chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immunoglobulin therapy, Muscle contracture, Muscular weakness, Nuclear magnetic resonance imaging abnormal, Rash
Clinical narrative: 9-13-2011 Appearance of "rash" - on face and chest treated with oral steroids and antihistamine. 9-25-2011 Rash still present. Treated with more prednisone. Nov - Dec 2011 - Treated with topicals; Jan 2012 more topicals. June 2012 muscle contractures, rash, fatigue, muscle weakness. July 2012 - Dermatomyositis - prednisone, SOLUMEDROL, IVIG, CELLCEPT.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: X-ray
Clinical narrative: 9-13-2011 Appearance of "rash" - on face and chest treated with oral steroids and antihistamine. 9-25-2011 Rash still present. Treated with more prednisone. Nov - Dec 2011 - Treated with topicals; Jan 2012 more topicals. June 2012 muscle contractures, rash, fatigue, muscle weakness. July 2012 - Dermatomyositis - prednisone, SOLUMEDROL, IVIG, CELLCEPT.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 73 years old female patient. On 19-JUN-2014 the patient was vaccinated with a single dose of ZOSTAVAX (lot # K000995, exp. 16-MAR-2015), subcutaneous about 1.5 inches above her left elbow. The patient developed redness at the injection site. The patient was subsequently evaluated by her unspecified physician, on an unspecified date, with an asthma exacerbation. The patient was treated with prednisone (manufacturer unknown) and an unspecified inhaler. Patient sought medical attention: visited office with unspecified physician. The outcome of redness at the injection site and asthma exacerbation was reported as recovering/resolving. Relatedness between redness at the injection site, asthma exacerbation and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP, HEPA
Symptoms: Hypersensitivity, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. Medical history, concurrent condition and concomitant medication not reported. On an unknown date the patient was vaccinated with VAQTA. Other suspect therapy included RECOMBIVAX. On an unknown date the patient experienced rash. The patient received both RECOMBIVAX and VAQTA on the same day, and developed a rash. The patient sought medical attention for the event. The rash was a hypersensitivity reaction. Physician declined to provide by additional details. Treatment for the event was unknown. The outcome of rash was reported as recovered/resolved. Action taken with the product was unknown. The causality of the event was not reported. No PQC was reported. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Unevaluable event
Clinical narrative: See attached description.
Age: 41.0
Sex: M
Vaccine: ANTH, HEPAB
Symptoms: Dyspnoea, Local swelling, Pain in extremity, Pallor, Tremor
Clinical narrative: Vaccinated 6-23 and 6-25, Pt with swollen rt arm with arm pain. Swelling got bigger. He then developed tremor, SOB and change in pallor. He reported back to us on 27 Jun and we advised him to go to ED. No diagnosis. Returned again on 2 July, again advised to go to ED. Has not heard from pt since that time.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Asthenia, Blood glucose normal, Decreased appetite, Dizziness
Clinical narrative: Nausea, vomiting, dizziness, not able to sleep, loss of appetite, weakness, abdominal pain.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count normal, Insomnia, Mean cell volume decreased, Metabolic function test, Nausea
Clinical narrative: Nausea, vomiting, dizziness, not able to sleep, loss of appetite, weakness, abdominal pain.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Protein total increased, Red blood cell count normal, Vomiting
Clinical narrative: Nausea, vomiting, dizziness, not able to sleep, loss of appetite, weakness, abdominal pain.
Age: 52.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin swelling
Clinical narrative: 5X7 RED RAISED SKIN ON BACK OF ARM WITH RED LINES COMING OUT TO ELBOW
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Arm soreness, general body aches, fatigue
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Injection site reaction described by patient as hard red and itchy.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Anaphylactic reaction, Cyanosis, Dizziness, Fatigue, Hypotension
Clinical narrative: Anaphylaxis (itchy mouth, signs of low blood pressure including visual disturbance, sudden severe fatigue, pale and blue tinged skin, swaying on feet, started to lose consciousness) treated with 0.15 mg intramuscular injection of epinephrine
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Loss of consciousness, Oral pruritus, Pallor, Visual impairment
Clinical narrative: Anaphylaxis (itchy mouth, signs of low blood pressure including visual disturbance, sudden severe fatigue, pale and blue tinged skin, swaying on feet, started to lose consciousness) treated with 0.15 mg intramuscular injection of epinephrine
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Extreme soreness in area of shot, headache, body aches the next day, cannot lift arm more than a few inches from body, nausea, abdominal,cramps, fatigue, dizziness
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Nausea, Pain
Clinical narrative: Extreme soreness in area of shot, headache, body aches the next day, cannot lift arm more than a few inches from body, nausea, abdominal,cramps, fatigue, dizziness
Age: 1.27
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous
Clinical narrative: diffuse erythematous rash on trunk and extremities
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Electrocardiogram normal, Loss of consciousness, Malaise, Nausea
Clinical narrative: Second dose of MCV4 administered to 18 y.o. female. Patient had first dose at age 11 (2007) and reported no adverse side effects. Patient stood up approx 5 minutes after administering MCV4 into left deltoid. Within 1-2 minutes of standing, patient stated that she didn't feel well. She then became pale and lost consciousness. Patient eased to the ground by NP and mother. Patient regained consciousness after being placed in lying position with legs elevated. On assessment after event pt was alert and oriented, bp 110/70, hr 70's, sp02 98%. Lungs sounds clear to auscultation, hearts sounds RRR, pupils round and reactive to light. No edema present to mouth, lips, tongue and no hives noted. Approx after 15-20 minutes of lying down, moved patient into sitting position and provided patient with orange juice. Patient tolerated sitting for about 10 minutes (bp 107/80 in sitting position. She then began to c/o lightheadedness and nausea, placed back into lying position. Ambulance called d/t pt recurrent symptoms of lightheadedness and unable to tolerate position changes. Spoke with mother on 7/8/14 regarding incident and pt prognosis. She stated that EMS administered fluids on route to the hospital. At the ED they did an EKG which was negative, monitored patient and sent her home within a few hours. Mother further stated that the daughter did not eat much that day and was anxious about getting a vaccine. Has hx of fainting in the past.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Pallor
Clinical narrative: Second dose of MCV4 administered to 18 y.o. female. Patient had first dose at age 11 (2007) and reported no adverse side effects. Patient stood up approx 5 minutes after administering MCV4 into left deltoid. Within 1-2 minutes of standing, patient stated that she didn't feel well. She then became pale and lost consciousness. Patient eased to the ground by NP and mother. Patient regained consciousness after being placed in lying position with legs elevated. On assessment after event pt was alert and oriented, bp 110/70, hr 70's, sp02 98%. Lungs sounds clear to auscultation, hearts sounds RRR, pupils round and reactive to light. No edema present to mouth, lips, tongue and no hives noted. Approx after 15-20 minutes of lying down, moved patient into sitting position and provided patient with orange juice. Patient tolerated sitting for about 10 minutes (bp 107/80 in sitting position. She then began to c/o lightheadedness and nausea, placed back into lying position. Ambulance called d/t pt recurrent symptoms of lightheadedness and unable to tolerate position changes. Spoke with mother on 7/8/14 regarding incident and pt prognosis. She stated that EMS administered fluids on route to the hospital. At the ED they did an EKG which was negative, monitored patient and sent her home within a few hours. Mother further stated that the daughter did not eat much that day and was anxious about getting a vaccine. Has hx of fainting in the past.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. On 02-JUN-2014, the patient was vaccinated with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Age: 6.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Fever 101.4 degrees F orally/highest since onset around 0300 this morning; tx: Instructed pt's father to give children's ibuprofen as directed on med label every 6 hrs.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the first dose of GARDASIL (strength, route, lot number and expiration date not reported). The physician stated that the patient fainted at an unspecified time afterwards. At the time of the report the outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from certified medical assistant refers to a patient of unknown age and unknown gender. Drug reactions, allergies and pertinent medical history were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were not reported). Concomitant therapies were not reported. On approximately 23-JUN-2014 (reported as the last week) the patient went to the reporter's office and was diagnosed with a zoster-like rash. Treatment given for the zoster-like rash was unspecified. Laboratory diagnostic studies were unspecified. The outcome of the zoster-like rash was unknown. The relationship between the zoster-like rash and ZOSTAVAX was not reported. Additional information has been requested. Correspondence containing a request for additional information is scheduled.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash to bilateral legs/arms, anterior abdomen. He got shingles vaccine in the clinic May 8th, then he notes rash started on 9th, worsened to 10th, 11th was worst, and now it is better but not resolved (as of the 14th).
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Fatigue, Feeling of body temperature change, Musculoskeletal stiffness, Nausea, Urticaria
Clinical narrative: Pt. stated stiff neck on (L) side after administration of Y.F. There was a welt at injection site, she felt warm, tiredness and nausea. S/s started 05/02/14. S/s lasted 1 week and used TYLENOL.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Large localized patch of red skin at left upper thigh in area that Dtap was given. 6.5 cm x 6.5 cm.
Age: 1.3
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite, Blood cholesterol, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered 6/25 around 6:30 pm. Pt called 6/27 to state injection site is red, swollen and hot to the touch. She noted she got along bite near injection site which had been scratched.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, TDAP
Symptoms: Dizziness, Feeling hot
Clinical narrative: Patient felt dizzy, and warm, and possible seizure for a few seconds.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: -72 hrs of fever, HA, myalgias and nausea. -Improved with NSAIDs.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Extra polio administered, no sign or symptoms. Physician notified. Event occurred 7/2/14 at 1040.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician assistant to a 62 year old female patient. Pertinent medical history, drug reactions and allergies were not reported. On 01-JUL-2014 the patient was intended to receive ZOSTAVAX, but was inadvertently administered (Oka/Merck) VARIVAX, 0.5 ml, subcutaneous (dose number and lot number were not reported). Concomitant therapies were not reported. No adverse effect reported. The outcome of inadvertently administered (Oka/Merck) VARIVAX was unknown. Additional information is not expected because the reporter refused additional contact.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large amount of swelling, pain, heat at site of injection. Pt unable to use arm site is Left upper arm. Pt received care from Dr.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient has shoulder pain and is receiving cortisone shots. MD claims this is from flu vaccine. Just reported.
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Allergy test, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Painful, red, hot, firm area at site of injection began after injection and progressed; 6/23 visited ER and area was about 10cm diameter. ER doctor gave SOLU-MEDROL IM 125mg; prednisone Rx for 20mg qd x5 day.
Age: 4.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Papule, Pruritus, Skin lesion
Clinical narrative: Scores of non erythematous papular itchy lesions, waist on lower extremities and face, as of my exam 6/30/14. No fever.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Local swelling, Malaise, Vomiting
Clinical narrative: June 10, 2014 pt had his school physical and received his PENTACEL in his Left arm and PROQUAD in his right L arm was warm that evening and swollen. By June 11, swelling was worse. By June 12, he was vomiting, feeling ill, with an arm significantly swollen, 1 inch larger in circ. from R arm.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Visual impairment
Clinical narrative: Pt felt sweaty, seeing black spots in vision. Pt lied down in room. BP stable, orthostatic BP's normal. Symptoms lasted 10 mins. Was not having vision difficulties while supine only when standing.
Age: 40.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Arthralgia, Local swelling, Myalgia, Rash
Clinical narrative: Pt c/o musle and joint aches, (R) mild leg rash and swelling after a dose of VIVOTIF (oral typhoid). Resolved after cessation.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Redness, firm lump size of quarter to 1/2 dollar at site of injection.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that the GARDASIL of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients GARDASIL have been administered since date of last excursion of 27-JAN-2014 is with Lot number 0420AE and expiry date 01-DEC-2014. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Live birth, No adverse event, Pregnancy
Clinical narrative: This spontaneous report was received from a nurse refers to a 27 year old female patient with purpura and blood dyscrasia for which she did not take medication. On an unknown date the patient was vaccinated with the first dose of GARDASIL injection 120 Y, route, dosage, lot number and expiration date were not reported. Concomitant therapy was not reported. The reporter informed that on an unknown date after vaccination, the patient discovered she was pregnant, she received her second dose of GARDASIL after she delivered her infant on an unspecified date, the pregnancy outcome was live birth, fetal outcome was unknown, but she could not get her third dose because her insurance ran out now that she has insurance, she would like to receive her third dose of GARDASIL, the patient was not reporting or demonstrating any adverse effects. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient were vaccinated with GARDASIL. Dose, route, lot number and expiration date were not reported. The physician reported that improperly stored GARDASIL was administered to unspecified patients on unspecified dates. No adverse effect reported. It was also reported that Td vaccine had been improperly stored. This is one of two reports from the same source (other case # 1407USA000389). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site cellulitis, Urticaria
Clinical narrative: Onset urticaria, cellulitis left thigh on 5/7/14 - ill visit 5/8/14 no fever. Dx: Urticaria. Dx: Cellulitis, unspecified. Treatemnt: KEFLEX susp. 250 mg/ml 1 tsp PO TID x 10 days. BENADRYL q6h x 24-48 hrs, then prn.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patients of unkonwn age. It was reported that the GARADASIL of unknown dose, have undergone a second temperature excursion date 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. GARDASIL have been administered since date of last excursion of 27-JAN-2014 is with Lot number J012212 and expiry date 18-FEB-2016. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that GARDASIL of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. GARDASIL have been administered since date of last excursion of 27-JAN-2014 is with Lot number H021861 and expiry date 09-OCT-2015. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that the PEDVAXHIB of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. PEDVAXHIB have been administered since date of last excursion of 27-JAN-2014 is with Lot number J010385 and expiry date 28-MAY-2016. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: HEP, HEPA, TYP
Symptoms: Injected limb mobility decreased
Clinical narrative: Pt c/o decreased ROM to (R) arm S/p immunization. Has to use his other arm to assist with movement. No obvious deformity, no edema or bruising to injection site. Warm/moist heat, monitor and F/u PCP PRN.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that the PEDVAXHIB of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. PEDVAXHIB, have been administered since date of last excursion of 27-JAN-2014 is with Lot number J009134 and expiry date 15-APR-2016. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 21 year old female patient who on 02-JUN-2014, was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly (lot number not reported). It was stated that when the patient received the vaccine she was about 1-2 weeks pregnant. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VAQTA. Dose, route, Lot number and expiration date were not reported. The physician reported that improperly stored VAQTA was administered to unspecified patients on unspecified dates. No adverse effect reported. It was also reported that tetanus and diphtheria vaccine had been improperly stored. This is one of  two reports from the same source (other case # 1407USA003778). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age. On 17-JUN-2014, the patient was vaccinated with GARDASIL (dose, route and lot # not provided) that was improperly stored. The product was supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, since the reporter does not want to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 12 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with (Oka/Merck) VARIVAX, lot number reported as J005693, expiration date 07-MAY-2015. Dose and route were not reported. No co-suspect and concomitant therapies were reported. The pharmacist reported that a dose of improperly stored (Oka/Merck) VARIVAX was administered to a patient (on an unknown date). No adverse effects have been observed. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Malaise, Visual impairment
Clinical narrative: Pt was given Tdap, MENACTRA and GARDASIL, 5-10 mins after injections. Pt was at cashiers station. Mother said she says doesn't feel well. Then pt says can't see. Put pt in chair and rolled her back to clinic room. Put on exam table. Mother at side. B/P 100/60. Mother denied any problems prior. After 10-15 mins pt sat up says "feels better" walked out with mother.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 27-JUN-2014 the patient was vaccinated with a expired dose of ZOSTAVAX lot # J002869, expiration date 14-JUN-2014. Dose and route were not reported. No co-suspect and concomitant therapies were reported. No adverse effects reported. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to a patient of 16 months old. On 01-JUL-2014 the patient was vaccinated with GARDASIL dose 1 (unknown route and dose). No adverse symptoms reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Nausea, Pyrexia
Clinical narrative: Had shots at 1pm on 7-1-14, no immediate issues. Nausea and vomiting x 1 on 7-2-14 at 530 - 6 am. Running fever off/on up to 102 degrees. Brought down with TYLENOL/MOTRIN. Appetite poor, and pt having tiredness. Napping daily and earlier than usual bed times.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vomiting
Clinical narrative: Had shots at 1pm on 7-1-14, no immediate issues. Nausea and vomiting x 1 on 7-2-14 at 530 - 6 am. Running fever off/on up to 102 degrees. Brought down with TYLENOL/MOTRIN. Appetite poor, and pt having tiredness. Napping daily and earlier than usual bed times.
Age: 1.52
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Induration
Clinical narrative: Hard 1 cm once sub q and mild erythema around. No pain. No tenderness. No discharge. (L) lateral femoral side.
Age: 51.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Abnormal behaviour, Gait disturbance, Headache, Hot flush, Irritability
Clinical narrative: 06/17/14 oral typhoid #1 taken. 06/18/14 headache, "couldn't walk a straight line, but not dizzy." 06/19/14 oral typhoid #2 taken. 06/20/14 headache, trouble walking, but "not as bad". 06/21/14 oral typhoid #3. 06/22/14 headache. 06/23/14 oral typhoid #4. 06/24/14 headache. Current (07/01/14): Headache 4x /week, nausea, cold/hot flashes. MD visit 7/1/14 pm. Behavior changes, irritability.
Age: 51.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Nausea
Clinical narrative: 06/17/14 oral typhoid #1 taken. 06/18/14 headache, "couldn't walk a straight line, but not dizzy." 06/19/14 oral typhoid #2 taken. 06/20/14 headache, trouble walking, but "not as bad". 06/21/14 oral typhoid #3. 06/22/14 headache. 06/23/14 oral typhoid #4. 06/24/14 headache. Current (07/01/14): Headache 4x /week, nausea, cold/hot flashes. MD visit 7/1/14 pm. Behavior changes, irritability.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, anatomical location and lo # were not provided). Concomitant medications were not reported. On an unknown date and unspecified amount of time afterwards the patient was vaccinated, he was diagnosed with shingles. The patient sought medical attention. The physician stated that on unknown date the patient was treated for shingles and has since recovered. Additional information is not expected because reporter refused additional information contact.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer's mother refers to a female patient of unknown age. Medical history was not reported. Approximately in July 2014 (also reported as last week) the patient was vaccinated with the fourth dose of GARDASIL lot number, expiration date, route and dosage were not reported). Concomitant therapy was not reported. The reporter informed that the patient received all 3 shots of GARDASIL on unspecified date in the year 2009. But her doctor accidentally gave her a fourth shot of GARDASIL. No adverse events were reported. Additional information is not expected, because no reporter details were provided.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site reaction, Injection site scab, Rash
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 69 year old male patient. The patient's medical history included severe shingle outbreaks. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (strength, dose number and lot number were unspecified). Concomitant therapies were not reported. On 19-JUN-2014, 2 days after onset of therapy the patient experienced soreness and red bumps surrounding the injection site. Some of the bumps appeared to be "scabbed over". There was also a red rash the size of a quarter on the right side of the patient's back; however, he did not experience any itching at this site. The outcome of the events were reported as recovering/resolving five days after the injection on 23-JUN-2014. Treatment was not given for the events. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a 69 year old male patient. The patient's medical history included severe shingle outbreaks. On 18-JUN-2014 the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (strength, dose number and lot number were unspecified). Concomitant therapies were not reported. On 19-JUN-2014, 2 days after onset of therapy the patient experienced soreness and red bumps surrounding the injection site. Some of the bumps appeared to be "scabbed over". There was also a red rash the size of a quarter on the right side of the patient's back; however, he did not experience any itching at this site. The outcome of the events were reported as recovering/resolving five days after the injection on 23-JUN-2014. Treatment was not given for the events. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient had an unspecified allergy to aspirin. On 14-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J014812, expiration date 20-FEB-2015, 1 vial, subcutaneous). Concomitant therapy was not reported. The patient reported to the pharmacist that she developed bumps on her stomach and legs on an unspecified date in June 2014 after receiving ZOSTAVAX. No lab diagnostics studies were performed. The patient did not seek medical attention. Outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 14 year old female patient. On 26-JUN-2014 the patient was vaccinated with LIQUID PEDVAXHIB (dose, route, lot # and dosage schedule were not reported). The reporter did not mention if the patient received LIQUID PEDVAXHIB prior to this dose. No adverse symptoms reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. On 30-JUN-2014 the patient was vaccinated with ZOSTAVAX (single dose, Lot #000783, Expiration date: 30-APR-2014), subcutaneous. On 30-JUN-2014 the patient was inadvertently administered ZOSTAVAX that had expired on 30-APR-2014. The ZOSTAVAX had been stored in the patient's home freezer at an unknown temperature for 1 year prior to administration. No adverse effects were reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Anxiety, Dizziness, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain
Clinical narrative: Immediately when vaccine Hep A was being injected patient felt shooting pain at site that radiated down her arm. At that time patient had a mild vasovagal reaction. She rested for 15 minutes and the nurse applied ice to injection site left deltoid. She then went home. One hour later while at home patient complained of severe left shoulder pain with movement. Pain kept her up all night. Took Ibuprofen with minimal relief. She was seen in student health on 05/14/14. She was having difficulty moving her left arm but denied any numbness or tingling.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Insomnia, Pain in extremity
Clinical narrative: Immediately when vaccine Hep A was being injected patient felt shooting pain at site that radiated down her arm. At that time patient had a mild vasovagal reaction. She rested for 15 minutes and the nurse applied ice to injection site left deltoid. She then went home. One hour later while at home patient complained of severe left shoulder pain with movement. Pain kept her up all night. Took Ibuprofen with minimal relief. She was seen in student health on 05/14/14. She was having difficulty moving her left arm but denied any numbness or tingling.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Insomnia, Pain
Clinical narrative: Immediately when vaccine Hep A was being injected patient felt shooting pain at site that radiated down her arm. At that time patient had a mild vasovagal reaction. She rested for 15 minutes and the nurse applied ice to injection site left deltoid. She then went home. One hour later while at home patient complained of severe left shoulder pain with movement. Pain kept her up all night. Took Ibuprofen with minimal relief. She was seen in student health on 05/14/14. She was having difficulty moving her left arm but denied any numbness or tingling.
Age: 25.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Pain in extremity, Presyncope
Clinical narrative: Immediately when vaccine Hep A was being injected patient felt shooting pain at site that radiated down her arm. At that time patient had a mild vasovagal reaction. She rested for 15 minutes and the nurse applied ice to injection site left deltoid. She then went home. One hour later while at home patient complained of severe left shoulder pain with movement. Pain kept her up all night. Took Ibuprofen with minimal relief. She was seen in student health on 05/14/14. She was having difficulty moving her left arm but denied any numbness or tingling.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 63 year old male patient. On 21-MAY-2014 during dialysis the patient received by intravenous route PNEUMOVAX 23 (dose 0.5 ml, intravenously, lot and indication were not reported). No adverse effect was reported. It was reported that the patient did not seek medical attention. No PQC involved. Follow up information has been received from the other health professional refers to a 63 year old male patient with disability, cancer, dialysis and no known allergy. On 21-MAY-2014 12:44 the patient was vaccinated with his first 0.5ml dose of PNEUMOVAX 23 (lot # was reported as J015868) intravenous. On 08-JUN-2014, the patient died. None noted. The cause of death was reported as cancer. The reporter considered died was reported to be not related to PNEUMOVAX 23 injection. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Condition aggravated, Death, Incorrect route of drug administration, Neoplasm malignant, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 63 year old male patient. On 21-MAY-2014 during dialysis the patient received by intravenous route PNEUMOVAX 23 (dose 0.5 ml, intravenously, lot and indication were not reported). No adverse effect was reported. It was reported that the patient did not seek medical attention. No PQC involved. Follow up information has been received from the other health professional refers to a 63 year old male patient with disability, cancer, dialysis and no known allergy. On 21-MAY-2014 12:44 the patient was vaccinated with his first 0.5ml dose of PNEUMOVAX 23 (lot # was reported as J015868) intravenous. On 08-JUN-2014, the patient died. None noted. The cause of death was reported as cancer. The reporter considered died was reported to be not related to PNEUMOVAX 23 injection. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Antibody test negative, Headache, Measles, Measles antibody positive, Morbillivirus test positive
Clinical narrative: Right sided parotitis after MMR booster.
Age: 27.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Pain in jaw, Parotitis
Clinical narrative: Right sided parotitis after MMR booster.
Age: 27.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Parotitis, Polymerase chain reaction, Rubulavirus test positive
Clinical narrative: Right sided parotitis after MMR booster.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Aphthous stomatitis, Blister, Injection site erythema, Injection site induration, Macule
Clinical narrative: This spontaneous report was received from a physician concerning a 23 year old male patient with no pertinent medical history or drug reaction/allergies. On 16-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose and strength were not reported) lot number reported as J009988, expiration date reported as 08-DEC-2015, subcutaneous for vaccination. Concomitant therapies included ADACEL and Hepatitis A vaccine (manufacturer unknown), vaccinated on 11-JUN-2014. The physician reported that on 01-JUL-2014, patient came to the office due to itchy bumps he has had for the last two days, on 29-JUN-2014. Upon inspection, the physician noted that the patient had a local reaction at the site of the (Oka/Merck) VARIVAX injection on the posterior aspect of the left arm which was mildly red with mild induration. The physician also reported that during the assessment of the patient, she noted that patient had about 10 to 12 lesions about 1/2-1 centimeter in width, with a red base located centrally in the lesions on his upper body. Patient was afebrile. After assessment, physician diagnosed patient as having a generalized reaction to the (Oka/Merck) VARIVAX. At the time of the report the outcome was reported as not recovered. Patient seek medical attention with the physician and received treatment with BENADRYL. No lab diagnostic studies were performed. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Papule, Rash pruritic, Rash pustular
Clinical narrative: This spontaneous report was received from a physician concerning a 23 year old male patient with no pertinent medical history or drug reaction/allergies. On 16-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose and strength were not reported) lot number reported as J009988, expiration date reported as 08-DEC-2015, subcutaneous for vaccination. Concomitant therapies included ADACEL and Hepatitis A vaccine (manufacturer unknown), vaccinated on 11-JUN-2014. The physician reported that on 01-JUL-2014, patient came to the office due to itchy bumps he has had for the last two days, on 29-JUN-2014. Upon inspection, the physician noted that the patient had a local reaction at the site of the (Oka/Merck) VARIVAX injection on the posterior aspect of the left arm which was mildly red with mild induration. The physician also reported that during the assessment of the patient, she noted that patient had about 10 to 12 lesions about 1/2-1 centimeter in width, with a red base located centrally in the lesions on his upper body. Patient was afebrile. After assessment, physician diagnosed patient as having a generalized reaction to the (Oka/Merck) VARIVAX. At the time of the report the outcome was reported as not recovered. Patient seek medical attention with the physician and received treatment with BENADRYL. No lab diagnostic studies were performed. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Injection site erythema, Injection site induration, Local reaction, Rash pruritic
Clinical narrative: This spontaneous report was received from a physician concerning a 23 year old male patient with no pertinent medical history or drug reaction/allergies. On 16-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose and strength were not reported) lot number reported as J009988, expiration date reported as 08-DEC-2015, subcutaneous for vaccination. Concomitant therapies included ADACEL and Hepatitis A vaccine (manufacturer unknown), vaccinated on 11-JUN-2014. The physician reported that on 01-JUL-2014, patient came to the office due to itchy bumps he has had for the last two days, on 29-JUN-2014. Upon inspection, the physician noted that the patient had a local reaction at the site of the (Oka/Merck) VARIVAX injection on the posterior aspect of the left arm which was mildly red with mild induration. The physician also reported that during the assessment of the patient, she noted that patient had about 10 to 12 lesions about 1/2-1 centimeter in width, with a red base located centrally in the lesions on his upper body. Patient was afebrile. After assessment, physician diagnosed patient as having a generalized reaction to the (Oka/Merck) VARIVAX. At the time of the report the outcome was reported as not recovered. Patient seek medical attention with the physician and received treatment with BENADRYL. No lab diagnostic studies were performed. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion, Skin reaction
Clinical narrative: This spontaneous report was received from a physician concerning a 23 year old male patient with no pertinent medical history or drug reaction/allergies. On 16-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose and strength were not reported) lot number reported as J009988, expiration date reported as 08-DEC-2015, subcutaneous for vaccination. Concomitant therapies included ADACEL and Hepatitis A vaccine (manufacturer unknown), vaccinated on 11-JUN-2014. The physician reported that on 01-JUL-2014, patient came to the office due to itchy bumps he has had for the last two days, on 29-JUN-2014. Upon inspection, the physician noted that the patient had a local reaction at the site of the (Oka/Merck) VARIVAX injection on the posterior aspect of the left arm which was mildly red with mild induration. The physician also reported that during the assessment of the patient, she noted that patient had about 10 to 12 lesions about 1/2-1 centimeter in width, with a red base located centrally in the lesions on his upper body. Patient was afebrile. After assessment, physician diagnosed patient as having a generalized reaction to the (Oka/Merck) VARIVAX. At the time of the report the outcome was reported as not recovered. Patient seek medical attention with the physician and received treatment with BENADRYL. No lab diagnostic studies were performed. Additional information has been requested.
Age: 1.53
Sex: F
Vaccine: FLUX, HEPA, PPV
Symptoms: Aphasia, Vomiting
Clinical narrative: From 6/12/14-6/23/14-spitting up small amounts of vomit and assumed it was a result of reflux. From 6/24/14-6/26/14-frequent vomiting. Noticed loss of language around this time.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: I noticed a small blister like spot on my left knee area, when I got up on July 4, 2014.  It was itchy.  I put on some Benadryl cream.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4
Symptoms: Dizziness, Hyperhidrosis, Pallor, Posture abnormal
Clinical narrative: FELT DIZZY AND SLID DOWN IN THE CHAIR. WAS IMMEDIATELY LAYED ON THE FLOOR. BLOOD PRESSURE 76/48 @ 9:36 PULSE 64 PALE AND SLIGHTY DIAPHORETIC. COOL CLOTH TO FOREHEAD. 9:40 BLOOD PRESSURE 78/48 PULSE 62
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: FELT DIZZY AND SLID DOWN IN THE CHAIR. WAS IMMEDIATELY LAYED ON THE FLOOR. BLOOD PRESSURE 76/48 @ 9:36 PULSE 64 PALE AND SLIGHTY DIAPHORETIC. COOL CLOTH TO FOREHEAD. 9:40 BLOOD PRESSURE 78/48 PULSE 62
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling face, Urticaria
Clinical narrative: Facial swelling and hives to facial area.
Age: 0.77
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Bacterial test negative, Pyrexia, Viral test negative
Clinical narrative: Spiked temp of 104.8 on the evening that he received his vaccines. Continued to have fevers and his highest temp was 105.3 on 7/9/14 at 5:30 AM. Was evaluated in our office on 7/8/14 and 7/9/14.
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram normal, Troponin I increased
Clinical narrative: Based upon internal review done on 07 July 2014, a significant correction was done to update the listedness of the case from unlisted to listed. This study case was received from the investigator in a trial on 30 June 2014. A male subject, date of birth and medical history not reported, experienced a slightly elevated troponin lab result, considered mild in severity, days after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported) on 06 February 2011. On 24 June 2014, 40 months post vaccination the Troponin I result was reported as 0.12 ng/mL. On 24 June 2014, electrocardiogram (ECG) was reported as normal. A redraw was performed on 30 June 2014 and the investigator will report the results once available. The subject did not require any medical treatment. The patient's outcome was reported as still present, not recovered. According to the investigator, the event of elevated troponin was considered other important medical event and remote possibility related to the trial product. Upon internal review done on 07 July 2014, the listedness of the events elevated troponin and potential myopericarditis was changed from unlisted to listed. Documents held by sender: None.
Age: 30.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a medical assistant refers to a 30 year old female patient. On 07-JUL-2014, the pregnant patient was inadvertently vaccinated with GARDASIL lot # J009788, 0.5 ml, intramuscular. The patient sought medical attention in the office. The patient became pregnant with LMP of 23-NOV-2013 and EDD of 30-AUG-2014. No adverse effects reported. No further information provided. Additional information has been requested.