chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at site beginning evening after vaccine given and spreading to encompass anterior aspect of upper arm.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Syncope
Clinical narrative: * Syncope episode 10 minutes after inj. * Provided O2 at 8L - x 10 -15 minutes - had pt lay flat. * Continued to complain of headache x 1 hour.
Age: 1.91
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Culture stool, Diarrhoea, Dysphemia, Parasite stool test, Pyrexia
Clinical narrative: 1) Diarrhea onset 9/6/12. 2) Fever onset 9/6/12. 3) Stuttering onset 9/10/12.
Age: 1.91
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Culture stool, Diarrhoea, Pyrexia
Clinical narrative: 1) Diarrhea onset 9/6/12. 2) Fever onset 9/6/12. 3) Stuttering onset 9/10/12.
Age: 1.37
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Started on 9-12-12, red, swollen area on (R) thigh, approx 1 1/2" circular, 9-13-12 2" x 3" circular, red, swollen area, warm to touch.
Age: 0.47
Sex: F
Vaccine: HIBV
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Pyrexia, Restlessness
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 6-month old female subject who was vaccinated with HIBERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice and respiratory syncytial virus. The subject received other vaccines, specific details were unknown. There were no concurrent medications. On the morning of 23 May 2012 the subject received unspecified dose of HIBERIX (unknown, left thigh) and experienced wrong vaccine administered. The subject was given HIBERIX instead of "regular HIB". On an unspecified date, less than one month after vaccination with HIBERIX, the subject experienced injection site pain, injection sire redness, high fever, and restlessness. The subject had a body temperature of 102, which was treated with TYLENOL. At the time of reporting the injection site pain, injection site redness, high fever, and restlessness were resolved.
Age: 0.47
Sex: F
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site pain in a 6-month old female subject who was vaccinated with HIBERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice and respiratory syncytial virus. The subject received other vaccines, specific details were unknown. There were no concurrent medications. On the morning of 23 May 2012 the subject received unspecified dose of HIBERIX (unknown, left thigh) and experienced wrong vaccine administered. The subject was given HIBERIX instead of "regular HIB". On an unspecified date, less than one month after vaccination with HIBERIX, the subject experienced injection site pain, injection sire redness, high fever, and restlessness. The subject had a body temperature of 102, which was treated with TYLENOL. At the time of reporting the injection site pain, injection site redness, high fever, and restlessness were resolved.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Received Tdap on 09/06/12 and 3 days later started with itching & developed extensive swelling, redness, induration & warm to touch it entire upper arm extending from left deltoid to above the elbow. Currently being treated for cellulitis of left upper arm with AUGMENTIN generic.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Received Tdap on 09/06/12 and 3 days later started with itching & developed extensive swelling, redness, induration & warm to touch it entire upper arm extending from left deltoid to above the elbow. Currently being treated for cellulitis of left upper arm with AUGMENTIN generic.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Dyspnoea, Erythema, Nausea
Clinical narrative: Patient claimed she has intense local pain redness swelling superficial pealing a rough surgical pattern rash redness difficult breathing weakness dizziness. After 2 weeks still have nausea when push or roll on it cause severe pain. MD. saw the patient on 9/5/12 gave her BENADRYL & told patient to apply Hydrocortisone MD said Pt still have reaction of redness more swelling on 9/11/12.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Rash, Skin exfoliation, Swelling
Clinical narrative: Patient claimed she has intense local pain redness swelling superficial pealing a rough surgical pattern rash redness difficult breathing weakness dizziness. After 2 weeks still have nausea when push or roll on it cause severe pain. MD. saw the patient on 9/5/12 gave her BENADRYL & told patient to apply Hydrocortisone MD said Pt still have reaction of redness more swelling on 9/11/12.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Dyspnoea, Injection site erythema, Injection site exfoliation, Injection site pain
Clinical narrative: Patient claimed she has intense local pain redness swelling superficial pealing a rough surgical pattern rash redness difficult breathing weakness dizziness. After 2 weeks still have nausea when push or roll on it cause severe pain. MD. saw the patient on 9/5/12 gave her BENADRYL & told patient to apply Hydrocortisone MD said Pt still have reaction of redness more swelling on 9/11/12.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Wheezing
Clinical narrative: Patient claimed she has intense local pain redness swelling superficial pealing a rough surgical pattern rash redness difficult breathing weakness dizziness. After 2 weeks still have nausea when push or roll on it cause severe pain. MD. saw the patient on 9/5/12 gave her BENADRYL & told patient to apply Hydrocortisone MD said Pt still have reaction of redness more swelling on 9/11/12.
Age: 1.27
Sex: F
Vaccine: DTP, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Small welt at injection site 12 days after admin.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Pain in extremity
Clinical narrative: Pt complained of redness, soreness, burning in arm of injection site.
Age: 13.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria, Local reaction
Clinical narrative: Patient got FLUZONE & had rash & hives reaction locally at the site. Recommended use of BENADRYL topical.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Lymphadenopathy
Clinical narrative: Significant axillary lymphadenopathy within 36 hours. Took several weeks c/o improve. Remains unresolved & enlarged lymph nodes. Remain at 3 months out.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Oral pain
Clinical narrative: Pt came in office for 3 yr check-up. Received flu vaccine. 10 mins later child started complaining eye's hurt than mouth. Seen at ER BENADRYL and Prednisolone was given and prescribed.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on hands, arms, feet, face, neck & chest.
Age: 16.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Burning sensation, Convulsion, Dizziness, Fatigue, Gaze palsy
Clinical narrative: Pt c/o HPV burning, 5 min later c/o feeling light headed pt sat down and seized up, eyes rolled back in head x 45 sec. Pt then reported feeling tired/headache, but over all, pt had Tdap in the past no problem.
Age: 16.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Headache
Clinical narrative: Pt c/o HPV burning, 5 min later c/o feeling light headed pt sat down and seized up, eyes rolled back in head x 45 sec. Pt then reported feeling tired/headache, but over all, pt had Tdap in the past no problem.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: Administered 9/10 on 9/13 patient returned to pharmacy. Red circle at injection site, hardened skin, severe itching, diffuse pink circle four inches in diameter around 1 inch red circle.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Received HPV, Tdap on 6/20/12. Returned 6/25/12 complains of pain and swelling in left upper arm. Pt advised to take ALEVE or ADVIL OTC CLARITIN. ATARAX Rx as PRN. Instructed to report if sx worsen or no improvement.
Age: 7.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: HPV4 was given to age 8 yr client. Wrong client was checked in with same first & last name but diff DOB. Patient did not have any adverse effects. No adverse reactions.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticarial reaction greater on arms, trunk & buttocks - sparse on legs & face.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema
Clinical narrative: Flu vaccine given 9-12-12 - redness to injection site Lt. deltoid - redness around neck & under chin.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Flu vaccine administered on 9/6/2012. On 9/8/2012, patient called into office triage and stated she had developed hives on 9/7/12 and swelling of hands on 9/8/12. Triage RN, per protocol, sent pt. to Hosp. ER for further eval. Pt. has NEOSPORIN allergy.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Pt. c/o pain and redness to (Lt) deltoid. Pt. seen 9-11-12 rec. injection. Dx: cellulitis -> pt seen again 9-13-12.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Significant redness & swelling w/in 24 hrs to entire (L) arm; treated w/ BENADRYL, KEFLEX, MOTRIN.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Oedema peripheral, Pain
Clinical narrative: Erythematous - sore - swollen right arm chills - no fever. Tired, achy, very fatigued (Put on Zithromycin 25- mg 500 mg 1st day 250 mg 4 days). Painful arm. Seen 9/11/12 & 9/13/12. Doing better on 9/13/12.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: Erythematous - sore - swollen right arm chills - no fever. Tired, achy, very fatigued (Put on Zithromycin 25- mg 500 mg 1st day 250 mg 4 days). Painful arm. Seen 9/11/12 & 9/13/12. Doing better on 9/13/12.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Fever 100-102 > 48 hours, chills, body aches, headache, left arm bright red, swollen, hard, hot (shoulder to elbow).
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever 100-102 > 48 hours, chills, body aches, headache, left arm bright red, swollen, hard, hot (shoulder to elbow).
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthma, Chest pain, Condition aggravated, Dizziness, Dry mouth
Clinical narrative: 10-15 minutes after shots were given pt developed nosebleed, skin pruritus & redness. SOLUMEDROL given, pt then reported chest pain dizziness dry mouth SOB pt transport to hospital via ambulance.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Epistaxis, Erythema, Pruritus, Sinusitis
Clinical narrative: 10-15 minutes after shots were given pt developed nosebleed, skin pruritus & redness. SOLUMEDROL given, pt then reported chest pain dizziness dry mouth SOB pt transport to hospital via ambulance.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: MD - (R) upper arm red, warm/tender to touch (not at inj site). 4 x 4cm largest red area. Advise ice, elevate, MOTRIN, BENADRYL -> if s/sx worse ER.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Information has been received from a Nurse practitioner, concerning a 19 year old female patient with no pertinent medical history and allergy to CEFTIN and TOPAMAX. On 23-MAY-2012, the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot # and expiration date not reported), and on 23-JUL-2012, the patient received intramuscularly the second 0.5 ml dose of GARDASIL (lot # and expiration date not reported). Concomitant medications included drospirenone, YAZ and LEXAPRO. On approximately May 2012, after the patient's first dose of GARDASIL, the patient experienced a non itchy rash on her knees and thighs. In 2012, the patient's non itchy rash had subsided. On 06-AUG-2012, two weeks after the patient's second dose of GARDASIL, the patient's same rash reappeared on her knees and thighs. The patient sought medical attention through office visit. Hydrocortisone cream was received as treatment for the event. At the time of the report, the patient's outcome of non itchy rash on her knees and thighs was reported as not recovered. Action taken regarding GARDASIL was not applicable. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts, Condition aggravated
Clinical narrative: This spontaneous report as received from a nurse refers to an approximately 25 years old female patient with a history of genital warts. In February, 2012, the patient was vaccinated with IM with the first 0.5 ml dose of GARDASIL at a health department. On 03-AUG-2012, the patient was vaccinated IM with the second dose 0.5 ml dose of GARDASIL (lot # reported as 0459AE, exp. date: 13-DEC-2014). It was reported that the patient presented to her practice on 02-AUG-2012 to be examined for genital warts. The doctor examined and treated for her genital warts, type unspecified. The patient was not pregnant. The outcome of genital warts was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report was received from a 60 years old female patient who on 16-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). On 16-AUG-2012, the patient developed an injection site reaction that was described as a shingles rash by her physician following vaccination with ZOSTAVAX. The patient stated that the injection site reaction started out as a swollen, red area that was irritating at the injection site that started shortly after vaccination with ZOSTAVAX (exact time frame unspecified). The injection site reaction developed after the next 3 days into a 2 by 2 area at the injection site that was red, raised, with a bumpy rash that was itchy. On 20-AUG-2012, the physician during an office visit described the area as a "shingles rash at the injection site". The patient was treated with ZONALON CREAM. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a 60 years old female patient who on 16-AUG-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). On 16-AUG-2012, the patient developed an injection site reaction that was described as a shingles rash by her physician following vaccination with ZOSTAVAX. The patient stated that the injection site reaction started out as a swollen, red area that was irritating at the injection site that started shortly after vaccination with ZOSTAVAX (exact time frame unspecified). The injection site reaction developed after the next 3 days into a 2 by 2 area at the injection site that was red, raised, with a bumpy rash that was itchy. On 20-AUG-2012, the physician during an office visit described the area as a "shingles rash at the injection site". The patient was treated with ZONALON CREAM. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician regarding an 19 years old male patient. On approximately 15-AUG-2012, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL, intramuscular injection, (Lot number was not provided). No other co-suspects were reported. No concomitant medications were reported. On 15-AUG-2012, the patient who had just received his second dose of GARDASIL, broke in hives soon after received the injection. The patient sought unspecified medical attention. The patient received an injection of BENADRYL as treatment for the adverse event. The patient's outcome was unknown. Additional information has been requested.
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 pharmacist noted that the patient was administered the first two doses in the GARDASIL vaccination schedule "2 years ago" and that the third dose of GARDASIL (intramuscularly, Lot#, dose/frequency were unspecified) would be administered today (28-AUG-2012). No adverse effect reported. It was unspecified whether the patient had sought medical attention or not. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 10 years old female patient with no pertinent medical history and on known drug reactions or allergies.. On 01-JUN-2012, the patient was vaccinated with first intramuscular 0.5 ml GARDASIL lot # 672652/0022AE exp date 28-SEP-2014. On 03-AUG-2012, the patient was vaccinated with second intramuscular 0.5 ml GARDASIL lot # 672652AE exp date 28-SEP-2014. The physician stated, that on 02-JUN-2012 approximately, within 24 hours of received dose 1 GARDASIL experienced itching and rash at the injection site and also on her legs and on 04-AUG-2012 approximately, within 24 hours of received dose 2 GARDASIL experienced itching and rash at the injection site and also on her legs. The patient sought medical attention by calling the physician. No treatment for the events was given. Laboratory and diagnostics were not performed. The patient recovered from theses symptoms after both doses. The outcome of both rash at the injection, both itching on her legs, both rash on her legs and both itching at the injection site was reported as recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: This spontaneous report as received from a nurse (L.V.N.) refers to a 12 years old female patient with asthma. The patient had drug allergies to loracarbef. The patient was vaccinated with a dose of GARDASIL (lot # reported as H010123, expiration date 16-JAN-2012) intramuscularly in the right arm on 14-AUG-2012. Concomitant medications included PROAIR, VERAMYST and ADVAIR. It was reported that the patient developed symptoms tingling and numbness on the palm of her right hand after receiving GARDASIL. The symptoms then progressed to the rest of the right arm and left arm. The patient sought for medical attention by going to an emergency room and released. No treatment was given. Lab diagnostics studies performed were reported as none At the time of the report, the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a female patient of unknown age. The patient was vaccinated with three dose of 0.5 ml GARDASIL (lot # unknown ) respectively in December, 2010, May, 2011 and on 22-AUG-2012. No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Amnesia, Disturbance in attention, Fatigue, Malaise
Clinical narrative: This spontaneous report as received from a registered nurse refers to a currently 16 years old female patient. The patient was vaccinated with a dose of GARDASIL (dose, route and lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that on an unknown date, the patient experienced malaise, fatigue, memory loss and difficulty concentrating after receiving GARDASIL. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. Patient's pertinent medical history and drug reactions or allergies were not provided. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL (route, dose, frequency, lot # and exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. On an unspecified date, the patient was vaccinated with the second dose of GARDASIL (route, dose, frequency, lot # and exp. date were not given). On 31-AUG-2012, the patient was in the office for the third dose of GARDASIL that was late. The nurse mentioned that the third dose was due in March 2012. The patient was not experiencing any known symptoms. No treatment information was reported. Additional information is not expected.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 4 months old female patient. The patient was vaccinated with the second dose of lot # (669072/1270Z expiration date 16-AUG-2012) ROTATEQ (dose and route not reported) on 20-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that they administered expirated ROTATEQ to child on 20-AUG-2012. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient with unspecified age, who on 10-NOV-2011, received his first dose of GARDASIL (dose, route, lot number were not reported). The nurse reported that the patient was in the office on 22-AUG-2012, to received his second dose of GARDASIL (dose, route, lot number and indications were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 11 years old female patient who on 28-AUG-2012 was vaccinated with the first dose of GARDASIL (lot # and dose was not reported). No other co-suspects were reported. Concomitant medications included: diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) te). On 28-AUG-2012, the patient fainted. It was given liquid (gingerale) to the treatment of the adverse event. No lab test was performed. The patient sought unspecified medical attention. At the time of the report, the outcome of fainted was reported as recovered/resolved on 28-AUG-2011. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to a patient who was vaccinated with the first and second dose of GARDASIL on 01-NOV-2007 and 25-NOV-2008 respectively. On 23-AUG-2012 the patient was in the office to receive the third dose. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (lot # reported as 0615AA, exp date 02-JUL-2012) on 31-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. At the time of the report, no adverse event was reported. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a consumer refers to her father, an 88 years old male patient without drug reactions/allergies and with concurrent conditions of congestive heart failure, low heart rhythm, pacemaker user and history of blood pressure. The patient's medical history included enlarged prostate. The patient was vaccinated under the skin with a dose of ZOSTAVAX (dose, lot# not reported) in the fall of last year, about in 2011. The patient also received unspecified concomitant medications. It was reported that the patient got a dose of ZOSTAVAX and about 9 months later, in 2012 the patient broke out with shingles. The patient had blisters on one of his legs and up into his buttock region. The pain was described as burning pulsation sensation. The patient went to the doctor and was diagnosed with shingles. The reporter reported it seemed to be a very minor case. It was reported that the patient still had remaining crusted blisters but the patient did not complain about any lingering pain. Unspecified lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant reporting on a patient of unknown age and gender who on 20-MAR-2012, was vaccinated IM with the first dose of VAQTA (lot# not reported). On 28-AUG-2012, the patient was vaccinated IM with the second dose of VAQTA (lot# not reported). The medical assistant noted that the second dose was administered "about three weeks too early". No adverse effect was reported. 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 doctor of pharmacy refers to an unspecified number of patients who on an unknown dates, might have received doses of PNEUMOVAX 23 (dose, route and lot numbers not reported) that had been exposed to temperatures not lower than -2.5 degrees C for unspecified periods of time, possibly since June 2012. No adverse effects were reported. Attempts are being made to obtain additional information identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Unevaluable event
Clinical narrative: This spontaneous report is the first of two reports (other case related: 1209USA004977) received from a Registered Nurse (RN) concerning a female patient in her 60's. The patient pertinent medical history and drug reactions or allergies were not given. On an unspecified date, one or two years ago, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously (Lot # and Exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. The RN reported that on an unknown date the patient broke out in a very mild case shingles with a year or two after receiving ZOSTAVAX. No treatment was given. The outcome was reported as recovered/resolved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 71 years old female patient who "four years ago" in approximately August 2008, was vaccinated with a 0.65 ml dose of ZOSTAVAX (route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The physician assistant reported that four years after receiving ZOSTAVAX on 21-AUG-2012, the patient developed shingles-like symptoms. The patient had a mild rash. The physician assistant was "pretty sure" that it was shingles. There were two dermatomes present and somewhat resembled a bug-bite. Unspecified antivirals were given as a treatment for the experience. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. The relatedness for the patient had a mild rash, the physician assistant was pretty sure that it was shingles and there were 2 dermatomes present and somewhat resemble a bug-bite was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to several patients of unknown age. The patients were vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that several patients had developed itching or burning after being administered the vaccine. No treatment information was reported. It was unknown if the patients sought medical attention. The pharmacist did not have any patient specific information. The outcome of itching and burning after being administered the vaccine was unknown. The relatedness for the reported event was for ZOSTAVAX. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 76 years old female patient with no pertinent medical history and no drug reactions or allergies who on 28-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 671779/0169AE, Exp. Date: 06-MAR-2013) (dose not reported). No other co-suspects were reported. Concomitant medications included CRESTOR and methotrexate. The pharmacist reported that a patient developed a reaction at the injection site consisted of red, swollen and warm area after receiving ZOSTAVAX. No treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered. The relatedness for patient developed a reaction at the injection site consisted of red, swollen and warm area warm unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report is the second of two reports (other case related: 1209USA001129) received from a Registered Nurse (RN) concerning a female patient in her 60's. The patient pertinent medical history and drug reactions or allergies were not given. On an unspecified date, one or two years ago, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously (Lot # and Exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. The RN reported that on an unknown date the patient broke out in a very mild case shingles with a year or two after receiving ZOSTAVAX. No treatment was given. The outcome was reported as recovered/resolved. 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 certified medical assistant concerning a patient of unknown age and gender who on 05-SEP-2012 was vaccinated with subcutaneously with an expired dose of M-M-R II, lot number 67246/0907, expired date 09-JUL-2012. No adverse events were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from a Bachelor of Science in Nursing reporting on herself who on an unknown date was vaccinated subcutaneously with a dose of ZOSTAVAX, 0.65 mL (lot # not provided). The patient received ZOSTAVAX and on an unspecified date experienced an injection site reaction. No specifics were given. No treatment was given for the event. The patient received medical attention and was not specific. On an unknown date, the patient recovered from the event. The relatedness for injection site reaction was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age. The patients were vaccinated with doses of ZOSTAVAX (Lot# not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that she heard that 2 other patients from other facilities developed similar symptoms like hers (the pharmacist's adverse event was captured in 1208USA010155). The pharmacist did not have any details for the 2 patients. It was unspecified if the patients sought medical attention. At the time of reporting, the patients' outcome was unknown. Attempts are being made to verify the existence of a patient. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 57 years old female patient with no drug reactions or allergies, who on 29-AUG-2012, was vaccinated subcutaneously with a dose of ZOSTAVAX (lot number 0566AE, Exp. Date: 01-APR-2013) (dose not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 29-AUG-2012, the same day that the ZOSTAVAX was administered there was a raised red rash three inches in diameter that developed around the injection site that was also warm to touch. No treatment was given for the experience. At the time of the report, the patient had not recovered. The patient sought medical attention by calling the pharmacist. The relatedness for there was a red raised rash three inches in diameter that was also warm to touch was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a newborn of an unknown age who on 21-AUG-2012, was vaccinated intramuscularly with the first 0.5 ml dose of RECOMBIVAX HB and on 24-AUG-2012, inadvertently was administered with a second 0.5 ml dose of RECOMBIVAX HB intramuscularly (lot numbers not reported). No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 62 years old male patient who on 22-AUG-2012 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number 0562AE, Exp. Date: 20-MAR-2013) that had been stored at room temperature since 17-JUL-2012. The pharmacist was not aware if the patient had experienced any adverse effects. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Information has been received from a pharmacist regarding to a 56 years old male patient. On 30-AUG-2012, the patient was vaccinated with 0.65mL of a dose of ZOSTAVAX, subcutaneous in right arm (lot # 670980/0731AA, expiration date 17-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. On 30-AUG-2012, the patient was vaccinated with expired ZOSTAVAX. No adverse effects reported. Patient's outcome was unknown. Additional information is not expected.
Sex: M
Vaccine: MEA
Symptoms: Measles
Clinical narrative: This spontaneous report was received from a Registered Nurse (RN) concerning on her son of unspecified age. The patient's pertinent medical history and drug reactions or allergies were not provided. In the early 1970's, the patient was vaccinated with a dose of measles (manufacturer unspecified)(route, dose, lot # and Exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. Th RN reported that on an unknown date her son developed measles (time frame from vaccination was unspecified). No treatment information was reported. The outcome of measles was reported as recovered/resolved on an unspecified. Additional information is not expected.
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Information has been received from a female nurse of an unknown age, reporting on herself. In 1997, "15 years ago", the patient was vaccinated with a dose of MMR II, dose, route and frequency were not provided. In 1997, the patient experienced a bad rash. No treatment was given for the event. The patient did not seek medical attention. At the time of the report, the patient had recovered from the bad rash (date not reported). Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Information has been received from a pharmacist regarding to a patient of unknown age and gender. On an unspecified date, the patient was vaccinated with, 0.65 ml dose of ZOSTAVAX (route and lot number were not provided), injection, to prevent shingles. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed nausea after getting ZOSTAVAX. No rash was reported. The patient sought medical attention. No treatment information was reported. The patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 80 years old female patient refers to herself. The patient was vaccinated with ZOSTAVAX (Lot #, dose/frequency, route and duration were unspecified) in July 2011. No other co-suspects were reported. Concomitant medications included: atenolol. The patient stated that after she received ZOSTAVAX in July 2011, she got shingles in February 2012. The patient had sought medical attention via office visit. No treatment was given for the event. At the time of reporting the outcome of shingles was unknown. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 5 years old female patient. Patient's pertinent medical history and drug reactions or allergies were not provided. On 30-AUG-2012, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX instead of the intended VARIVAX (Merck). No adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 82 years old female patient. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number 0565AE) on 16-AUG-2012. No other co-suspects or concomitant medications were reported. The patient went into the pharmacy on 20-AUG-2012 and had itching all over her body, no rash, no redness. The itching was almost gone after taking BENADRYL for 2 days, and on 22-AUG-2012 the itching she had was not as irritating as it had been. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist concerning a 59 years old female patient who on 08-SEP-2012 vaccinated with an expired dose ZOSTAVAX (lot # 670820/0660AA, Exp. 04-AUG-2012) (dose and route not reported). The consumer's relevant medical history, concomitant medications, and past drug history are unknown. It was unknown if there was any relevant laboratory data. As of 08-SEP-2012, it was unknown if the consumer continued taking ZOSTAVAX. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Maternal exposure during pregnancy, Pregnancy test negative
Clinical narrative: Information has been received from a consumer for VARIVAX (merck), a Pregnancy Registry product, concerning herself with drug allergy to ZITHROMAX and no pertinent medical history. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with VARIVAX (merck) (dose, route and lot number not provided) on 13-APR-2012. No other co-suspects were reported. There were no concomitant medications. The patient was 5 weeks of pregnancy and approximate LMP of 02-AUG-2012 and an EDD of 09-MAY-2013. Approximately on 23-AUG-2012, two weeks ago the patient did pregnancy test and found she was pregnant after receiving VARIVAX (merck). No treatment information was given. The patient sought medical attention via phone call. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a sales representative concerning his 1 year old daughter who on an unknown date about 4 or 5 year ago received the first dose of VARIVAX (Merck) (route, lot number and expiration date were not provided). The physician reported that his daughter developed shingles on her shoulder. The patient received the second dose as schedule with no problems. At the time of the report, the patient recovered from the event. Additional information is not expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a physician concerning a 79 year old male patient with high cholesterol who on 23-AUG-2012 was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). No other co-suspects were reported. Concomitant medications included pravastatin and finasteride. On 29-AUG-2012 the patient experienced red circle developed at injection site when he received ZOSTAVAX. No treatment information was reported. The outcome of red circle developed at injection site when he received ZOSTAVAX was unknown. Additional information had been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Local swelling, Rash pruritic, Rash vesicular, Scab
Clinical narrative: Information has been received from a 69 year old female consumer concerning herself. The patient had no pertinent medical history and no known drug reactions or allergies. On approximately June of 2012, "2 months ago", the patient was vaccinated subcutaneously with one dose of ZOSTAVAX, one time injection. There were no concomitant medications. On 15-JUN-2012 she had swollen area around the right arm, after injection. The patient experienced pain in her back, and started breaking out in a rash. Patient stated rash itched and was crusty, and similar to chickenpox. Patient also stated that her physician had not diagnosed it as shingles, which she believed it to be. Consumer also stated that the chest and top part of her arm is where the rash still existed. No treatment was given for the events. At the time of the report, the patient's outcome for itched and crusty rash, similar to chickenpox and pain in her back was unknown. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Local swelling
Clinical narrative: This spontaneous report was received from a doctor of pharmacy refers to a 52 years old male patient who on 21-AUG-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 22-AUG-2012, the patient developed an injection site reaction after receiving a dose of ZOSTAVAX. The patient had a red raised area in three inches in diameter. No treatment information was reported. At the time of the report, the patient had not recovered. It was unspecified if the patient sought medical attention. The relatedness for the patient had red raised are in 3 inches in diameter was unknown for ZOSTAVAX. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report was received from a registered nurse refers to an actually 60 years old female patient with allergy to thimerosal. On 06-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number 0565AE, Exp. Date: 23-MAR-2013) (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the patient went on vacation after receiving ZOSTAVAX on 06-AUG-2012, and at an unspecified time, in approximately August 2012, the patient developed a rash. It was stated that the patient was in contact with poison ivy and a wasp sting while she was on vacation but when the patient went to see a physician at an unspecified urgent care facility, the physician diagnosed the rash as a varicella-like rash in approximately August 2012. The patient called to registered nurse on 21-AUG-2012 and informed her of this occurrence. The registered nurse did not know if any treatment was prescribed for the experience and she did not known if the patient had recovered, however it was reported that the patient was recovering. The relatedness for patient was diagnosed with varicella-like rash on her back was unknown for ZOSTAVAX. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of a 56 years old female patient with unknown relevant medical history or relevant past drug history who on 06-SEP-2012 was vaccinated with a dose of ZOSTAVAX (Lot# 0423AE, EXP. 02-APR-2013) (SQ, dose not reported) for prevention of shingles. Concomitant medications included WELLBUTRIN XL, lorazepam, NORVASC, FLONASE spray and PROTONIX. On 08-SEP-2012 the patient experienced injection site was hard, red and swollen. There were no relevant laboratory tests. As of 09-SEP-2012, the patient was not going to receive another ZOSTAVAX. It was unspecified whether the patient sought medical attention or not. At the time of reporting, the patient had not recovered. Additional information has been requested.