chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Visual acuity tests normal, Visual field tests normal, Vitreous floaters
Clinical narrative: Initial report was retrieved from the scientific literature on 25 March 2013. The following is verbatim from the report: "A previously health 33-year-old male was referred to our retina service for sudden onset of intermittent floaters and flashing lights in his right eye which developed 3 weeks following inactivated hepatitis A, yellow fever, and typhoid vaccinations. These vaccines were given prophylactically in preparation for a 2-week trip at [a clinic]. The patient had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. There was no history of autoimmune disease or recent viral illness. There was no family history of autoimmune disease. The patient was diagnosed as having acute multifocal choroiditis and observed. After 2 weeks, the patient continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the nonprogressive examination findings and given the excellent visual acuity, it was decided to continue close observation. At 8 weeks, the patient's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy." Outcome was recovered. Documents held by sender: None.
Age: 33.0
Sex: M
Vaccine: HEPA, TYP, YF, HEPA, TYP, YF
Symptoms: Angiogram abnormal, Angiogram retina abnormal, Choroiditis, Fundoscopy abnormal, Inflammation
Clinical narrative: Initial report was retrieved from the scientific literature on 25 March 2013. The following is verbatim from the report: "A previously health 33-year-old male was referred to our retina service for sudden onset of intermittent floaters and flashing lights in his right eye which developed 3 weeks following inactivated hepatitis A, yellow fever, and typhoid vaccinations. These vaccines were given prophylactically in preparation for a 2-week trip at [a clinic]. The patient had previously received one dose of the hepatitis A vaccine 12 years prior (he did not complete the series) and had never before been exposed to typhoid or yellow fever immunizations. On examination, visual acuity was 20/20 in both eyes. Pupil responses, visual fields to confrontation, and intraocular pressures (14 mmHg) were normal bilaterally. Slit lamp examination revealed 1+ anterior vitreous inflammation bilaterally. Fundus examination of the right eye revealed a few scattered peripheral nonpigmented chorioretinal lesions. The macula and optic nerve appeared normal, and the left fundus was unremarkable. Fluorescein angiography of the right eye demonstrated scattered peripheral hyperfluorescent lesions correlating with those seen in the fundus, and there was no evidence of disc leakage. A comprehensive review of systems was negative for fever, rash, oral ulcers, arthralgias, headache, or vertigo. There was no history of autoimmune disease or recent viral illness. There was no family history of autoimmune disease. The patient was diagnosed as having acute multifocal choroiditis and observed. After 2 weeks, the patient continued to describe occasional floaters. His ocular examination revealed continued low grade anterior vitreous inflammation and the peripheral retinal lesions began to demonstrate early hyperpigmentation. Because of the nonprogressive examination findings and given the excellent visual acuity, it was decided to continue close observation. At 8 weeks, the patient's symptoms had resolved, the vitreous was clear of cellular inflammation, and the fundus revealed punched out areas of retinal pigment epithelium atrophy." Outcome was recovered. Documents held by sender: None.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning an approximately 58 year old male patient with high blood pressure and no drug reactions or allergies. The medical history of the patient included shingles and was exposed to someone with the shingles on 19-MAR-2013. On 25-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000435 and 10-APR-2014 respectively, dose and route unspecified). Concomitant therapies included gabapentin and unspecified pain medications. On an unknown date, approximately in March 2013 (reported as now), the patient experienced shingles. The patient sought medical attention (contacted pharmacist). The patient was treated with valacyclovir. The outcome of shingles was reported as not resolved. VZVID packet accepted and faxed to the pharmacist. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 5 year old patient of unknown gender. The nurse reported that a 5 year old was vaccinated with a dose of GARDASIL (Lot number, expiry date and dose were not reported), intramuscular on 04-APR-2013. The nurse reported that the order for the patient was for poliovirus vaccine inactivated (IPV) and was misread or interpreted as Human papillomavirus (HPV) vaccine. No product confusion was discovered. No adverse event reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Asthenia, Dizziness, Full blood count, Headache, Pain
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 11 year old male patient with VIGAMOX allergy and none pertinent medical history. On 25-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H010649 and exp date 20-FEB-2013) 1 vial, intramuscular (dose, not reported). No other co suspects were reported. No concomitant therapy was reported. The healthcare worker reported that on 02-APR-2013, the patient developed headache, dizziness, body aches and body weakness after receiving the first dose of GARDASIL. The patient sought medical attention, the patient saw the physician. Treatment was not given. CBC and UA were performed. The outcome of the patient developed headaches, the patient developed body weakness, the patient developed body aches and the patient developed dizziness was reported as recovering/resolving. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Urine analysis
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 11 year old male patient with VIGAMOX allergy and none pertinent medical history. On 25-MAR-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H010649 and exp date 20-FEB-2013) 1 vial, intramuscular (dose, not reported). No other co suspects were reported. No concomitant therapy was reported. The healthcare worker reported that on 02-APR-2013, the patient developed headache, dizziness, body aches and body weakness after receiving the first dose of GARDASIL. The patient sought medical attention, the patient saw the physician. Treatment was not given. CBC and UA were performed. The outcome of the patient developed headaches, the patient developed body weakness, the patient developed body aches and the patient developed dizziness was reported as recovering/resolving. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Induration, Injection site inflammation, Skin warm, Tenderness
Clinical narrative: Patient had HPV #2 on 2/20/13 - (R) upper arm recently developed quarter sized area of firmness and light erythema, warm to touch, tender with direct pressure, ? of cellulitis, localized inflammation (R) upper arm. Treatment - supportive care.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 73 year old male patient. On 28-JAN-2009 the patient was vaccinated with ZOSTAVAX (lot number not provided). On 02-MAR-2013 (about a month ago) the patient experienced a mild case of the shingles. The shingles were only in the patient's right upper arm. The patient sought medical attention (unspecified). The outcome of a mild case of the shingles was reported as recovering/resolving. The relatedness was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Child was given vaccine, went to leave and passed out in the lobby. Mom caught the child & made us aware that she did not hit her head. She was brought back to a room to lay down legs elevated & BP was taken. Color was very pale but BP was good - 90/62. After laying down for 10 min child was okay to sit up. BP taken again 84/52. Remained sitting for 5-7 then colored returned & child left with mother with no problems.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. The physician noted an unspecified female patient was administered her one and only dose of GARDASIL (Lot # was not reported) intramuscular about two weeks ago (Approx. on 15-MAR-2013) . About 10 days after that administration of GARDASIL (Approx. 25-MAR-2013), the patient experienced abdominal pain, diarrhea, vomiting and nausea. No treatment was given for events. Concomitant therapies included ALDARA. The patient sought medical attention in the office. The outcome of abdominal pain, diarrhea, vomiting and nausea was unknown.The relation between events and GARDASIL was unknown. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient was administered FLUVIRIN on 10-29-12. Patient's mother contacted pharmacy on 4-5-13 stating that from the administration date until present, her daughter complains of pain and soreness in the arm near injection site. Patient has sought medical attention and used SALONPAS patches with no relief.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 16 year old male patient. On 19-OCT-2012, the patient was vaccinated with first dose of GARDASIL, (lot number, expiry date and route was not reported). On 26-DEC-2012, the patient was vaccinated with second dose of GARDASIL, (lot number, expiry date and route was not reported). On 01-APR-2013, the patient was vaccinated with their dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. The patient got his GARDASIL doses a little bit early. No adverse event was reported. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 04-FEB-2013 the patient was vaccinated with GARDASIL injection (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The healthcare worker reported that patient received a dose of CERVARIX in April 2011 and a dose of GARDASIL on 04-APR-2013. No adverse effect reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia, Somnolence
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a 63 years old female patient. On 18-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). On 26-MAR-2013, the patient reported to the pharmacist that she experienced feelings of sleepiness, sensitivity in her arms and tingling after receiving ZOSTAVAX. The outcome of the reported events were unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Swollen arm, red, hot, hurt to move. Rx: KEFLEX 250/5ml given 2 tsp P.O BID x10 day. TAC 0.1% given apply BID.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Pain and swelling in all joints - hips, knees, back, arms, legs, feet - more pronounced pain and swelling in both hands. States fingers are swollen on both hands preventing her from removing her rings.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 04-APR-2013, the patient was vaccinated with the first dose of (Merck) VARIVAX (lot number reported as 670180/0435AA) that had expired on 21-MAR-2013. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Rash
Clinical narrative: This spontaneous report was received from a Medical Assistant regarding an "about 2 years old" male patient with no pertinent medical history or drug reactions or allergies reported. The medical assistant reported that the patient who was new to the practice was administered unspecified vaccinations in February 2013 which may include (Merck) VARIVAX (lot number and expiration date not reported) (dose, route and anatomical location not reported). The reporter stated that on an unknown date the patient experienced a "painful rash on his left buttock" which has been diagnosed as possible shingles. No medical history or vaccination records were available at the time of the report. The outcome for the "painful rash on his left buttock" which has been diagnosed as possible shingles was reported as not recovered. No treatment information was specified by the reporter. No laboratory diagnostic studies were performed. The patient sought medical attention by an office visit. The reporter did not assess the relatedness between the "painful rash on his left buttock" which has been diagnosed as possible shingles and (Merck) VARIVAX. 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 pharmacist concerning a patient of unknown age and gender who on 03-APR-2013 was vaccinated with a dose of ZOSTAVAX that had expired on 02-apr-2013 (lot number not provided). No adverse effects had been reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 20-MAR-2013 the patient was vaccinated with a dose of expired ROTATEQ (dose, route not reported)(lot number 670539/0678AA, expiry date 15-MAR-2013). No adverse event reported. It was unspecified if the patient had sought medical attention. Action taken and causality of ROTATEQ were not reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 year old female patient with headaches who on 19-NOV-2012, was vaccinated with ZOSTAVAX lot # 672676/0069AE (dose and route not provided). Concomitant therapies included trazodone hydrochloride, CELEXA, amlodipine and NAPROSYN. The pharmacist, stated that on 02-APR-2013, the patient reported that she experienced three outbreaks of shingles, after receiving ZOSTAVAX on 19-NOV-2012. The patient reported outbreaks of shingles occurred on 03-DEC-2012 (two weeks after receiving ZOSTAVAX), around January 2013 and on 30-MAR-2013. Pharmacist was not aware of how extensive the rash was with the outbreaks of shingles and reported that the patient had been prescribed FAMVIR for earlier outbreaks. No further information was provided. The outcome of three events of shingles was unknown. The relatedness adverse events was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Menorrhagia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age with no pertinent medical history and no drug reactions or allergies. On an unknown date the patient was vaccinated with GARDASIL injection (lot # and expiration date unspecified) (dose, route and anatomical location unspecified) for vaccination. Concomitant medications were not reported. The healthcare worker reported that on an unknown date the patient developed heavy periods with cramps after receiving a dose of GARDASIL. At the time of the report the outcome of heavy periods and cramps was reported as recovered/resolved. Patient sought medical attention by seeing the physician. Therapy with MEDRIOL was given as treatment. Laboratory tests were not reported. The reporter stated that this is 4 of 4 cases reported the same day. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Full blood count, Measles, Metabolic function test, Otitis media, Pyrexia
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old male patient without pertinent medical history or drug reactions/allergies. On 13-MAR-2013 the patient was vaccinated with M-M-R II (dose and lot# not reported) (dose and lot# not reported) and (Merck) VARIVAX (dose and lot# not reported) concomitantly on the same day. On 22-MAR-2013, the patient was diagnosed with otitis media and was prescribed amoxicillin. The patient later developed a fever and a body rash that was diagnosed as a "vaccine induced measles rash". "Blood work-CBC. BMP" was performed without result At the time of reporting, the patient was recovering from the events. The patient sought medical attention by office visit. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 15 month old male patient without pertinent medical history or drug reactions/allergies. On 13-MAR-2013 the patient was vaccinated with M-M-R II (dose and lot# not reported) (dose and lot# not reported) and (Merck) VARIVAX (dose and lot# not reported) concomitantly on the same day. On 22-MAR-2013, the patient was diagnosed with otitis media and was prescribed amoxicillin. The patient later developed a fever and a body rash that was diagnosed as a "vaccine induced measles rash". "Blood work-CBC. BMP" was performed without result At the time of reporting, the patient was recovering from the events. The patient sought medical attention by office visit. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Ultrasound scan normal, X-ray normal
Clinical narrative: Annual exam 3/8/13 received shingles vaccine left deltoid on 3/17/13 she presented to urgent care for severe pain (L) shoulder radiating to fingers, symptoms started 5 days after vaccine. Treated with PERCOCET, NSAID's, ice, LIDODERM, gabapentin. US and X-ray done, OK. Pain finally started improving 1st week of April.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Injection site discomfort, Rash macular
Clinical narrative: Erythema, macular and blotchy and irregular in pattern extends approximately 2 inches in diameter. No warmth of skinat site left anterior thigh (not lateral) site of VARIVAX vaccine given 3-26-13. Pt is afebrile. Discomfort at site relieved with TYLENOL 1 dose.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count normal, Injection site bruising, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right shoulder - upper arm swollen warm tender bruising 15 x 18 cm after Tdap vaccination 2 days prior.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Erythema, Urticaria
Clinical narrative: Hives - bilateral lower legs 10 minutes after vaccines. Administered Q-DRYL per dr. hives resolved. Diffuse redness with hives only in lower extremity.
Age: 75.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Headache, Mass, Skin warm, Swelling
Clinical narrative: Swollen, red, hot, egg shaped lump. Advised by a pharmacist from pharmacy to ice pack it. Headaches.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Feeling hot, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 12x10cm area of redness at site of ZOSTAVAX pain 8/10 - 10/10 at injection site. Flu-like symptoms itching, headache, warmth and lump. PNEUMOVAX 4.5cm area of redness and just "achy".
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: 12x10cm area of redness at site of ZOSTAVAX pain 8/10 - 10/10 at injection site. Flu-like symptoms itching, headache, warmth and lump. PNEUMOVAX 4.5cm area of redness and just "achy".
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Patient came into pharmacy at 9AM (3/25/13) had redness, swelling with warmth at injection site. Also vesicles are present at injection site, refer patient to primary care physician for evaluation.
Age: 1.78
Sex: F
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Rash.
Age: 28.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Injection site redness, induration and itching to left arm.
Age: 75.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swelling, sore (L) bicep, hot.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Burning sensation, Dysaesthesia, Headache, Injection site pain
Clinical narrative: Patient noted vaccine burned a bit more at time of injection on 2/28/13 compared to first dose administered 12/28/12. Subsequent to that the burning generalized up and down arm and onto right shoulder. Also has had a dull headache since then. Notes pain & difficulty reaching behind her. She is having difficulty drawing & lifting things with right arm. (At time of visit on 3/5/13 at 8:50am). Dx: Dysesthesia (favor early RSD). Treatment: GRALISE tablet 600mg starter pack.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient noted vaccine burned a bit more at time of injection on 2/28/13 compared to first dose administered 12/28/12. Subsequent to that the burning generalized up and down arm and onto right shoulder. Also has had a dull headache since then. Notes pain & difficulty reaching behind her. She is having difficulty drawing & lifting things with right arm. (At time of visit on 3/5/13 at 8:50am). Dx: Dysesthesia (favor early RSD). Treatment: GRALISE tablet 600mg starter pack.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site haemorrhage, No adverse event
Clinical narrative: While injecting, I noted bright red blood in hole - I removed the needle syringe, pushed the sm amt blood out, used a new needle and re-injected at a different (L) deltoid site. There were no apparent adverse effects.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Developed hives on rt upper arm that eventually spread across chest. Took BENADRYL with some relief. 4-8-13: Hives not present.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, redness, severe induration lower half of posterior upper right arm - 5 inches in diameter at its worst and felt very tired x 2 days. still 2" in diameter redness and mild induration.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Feeding disorder of infancy or early childhood, Pyrexia
Clinical narrative: Baby had episode of high pitch crying and was inconsolable > 3 hours following first set of immunizations given 3/11/13. She had a decrease in appetite. Also low grade fever of about 99F per Dad. Decrease in feeding lasted approximately 1 week.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Erythema, swelling, bumps at 1cm x 1.5 diameter at both thighs.
Age: 1.17
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: 14 month female with immunization delay, immunization catch up and well child check on 4/1/13. Developed fever to 103 that evening and had seizure. Parents called 911 and taken to ED.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: 5-7 days after receiving vaccine, patient presented w/ red spots/rash all over body. Patient treated by dermatologist since 12/2012 and was referred to us today to check with manufacturer. This was first time adverse reaction brought to our attention.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: 5-7 days after receiving vaccine, patient presented w/ red spots/rash all over body. Patient treated by dermatologist since 12/2012 and was referred to us today to check with manufacturer. This was first time adverse reaction brought to our attention.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 4/4/13 Pt awakened with c/o itchy. sl painful, red, swollen, warm to touch inj.site (L) tricep) 1 d after VARIVAX administered on 4/1/13. Treated with BENADRYL spray 1-2 x/day; No fever/ 3/4/13: Erythema 3.5" long x 3" wide; induration 1 1/2"; circumf: 3 1/2" sl pallor, decreased itching, no pain, no fever local reaction improving.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Pallor
Clinical narrative: 4/4/13 Pt awakened with c/o itchy. sl painful, red, swollen, warm to touch inj.site (L) tricep) 1 d after VARIVAX administered on 4/1/13. Treated with BENADRYL spray 1-2 x/day; No fever/ 3/4/13: Erythema 3.5" long x 3" wide; induration 1 1/2"; circumf: 3 1/2" sl pallor, decreased itching, no pain, no fever local reaction improving.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Rash, Swelling face
Clinical narrative: Patient had sporadic rash on chest noted prior to immunization administration. Approx. 20 min following administration mother called stating patient's cheeks were swollen and patient was coughing. Advised mother to return to clinic with patient. Arrived approx. 5 min later and patient was examined by Dr. ZYRTEC administered per wt/age. O2 sat 98%. Care resumed by Dr.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin positive, Vaginal haemorrhage
Clinical narrative: Patient had mild vaginal spotting on day of and prior to vaccination. She was pregnant and miscarried/started bleeding more heavily 20 days later.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Bone pain, Dizziness, Drug screen negative, Injection site pain, Loss of consciousness
Clinical narrative: Woke up dizzy, upper arms hurt to the bone, by afternoon hurt to try to raise them. Has hurt ever since, dizzy everyday, general sick feeling, passed out in class on a dizzy spell.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Pain, Pain in extremity, Pregnancy test negative
Clinical narrative: Woke up dizzy, upper arms hurt to the bone, by afternoon hurt to try to raise them. Has hurt ever since, dizzy everyday, general sick feeling, passed out in class on a dizzy spell.
Age: 0.22
Sex: M
Vaccine: BCG
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site scab
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 04-JAN-2013, the patient was vaccinated with BCG vaccine USP. No dosage information was reported. No lot number or expiration date was reported. No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient received BCG vaccine USP via the intradermal route. There were no known adverse effect. No further information was available. Follow up information received from the physician regarding the 5 month old male patient. Contact details of vaccine administrator and patient were updated the patient had no pre existing allergies. BCG vaccine USP, (lot# 4511121-A) given intradermally instead of percutaneous. On 04-JAN-2013, vaccination site became red and indurated and painful medically significant-as events required medical intervention). The patient was seen by infectious disease doctor and was started on rifampin and isoniazid to prevent any adverse reactions. The patient did not have laboratory tests performed. Area was drained on its own and is now scabbed and healing. Medication was given for 6 weeks. Prophylactic anti T.B medicines to prevent abscess or lymph node enlargement. No surgical problems or other complications. Illness at time of vaccination was none. Twin sibling was also vaccinated with the same vaccine. This is 1 of 2 reports from the same source. Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV1
Symptoms: Convulsion
Clinical narrative: Seizures within 24 hours of having 1st set of vaccines.
Sex: U
Vaccine: HIBV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. On 25-MAR-2013, the patient was inadvertently vaccinated with a 0.5 ml dose of PEDVAXHIB (Lot #1246Z), intramuscularly that had expired on 22-OCT-2012. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: Oedema peripheral
Clinical narrative: This spontaneous report as received from an administering registered nurse refers to a patient of unknown age and unknown gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (dose, route and lot# not reported) in the arm. The patient was also vaccinated with a dose of KINRIX (manufacturer GlaxoSmithKline) on the same arm. Subsequently, on an unknown date, the patient's arm swelled. The patient did not receive any treatment and did not seek any medical attention. On an unspecified date, the patient's outcome was recovered. Additional information is not expected.
Age: 0.34
Sex: F
Vaccine: HIBV
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old female patient. On 11-MAR-2013 the patient was vaccinated with her first dose of PEDVAXHIB (lot number 0419AE, expiry date 17-AUG-2014). On 11-MAR-2013 the patient experienced "small knot" at the injection site. The outcome of adverse event was recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin normal, Insomnia, Rash pruritic
Clinical narrative: This spontaneous report as received from a 82 year old male consumer. On 01-NOV-2012 the patient with no drug reactions/allergies was vaccinated with ZOSTAVAX (lot number was not reported) developed a severe itching rash on his legs the same day. There was no concomitant therapy. The rash progressed quickly and has maintained its severity. The patient explained that the rash became so severe at times that he was unable to sleep, sometimes for 2 night stretches. The patient had sought medical attention with 3-4 dermatologist who associated the rash with Eczema, however the Vascular physician who also evaluated the patient did not feel that Eczema was an accurate diagnosis. The patient treated with OTC topical creams. Biopsy completed and confirmed to rule out scabie infection. The outcome of event was unknown. The patient received unspecified flu vaccine 1 week after ZOSTAVAX vaccination. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: This spontaneous report as received from a 46 year old female nurse concerning herself with high blood pressure and LORTAB, as well as an anaphylactic reaction to erythromycin eye drops. On 01-APR-2013 (earlier today) the patient was vaccinated with PNEUMOVAX23, intramuscular. Concomitant therapies included lisinopril, PAXIL, vitamin d (unspecified), iron (unspecified) and cyanocobalamin (vitamin B-12). On 01-APR-2013, her arms was swollen to twice its size the eight inches around the injection site, the site was also red and warm, the arm arches, and the joint hurts. At the time of report, the outcome of events was not recovered. None lab diagnostics studies performed. Action taken was not provided. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a 46 year old female nurse concerning herself with high blood pressure and LORTAB, as well as an anaphylactic reaction to erythromycin eye drops. On 01-APR-2013 (earlier today) the patient was vaccinated with PNEUMOVAX23, intramuscular. Concomitant therapies included lisinopril, PAXIL, vitamin d (unspecified), iron (unspecified) and cyanocobalamin (vitamin B-12). On 01-APR-2013, her arms was swollen to twice its size the eight inches around the injection site, the site was also red and warm, the arm arches, and the joint hurts. At the time of report, the outcome of events was not recovered. None lab diagnostics studies performed. Action taken was not provided. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with the booster of VAQTA (lot # not reported) (25/0.5 U/ml, intramuscular, 0/5 ml). It was reported that the patient received the booster dose 15 days prior to the minimum interval of 6 months from the first dose. No adverse effects were reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This spontaneous report was received from an approximately 70-year-old female patient of unknown age with no pertinent medical history. Current conditions included allergy to ZANTAC IV. On 14-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on an unknown date in February 2013, the patient developed bright red hard spot that spread about 8 inches down the arm where (she) received ZOSTAVAX. The patient stated the spot was "itchy". As the spot faded, the patient stated that "it turned darker brown and got smaller". Treatment was not rendered for the events. The events recovered on an unknown date sometime in early March 2013. The patient did not seek medical attention for the events. Laboratory diagnostic studies were not performed. Causality was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report was received from an approximately 70-year-old female patient of unknown age with no pertinent medical history. Current conditions included allergy to ZANTAC IV. On 14-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on an unknown date in February 2013, the patient developed bright red hard spot that spread about 8 inches down the arm where (she) received ZOSTAVAX. The patient stated the spot was "itchy". As the spot faded, the patient stated that "it turned darker brown and got smaller". Treatment was not rendered for the events. The events recovered on an unknown date sometime in early March 2013. The patient did not seek medical attention for the events. Laboratory diagnostic studies were not performed. Causality was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. No medical history or concurrent conditions were reported. On 10-JAN-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous at an unknown site. No lot number or expiration date was reported. No other co-suspects were reported. No concomitant medications were reported. The pharmacist stated that the patient developed jaw pain shortly after administration of ZOSTAVAX. The patient sought medical attention by calling the pharmacy but did not received treatment for the adverse event. The jaw pain resolved but lasted for about one week. No reporter causality was provided. Additional information has been requested.
Age: 0.27
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizures 101.8 lasting > 30 minutes.
Age: 35.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Pain in extremity, Swelling, White blood cell count increased
Clinical narrative: Arm pain - s/p injection on Wednesday. Has had pain, noticed redness & swelling. Meds: vancomycin, KEFLEX, WBC 23.7.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient received the first and second dose of GARDASIL (lot number not provided) in February 2012 and April 2012, respectively. The patient was in the office to receive the third dose of GARDASIL (lot number not provided) on 04-APR-2013. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Sneezing
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an infant patient of unknown age. On 02-APR-2013, the patient was vaccinated (route unknown) with ROTATEQ (lot number and expiry date not reported). On 02-APR-2013, the patient experienced sneezing while or directly following administration. The outcome of sneezing while or directly following administration is unknown. The reporter did not assess the relationship of the event to ROTATEQ. This case is related to case 1304USA002452 (same reporter link). Additional information is not expected.
Age: 25.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 25 year old patient of unknown gender. No medical history provided. On an unknown date the patient was inadvertently vaccinated with ZOSTAVAX, (dose unknown, subcutaneous, Lot# unknown, indication: prophylaxis ("immunization")) instead of VARIVAX. There was no concomitant medication. No adverse effects noted. No treatment was given. The patient sought medical attention. No further information reported. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Feeling abnormal, Myalgia, Nervousness, Neuralgia
Clinical narrative: This spontaneous report as received from a 56 year old female patient with medical history of auto-immune disorders and brain infarction and with drug reactions/allergies to enalapril, MOBIC KEFLEX, tetracycline and penicillin. The caller(patient) stated she had had shingles in the past and had experienced post herpetic nerve pain. The caller stated her immunology doctor(who she did not wish to specify a name) had advised her to ZOSTAVAX. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot #, dose number were unspecified). Concomitant therapies included aspirin, CELEXA, acetaminophen, NORCO and XANAX. Patient stated that after she received ZOSTAVAX, the same night she developed severe muscular pain in every joint. She ran a Fever of 100 to 102 degrees which lasted for 3 days. She began feeling nervous and "edgy". She continued to have severe pain in the nerves in her back. It feels like post herpetic nerve pain. Patient had sought unspecified medical attention. TYLENOL and other pain medication were given for the events. The outcome of fever was reported as recovered on 23-MAR-2013, "lasted for 3 days", the outcome of other events were reported as not recovered. Drug relationship was not provided. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a 56 year old female patient with medical history of auto-immune disorders and brain infarction and with drug reactions/allergies to enalapril, MOBIC KEFLEX, tetracycline and penicillin. The caller(patient) stated she had had shingles in the past and had experienced post herpetic nerve pain. The caller stated her immunology doctor(who she did not wish to specify a name) had advised her to ZOSTAVAX. On 21-MAR-2013 the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot #, dose number were unspecified). Concomitant therapies included aspirin, CELEXA, acetaminophen, NORCO and XANAX. Patient stated that after she received ZOSTAVAX, the same night she developed severe muscular pain in every joint. She ran a Fever of 100 to 102 degrees which lasted for 3 days. She began feeling nervous and "edgy". She continued to have severe pain in the nerves in her back. It feels like post herpetic nerve pain. Patient had sought unspecified medical attention. TYLENOL and other pain medication were given for the events. The outcome of fever was reported as recovered on 23-MAR-2013, "lasted for 3 days", the outcome of other events were reported as not recovered. Drug relationship was not provided. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old female patient. On 20-MAR-2013 the patient was vaccinated with 0.5 ml expired PROQUAD (lot number 667182/1435Z, expiry date 27-MAR-2012) subcutaneously in the left arm. No adverse effects reported at reporting time. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 year old patient. Nurse reported that the accidental administration of both PROQUAD (Lot #, dose/frequency and route were unspecified) and VARIVAX (Merck) (Lot #, dose/frequency and route were unspecified) occurred today, 27-MAR-2013, to the patient. The outcome and drug relationship were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 16-FEB-2013 the patient was vaccinated with 0.65 ml ZOSTAVAX (19400 PFU) subcutaneously. It was reported that 22 vials of ZOSTAVAX (lot number H012138, expiry date 25-SEP-2013) were exposed to 70F for 5 minutes and called to assess temperature stability on 01-NOV-2012. They were determined to "must be used within three months 1 vial of ZOSTAVAX administered to the patient of 16-FEB-2013, no adverse effects noted. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Pallor
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative refers to a 2 month old male patient. On 02-APR-2013, the patient was vaccinated with a dose of ROTATEQ, (lot number J00035, expiry date was unknown and route was oral). Other suspect therapies included PENTACEL, PREVNAR 13 and HEPATITIS B VIRUS VACCINE (possibly RECOMBIVAX). On 02-APR-2013, the patient was reported to have turned pale and to have had severe diarrhea. The patient was taken to the emergency room for evaluation. The patient was not hospitalized. The patient did not get laboratory tests performed. The outcome of the reported events were unknown. The patient sought medical attention. 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 health care worker refers to a patient of unknown age. On 06-APR-2013, the patient was vaccinated with a dose of VAQTA, (lot number, expiry date was not reported and route was intramuscular) and could not support the temperatures they went down to. Concomitant medications were not reported. No adverse reactions were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 02-APR-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot# 1346AA, expiration date 27-OCT-2012). It was not known which of the three doses in the ROTATEQ vaccination series this dose was. No adverse effect reported. No patient contact details available. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TDAP, YF
Symptoms: Formication, Hyperaesthesia, Induration, Injection site reaction, Laboratory test
Clinical narrative: 11/22/12 itch on back, "hard around arm with Y.F. vax. No rash, erythema or induration. 1/7/13 hyperalgesic at injection site, abdomen, back, thigh "feels like sunburn". Crawly sensation. No motor symptoms. Improved on Gabapentin - is now weaning off Gabapentin.
Age: 35.0
Sex: M
Vaccine: HEPAB, IPV, MNQ, TDAP, YF
Symptoms: Pruritus
Clinical narrative: 11/22/12 itch on back, "hard around arm with Y.F. vax. No rash, erythema or induration. 1/7/13 hyperalgesic at injection site, abdomen, back, thigh "feels like sunburn". Crawly sensation. No motor symptoms. Improved on Gabapentin - is now weaning off Gabapentin.