chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unknown number of patients of unknown demographics. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that unknown number of patients were vaccinated with GARDASIL (dose strength, route not reported) that had been improperly stored approximately on an unknown date in July 2014 (reported as between 09-JUL-2014 and 16-JUL-2014). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Influenza like illness
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported). The patient experienced immediately flu-like symptoms after administered a dose of GARDASIL. The patient sought medical attention in office. It was unknown if treatment was given. The outcome of immediate flu-like symptoms was unknown. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 4 year old child of unknown gender. Medical history and concurrent conditions were not reported. On 20-DEC-2014, the patient was vaccinated an improperly stored dose of (Oka/Merck) VARIVAX (lot # H018237, expiration date 04-OCT-2014), 0.5 ml, subcutaneous (strength and indication not reported). No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. This case has been linked with case 1407USA003655, 1407USA005531 and 1407USA011074.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a practice manager (health worker) refers to a 55 year old female patient with allergy to penicillin. The patient's pertinent medical history included fatigue, heart murmur, obesity, osteoarthritis, vitamin d deficiency. On 09-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J011548, expiration date 19-DEC-2014, subcutaneous). Concomitant therapies included ADVIL and vitamin d (unspecified). The practice manager stated that the patient called in to the office today, 15-JUL-2014, to report that after receiving a dose of ZOSTAVAX she developed a reaction. The patient reported to the practice manager that on "Saturday" (on 12-JUL-2014) the injection site was swollen "to the size of a soft ball", red, itchy and burning. The patient reported that "by Sunday (13-JUL-2014) it was almost done". The patient reported that to the practice manager that she placed ice and BENADRYL cream on the injection site for treatment. The practice manager stated "as of today, it was completely gone". No lab diagnostics studies were performed. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to several unspecified patients of unknown age and gender. On an unknown date, the unspecified patients were vaccinated with the first GARDASIL. On an unknown date, the several unspecified patients had received their second dose of GARDASIL a year after their first dose of GARDASIL. No adverse effects were reported. At the time of the report the action taken was unknown. This is one report of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. None pertinent medical history, drug reactions or allergies were reported. On 24-JUL-2014 the patient was administered with an expired dose of M-M-R II lot # H013040, expiration date 17-JUL-2014, (strength, dose, dose number, formulation, route and anatomical location were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of administered an expired dose of M-M-R II was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to unspecified number of patients of unknown ages and genders. No information received regarding medical history and concurrent conditions. The nurse reported that since 01-JUL-2014, unspecified patients might have been administered with (Oka/Merck) VARIVAX (dose, lot # and route were not reported) that were not stored properly. No adverse effects reported. All telephone attempts to obtain follow-up information have been unsuccessful.  This is one of several (1407USA004083, 1407USA004727, 1407USA004728, 1407USA004725, 1407USA004726) report received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer via company representative refers to her aunt, a 68 year old female patient with lupus. Medical history was unspecified by reporter. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous injection, strength, dosage, dose number, lot # and expiration date not reported). Concomitant medications were not reported. The reporter stated that the patient developed shingles on an unspecified date after receiving the ZOSTAVAX. It was unknown if the patient sought medical attention. The outcome of the event was unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse. On 07-JUL-2014, the reporter requested stability for doses of PNEUMOVAX23 which were evaluated and supported. On 22-JUL-2014, the reporter was requesting stability data for an additional temperature excursion, and she reports that the doses of PNEUMOVAX23 (dose, frequency and route unknown) that were supported on 07-JUL-2014, have been administered to unspecified number of patients on unspecified dates since 07-JUL-2014. Concurrent conditions and relevant medical history of the patients was unknown. Concomitant medications were not reported. No adverse effect was observed or reported. This case is linked to #1407USA012043 and # 1407USA012379 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse. On 07-JUL-2014, the reporter requested stability for doses of ROTATEQ which were evaluated and supported. On 22-JUL-2014, the reporter was requesting stability data for an additional temperature excursion, and she reports that the doses of ROTATEQ (dose, frequency and route unknown) that were supported on 07-JUL-2014, have been administered to unspecified number of patients on unspecified dates since 07-JUL-2014. Concurrent conditions and relevant medical history of the patients was unknown. Concomitant medications were not reported. No adverse effect was observed or reported. Product quality issue was not involved. This case is linked to #1407USA012378 and #1407USA012379 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse. On 07-JUL-2014, the reporter requested stability for doses of (Oka/Merck) VARIVAX which were evaluated and supported. On22-JUL-2014, the reporter was requesting stability data for an additional temperature excursion, and she reports that the doses of (Oka/Merck) VARIVAX (dose, frequency and route unknown) that were supported on 07-JUL-2014, have been administered to unspecified number of patients on unspecified dates since 07-JUL-2014. Concurrent conditions and relevant medical history of the patients was unknown. Concomitant medications were not reported. No adverse effect was observed or reported. Product quality issue was not involved. This case is linked to #1407USA012378 and #1407USA012043 via same reporter link. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Blood test, Rash generalised
Clinical narrative: Rash the developed on abdomen, spreading to lower back, spreading to shoulders. This rash has continued to present erupting in the same areas.  Has now spread to left leg, lower and then upper.  Have been seen multiple times in PCP office along with two visits to a dermatologist.  Given multiple creams, prednisone and antihistamines with no effect.  Had biopsy completed on one area.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus
Clinical narrative: Pt had almost immediate itching and redness at site and has increased in size. Left upper outer arm has redness and mildly indurated with small mass palpated. Non tender and non warm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3 inch red swelling at injection (DTAP) spot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 7/22/14 1:35PM: Mother called office and reported that the patient had swelling and redness at the site of injection, right arm. Mother was instructed to apply cold compress to the site and give OTC pain/fever reducer if necessary. 7/24/2014 10:00AM: Mother called to report the patient had been admitted to Medical Center due to increased swelling and redness at the site and fever. Patient was hospitalized for 3 days and was treated with IV antibiotics.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Hypersensitivity, Local reaction, Skin mass, Skin warm
Clinical narrative: Felt bump under skin and gradual increase in pink coloring. on 7/11/14 patient spoke to this CHN as  spot had increased and was reported to be size of a medium egg and was warm. Without noted itching or pain. No history of immunization problems in the past.  CHN referred to local urgent care as her MD closed. She went to urgent care on that date and told that she had experienced "a localized allergic reaction" and was given 60 mg of prednisone as a 1 time dose and was to apply warm packs 3-5 times per day for 3-5 days. She given instructions to return or call her MD if any streaking on negative changes were noted.  As of 7/28/14 she returned call to this CHN to report treatment and to say that the lump is gone. Her immunization history shows that she received  single antigen immunizations in the late 1960's to early 1970's.
Age: 1.6
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ear infection, Pyrexia
Clinical narrative: Started running a high temp early Saturday morning temp anywhere from 103-105 degrees. Went to doctor and started on Z-pack for ear infection. No other symptoms noted. Still having temp. Started ATB on 7/27/14.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: patient returned to pharmacy to show a localized redness welp on back of arm from injection on friday. advised to put cold compresses on arm and call us if no resolve within 24 hours
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Nausea, Vomiting
Clinical narrative: Cellulitis, N/V.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Alanine aminotransferase decreased, Dysphonia, Monocyte percentage decreased, Neutrophil percentage increased, Oropharyngeal pain
Clinical narrative: Patient developed hoarseness of voice, sore throat, sensation of swelling of his throat and fever. No fever at time of vaccine administration.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Pharyngeal oedema, Pyrexia, White blood cell count increased
Clinical narrative: Patient developed hoarseness of voice, sore throat, sensation of swelling of his throat and fever. No fever at time of vaccine administration.
Age: 0.44
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram normal, Eye movement disorder, Movement disorder, Ultrasound skull normal
Clinical narrative: Parents state two short-lived < 3 minutes with eyes in back of head without GTC movement but sporadic arm movement. Vaccines given 05/22/2014 with report 06/10/14 with concern.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rashes all over body = given BENADRYL (liquiud) - over the counter.
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Local reaction - swelling/induration at injection site began day of injection, improving 7/21/14.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local swelling at injection site, mild erythema approximately 5cm x 5cm at (L) triceps SQ injection site. No fever, chills, or sign and symptom of infection. No systemic symptom of allergic reaction or cardiopulmonary, neurological or other complication.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Mild rash at injection site. Recommended called MD and OTC hydrocortisone 1% crm at MD approval.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Eye infection, Eye pruritus, Glossodynia, Swollen tongue, Tongue disorder
Clinical narrative: Both eyes itchy, tongue swollen and sore and white spots. Itched eyes, right eye infected, Antibiotic ordered. BENADRYL taken. Gets some reaction to strawberries.
Age: 43.0
Sex: F
Vaccine: TD
Symptoms: Activities of daily living impaired, Asthenia, Mobility decreased, Pain
Clinical narrative: Constant pain that feels like a toothache that started on the day the vaccine was given, weakness, limited mobility, difficulty with certain activities due to sharp pain - pouring coffee, carrying a bucket of water, for example. Pain is 8/10.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Left arm still sore and cannot move arm outwards to the left.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red raised area around injection site that is warm to touch- measuring 9x8 cm Pain. Difficulty lifting arm.
Age: 50.0
Sex: M
Vaccine: ANTH, FLU3, MNQ
Symptoms: Hypoaesthesia, Insomnia, Tinnitus
Clinical narrative: Numbness in right arm, ringing in ears, inability to sleep through the night.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Eyelid oedema, Pharyngeal oedema
Clinical narrative: Eye swelling shut, throat swelling, trouble breathing.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache
Clinical narrative: Pt's mother reported headache and dizziness, which prompted ER visit. Event was reported on 7/28/14 at 3:00pm. Unable to reach her to determine when the symptoms started.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Rash generalised
Clinical narrative: Patient broke out with rash all over body just a few hours after receiving vaccinations.  Patient went to Urgent Care and was given a steroid shot and sent home with a prescription for a steroid and Zantac.  Mother was also giving Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever of approximately 101 degrees F lasting for 2 days. Muscle aches and fatigue lasting at least three days.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Foot deformity, Gait disturbance
Clinical narrative: Patient's left foot began to toe inward.  He denied any pain and there was no trauma, injury, splinter or bruising.  Passive movement was all intact and non-painful.  He walked on the lateral aspect of his foot for about 48 hours before the gait abnormality resolved.  This occurred 17 days after he received the MMR vaccine.  (The vaccine was also administered on the left side which may or may not be related.) No other neurological symptoms occurred at the time or since the abnormality.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pallor, Pyrexia, Rash erythematous, Rash maculo-papular
Clinical narrative: Generalized blanching erythematous mac-pap rash and tactile high fever.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: 104 Fever. Treated fever for 4 days before subsiding. Rash noted day five to trunk, neck, face.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever above 102 for 3 days. Bad rash on torso and face.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema
Clinical narrative: 4.5 cm diameter red spot.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 106.3.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: TC from mother stating that client has a large, red, hard area between the sites of the vaccines on (L) arm. Client has called PCP and awaiting call back. Cold compresses applied. Started 7/7/14 pm. Attempted 2 TC no responses.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Swelling of whole of thigh after single dose of DTaP, happened after first dose also; parents did not want any vaccines, convinced them to get it.
Age: 0.18
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 5.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Unevaluable event
Clinical narrative: Vaccine - PREVNAR 13 was administered to child who is 5 yrs 4 mos. Which was not required for school entry.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Pt had red rash approx 2" diameter with 1 welt. Instructed to use BENADRYL oint.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Local swelling, Myositis, Swollen tongue, Vasculitis
Clinical narrative: Inflammation in the muscle, blue veins, swelling of tongue and in the legs, constant, arms vasculitis.
Age: 17.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: 06/28/2014 Pt states that he noticed redness to arm next morning after receiving varicella. Low fever and aching all over. Redness has decreased to area 4 inches x 3.75 inches area. Pt states it is better today.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: After 5th vaccine administered pt became pale, denied need to lay down. Pt remained sitting on exam table with back leaning against wall while nurse updated paperwork in room. Pt becomes diaphoretic, pale, dizzy. Assisted to lying on exam table, cool cloth provided to forehead, BP 104/68. Pt remained lying for about 30 min, assisted to sitting for additional 15 min. Recovered, skin pink, warm, dry. Denies dizziness, left clinic.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Panic attack, Pyrexia, Rash, Tremor, Urticaria
Clinical narrative: Vaccine administered to pt's left arm on 7/17/14. Had panic attack night of 7/17/14. Shaky with low-grade fever (99.9) on 7/18/14 - developed rash/hives on (L) arm and (L) thigh 7/23/14.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Crying, Hyperkeratosis, Infection, Local swelling, Papule
Clinical narrative: After 7/31/13 HPV, multiple flat warts appeared on hands and knees. 2nd dose 10/18/13, warts immediately intensified to > 100. 3rd Booster declined. Warts have persisted for almost a year. Patient has been seeing a Dermatologist for this condition since 10/18/13. 11/26/13 Spoke with pt mom states hands "oozy" concerned re: infxn and has developed new areas. Sched pt OV today. 11/26/13 hand draining (1) s/p ALDARA to VV. (R) hand - swollen with tender, warmth and open, draining areas. (2) Infected Rx KEFLEX 250 QID x 14d with food. D/C ALDARA for now. D/C TAC for 2 wks. 12/6/2013 CC - hand. S/P VV -> ALDARA - infection (R) dorsal hand (+). (+) retention hyperkatatosis palms. Wash hands, cont Vaseline. D/C ALDARA. 12/27/13 - new Rx request for cephalexin 500mg #56 1 PO QID x 14 days. (+) Pt crying d/t personal reasons. 10/28/2013 CC: hands "flat VV". (+) Itchy and miserable, esp since starting ALDARA/Saran wrap D/C a few days ago. (B) dorsal knuckles/PIP. Tan and erythematous VV papules flat approximately 100s of them (+) tender. VV with secondary inflamed rxn after ALDARA with occlusion. SW pt and mom at length. (R) TAC 0.1% oint BID x 5d. (S) TOPICORT .025 oint BID then resume ALDARA 3 x 1 wk no occlusion. F/U 2 wks. 11/18/2013 CC: hands - VV - s/p ALDARA x 3 wks and TAGAMET able to tolerate QD. No pain, pt feels better. (+) fissured plaque (R) dorsal hand and papules (R) dorsal hands. No obvious VV, hard to tell. ALDARA QD x 3 wks took 1 RF cont TAGAMET. Recheck 1 mo.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pruritus, Rash papular, Secretion discharge, Skin fissures, Skin papilloma
Clinical narrative: After 7/31/13 HPV, multiple flat warts appeared on hands and knees. 2nd dose 10/18/13, warts immediately intensified to > 100. 3rd Booster declined. Warts have persisted for almost a year. Patient has been seeing a Dermatologist for this condition since 10/18/13. 11/26/13 Spoke with pt mom states hands "oozy" concerned re: infxn and has developed new areas. Sched pt OV today. 11/26/13 hand draining (1) s/p ALDARA to VV. (R) hand - swollen with tender, warmth and open, draining areas. (2) Infected Rx KEFLEX 250 QID x 14d with food. D/C ALDARA for now. D/C TAC for 2 wks. 12/6/2013 CC - hand. S/P VV -> ALDARA - infection (R) dorsal hand (+). (+) retention hyperkatatosis palms. Wash hands, cont Vaseline. D/C ALDARA. 12/27/13 - new Rx request for cephalexin 500mg #56 1 PO QID x 14 days. (+) Pt crying d/t personal reasons. 10/28/2013 CC: hands "flat VV". (+) Itchy and miserable, esp since starting ALDARA/Saran wrap D/C a few days ago. (B) dorsal knuckles/PIP. Tan and erythematous VV papules flat approximately 100s of them (+) tender. VV with secondary inflamed rxn after ALDARA with occlusion. SW pt and mom at length. (R) TAC 0.1% oint BID x 5d. (S) TOPICORT .025 oint BID then resume ALDARA 3 x 1 wk no occlusion. F/U 2 wks. 11/18/2013 CC: hands - VV - s/p ALDARA x 3 wks and TAGAMET able to tolerate QD. No pain, pt feels better. (+) fissured plaque (R) dorsal hand and papules (R) dorsal hands. No obvious VV, hard to tell. ALDARA QD x 3 wks took 1 RF cont TAGAMET. Recheck 1 mo.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Skin plaque, Skin warm, Tenderness
Clinical narrative: After 7/31/13 HPV, multiple flat warts appeared on hands and knees. 2nd dose 10/18/13, warts immediately intensified to > 100. 3rd Booster declined. Warts have persisted for almost a year. Patient has been seeing a Dermatologist for this condition since 10/18/13. 11/26/13 Spoke with pt mom states hands "oozy" concerned re: infxn and has developed new areas. Sched pt OV today. 11/26/13 hand draining (1) s/p ALDARA to VV. (R) hand - swollen with tender, warmth and open, draining areas. (2) Infected Rx KEFLEX 250 QID x 14d with food. D/C ALDARA for now. D/C TAC for 2 wks. 12/6/2013 CC - hand. S/P VV -> ALDARA - infection (R) dorsal hand (+). (+) retention hyperkatatosis palms. Wash hands, cont Vaseline. D/C ALDARA. 12/27/13 - new Rx request for cephalexin 500mg #56 1 PO QID x 14 days. (+) Pt crying d/t personal reasons. 10/28/2013 CC: hands "flat VV". (+) Itchy and miserable, esp since starting ALDARA/Saran wrap D/C a few days ago. (B) dorsal knuckles/PIP. Tan and erythematous VV papules flat approximately 100s of them (+) tender. VV with secondary inflamed rxn after ALDARA with occlusion. SW pt and mom at length. (R) TAC 0.1% oint BID x 5d. (S) TOPICORT .025 oint BID then resume ALDARA 3 x 1 wk no occlusion. F/U 2 wks. 11/18/2013 CC: hands - VV - s/p ALDARA x 3 wks and TAGAMET able to tolerate QD. No pain, pt feels better. (+) fissured plaque (R) dorsal hand and papules (R) dorsal hands. No obvious VV, hard to tell. ALDARA QD x 3 wks took 1 RF cont TAGAMET. Recheck 1 mo.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling at injection site 48 hours after vaccine. Treated with 7-10 days of antibiotics.
Age: 2.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red bumps all over body/rash. Afebrile. Mom applied BENADRYL cream to rash and it was gone the next day. Child did not complain about itching.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Fatigue, Headache, Neck pain, Pain
Clinical narrative: Pt reported feeling very achy; very tired; "feverish" and "horrible headache" evening and night of 7/22/14. On 7/23/14 AM pt had temp of 101.6 oral upon awakening. Slept most of day. In office 7/24/14 for PPD read. Pt reports feeling back to normal, but says had low grade temp, and neck and lower back soreness up until bedtime 7/23/14.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Somnolence, Tuberculin test negative
Clinical narrative: Pt reported feeling very achy; very tired; "feverish" and "horrible headache" evening and night of 7/22/14. On 7/23/14 AM pt had temp of 101.6 oral upon awakening. Slept most of day. In office 7/24/14 for PPD read. Pt reports feeling back to normal, but says had low grade temp, and neck and lower back soreness up until bedtime 7/23/14.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Immediate post-injection reaction, Oral administration complication, Vomiting projectile
Clinical narrative: Patient projectile vomited large amounts immediately upon dosing with 2-3 drops of ROTATEQ. MA attempted x2, both times pt had projectile vomiting. Mom denies any history of spitting or vomiting.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Headache, Immediate post-injection reaction, Injection site pruritus
Clinical narrative: Vaccination 7/25/2014. Right after vaccination, had headache and still present. Off and on, no medications. Vaccination site itchiness 7/25/2014 then itchy and redness starting 7/26/2014 up to now. Upper stomach discomfort starting 7/28/2014. Normal BM, urination. No fever/chills.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Vaccination 7/25/2014. Right after vaccination, had headache and still present. Off and on, no medications. Vaccination site itchiness 7/25/2014 then itchy and redness starting 7/26/2014 up to now. Upper stomach discomfort starting 7/28/2014. Normal BM, urination. No fever/chills.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Pt. received vac. 7/25/14 at 0915 AM. Pt. reported rash to bilateral arms from waist to elbow 7/25/14 at 1630 PM. Was seen by provider at urgent care on 7/25/14 evening, also 7/29/14 AM. F/u scheduled with MD 7/29/14 AM 0700.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Convulsion, Eye movement disorder
Clinical narrative: MA called provider to report pt not reacting well to vaccine "having seizure" upon entering of room; pt lying on exam table A and O x 3 pulse ox 98% RA, moved all extremities w/o restriction, normal speech. Mother present during episode and states that eye rolled back (pt fell backward with no limb jerking or incontinence. Vitals reviewed no distress at 10:30 am pt. reevaluated no changes as above. ED precautions given per PCP.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling 7-17-14 at 5pm; redness 7-17-14; hot 7-17-14.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt had a large erythematous region on her left arm at the injection site. Pharmacy sent pt to physician's office. Patient received a common antibiotic and is being monitored.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Exposure during pregnancy, Injection site pain, Pain
Clinical narrative: Pt went to MD complained of shooting pain in back and arm where shot was administered. Patient has had severe pain since day of injection until present. She reported complaint to pharmacy provider 7/25/14.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired drug administered, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to two patients of unknown age and gender. On 29-MAY-2014, the patients were vaccinated with PROQUAD (Merck) lot # H020851, expiration date 26-MAY-2014, intramuscular. On 29-MAY-2014, 2 patients received PROQUAD (Merck) via the intramuscular route. There were no known adverse effects. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Follow-up received from the other health professional, provided information about 52 months female patient, who on 29-MAY-2014 at approximately 04:00PM was vaccinated with the first dose of PROQUAD (Merck) lot # H020851 in the left arm. None other concomitant medications was reported. This is one of several reports received from the same source. Additional information is not expected, questionnaire was received.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On 21-JUL-2014 the patient was vaccinated with an expired dose of PNEUMOVAX23 intramuscular, right arm, 0.5 ml, lot # H021941 and expiration date 11-JUL-2014. No adverse effects reported. Additional information is not expected because the pharmacist refused additional contact.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II, HSA (dose, lot # and route were not reported), after being stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This spontaneous report as received from a nurse via a company representative 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 ZOSTAVAX. Dose, route, frequency, lot number and expiration date not reported. No co-suspect and concomitant therapies were reported.  The nurse reported that unspecified number of patients experienced redness and itching after receiving ZOSTAVAX. The outcome of redness and itching after receiving ZOSTAVAX was unknown. Additional information is not expected. (Not allowed to contact physician).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL (dose, lot # and route were not reported), after being stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 GARDASIL that was improperly stored. Dose, route, frequency, lot number and expiration date were not reported. No adverse effect reported. This is one of two reports from the same source (other case # 1407USA012568). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse 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 patients were vaccinated with PNEUMOVAX23 that was improperly stored. Dose, route, frequency, lot number and expiration date were not reported. No adverse effects reported. This is one of two reports from the same source (other case # 1707USA012406). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The medical assistant reported that an excursion of SF for up to 3 minutes each day over the past 30 days, totaling 90 minutes. The product affected was PROQUAD (Merck) (dose and route not reported), lot numbers of product involved in the excursion(s), and which may have been administered, are as follows: Lot reported as K004712 expiration date 02-AUG-2015; lot K005885 expiration date 24-OCT-2015. The product was also involved in a supported excursion on 13-JUN-2014 of 7F for up to 16 minutes. The reporter presumes that the vaccine had been administered post excursion but is not 100% sure. She states that no one has reported any adverse effects post receipt of any vaccination administered at her office. This is one of several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Injection site erythema
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 60 year old female patient with no pertinent medical history and no drug reactions or allergies. On 23-JUL-2014, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # K000328, expiration date 06-MAR-2015) subcutaneously in the left arm. The pharmacist report that on 25-JUL-2014, the patient sought medical attention at pharmacy by going into pharmacy and stated she experienced headache, felt horrible and had a super, bright red, golf ball size area at her left arm ZOSTAVAX injection site since an unspecified date after the administration of ZOSTAVAX. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: RUB
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a 29 year old female patient refers to herself with no allergies or medical history. The patient did not have measles immunity. On 04-AUG-2008, the patient was vaccinated with a dose of unspecified rubella containing vaccine (dose and route unknown). There were no concomitant medication. The patient explained that she developed a "massive reaction" after receiving an unspecified Rubella containing vaccine. The patient stated that the reaction included development of hives over her entire body which lasted for about 5 days and began about 1 day after receipt of vaccine ( on 05-AUG-2008). There were no lab diagnostics studies performed. The patient sought medical attention via calling the physician. The patient was unsure if the vaccine she received was the M-M-R II or the now discontinued MERUVAX II. The patient provided the following lot identification information for the vaccine: Lot# 659371/1815U, which was valid for MERUVAX II, and not valid for M-M-R II; Expiration Date : 11-AUG-2009. The outcome of the event was reported as recovered on 09-AUG-2008 last for about 5 days (also reported as "within 1 week following vaccination") Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Nasal obstruction, Pulse pressure decreased
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 53 year old female patient. On 08-JUL-2014 the patient was vaccinated with ZOSTAVAX lot # K000327, expiration date: 05-MAR-2015, 0.65 ml, subcutaneous for vaccination. 24 hours after receiving ZOSTAVAX, the patient experienced redness at the injection site which was 3.5 inches in diameter. The patient also said she had difficulty breathing, she could "hardly feel a pulse" and it felt like her nasal passages were closed. The patient treated herself with Benadryl and recovered at unspecified time. The patient sought medical attention by calling the pharmacy. This is one of several reports received from the same reporter and same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician refers to a 70 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was 662856/1559X, expiration date was 28-APR-2010) (dose and frequency were unknown) subcutaneous. On 03-JUL-2014 the patient experienced shingles and post herpetic neuralgia (PHN). The patient seek medical attention via an office visit. The outcome of shingles and PHN was reported as recovering/resolving. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Carpal tunnel decompression, Carpal tunnel syndrome, Cerebral infarction, Coagulation test normal, Colonoscopy
Clinical narrative: This spontaneous report as received from a physician refers to a 70 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was 662856/1559X, expiration date was 28-APR-2010) (dose and frequency were unknown) subcutaneous. On 03-JUL-2014 the patient experienced shingles and post herpetic neuralgia (PHN). The patient seek medical attention via an office visit. The outcome of shingles and PHN was reported as recovering/resolving. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Herpes zoster, Mammogram, Post herpetic neuralgia, Sinus operation, Smear cervix
Clinical narrative: This spontaneous report as received from a physician refers to a 70 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was 662856/1559X, expiration date was 28-APR-2010) (dose and frequency were unknown) subcutaneous. On 03-JUL-2014 the patient experienced shingles and post herpetic neuralgia (PHN). The patient seek medical attention via an office visit. The outcome of shingles and PHN was reported as recovering/resolving. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, PPV, VARZOS
Symptoms: Spinal operation, Transient ischaemic attack
Clinical narrative: This spontaneous report as received from a physician refers to a 70 years old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# was 662856/1559X, expiration date was 28-APR-2010) (dose and frequency were unknown) subcutaneous. On 03-JUL-2014 the patient experienced shingles and post herpetic neuralgia (PHN). The patient seek medical attention via an office visit. The outcome of shingles and PHN was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the unspecified patients were vaccinated with M-M-R II (therapy type, strength, dose and lot# were unknown). No concomitant medications were reported. The nurse reported that since 01-JUL-2014, the unspecified patients may have been administered M-M-R II, which were not stored properly. No adverse effects reported. This is one of the several report received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker refers to an unspecified number of patients of unkonwn age and gender. On an unknown date the patients were vaccinated with VAQTA (dose, lot # and route were not reported), after being stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAX HB (dose, lot # and route were not reported), after being stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to the reporter did not want to be contacted again.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant refers to a patient of unknown age and gender. On 05-MAR-2014, the patient was vaccinated with GARDASIL dose 1, 0.5 ml Intramuscular. On 05-MAY-2014, the patient was vaccinated with GARDASIL dose 2, 0.5 ml Intramuscular. On 04-JUN-2014 the patient was vaccinated with GARDASIL dose 3, 0.5 ml intramuscular. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The medical assistant reported that an excursion of SF for up to 3 minutes each day over the past 30 days, totaling 90 minutes. The product affected was M-M-R II (dose and route not reported), lot numbers of product involved in the excursion(s) were not reported. Excursion not supported. The product was also involved in a supported excursion on 13-JUN-2014 of 7F for up to 16 minutes. The reporter presumed that the vaccine had been administered post excursion but was not 100% sure. She stated that no one had reported any adverse effects post receipt of any vaccination administered at her office. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The medical assistant reported that an excursion of SF for up to 3 minutes each day over the past 30 days, totaling 90 minutes. The product affected was VARIVAX (Merck) (dose and route not reported), lot numbers of product involved in the excursion(s), and which may have been administered, are as follows: lot J009989 expiration date 12-AUG-2015; lot J012210 expiration date 28-SEP-2015; lot reported as J013730 expiration date 30-OCT-2015; lot reported as J014229 expiration date 08-NOV-2015. The product was also involved in a supported excursion on 13-JUN-2014 of 7F for up to 16 minutes. The reporter presumes that the vaccine had been administered post excursion but is not 100% sure. She states that no one has reported any adverse effects post receipt of any vaccination administered at her office. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 2 patients (no demographics or the treating physician were provided for either patient). On an unknown date the patients were vaccinated with ZOSTAVAX. On an unknown date the patients experienced mild case of shingles. The outcome of mild case of shingles was unknown. Relatedness  between event and vaccination with ZOSTAVAX was not reported. Additional information is not expected, reporter declined to be contacted.
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot #, expiration date, dose, route unspecified). On an unknown date the patient experienced thyroid disease. The outcome of thyroid disease was unknown. This is one of several reports received from same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARADSIL (lot #, expiration date, dose, route unspecified). On an unknown date the patient experienced thyroid disease. The outcome of thyroid disease was unknown. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. About 18 months ago, in approximately January 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose was unknown) subcutaneous at another facility. On 14-JUL-2014 the patient was inadvertently administered the second dose of ZOSTAVAX (lot#, expiration date, dose was unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that he heard from an unspecified healthcare that the patient was vaccinated with two doses of ZOSTAVAX (lot #, expiration date, strength, dose were unknown). The doses were given approximately 3 to 6 months apart. No symptoms were reported. Additional information is not expected.