chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Rib excision, Spinal laminectomy, Spinal operation
Clinical narrative: Spontaneous information received on 03MAY2013 and 08MAY2013 from a family member of a consumer. An adult male experienced Valley Fever (coccidioidomycosis), and subsequently died. Medical history - the subject was reportedly in good physical condition. No known medical history. History of events per adult subject's father. Subject was immunized in October of 2007. Within a day of vaccination he experienced pain and illness, though the father could not remember the nature of immediate post-vaccination symptoms. He was eventually diagnosed with Valley Fever (coccidioidomycosis) contracted during his time at work. "He did not respond to treatment. The doctors said his immune system was not working. He had several surgeries. He was given many drugs that did not stop the infection." Reportedly, he was let go due to his illness. In 2011 he had 3 surgeries to remove 2 1/2 ribs and portions of his spinal bones, and further surgery to reinforce his spine. In 2013, he had "pockets" of infection in his bones; belly, and brain as well as his lungs. He refused treatment with a ventilator and subsequently died on 22APR2013. Per the subject's father: "His work gave him the vaccines. The doctors treated his infection. The doctors said the vaccine did not cause his infection. They said the vaccines did not cause his immune system to stop working. The employer said we could not sue. The employer is not telling us everything."
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Vomiting
Clinical narrative: Baby developed vomiting, bloody stools. Seen in urgent care -> transferred to hospital for enema reduction of intussusception.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ, PPV
Symptoms: Blood culture, Injection site erythema, Injection site induration, Pyrexia, White blood cell count increased
Clinical narrative: Fever/erythema and induration (L) deltoid. Blood culture sent/WBC 40K/ROCEPHIN.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unspecified age ("between 18 and 24 years old"). On an unknown date the patient was vaccinated subcutaneously with an expired dose of 0.5 ml M-M-R II (lot # 669672/0155AA, expiry date 01-FEB-2013). No adverse effects reported. The patient sought medical attention via office visit. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative, Type 1 diabetes mellitus
Clinical narrative: This spontaneous report received from a medical assistant concerning a current 28 year old female patient with no known drug allergies. On an unknown date the patient was vaccinated with M-M-R II (dose, route and lot# not reported) as a child. On an unspecified date, the patient was diagnosed with Type I diabetes treated with insulin. It was reported that the patient had Measles, Mumps and Rubella titers drawn for employment. There was documented that patient received M-M-R II as a child, but the titers came back negative on an unspecified date. There was no treatment given for the event. At the time of reporting, the patient's outcome was unknown. The patient did not seek any medical attention. Additional information is not expected.
Age: 0.36
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX vaccine given to a 4 month old. No reaction noted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Painful red rash at injection site. Was painful since the vaccine was administered - unknown when the rash developed - notivied 5/14/13.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphagia, Cardiac operation, Death, Faecal incontinence, Fatigue
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 77 years old male patient with cancer. Approximately in May 2010, reported as approximately 3 years ago, patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number and expiration date not reported). Reporter stated that patient wasn't on anything and was pretty healthy. No concomitant medications were reported. On an unknown date the patient experienced cancer. Approximately in May 2011, reported as about two years ago, patient died. Reporter stated that she didn't know if it was from cancer or vaccine and none of doctors could pinpoint the reason of death. On an unknown date the patient even had to have open heart surgery. Consumer reported also that at the end of his life (approximately in 2011) he experienced breaking out over his entire body, extremely painful, he couldn't eat, couldn't sleep and had temporary loss of bowel control. The patient complained also about pain through his entire body and severe fatigue. On an unknown date patient was hospitalized and then moved to hospice facility. He sought medical attention. The treatment given for the events were reported by the consumer as: the doctors said "maybe it's this maybe it's that". The outcome of open heart surgery, cancer, breaking out over his entire body, extremely painful, couldn't eat, couldn't sleep, temporary loss of bowel control, pain through his entire body and severe fatigue was not reported. The relatedness open heart surgery, cancer, breaking out over his entire body, extremely painful, couldn't eat, couldn't sleep, temporary loss of bowel control, pain through his entire body and severe fatigue between and ZOSTAVAX was not reported. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Neoplasm malignant, Pain, Rash generalised
Clinical narrative: This spontaneous report as received from a consumer refers to an approximately 77 years old male patient with cancer. Approximately in May 2010, reported as approximately 3 years ago, patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number and expiration date not reported). Reporter stated that patient wasn't on anything and was pretty healthy. No concomitant medications were reported. On an unknown date the patient experienced cancer. Approximately in May 2011, reported as about two years ago, patient died. Reporter stated that she didn't know if it was from cancer or vaccine and none of doctors could pinpoint the reason of death. On an unknown date the patient even had to have open heart surgery. Consumer reported also that at the end of his life (approximately in 2011) he experienced breaking out over his entire body, extremely painful, he couldn't eat, couldn't sleep and had temporary loss of bowel control. The patient complained also about pain through his entire body and severe fatigue. On an unknown date patient was hospitalized and then moved to hospice facility. He sought medical attention. The treatment given for the events were reported by the consumer as: the doctors said "maybe it's this maybe it's that". The outcome of open heart surgery, cancer, breaking out over his entire body, extremely painful, couldn't eat, couldn't sleep, temporary loss of bowel control, pain through his entire body and severe fatigue was not reported. The relatedness open heart surgery, cancer, breaking out over his entire body, extremely painful, couldn't eat, couldn't sleep, temporary loss of bowel control, pain through his entire body and severe fatigue between and ZOSTAVAX was not reported. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Fever, erythema and induration area of injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left lateral upper arm swelling, redness and warmth. Positive itching and, discomfort approximately 24 hours after injection.
Sex: U
Vaccine: DTAP
Symptoms: Irritability
Clinical narrative: Irritable. Documents held by sender: None.
Age: 5.0
Sex: M
Vaccine: HEPA, MMRV, TDAP
Symptoms: Injection site pain, Injection site urticaria, Wheezing
Clinical narrative: PROQUAD immunization given on the left triceps, reaction occurred within ten minutes - injection site became welted and painful - wheezing heard. Administration 0.24 ml Epinephrine/10ml x BENADRYL.
Age: 0.2
Sex: U
Vaccine: DTAP
Symptoms: Blood test normal, Petechiae
Clinical narrative: Initial report received from a healthcare professional (physician) on 10 September 2012. A 02-month-old patient whose gender medical history and concomitants medications were not reported; had received intramuscular (IM) DAPTACEL injection (batch number, dose, dose number were not reported) in left thigh region on unspecified date. 12 days after vaccination, the patient has small amount of petechiae on both lower extremities. The patient had blood work done which was negative. It was reported that MD did not had patient chart and could not provide further information. Details of treatment was not reported. The patient's outcome was unknown. Documents held by sender: None.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age, unknown gender. On 10-MAY-2013 the patient was vaccinated with first dose of GARDASIL (lot # 668261/1397AA) that expired on 09-APR-2013 (strength, dose, frequency, route and site unspecified). The patient was not experiencing any symptoms. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: TYP, YF
Symptoms: Feeling abnormal, Headache
Clinical narrative: Headache, puny feeling that comes and goes.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site erythema, Injection site movement impairment, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Rt arm swollen, hot and red. Mom states pt c/o of hurting and could not lift her arm very far. Went to the ER.
Age: 43.0
Sex: F
Vaccine: TYP, YF
Symptoms: Dysphonia, Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath, hoarseness, tired feeling, headache; ibubrofen was taken and it helped some per patient.  Told to call doctor.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Diet refusal, Pyrexia
Clinical narrative: Child would not eat and fever started per mother child would not eat until next day when we had her come in to be checked out because the mother stated she had not eaten in over 12 hours and fevers hadn't broken.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot
Clinical narrative: Arm of injection is red and hot. Erythema has spread down patient's arm over the past few days.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Site of injection became red and itchy with in 30 min or less. Over next four days pt describes pain as if someone punched her and on incident of it feeling a sharp pain only at site.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: Mild pain, could not move the arm. Symptoms peaked Saturday night Sunday.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Blister, Erythema, Feeling hot
Clinical narrative: Red area, warmth and small vesicles.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: When child woke up Sunday AM mother states his lt arm was red, warm to touch and sl swollen.  When she called to report incident on Monday AM, she states area has grown to approx 5 inches in diameter. Area is warm to touch red and hard. She had just been contacted by school nurse with concerns about the area and was encouraged to call and report it to the HD.  Advised client to contact MD to assess it and requested that mother call back to HD with outcome of MD visit.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Pain in extremity, Rash
Clinical narrative: Extreme swelling of left arm from shoulder to elbow. Burning/hot sensation in full arm, Red rash from shoulder down to forearm. Above lasted 4 days. Day 5 soreness and slight rash on upper arm.
Age: 11.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: The child was given 1 Tdap and 1 Flu imunizations in the morning and 1 Tdap and 1 Flu immunizations in the afternoon because of duplicate consents. The child did not verbalize that she received shots in the morning even though she was asked when was the last time she received shots.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Breath sounds abnormal, Chest X-ray, Cough, Fall, Gait disturbance
Clinical narrative: Exactly a week after the chicken pox vaccine patient started with fever of 101. Sudden onset. Did not have any cold symptoms that day. Then he was fussy, when walking he was just stumbling around and would fall over. Then on 05/18/2013 he started with slight wheezing, cough and rattling in chest. Was taken to doctor's office on 05/20/2013.
Age: 1.02
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability, Pyrexia, Wheezing
Clinical narrative: Exactly a week after the chicken pox vaccine patient started with fever of 101. Sudden onset. Did not have any cold symptoms that day. Then he was fussy, when walking he was just stumbling around and would fall over. Then on 05/18/2013 he started with slight wheezing, cough and rattling in chest. Was taken to doctor's office on 05/20/2013.
Age: 1.34
Sex: M
Vaccine: MMR, PPV, PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: THERE WAS NO ADVERSE SIGNS OF SYMPTOMS.
Age: 1.34
Sex: M
Vaccine: MMR, PPV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: THERE WAS NO ADVERSE SIGNS OF SYMPTOMS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Audiogram abnormal, Deafness unilateral, Ear congestion, Eustachian tube dysfunction, Hypoacusis
Clinical narrative: Patient reports left ear fullness with an inability to hear the day following the administration of Zostavax, with NO associated pain, fever, or discharge from the ear.  Also experiencing vertigo described as the feeling one gets after getting off a roller coaster and muffled hearing. Seen on 4/22/13 for on-going symptoms for Eustachian Tube Dysfunction r/o allergic rhinitis.  Rx'd fluticasone nasal suspension and took pseudoephedrine with no relief. Symptoms worsened as reported by patient 4/24/2013 in left ear.  Rx'd prednisone 1000 mg taper over 16 days and Valtrex 1000 mg twice daily on 4/29/2013 and began to improve.  Audiology exam on 4/29/2013 showed mild hearing loss in left ear.  MRI was negative for acoustic neuroma.  Pt reported tinnitus in left ear on 5/17/2013.  Symptoms continue to improve.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Tinnitus, Vertigo
Clinical narrative: Patient reports left ear fullness with an inability to hear the day following the administration of Zostavax, with NO associated pain, fever, or discharge from the ear.  Also experiencing vertigo described as the feeling one gets after getting off a roller coaster and muffled hearing. Seen on 4/22/13 for on-going symptoms for Eustachian Tube Dysfunction r/o allergic rhinitis.  Rx'd fluticasone nasal suspension and took pseudoephedrine with no relief. Symptoms worsened as reported by patient 4/24/2013 in left ear.  Rx'd prednisone 1000 mg taper over 16 days and Valtrex 1000 mg twice daily on 4/29/2013 and began to improve.  Audiology exam on 4/29/2013 showed mild hearing loss in left ear.  MRI was negative for acoustic neuroma.  Pt reported tinnitus in left ear on 5/17/2013.  Symptoms continue to improve.
Age: 66.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Blood culture negative, Cellulitis, Chills, Injection site erythema, Injection site pain
Clinical narrative: Fevers to 102.7, chills, rigor, redness, pain and erythema at site of injection, leukocytosis of 23,000 noted in ER, diagnosed with cellulitis, started on antibiotics, blood cultures negative thus far.
Age: 66.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Leukocytosis, Pyrexia, White blood cell count increased
Clinical narrative: Fevers to 102.7, chills, rigor, redness, pain and erythema at site of injection, leukocytosis of 23,000 noted in ER, diagnosed with cellulitis, started on antibiotics, blood cultures negative thus far.
Age: 68.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Dyspnoea, Hypertension, Nausea, Vomiting
Clinical narrative: NAUSEA, HIGH BLOOD PRESSURE, UNABLE TO BREATHE, VOMITING, DIARRHEA.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy
Clinical narrative: Information has been received from a physician concerning an adult female patient for GARDASIL, a Pregnancy Registry product. It was reported that the patient, on an unknown dates, received the first and the second dose of GARDASIL (dose and lot # not reported). It was reported that the patient was pregnant (dates of last menstrual period and estimated date of delivery unknown) and the physician was asking if the third dose of GARDASIL could be given in pregnancy. The patient will turn 26 before the pregnancy is completed. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old female patient with no pertinent medical history and no drug reactions/allergies. On 22-APR-2013 the patient was vaccinated with ZOSTAVAX (lot # H020846, exp 20-FEB-2014) subcutaneously. There was no concomitant medication. The pharmacist reported that a patient experienced an injection site reaction following vaccination with ZOSTAVAX. The pharmacist described the injection site reaction that started the day after vaccination with ZOSTAVAX on 23-APR-2013, as a swollen, itchy, red area at the injection site. The pharmacist reported that the original injection site reaction improved (time frame of improvement unspecified), but there was still a discolored area at the injection site, described as looking like a bruise, but did not hurt or itch. The patient contacted pharmacist for medical attention. No treatment was given for the events. No lab diagnostics studies were performed. This is one of several reports from the same source. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy, Human papilloma virus test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a consumer, for GARDASIL a pregnancy registry product, concerning a 27 year old female patient with erythromycin allergies/ erythromycin reactions and none pertinent medical history. The patient received a first dose of an unspecified HPV vaccine "a little over a week ago (approximately 2013) and might possibly be pregnant." The patient became pregnant. The LMP and EDD were not known. The pregnancy outcome was outcome pending. Consumer stated "he thought the patient (his girlfriend) was at the end of menstrual cycle now" and "the patient (his girlfriend) received GARDASIL, intramuscular, injection 120Y (lot number not provided) in approximately 2013 because she had a positive HPV test." No concomitant medication. No sought medical attention. No treatment was given for AE. No lab diagnostics studies performed. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 6 month old female patient. On 08-MAY-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot# 0184AA, expiration date 05-OCT-2012) which was the 3rd dose in the series. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine was given the afternoon of 5/13/13. That night mother noted his arm there was no redness. On 5/15/13 redness was noted below the injection site. There was an area of redness and warmth. The arm (upper) was swollen compared to the other arm. No itching, pain or breathing difficulties. No treatment. On 5/17/13 area had mostly resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to unknown number of patients. On unknown dates the patients were vaccinated with ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that there might have been other patients that experienced injection site reactions following vaccination with ZOSTAVAX, but the pharmacist could not provide specific details of other injection site reactions with ZOSTAVAX at the time of the call. The outcome of injection site reactions is unknown. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot # were unknown). On an unknown date the patient experienced itchiness and redness at the unspecified injection site. The outcome of event was reported as recovered/resolved. The patient had sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Injection site pruritus, Injection site vesicles, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On approximately 01-MAY-2013 (reported as a week ago) the patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot# not provided). On approximately 01-MAY-2013 (reported as a week ago) the patient experienced itching, water blisters around the injection site area, redness and swelling after receiving the ZOSTAVAX vaccine. The patient also went to employee health services and was diagnosed with cellulitis. Therapy was not reintroduced. All reactions cleared within 24 hours. The patient recovered in approximately May, 2013. This is one of several reports from same reporter. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 89 year old female patient. In 2008 the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). At some time over the past few weeks, approximately in 2013 the patient developed ophthalmic zoster. The outcome of ophthalmic zoster was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site vesicles, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age (anonymous, exact number of patients unspecified). On approximately 01-MAY-2013 (reported as a week ago) the patients were vaccinated subcutaneously with a dose of ZOSTAVAX (lot# not reported). On approximately 01-MAY-2013 (reported as a week ago) the patients experienced itching, water blisters around the injection site area, redness and swelling after receiving the ZOSTAVAX vaccine. Therapy was not reintroduced. All reactions cleared within 24 hours. The patient recovered in approximately May, 2013. This is one of several reports from same reporter. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: TD, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician refers to a 67 year old male patient with benign prostatic hypertrophy, carpal tunnel, hypertension, skin neoplasm, spinal stenosis, scalp malignant squamous cell carcinoma, organic impotence and hyperlipidemia. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX lot # J000436, exp. 10-APR-2014, subcutaneous in the left arm. Concomitant therapy included tetanus and diphtheria toxoids, absorbed (manufacturer unknown) administered on the same day at separate site. Concomitant therapy also included other unspecified medications. The physician reported that the patient developed an injection site reaction following vaccination with ZOSTAVAX. The physician described the injection site reaction as an erythematous, indurated, swollen area at the injection site about 5 by 15 cm in size. No lab test was done. The patient was not recovered from the event. The patient contacted office to seek medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: The primary reporter is the pharmacist. She reported that M-M-R II (dose, strength, route and lot # was unknown) had been exposed to 48F for 48 hours, and was unsure if it had been administered to any patients. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Developed redness/swelling/itching at site 6 hours after injection. Worsened overnight and next day, antihistamines improving.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia
Clinical narrative: No c/o difficulty breathing just having swallowing difficulty.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: Information has been received from a registered nurse and a Licensed Practical Nurse concerning an unspecified patient who on 08-MAY-2013 was vaccinated with a dose of VARIVAX (merck) (lot# H012506, exp. 25-JUN-2014). The registered nurse reported that she was reviewing vaccine logs at a local clinic and that the temperature log for the freezer has been inconsistent and the VARIVAX (merck) may have reached improper temperatures. Nurse reported that VARIVAX (merck) had been out of recommended temperature range since 01-FEB-2013 and had not been back into proper temperature range. Highest temperature reached was 20.1 F. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a healthcare worker at a physician office, who is not a health care professional, refers to unspecified number of patients of unknown demographics. On an unknown date in 2013 (reported as recently), the patient was vaccinated with dose of PNEUMOVAX 23 (Lot number, expiry date, route and dose were not reported). On an unknown date in 2013 (reported as recently), the patient have experienced more redness at the injection site after the administration of PNEUMOVAX 23. The outcome of more redness at the injection site after the administration of PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Injection site erythema, Injection site nodule
Clinical narrative: Large reddened swollen knot at injection site associated with a temperature of 103 degrees. Keeps spreading and worsening.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Asthenia, Injection site erythema, Local reaction, Petechiae, Somnolence
Clinical narrative: Vomiting morning after vaccine x 1 resulting in periorbital petechiae. Puny, very sleepy and energyless Sat am. Large swelling and erythematous local rxn at (R) deltoid, arm (upper).
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling, Vomiting
Clinical narrative: Vomiting morning after vaccine x 1 resulting in periorbital petechiae. Puny, very sleepy and energyless Sat am. Large swelling and erythematous local rxn at (R) deltoid, arm (upper).
Age: 23.0
Sex: U
Vaccine: TYP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting one full day after 3rd dose. Diarrhea one week.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # and expiration date unspecified) (dose and route unspecified). The pharmacist reported that the patient received a dose of improperly stored ZOSTAVAX. The vaccine was given to the patient after it was exposed to 70 F for 48 hours and then refrigerated for 24 hours. No adverse effect reported. Follow up information was received from pharmacist who stated that the ZOSTAVAX was only exposed to 70 F for 64 hours. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site pain, Injection site swelling
Clinical narrative: After pt was given Tdap vaccine she developed swelling and pain at injection site. Pt stated sx continued for approx 1 week that she decided to go to urgent care. Pt was diagnosed with cellulitis and treated with KEFLEX. Her arm did improve on KEFLEX and will f/u with RP if needed.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Tonic-clonic like movements and syncopal episode following GARDASIL administration.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site swelling, redness, pruritus, tingling and heat on day 2. Rx Ibuprofen and ice.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Hypotonia, Mydriasis, Pallor, Tonic clonic movements
Clinical narrative: About 5 mins after vaccine administration, patient became pale, limp (slumped back) with a few tonic clonic jerks of her upper extremities, pupils dilated to 5 mm bilaterally - 30 seconds later arousable and interactive and felt fine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Headache, Injection site erythema, Injection site pain
Clinical narrative: Swelling beginning 9 hrs after injection, redness, pain at site and down left arm, pain in left leg as well, no fever. Redness and heat has increased from elbow to shoulder. Went to clinic Friday night 7pm with swelling and redness at site only. Now there is a red raised lesion above and below site (Sun 11 AM). Minor head pain beginning Sat PM lesion is flat, customer feels better 5/14/13 9:45 AM.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Skin lesion
Clinical narrative: Swelling beginning 9 hrs after injection, redness, pain at site and down left arm, pain in left leg as well, no fever. Redness and heat has increased from elbow to shoulder. Went to clinic Friday night 7pm with swelling and redness at site only. Now there is a red raised lesion above and below site (Sun 11 AM). Minor head pain beginning Sat PM lesion is flat, customer feels better 5/14/13 9:45 AM.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria present on abdomen about 1 1/2 hrs after receiving today's vaccines. No shortness of breath. No skin reaction at site of immunizations symptoms improved s/p BENADRYL.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Oedema peripheral, Pruritus, Pyrexia
Clinical narrative: Fever, chills arm red and swollen (left) itchy. Size of silver dollar Prednisone prescribed.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dysarthria, Dyskinesia, Narcolepsy
Clinical narrative: This spontaneous report was received from a healthcare student, regarding an unknown age and gender patient with no pertinent medical history reported. On 01-MAY-2013 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not specified) (dose and route not specified). The first dose was administered in April 2012. No other suspect therapies or concomitant medications were reported. The reporter stated that the patient developed narcolepsy, slurred speech, abnormal movements and weakness after receiving second dose of GARDASIL. It was reported that the patient was hospitalized at an unspecified hospital on an unspecified date. The outcome for narcolepsy, slurred speech, abnormal movements and weakness was unknown at the time of the report. No treatment information was reported. The reporter did not assess the causality between GARDASIL and narcolepsy, slurred speech, abnormal movements and weakness. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Asthenia, Dysarthria, Dyskinesia, Narcolepsy
Clinical narrative: This spontaneous report was received from a healthcare student, regarding an unknown age and gender patient with no pertinent medical history reported. On 01-MAY-2013 the patient was vaccinated with the second dose of GARDASIL (lot number and expiration date not specified) (dose and route not specified). The first dose was administered in April 2012. No other suspect therapies or concomitant medications were reported. The reporter stated that the patient developed narcolepsy, slurred speech, abnormal movements and weakness after receiving second dose of GARDASIL. It was reported that the patient was hospitalized at an unspecified hospital on an unspecified date. The outcome for narcolepsy, slurred speech, abnormal movements and weakness was unknown at the time of the report. No treatment information was reported. The reporter did not assess the causality between GARDASIL and narcolepsy, slurred speech, abnormal movements and weakness. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age who on an unknown date, was vaccinated with a dose MMR II (dose, route and lot number not reported) that was expired. No adverse effect was reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site reaction, Local reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no pertinent medical history and no drug reactions or allergies. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000436, expiration date 10-APR-2014) 0.65 ml, once, subcutaneous for prevention. Concomitant therapies included PLAVIX and COZAAR. The pharmacist reported that on 13-MAY-2013, a few hours after receiving ZOSTAVAX in her left arm, patient developed a spot at the site of injection. Pharmacist stated at that time, the spot was just a localized reaction. The patient then went to see her unspecified primary care provider on an unspecified date, at which time the red spot had grown to 5-6 inches in length and 3 inches in diameter. Pharmacist reported that the patient's primary care provider referred to an unspecified reconstructive skin surgeon who diagnosed her reaction as an outbreak of shingles. Pharmacist reported that patient was currently still experiencing the outbreak of shingles. Treatment was not given and laboratory tests were not performed. At the time of the report the outcome of outbreak of shingles and localized reaction was reported as not recovered/not resolved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no pertinent medical history and no drug reactions or allergies. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # J000436, expiration date 10-APR-2014) 0.65 ml, once, subcutaneous for prevention. Concomitant therapies included PLAVIX and COZAAR. The pharmacist reported that on 13-MAY-2013, a few hours after receiving ZOSTAVAX in her left arm, patient developed a spot at the site of injection. Pharmacist stated at that time, the spot was just a localized reaction. The patient then went to see her unspecified primary care provider on an unspecified date, at which time the red spot had grown to 5-6 inches in length and 3 inches in diameter. Pharmacist reported that the patient's primary care provider referred to an unspecified reconstructive skin surgeon who diagnosed her reaction as an outbreak of shingles. Pharmacist reported that patient was currently still experiencing the outbreak of shingles. Treatment was not given and laboratory tests were not performed. At the time of the report the outcome of outbreak of shingles and localized reaction was reported as not recovered/not resolved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Disturbance in attention, Feeling abnormal, Herpes zoster, Influenza like illness
Clinical narrative: This spontaneous report as received from a 79 year old female consumer (reporting on herself). The patient had current conditions including blood pressure issues, chronic bronchitis, chronic obstructive pulmonary disease (COPD) with emphysema and glaucoma. The patient did not have any drug reaction allergy. It was reported that about five years ago, approximately in May 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (1 dose, route unspecified). Concomitant therapy included minerals (unspecified), CENTRUM SILVER (OTC product), calcium carbonate, CALTRATE 600 PLUS VITAMIN D (OTC product), ibuprofen, oxygen, fluticasone propionate, ADVAIR, SPIRIVA, albuterol, gabapentin, lisinopril, baby aspirin (OTC product) self prescribed, hydrochlorothiazide HGTZ and TRUSOPT. On or about 03-APR-2013, the patient broke out with shingles. She said at first she felt as if she was getting the flu and this lasted a day or two. Finally she felt feverish and she went to bed and slept 19 hours straight and when she woke up she noticed blisters erupting on the left side of her face above her eyebrow. She said she went to the doctor about 4 days later. The patient described the having itching, painful blisters in the left side of her face and scalp and on around her left eye. She also said that since this occurred she had been having her feet swelling as well as her ankles. The patient also said that for the past few weeks she does not felt as "sharp" as she usually did. She claimed she was having a hard time focusing on what she was saying and seemed forgetful. The patient sought medical attention and was given acyclovir, NEURONTIN, ZADITOR, erythromycin, VICODEN and tramadol as a treatment for adverse events. Laboratory diagnostic studies were not performed recently. At the time of the report the flu symptoms were recovered, the shingles, swelling of ankles and feet were reported as recovering. The event hard time focusing on what she was saying and seemed forgetful were reported as not recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Memory impairment, Oedema peripheral, Pain, Pruritus
Clinical narrative: This spontaneous report as received from a 79 year old female consumer (reporting on herself). The patient had current conditions including blood pressure issues, chronic bronchitis, chronic obstructive pulmonary disease (COPD) with emphysema and glaucoma. The patient did not have any drug reaction allergy. It was reported that about five years ago, approximately in May 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (1 dose, route unspecified). Concomitant therapy included minerals (unspecified), CENTRUM SILVER (OTC product), calcium carbonate, CALTRATE 600 PLUS VITAMIN D (OTC product), ibuprofen, oxygen, fluticasone propionate, ADVAIR, SPIRIVA, albuterol, gabapentin, lisinopril, baby aspirin (OTC product) self prescribed, hydrochlorothiazide HGTZ and TRUSOPT. On or about 03-APR-2013, the patient broke out with shingles. She said at first she felt as if she was getting the flu and this lasted a day or two. Finally she felt feverish and she went to bed and slept 19 hours straight and when she woke up she noticed blisters erupting on the left side of her face above her eyebrow. She said she went to the doctor about 4 days later. The patient described the having itching, painful blisters in the left side of her face and scalp and on around her left eye. She also said that since this occurred she had been having her feet swelling as well as her ankles. The patient also said that for the past few weeks she does not felt as "sharp" as she usually did. She claimed she was having a hard time focusing on what she was saying and seemed forgetful. The patient sought medical attention and was given acyclovir, NEURONTIN, ZADITOR, erythromycin, VICODEN and tramadol as a treatment for adverse events. Laboratory diagnostic studies were not performed recently. At the time of the report the flu symptoms were recovered, the shingles, swelling of ankles and feet were reported as recovering. The event hard time focusing on what she was saying and seemed forgetful were reported as not recovered. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a 79 year old female consumer (reporting on herself). The patient had current conditions including blood pressure issues, chronic bronchitis, chronic obstructive pulmonary disease (COPD) with emphysema and glaucoma. The patient did not have any drug reaction allergy. It was reported that about five years ago, approximately in May 2008, the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (1 dose, route unspecified). Concomitant therapy included minerals (unspecified), CENTRUM SILVER (OTC product), calcium carbonate, CALTRATE 600 PLUS VITAMIN D (OTC product), ibuprofen, oxygen, fluticasone propionate, ADVAIR, SPIRIVA, albuterol, gabapentin, lisinopril, baby aspirin (OTC product) self prescribed, hydrochlorothiazide HGTZ and TRUSOPT. On or about 03-APR-2013, the patient broke out with shingles. She said at first she felt as if she was getting the flu and this lasted a day or two. Finally she felt feverish and she went to bed and slept 19 hours straight and when she woke up she noticed blisters erupting on the left side of her face above her eyebrow. She said she went to the doctor about 4 days later. The patient described the having itching, painful blisters in the left side of her face and scalp and on around her left eye. She also said that since this occurred she had been having her feet swelling as well as her ankles. The patient also said that for the past few weeks she does not felt as "sharp" as she usually did. She claimed she was having a hard time focusing on what she was saying and seemed forgetful. The patient sought medical attention and was given acyclovir, NEURONTIN, ZADITOR, erythromycin, VICODEN and tramadol as a treatment for adverse events. Laboratory diagnostic studies were not performed recently. At the time of the report the flu symptoms were recovered, the shingles, swelling of ankles and feet were reported as recovering. The event hard time focusing on what she was saying and seemed forgetful were reported as not recovered. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Red itchy hive at injection site.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Rash and Urticaria Pruritus. Treatment: Diphenhydramine 25 MG PRN, Prednisone as directed.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Local swelling
Clinical narrative: Parent called 8 days later - small red bump, mild swelling to area.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Injection site anaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Pain, numbness, redness at site, chills and night sweats. DX: Cellulitis vs. different sort of pneumococcal vaccine reaction. Given BIAXIN 500mg BID x 7 days.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Night sweats
Clinical narrative: Pain, numbness, redness at site, chills and night sweats. DX: Cellulitis vs. different sort of pneumococcal vaccine reaction. Given BIAXIN 500mg BID x 7 days.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Back pain, Glossodynia, Hyperhidrosis, Hypoaesthesia, Injection site pain
Clinical narrative: The day following vaccination, client experienced soreness at injection site on arms (both), began with shooting back pain, leg cramps and numbness x 2 1.2 weeks. Week after vaccination, began with fever, sweating and rash over entire body, itching sore tongue and enlargement and sores on tongue. Went to MD at this time. Rash, tongue sores resolved after 4-5 days.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Laboratory test normal, Muscle spasms, Pruritus, Pyrexia, Rash generalised
Clinical narrative: The day following vaccination, client experienced soreness at injection site on arms (both), began with shooting back pain, leg cramps and numbness x 2 1.2 weeks. Week after vaccination, began with fever, sweating and rash over entire body, itching sore tongue and enlargement and sores on tongue. Went to MD at this time. Rash, tongue sores resolved after 4-5 days.
Age: 31.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Swollen tongue, Tongue ulceration
Clinical narrative: The day following vaccination, client experienced soreness at injection site on arms (both), began with shooting back pain, leg cramps and numbness x 2 1.2 weeks. Week after vaccination, began with fever, sweating and rash over entire body, itching sore tongue and enlargement and sores on tongue. Went to MD at this time. Rash, tongue sores resolved after 4-5 days.