, heartburn, excessive burping. My spouse reported that I was feverish throughout the night of 05/09/2013 and 05/10/2013; I awoke both nights drenched in perspiration.  Flu like symptoms and dull headache continued until about mid-day on 05/11/2013.  The injection site remains sore (05/12/2013 at 7:00 AM, much like a bruise that is a day or so old.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Night sweats, Pyrexia
Clinical narrative: Flu like symptoms began to develop with a dull headache; left arm from shoulder to wrist had begun to ache; by morning of 05/09/2013 (5:00 AM) all joints in left side from hip to shoulder ached and felt tender, dull headache continued; by 12:00 PM on 05/09/2013 all joints right and left side ached.  By evening of 05/09/2013 and through most of 05/10/2013 the joint aches had spread to my ankles and feet. While not completely debilitating, the discomfort was distracting and I felt clumsy. My appetite was diminished; I experienced flatulence, heartburn, excessive burping. My spouse reported that I was feverish throughout the night of 05/09/2013 and 05/10/2013; I awoke both nights drenched in perspiration.  Flu like symptoms and dull headache continued until about mid-day on 05/11/2013.  The injection site remains sore (05/12/2013 at 7:00 AM, much like a bruise that is a day or so old.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: Informed of event on 5/9/2013. Pt initially had a bump at injection site then developed an itchy rash. She called her PCP and was instructed to take BENADRYL and use hydrocortisone.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 5/7/13, pt received immunization in (L) anti thigh Dtap site is red, swollen, warm to touch, size of baseball states parent. Recommended BENADRYL, cold compress. OV tomorrow. 5/9/13 OV-pt is slightly improved. Afebrile.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Blood culture, Body temperature increased, Chest X-ray, Febrile convulsion, Full blood count
Clinical narrative: 9 days post VARIVAX vaccine pt had 105.6 temp, a febrile seizure and (+) varicella rash about 5 lesions.
Age: 1.51
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin lesion, Urine analysis
Clinical narrative: 9 days post VARIVAX vaccine pt had 105.6 temp, a febrile seizure and (+) varicella rash about 5 lesions.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm, itchy/burning sensation, at sight of INJ. Abnormal large 6 inches.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: 5/10 began w/ swelling, pain and redness over (L) deltoid inoculation site. One episode of tactile fever that resolved. Urticaria developed on left leg and arm lasting one night. Resolved w/o meds. Continues to have dermal edema on (L) deltoid.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Bilevel positive airway pressure, Chest X-ray, Chronic obstructive pulmonary disease, Computerised tomogram thorax, Condition aggravated
Clinical narrative: (R) upper arm pain. Tdap given April 11, 2013 - fever, body aches within 6 hrs. Worsening dyspnea over next week, finally admitted to hospital with worsening COPD, O2 dependent, continues to smoke. End stage COPD.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Electrocardiogram, Pain, Pain in extremity, Pulmonary function test
Clinical narrative: (R) upper arm pain. Tdap given April 11, 2013 - fever, body aches within 6 hrs. Worsening dyspnea over next week, finally admitted to hospital with worsening COPD, O2 dependent, continues to smoke. End stage COPD.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: (R) upper arm pain. Tdap given April 11, 2013 - fever, body aches within 6 hrs. Worsening dyspnea over next week, finally admitted to hospital with worsening COPD, O2 dependent, continues to smoke. End stage COPD.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dysphagia, Mobility decreased, Movement disorder, Somnolence
Clinical narrative: Whole body unable to move, can't speak. Upon entering into the emergency room in hospital, person cannot stay awake or swallow normal. Person is capable to do normal things or eat or speak but after the shot from doctor, changes next day, his balance/movement and speech. Voice but no speech.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Whole body unable to move, can't speak. Upon entering into the emergency room in hospital, person cannot stay awake or swallow normal. Person is capable to do normal things or eat or speak but after the shot from doctor, changes next day, his balance/movement and speech. Voice but no speech.
Age: 1.11
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test normal, Pyrexia
Clinical narrative: Mother took child to local Emergency Room because of fever of 102.9. While waiting in ER, fever increased to 104.9. Was told by ER physician probably due to immunizations day before as labs WNL.
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Asthenia, Dizziness, Dyspnoea, Myalgia, Orthostatic hypotension
Clinical narrative: Sent to Emergency room by telephone advice for short of breath, dizzy, and weak, muscle pains. Received intravenous fluids for orthostatic hypotension.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Patient reports right arm pain and weakness.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site pain, Insomnia, Pain in extremity, Rash erythematous
Clinical narrative: Red rash and tenderness at injection site. On 5-10 arm very sore, rash spreading, unable to sleep at night and had headache.  5-11 thru 5-13 rash continues to spread.
Age: 1.64
Sex: F
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Patient was brought in by mother on Friday, May 10,2013 for rash on trunk and back.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Local swelling
Clinical narrative: Patient has localized swelling and redness at site of injection.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Pallor
Clinical narrative: Client received vaccine in school Tdap clinic.  He complained of feeling nauseated and was noted to have pale lips 30 min after receiving vaccine.  Client was sent home; he returned to school the following day without any complaints of discomfort.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Lip swelling, Rash erythematous
Clinical narrative: Pt complaining of redness at injection site with red mark. Redness and red spot subsided after a few days, but another smaller red mark appeared near inj. site. Pt also complaining of swollen lower lip. Pt mostly concerned about recurrence of red rash.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Lip swelling, Rash erythematous
Clinical narrative: Pt complaining of redness at injection site with red mark. Redness and red spot subsided after a few days, but another smaller red mark appeared near inj. site. Pt also complaining of swollen lower lip. Pt mostly concerned about recurrence of red rash.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Skin discolouration, Skin warm
Clinical narrative: Per mom pts legs, bilateral, turned purple-blue.  From waist up normal colored.  Called EMS, per note from ER EMS stated that legs were blue, when they got to ER the ER reports that pt was not blue anymore, was warm, dry and pink.  On discharge from ER (per ER note) pt alert, smiling and playing with mom.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Subjective fevers. 3cm tender induration to (R) arm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt received vaccine on a Monday and by Tuesday she had a very large hive/welt. She said it did itch. She said Wednesday that it was getting better and that she was taking BENADRYL at night. No breathing problems though.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis left arm - treatment amoxicillin-pot clav 875-125 mg 1 BID x 10 days.
Age: 1.22
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Irritability, Rash papular
Clinical narrative: Got vaccines at recent WCC (see below) on 5/1/13. Broke out w/ 2-3 mm papular rash on hands, feet, and around mouth on 5/4/13. Erythem. but does not seem to itch. Has spread to arms, legs and trunk. Episodes of extreme irritab. x 30 min/episode. No fever.
Age: 1.34
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, PNC
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No adverse reaction noted.
Age: 0.44
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Pyrexia
Clinical narrative: After second set of vaccines (given 12/28/12) child had high fever (over 103) x 3 day as well as fussiness. Gave infant TYLENOL that helped a bit but once it wore off her fever came back. After the three days she was back to her normal self. Mother in today 05/08/13 to get other vaccines per her child's NP schedule: Dtap and PNEUMOVAX today and others spread out.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Abasia, Asthenia, Immunoglobulin therapy, Intensive care, Laboratory test
Clinical narrative: Tingling, numbness started in fingers and feet the day after receiving vaccine, progressed to weakness and eventually after 2 wks was unable to walk or lift arms. Hospitalized in ICU and treated with IVIG, PT and OT.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Lumbar puncture, Mobility decreased, Nuclear magnetic resonance imaging, Paraesthesia
Clinical narrative: Tingling, numbness started in fingers and feet the day after receiving vaccine, progressed to weakness and eventually after 2 wks was unable to walk or lift arms. Hospitalized in ICU and treated with IVIG, PT and OT.
Age: 47.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Nausea
Clinical narrative: C/O nausea and fatigue.
Age: 0.15
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Rash erythematous, Screaming, Skin discolouration
Clinical narrative: Immunizations given at 0845, she screamed from 12:30-2:45/pm. Her foot was purple with red spots.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age with dialysis. On 06-MAY-2013 the dialysis patient was vaccinated inadvertently with a dose of RECOMBIVAX HB (lot # 0276AE, expired date 27-MAR-2013) (1 ml, intramuscular) dialysis formulation. No adverse effects reported. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Blood test, Exposure during pregnancy
Clinical narrative: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female patient without drug reactions/allergies. The patient did not have pertinent history. On 30-APR-2013 the patient was vaccinated with her first dose of GARDASIL. There was no concomitant medications. Later it was found that she was pregnancy. It was reported that the patient's last menstrual period (LMP) date was estimated to be between 03-MAR-2013 and 07-MAR-2013. The patient became pregnant with estimated date of conception (EDD) of 08-DEC-2013. Initial exposure to GARDASIL was at 8 weeks(s). No treatment was given for adverse event. Blood work was performed. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Local reaction, Nausea, Vomiting
Clinical narrative: Small red local reaction at inj site on LT arm. Nausea and vomiting evening 1 day later. Patient took BENADRYL - OTC.
Age: 0.5
Sex: M
Vaccine: DTAPIPV, HIBV, RVX
Symptoms: Crying, Injection site mass, Pyrexia, Screaming
Clinical narrative: High fever of 103.6 degrees Fahrenheit, inconsolable crying and screaming, large lump under injection sites.
Age: 89.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue
Clinical narrative: She complains of arthralgia's and fatigue.
Age: 5.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Patient received MMR #2, Varicella #2 and Havrix Hep A #2 in office at appt. Prior to departure patient began to quickly develop reaction including severe generalized swelling, redness and itching. Due to rapid response continuing to worsen, severity of reaction and extensive covearge of face and upper body concerns developed for possible affect to airway if not managed. Unable to use Benadryl due to inability to rule out its possible trigger of previous anaphylactic reaction patient was given epinephrine per peds pen and transported to ER for continuous monitoring and further treatment if indicated.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 06-MAY-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot # 0801AA, expired date 28-APR-2013) orally. This was patient's first dose. No adverse effect report. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Full blood count, Human chorionic gonadotropin positive, Lipids, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a Certified Medical Assistant refers to a 17 year old female patient with no pertinent medical history and no drug reactions or allergies. On 26-APR-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot #: H021346, exp. date: 01-OCT-2015) for HPV prevention. There was no concomitant medication. The healthcare worker reported that GARDASIL was administered to a pregnant patient on 26-APR-2013. The healthcare worker reported blood was drawn for testing on 26-APR-2013 and HCG level results were received on 29-APR-2013 indicating a pregnancy of 5 weeks gestation. There were lab diagnostics studies performed without results, including: complete blood count (CBC), comprehensive lipid panel and urinalysis. The patient became pregnant with LMP of 22-MAR-2013 and EDD of 27-DEC-2013. Initial exposure to GARDASIL was at 5 week(s). The healthcare worker reported that the patient had not been notified of the pregnancy. No adverse experience symptoms reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: This spontaneous prospective pregnancy report as received from a Certified Medical Assistant refers to a 17 year old female patient with no pertinent medical history and no drug reactions or allergies. On 26-APR-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot #: H021346, exp. date: 01-OCT-2015) for HPV prevention. There was no concomitant medication. The healthcare worker reported that GARDASIL was administered to a pregnant patient on 26-APR-2013. The healthcare worker reported blood was drawn for testing on 26-APR-2013 and HCG level results were received on 29-APR-2013 indicating a pregnancy of 5 weeks gestation. There were lab diagnostics studies performed without results, including: complete blood count (CBC), comprehensive lipid panel and urinalysis. The patient became pregnant with LMP of 22-MAR-2013 and EDD of 27-DEC-2013. Initial exposure to GARDASIL was at 5 week(s). The healthcare worker reported that the patient had not been notified of the pregnancy. No adverse experience symptoms reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Erythema, pain, tenderness, swelling, warmth, and pruritus 6" long and there is a knot at the injection area.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Erythema, pain, tenderness, swelling, warmth, and pruritus 6" long and there is a knot at the injection area.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Convulsion, Fall, Head injury
Clinical narrative: 5-10 min after receiving vaccine child fell off exam table (possible syncopal episode) hit head and had a seizure.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old female patient with hypothyroidism and with no known allergies. The patient was not pregnant. on 30-APR-2013 the patient was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown). The patient experienced redness, warmth, swelling, and pain at the injection site after receiving GARDASIL. The patient sought unspecified medical attention, and was given "antibiotics" for treatment. At the time of this report the patient was not recovered. Additional information has been received.
Age: 50.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Headache, Injection site bruising, Nausea, Pain
Clinical narrative: Bruising a site, body aches, nausea, headache.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blood test, Idiopathic thrombocytopenic purpura, Increased tendency to bruise, Oral mucosal blistering
Clinical narrative: 4-9-13 child woke up with blisters in mouth, bruising easily. Seen by PCP 4-9-13. Seen by PCP 4-11-13 - Blood work done referred to hospital 4-12-13 - Diagnosed with ITP.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Rash papular, Rash pruritic, Swelling
Clinical narrative: Mom says swelling, rash itchy. Itchy rash (papular) noted on both deltoids. No swelling noted today. (Local reaction).
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Computerised tomogram, Convulsion, Intensive care, Lumbar puncture
Clinical narrative: Child had a seizure lasting approximately 25-> 45 minutes required ATIVAN and VERSED. Hospitalized PICU.
Age: 0.33
Sex: M
Vaccine: DTP, HIBV, IPV, PNC, RV5
Symptoms: Blood culture negative, C-reactive protein increased, Culture urine negative, Fontanelle bulging, Full blood count normal
Clinical narrative: Low grade fever, bulging fontanelle requiring hospital admission for observation. Immunizations were given the day prior to admission.
Age: 0.33
Sex: M
Vaccine: DTP, HIBV, IPV, PNC, RV5
Symptoms: Laboratory test normal, Pyrexia, Urine analysis normal
Clinical narrative: Low grade fever, bulging fontanelle requiring hospital admission for observation. Immunizations were given the day prior to admission.
Age: 0.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Chest X-ray, Cyanosis, Dyspnoea, Fatigue, Full blood count
Clinical narrative: Fever began 4/19. was 104 at ED, no temp take at home. Was at bd party. Was staring, large pupils, not responding ?lips turned blue. Breathing harder and faster. "Was tense and shaking" lasted 1 min total. Very tired for 1hr after. Taken to ER. Given rocephin/omnicef.
Age: 0.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Mydriasis, Pyrexia, Respiratory rate increased, Staring, Tension
Clinical narrative: Fever began 4/19. was 104 at ED, no temp take at home. Was at bd party. Was staring, large pupils, not responding ?lips turned blue. Breathing harder and faster. "Was tense and shaking" lasted 1 min total. Very tired for 1hr after. Taken to ER. Given rocephin/omnicef.
Age: 0.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Fever began 4/19. was 104 at ED, no temp take at home. Was at bd party. Was staring, large pupils, not responding ?lips turned blue. Breathing harder and faster. "Was tense and shaking" lasted 1 min total. Very tired for 1hr after. Taken to ER. Given rocephin/omnicef.
Age: 0.54
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Blood test normal, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: 8/17/2012 Fever of 104F.  Fever was kept at 101F with the use of Tylenol.  After fever subsided, the patient developed a runny nose and was congested.  On 8/29/2012 and 8/30/2012 patient had sizures.
Age: 0.54
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: 8/17/2012 Fever of 104F.  Fever was kept at 101F with the use of Tylenol.  After fever subsided, the patient developed a runny nose and was congested.  On 8/29/2012 and 8/30/2012 patient had sizures.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Bed rest, Fatigue, Motor dysfunction, Pyrexia
Clinical narrative: 48 hours of high fever; persistent fatigue and weakness after fever; awkward motor skills. Full bed rest, lots of fluids. Fever broke after 48 hours.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Dizziness, Hypoacusis, Nausea, Paraesthesia
Clinical narrative: Dizziness, nausea, arm tingling, hearing muffled.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Lip swelling
Clinical narrative: 5/10/2013 1:39pm: Mom noticed patients lips swollen 50 minutes following receiving vaccine (1/2 way through lunch, no new foods that Mom know of, no new foods). Benadryl given by mom at approximately 12:45pm.
Age: 1.39
Sex: M
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Spreading reddened area, on leg af injection site. Pt referred to family medicine to MD and antibiotics were prescribed.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Urticaria
Clinical narrative: Generalized hives.
Age: 17.0
Sex: M
Vaccine: HEPA, MEN
Symptoms: Dizziness, Pallor, Presyncope
Clinical narrative: Patient had a vasovagal response to vaccination. Felt light-headed and dizziness after vaccination, lost color in his face. After several minutes (approx. 5 mins) patient regained color. He was able to walk around and was fine after a few minuted.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered, No adverse event
Clinical narrative: No adverse event as a result of giving expired vaccine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash. Methylprednisolone mg every day, diphenhydramine 25 mg TID.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pyrexia, Vaccination site cellulitis
Clinical narrative: Information has been received from a pharmacy representative regarding a female who on 17-APR-2013, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #H017759; Expiration: 04-JUL-2014) "on her left hand." It was reported that the patient experienced a side effect, namely, a "cellulite" on the area where the vaccine was administered. The patient experienced fever, redness, and swollen arm. The patient sought medical treatment and was prescribed antibiotics. At the time of reporting the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. Physician was informed by an unspecified physician that a patient received two doses of with VARIVAX (merck) (dose, frequency, rout, lot# unknown) in 2009 separated by four weeks. On an unspecified date, titers were drawn which showed "antibody response below 0.9." Physician did not have any further information in regards to this case because she reports that it was not her patient and it was just a question asked to her by another unspecified physician. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients of unknown age. On numerous unspecified dates, numerous unspecified patients were vaccinated with RECOMBIVAX HB (dose, strength and frequency not provided). RECOMBIVAX HB was improperly stored. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients of unknown age. On numerous unspecified dates, numerous unspecified patiens were vaccinated with GARDASIL (dose, strength and frequency not provided). GARDASIL was improperly stored. This is one of several reports from the same source.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Loss of consciousness, Pallor, Sluggishness, Syncope
Clinical narrative: 11:40AM client walked into school clinic for Tdap imm. Rec'd imm. and walked back to classroom 5 mins later. Teacher noticed client put head down on desk as if she "passed out". Teacher summons assistance. Staff member escorted client to clinic. While en route in hallway, student fainted. Staff member witnessed and guided to floor. Summoned nurse. Assisted student. No apparent injury. Awake and alert but sluggish. PERLA. Skin pale, dry. Taken to clinic via w/c to cot. Quickly responded with cool cloth and supine position. 2:00 Pt. was picked up by parent and taken home.
Age: 15.0
Sex: F
Vaccine: IPV
Symptoms: Asthenia, Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Patient received third IPV on 5-10-13. Felt lightheaded, nauseous, numbness in (L) arm and weakness. Sent to ED via ambulance per mom request for evaluation. Sent home. Followed up with PCP in 5-13-13.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 69 year old female patient with morphine allergy. The patient was vaccinated with a dose of ZOSTAVAX (1 time vaccine, dose and lot # unknown), subcutaneous to prevent shingles, 4 years ago, in approximately May 2009. Concomitant therapies included AMBIEN and FOSAMAX. The patient stated she had been diagnosed with shingles on 22-APR-2013. She stated it first broke out under her right breast, and spread in a 6-8 inch band from her front right side (sternum), to her middle right back side. The patient sought unspecified medical attention and was treated with acyclovir. No lab tests were performed. The outcome of shingles was unknown. Additional information has been requested.
Age: 0.78
Sex: M
Vaccine: PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event extra dose given.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: She has a red, warm, swollen area approximately 4 x 3 cm on (L) upper arm.
Age: 8.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Injection site reaction
Clinical narrative: Pt developed a reaction to Tdap vaccine site of im injection on Rt deltoid. Pt was given BENADRYL and TYLENOL.
Age: 0.01
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 2 day old male patient. Medical assistant reported that a baby was given a dose of RECOMBIVAX HB (lot#, route and dose unknown) 5mcg/0.5ml on 05-MAY-2013 and another dose on 07-MAY-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. The outcome and action taken were not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients of unknown age. On numerous unspecified dates, numerous unspecified patients were vaccinated with VAQTA (dose, strength and frequency not provided). VAQTA was improperly stored. This is one of several reports from the same source. Additional information has been requested.
Age: 0.99
Sex: F
Vaccine: VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 11 month old female patient. On 12-AUG-2004 the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route, lot number not reported). The outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site irritation, Nausea
Clinical narrative: This spontaneous report as received from a female patient of unknown age refers to herself with no pertinent medical history and no drug reactions/allergies. On 03-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot# was not reported). There was no concomitant therapy. On 03-MAY-2013, the patient experienced headache, irritation at the injection site and intermittent nausea. It was not reported if the patient seek medical attention. No treatment was given for the adverse event. No lab diagnostics studies was performed. The outcome of the adverse events was unknown. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Asthenia, Autonomic nervous system imbalance, Cardiac arrest, Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: This spontaneous report as received from a 60 years old female nurse with arthritis, drug allergy to CIPRO (really bad nightmares), drug allergy to IMURAN (extreme nausea), allergies, drug allergy to penicillin (rash and facial swelling) and hot flashes refers to herself. It was also reported as that the patient had no pertinent medical history. On 05-MAY-2012 (also reported as 08-MAY-2012) the patient was vaccinated with ZOSTAVAX (lot# reported as 1606AA, expiration date unspecified) 0.65 ml, subcutaneous in the right arm. Concomitant therapies included levothyroxine sodium (manufacture unknown) 0.75 mcg, ibuprofen for arthritis, gabapentin for hot flashes and SUDAFED as needed for allergies. On 12-MAY-2012, the patient began experienced "shortness of breath at rest, increased heart rate, labile blood pressure, and autonomic dysfunctions." On 25-MAY-2012, the patient had a lumbar puncture and unspecified labs done which resulted "negative". She reported that an unspecified physician diagnosed her with "anxiety" after her test result in regards to the symptoms that she was experiencing. She had three separate trips to a hospital, "between May and June 2012" due to generalized weakness. On one occasion in "mid-June", she was admitted overnight to the hospital for diagnosis of anxiety. On 09-JUL-2012, the patient was diagnosed with Guillain-Barre syndrome after having an office visit with physician. An electromyography was done on 11-JUL-2012 which showed severe demyelinating neuropathy. On 12-JUL-2012, the patient was again admitted to the hospital. The patient reported she was given an unspecified treatment in the hospital for Guillain-Barre syndrome but did not respond, so the hospital classified her condition as chronic inflammatory demyelination polyneuropathy (CIDP). During her hospital stay, she reported that she "coded" twice. She reported that she was not discharged from the hospital until the "beginning of September 2012". She stated that she went back in a "couple of days later" because she needed IgG (immunoglobulin G). Since then, she reported that she receives IgG "every three weeks and now walks with a cane at times". The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Demyelinating polyneuropathy, Dyspnoea, Electromyogram abnormal, Heart rate increased, Immunoglobulin therapy
Clinical narrative: This spontaneous report as received from a 60 years old female nurse with arthritis, drug allergy to CIPRO (really bad nightmares), drug allergy to IMURAN (extreme nausea), allergies, drug allergy to penicillin (rash and facial swelling) and hot flashes refers to herself. It was also reported as that the patient had no pertinent medical history. On 05-MAY-2012 (also reported as 08-MAY-2012) the patient was vaccinated with ZOSTAVAX (lot# reported as 1606AA, expiration date unspecified) 0.65 ml, subcutaneous in the right arm. Concomitant therapies included levothyroxine sodium (manufacture unknown) 0.75 mcg, ibuprofen for arthritis, gabapentin for hot flashes and SUDAFED as needed for allergies. On 12-MAY-2012, the patient began experienced "shortness of breath at rest, increased heart rate, labile blood pressure, and autonomic dysfunctions." On 25-MAY-2012, the patient had a lumbar puncture and unspecified labs done which resulted "negative". She reported that an unspecified physician diagnosed her with "anxiety" after her test result in regards to the symptoms that she was experiencing. She had three separate trips to a hospital, "between May and June 2012" due to generalized weakness. On one occasion in "mid-June", she was admitted overnight to the hospital for diagnosis of anxiety. On 09-JUL-2012, the patient was diagnosed with Guillain-Barre syndrome after having an office visit with physician. An electromyography was done on 11-JUL-2012 which showed severe demyelinating neuropathy. On 12-JUL-2012, the patient was again admitted to the hospital. The patient reported she was given an unspecified treatment in the hospital for Guillain-Barre syndrome but did not respond, so the hospital classified her condition as chronic inflammatory demyelination polyneuropathy (CIDP). During her hospital stay, she reported that she "coded" twice. She reported that she was not discharged from the hospital until the "beginning of September 2012". She stated that she went back in a "couple of days later" because she needed IgG (immunoglobulin G). Since then, she reported that she receives IgG "every three weeks and now walks with a cane at times". The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Labile blood pressure, Laboratory test normal, Lumbar puncture normal, Walking aid user
Clinical narrative: This spontaneous report as received from a 60 years old female nurse with arthritis, drug allergy to CIPRO (really bad nightmares), drug allergy to IMURAN (extreme nausea), allergies, drug allergy to penicillin (rash and facial swelling) and hot flashes refers to herself. It was also reported as that the patient had no pertinent medical history. On 05-MAY-2012 (also reported as 08-MAY-2012) the patient was vaccinated with ZOSTAVAX (lot# reported as 1606AA, expiration date unspecified) 0.65 ml, subcutaneous in the right arm. Concomitant therapies included levothyroxine sodium (manufacture unknown) 0.75 mcg, ibuprofen for arthritis, gabapentin for hot flashes and SUDAFED as needed for allergies. On 12-MAY-2012, the patient began experienced "shortness of breath at rest, increased heart rate, labile blood pressure, and autonomic dysfunctions." On 25-MAY-2012, the patient had a lumbar puncture and unspecified labs done which resulted "negative". She reported that an unspecified physician diagnosed her with "anxiety" after her test result in regards to the symptoms that she was experiencing. She had three separate trips to a hospital, "between May and June 2012" due to generalized weakness. On one occasion in "mid-June", she was admitted overnight to the hospital for diagnosis of anxiety. On 09-JUL-2012, the patient was diagnosed with Guillain-Barre syndrome after having an office visit with physician. An electromyography was done on 11-JUL-2012 which showed severe demyelinating neuropathy. On 12-JUL-2012, the patient was again admitted to the hospital. The patient reported she was given an unspecified treatment in the hospital for Guillain-Barre syndrome but did not respond, so the hospital classified her condition as chronic inflammatory demyelination polyneuropathy (CIDP). During her hospital stay, she reported that she "coded" twice. She reported that she was not discharged from the hospital until the "beginning of September 2012". She stated that she went back in a "couple of days later" because she needed IgG (immunoglobulin G). Since then, she reported that she receives IgG "every three weeks and now walks with a cane at times". The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old patient (gender not provided). No information regarding the patient's medical history was provided. On 04-MAY-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml subcutaneously, lot # H021710. The pharmacist reported that she took the vial of ZOSTAVAX that expired in March 2013 from a carton of lot # H021710 (expiry date: 03/07/2014). The pharmacist did not document the lot # and expiration date of the dose of ZOSTAVAX, and she discarded the vial in the sharps container of her facility. No adverse effect has been observed or reported. No outcome was reported. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old patient (gender not provided). No information regarding the patient's medical history was provided. On 04-MAY-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml subcutaneously, lot # H021710. The pharmacist reported that she took the vial of ZOSTAVAX that expired in March 2013 from a carton of lot # H021710 (expiry date: 03/07/2014). The pharmacist did not document the lot # and expiration date of the dose of ZOSTAVAX, and she discarded the vial in the sharps container of her facility. No adverse effect has been observed or reported. No outcome was reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age who had numerous allergies and received numerous allergy shot. On an unknown date the patient was vaccinated with PNEUMOVAX 23. The pharmacist reported that "getting the pneumonia vaccine almost killed her". The outcome of event was unknown. The relationship between event and therapy was unknown. Additional information has been requested.
Age: 1.32
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Cough, Injection site urticaria, Otitis media, Skin lesion, Urticaria
Clinical narrative: (VAERS filed by HC- urticaria w/i 6-8 hrs post-vaccine receipt) 17 mo old girl who developed urticaria about 6-8 hours after vaccine receipt on 29 MAR 2013. Dtap, influenza split vaccine, and Hib vaccines all injected into her upper thighs. She tolerated the vaccines well without any immediate reaction or rash. Mother reported that night, patient developed hives on her right arm that lasted for about 2 hours and resolved before she went to sleep. They were raised lesions on an erythematous base. They were not pruritic. They did not leave a mark after they resolved. They returned the next day this time on her legs. PER CLINIC On March 30th: patient developed blanchable welts over her body. Mom reported that she has none on her face, no swelling of the lips or tongue, no difficulty breathing. Mom reported that she has had no fever, she doesn't seem bothered by the welts, but they are moving around and spreading. She has otherwise been well. PER ALLERGY HPI on 8 MAY: The lesions came and went and no individual lesion lasted longer than 24 hours. This lasted for 1 week. The injection sites remained clear without any rash or swelling. In addition, patient had gastroenteritis with vomiting and diarrhea during this time that began March 14, resolved within a week or so, but returned. Mother said her only medication at the time was probiotic. In addition, around the time of her vaccine receipt, she also had a cough about which mother spoke to PCM on April 1. She was ultimately diagnosed with otitis media April 5 and given amoxicillin. The rash had resolved around that time. She had no angioedema at any time during this period. Patient had had Dtap and Hib before, but this was the first time having the flu vaccine. She has never had urticaria before.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Hypopnoea, Insomnia, Musculoskeletal chest pain, Musculoskeletal discomfort
Clinical narrative: Vaccine was injected by the pharmacist in upper right arm in fatty tissue on 4/5/13 at 11:00 am. All symptoms were on my right side. About five hours after the shot I noticed that breathing deep breaths were becoming painful in my right rib cage just below my right breast. Felt like I had a cracked rib though nothing was particularly painful to the touch. To avoid pain I restrained my breathing to shallow breaths, but stomach hiccups and yawning were painful. By 7:00 pm that evening, the "cracked rib" pain became so painful I had to breathe in extremely shallow breaths. Pain level was about a 10, same as  a kidney stone. Wrapping my upper chest with an ace bandage helped. Could only lay my back to avoid rib area pain. Slept only a few hours off and on during the night. By 7:00 am the next morning pain subsided and I could breathe almost normally as long as I didn't take deep breaths, and I slept for six hours. By six pm later that day, I could breathe normally without pain, but deep, sudden breaths would create discomfort in my rib cage and neck area. Painful symptoms continue to subside, but now deep breaths cause some pain in the sinews in my right neck going from my shoulder to my head. Also during the same time frame, my right shoulder became painful like I had slammed it against a brick wall. No particular position relieved the pain. Shoulder pain also subsided at about the same pace. Pain in both areas subsided over next few days and pretty much undetectable for four days later.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Neck pain, Pain, Painful respiration
Clinical narrative: Vaccine was injected by the pharmacist in upper right arm in fatty tissue on 4/5/13 at 11:00 am. All symptoms were on my right side. About five hours after the shot I noticed that breathing deep breaths were becoming painful in my right rib cage just below my right breast. Felt like I had a cracked rib though nothing was particularly painful to the touch. To avoid pain I restrained my breathing to shallow breaths, but stomach hiccups and yawning were painful. By 7:00 pm that evening, the "cracked rib" pain became so painful I had to breathe in extremely shallow breaths. Pain level was about a 10, same as  a kidney stone. Wrapping my upper chest with an ace bandage helped. Could only lay my back to avoid rib area pain. Slept only a few hours off and on during the night. By 7:00 am the next morning pain subsided and I could breathe almost normally as long as I didn't take deep breaths, and I slept for six hours. By six pm later that day, I could breathe normally without pain, but deep, sudden breaths would create discomfort in my rib cage and neck area. Painful symptoms continue to subside, but now deep breaths cause some pain in the sinews in my right neck going from my shoulder to my head. Also during the same time frame, my right shoulder became painful like I had slammed it against a brick wall. No particular position relieved the pain. Shoulder pain also subsided at about the same pace. Pain in both areas subsided over next few days and pretty much undetectable for four days later.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abnormal behaviour, Chest discomfort, Confusional state, Cough, Crying
Clinical narrative: Tightness in chest; Labored breathing; Behavior changes; Insomnia; Dry-hoarse cough; Staring-eye become fixated; Crying; Nervous; Despondent; Incessant talking (repeating herself over & over); Confused; Can't focus/concentrate; Patient never experienced this before.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Disturbance in attention, Dysphonia, Dyspnoea, Insomnia, Logorrhoea
Clinical narrative: Tightness in chest; Labored breathing; Behavior changes; Insomnia; Dry-hoarse cough; Staring-eye become fixated; Crying; Nervous; Despondent; Incessant talking (repeating herself over & over); Confused; Can't focus/concentrate; Patient never experienced this before.