chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 79 year old male with ice cream and butter allergy and a history of chickenpox, who on 27-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 656394/0162U) into the right deltoid (upper arm subcutaneous). Concomitant therapy included DURABAC, aspirin, ferrousSO4, SYNTHROID, lisinopril-HCTZ, ZOCOR, tamsulosin hydrochloride, folic acid, amiodarone hydrochloride, travoprost, COUMADIN, clobetasol propionate, VALTREX and ALLEGRA. On 05-SEP-2008 the patient developed four lesions distributed in the lower right side towards his abdomen, the patient had some bloody discharge and he complained of he was having fever 101.5 and was diagnosed as shingles. He had large oozing blisters and pain, which he quanitified as a 9 out of 10. He was given samples of LEVAQUIN 750 mg and LYRICA 75 mg PO HS x 1 week, then to increase to BID if still symptomatic. Shingles was persisting. No PCR sample was taken. No further information is available.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Wound secretion
Clinical narrative: Information has been received from a physician concerning a 79 year old male with ice cream and butter allergy and a history of chickenpox, who on 27-MAR-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 656394/0162U) into the right deltoid (upper arm subcutaneous). Concomitant therapy included DURABAC, aspirin, ferrousSO4, SYNTHROID, lisinopril-HCTZ, ZOCOR, tamsulosin hydrochloride, folic acid, amiodarone hydrochloride, travoprost, COUMADIN, clobetasol propionate, VALTREX and ALLEGRA. On 05-SEP-2008 the patient developed four lesions distributed in the lower right side towards his abdomen, the patient had some bloody discharge and he complained of he was having fever 101.5 and was diagnosed as shingles. He had large oozing blisters and pain, which he quanitified as a 9 out of 10. He was given samples of LEVAQUIN 750 mg and LYRICA 75 mg PO HS x 1 week, then to increase to BID if still symptomatic. Shingles was persisting. No PCR sample was taken. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Information has been received from a 78 year old female with no known allergies or pertinent medical history who on 26-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR and SYNTHROID. A few days after administration, the patient experienced a mild case of shingles on her face. It looked like a rash formed and then a few days later little blisters formed. The patient's physician prescribed her VALTREX and it cleared right up. Routine labs were performed every ninety days. A month after administration of ZOSTAVAX , April 2008 the patient recovered. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an around 60 year old patient who on approximately 29-AUG-2008, "1 week ago", was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 31-AUG-2008, "2 days after ZOSTAVAX (Oka/Merck) was given", the patient developed shingles-like rash.  The patient contacted the physician and was started on anti-viral medication and the rash was starting to improve.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a female consumer who was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  The patient developed blisters all over her body 4 days after getting the vaccination.  The outcome was unknown.  It was not specified if the patient sought medical attention or not.  No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Inhibitory drug interaction, Migraine
Clinical narrative: Information has been received from a 71 year old female with migraine headache who in April 2008, was vaccinated with a single dose of ZOSTAVAX (Merck) 0.65 ml SQ.   Concomitant therapy included IMITREX.  The patient indicated that the dose of ZOSTAVAX (Merck) made her IMITREX ineffective.  Prior to receiving ZOSTAVAX (Merck), her IMITREX took effect within 24 hours.  Since receiving ZOSTAVAX (Merck), her migraine lasted 4 days.  The patient did not seek any medical attention.  No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Rash, Scab, Skin lesion
Clinical narrative: Information has been received from a nurse practitioner concerning an 80 year old female with hypertension and arthritis and a history of herpes zoster who on 28-AUG-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck) in her left arm.  Concomitant therapy included MOBIC.  On 28-AUG-2008 the patient was splashed on the left arm with ZOSTAVAX due to technical problems with the syringe and needle (the needle separated from the syringe as the practitioner was attempting to administer the vaccine).  The area of the left upper arm was washed thoroughly at the time and the patient was then administered a complete dose of ZOSTAVAX (Oka/Merck).  On 29-AUG-2008 the patient developed a rash on her right buttock.  On 01-SEP-2008 the patient went to the office and was examined by the nurse practitioner.  The exam revealed that "sparse lesions that were healing and crusted".  No laboratory or diagnostics tests were performed.  The patient was prescribed acyclovir.  At the time of this report, the patient was recovering.  Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Rash
Clinical narrative: Information has been received from a physician concerning a male patient in his 80's who on 02-AUG-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck) 0.65 ml SQ.  Subsequently the patient experienced a headache and a rash.  The patient's headache and rash persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Pyrexia, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female who on 18-AUG-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658085/0882U) instead of VARIVAX (Oka/Merck) (administration site not reported).  According to the medical assistant, both vaccines were stored next to each other and she did not double check to make sure she was getting the correct vaccine to be administered.  It is not a PQC but a human error.  The patient's mother called the office to report that on 19-AUG-2008 and 20-AUG-2008 the patient developed a fever for a couple of days.  The outcome of the fever was reported as recovered.  Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 79 year old female with hypothyroidism, hypercholesterolaemia, lupus erythematosus, hypertension, osteoporosis and allergic to "EES" and lisinopril (Refer to WAES # 0809USA01786) and a history of chickenpox in childhood who on 11-JUN-2007 was vaccinated with ZOSTER vaccine live (Oka/Merck), Lot # 657558/0461U, 0.65 mL, in her right deltoid, subcutaneously.  Concomitant therapy included ATENOLOL, LOVASTATIN (manufacturer unknown), SYNTHROID, PLAQUENTL, and RECLAST.  On 25-AUG-2008 the patient experienced shingles.  It was reported that the patient had vesicular rash with more than 20 lesions in her right T4 - T5 dermatome under breast.  The patient had severe pain and had a maxim of temperature of 98.6 degrees.  It was reported that the patient was not exposed recently to chickenpox or herpes ZOSTER, there was no direct fluorescent antibody done and there was no specimen collected for PCR.  The patient sought medical attention, contracted physician's office.  At the time of the report the patient recovered from shingles, but was still being treated with VICODIN and NEURONTIN.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning herself, a 63 year old female with a history of herpes zoster and a penicillin allergy who at 4pm on 27-SEP-2007 was vaccinated with a dose of ZOSTER vaccine. Concomitant therapy included vitamins (unspecified). On 29-AUG-2008 the patient developed 2 inch segmented lines of vesicles on the left side if her mid abdomen which were very tender touch. She applied lidocaine to the area and began taking VALTREX 500 mg daily, adjusting the dose to TID when the outbreak was worst, She continued to break out, mostly on the upper part of her legs for the next 2 1/2 weeks. She indicated that this was a mild case of shingles compared to what she experienced prior to ZOSTER vaccine. She indicated that she was concerned that she had this outbreak. She did not seek any medical attention. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Vaginal lesion, Vulvovaginal pruritus
Clinical narrative: Information has been received from a 68 year old female with hypertension who about 2-3 months ago, in approximately June 2008, was vaccinated with ZOSTER vaccine, 0.65 ml, subcutaneous. Concomitant therapy included PRAVACHOL, CLARITAN, and lisinopril. The caller reported that about 3 weeks after receiving ZOSTER vaccine, in approximately June 2008 she experienced itching and marks in vaginal area; and also itching on face after receiving ZOSTER vaccine, Physician prescribed "VOLTREX" for the latter events; but it had not helped according to caller. At the time of reporting, the patient had not recovered yet. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence, Injection site hypersensitivity, Injection site pain
Clinical narrative: Information has been received from a male who on 4-AUG-2008 was vaccinated with ZOSTER vaccine. The patient reported that after receiving vaccination, he experienced diarrhea in the morning, but also pain and sensitivity at the injection site for 2 to 3 days. The patient reported that his diarrhea was controlled by IMODIUM. The patient reported that his diarrhea had improved already but he still felt a little gas pain in his stomach from time to time. Lot # was not provided. This is one of two reports received from the same source, Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who in October 2007, was vaccinated with ZOSTER vaccine injection, and "over this past weekend", on approximately 30-AUG-2008, the patient developed shingles. The patient was recovering from shingles. As of 3-SEP-2008, the date of this report, the patient sought unspecified medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a 66 year old female with no known drug allergies and abnormal cholesterol and blood pressure who in February 2008, was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included CRESTOR, MSD, LEVAQUIN, doxazosin mesylate and hydrochlorothiazide (manufacturer not specified).  The patient reported getting shingles after receiving ZOSTAVAX (Merck).  Two weeks ago, on approximately 20-AUG-2008, it started as a blister on her forehead and moved to her hairline and down to her left eye.  Then she had a scab on her left eyelid.  She noted that "I looked like a gargoyle".  She was given "generic VALTREX" and she went to her ophthalmologist every 2 days to make sure it did not advance to her cornea.  No labs/diagnostics were performed.  The patient reported she was not warned of the efficacy rate.  She was told ZOSTAVAX (Merck) would prevent shingles entirely, or she might only develop a mild case.  At that time of the report the patient had not recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from an office manger concerning a female who in April 2008, was vaccinated with ZOSTER vaccine live (Oka/Merck) and developed a "light rash" post vaccination.  It was unknown if the patient sought medical attention.  Additional information has been requested.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia
Clinical narrative: Information has been received from a nurse in physician's office, concerning an 88 year old female who in June 2007, was vaccinated with ZOSTER (Oka/Merck) in her left deltoid.  It was reported that the patient on 08-AUG-2008 experienced symptoms of herpes ZOSTER that began with tingling.  Nurse reported hat the patient on 21-AUG-2008 was diagnosed with shingles.  No lot number was provided.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from an 80 year old female with blood pressure and thyroid problems, allergy to penicillin and "betadine" and "problems with hormones", who 1.5 years ago, in approximately March 2007, was vaccinated with ZOSTAVAX (Oka/Merck) 0.65 ml, subcutaneously.  Concomitant therapy included "blood pressure medicine" and "thyroid medicine".  The patient reported that 3 weeks ago (on approximately 19-AUG-2008) she developed shingles on her waist and back on her left side, she also was experiencing "itchiness" and pain.  At the time of reporting the patient had not recovered.  The patient sought medical attention.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who on an unspecified date was vaccinated with ZOSTAVAX (Merck).  Per physician, the patient received ZOSTAVAX (Merck) and later developed a bad case of shingles.  Per physician, "this is the worst case of shingles he has ever seen".  Lot # was not available.  It is unknown whether the patient had history of shingles prior to receiving ZOSTAVAX (Merck).  The patient's bad case of shingles persisted.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who on an unspecified date was vaccinated with ZOSTAVAX . Per physician, the patient received ZOSTAVAX and developed a bad case of shingles. Lot # was not available. At the time of reporting the patient's shingles persisted. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning his wife who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (route and administration site not reported).  Subsequently the patient developed a rash on her entire arm.  It was not specified which arm was affected.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmological examination normal, Rash vesicular
Clinical narrative: Information has been received from two nurses concerning a 68 year old female with allergies to morphine, amoxicillin, sulfonamides, aspirin, DAYPRO, CELEBREX, and codeine, hypertension, arthritis and hypothyroidism who on 11-AUG-2008 was vaccinated with the first dose of ZOSTER (Oka/Merck) (lot # 658325/1429U) into her left arm (also reported as 13-AUG-2008 by the follow up nurse).  Concomitant therapy included K-DUR, omeprazole, RESTASIS, SYNTHROID, metoprolol, AVAPRO, PREMARIN and ibuprofen.  On 28-AUG-2008, the patient experienced a rash type vesicular on the left side of her forehead in the supraorbital nerve distribution above in left eye with multiple vesicular lesions.  The patient was examined by her primary physician and unspecified ophthalmologist on that day.  She did not have any recent chicken pox or shingles exposure.  The physician noted an early shingles rash above the left eye and described it as herpes ZOSTER and prescribed ZOVIRAX as well as CLOBETASONE topical cream.  The eye exam was normal.  The patient had a follow-up appointment in one week.  At the time of the report, the patient's shingles and rash on the left side of her forehead persisted.  The sample of the lesion was collected on 02-SEP-2008.  The sample was taken from a vesicular lesion (site not specified).  The results of the varicella ZOSTER virus identification polymerase chain reaction test were: The VZV DNA was amplified, which showed the wild-type and it was not B-globin DNA amplified.  Interpretacion: Adequate specimen, wild type strain.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Computerised tomogram normal, Facial pain, Hypersomnia, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a 61 year old female patient with hypertension, type 2 diabetes mellitus, hypercholesterolaemia and reflux and a history of a bad case of shingles on the right half of her face (approximately 2003) and a stroke (2005), who, in approximately August 2007, was vaccinated with a dose of ZOSTAVAX (Merck).  Concomitant therapy included CELEBREX, losartan potassium-HCTZ (MSD), ACTOS, ezetimide (MSD), NEXIUM, ZOLOFT and SANCTURA.  The patient reported that within the past three months, since May 2008, she started to get some sores on her lip, which she thought were cold sores so she put medicine on them and they went away.  The patient stated that at the moment,  on the right half of her face she had extreme pain which the physician stated it was post herpetic neuralgia.  The patient stated she slept a lot because it helped the pain.  The patient reported she had seen her physician and neurologist who had done a MRI and CAT scan that came back fire.  On approximately 18-AUG-2008, she was given LYRICA.  The patient stated that she took PREGABALIN 6 times a day and it was not helping with her pain, and she was going to speak to her physician to see if there was something else she could take.  The patient stated that the reaction she was experiencing after having received ZOSTAVAX, was far worse than the shingles itself.  At the time of the report, the patient had not recovered.  The patient sought medical attention.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Information has been received from a 61 year old female patient with hypertension, type 2 diabetes mellitus, hypercholesterolaemia and reflux and a history of a bad case of shingles on the right half of her face (approximately 2003) and a stroke (2005), who, in approximately August 2007, was vaccinated with a dose of ZOSTAVAX (Merck).  Concomitant therapy included CELEBREX, losartan potassium-HCTZ (MSD), ACTOS, ezetimide (MSD), NEXIUM, ZOLOFT and SANCTURA.  The patient reported that within the past three months, since May 2008, she started to get some sores on her lip, which she thought were cold sores so she put medicine on them and they went away.  The patient stated that at the moment,  on the right half of her face she had extreme pain which the physician stated it was post herpetic neuralgia.  The patient stated she slept a lot because it helped the pain.  The patient reported she had seen her physician and neurologist who had done a MRI and CAT scan that came back fire.  On approximately 18-AUG-2008, she was given LYRICA.  The patient stated that she took PREGABALIN 6 times a day and it was not helping with her pain, and she was going to speak to her physician to see if there was something else she could take.  The patient stated that the reaction she was experiencing after having received ZOSTAVAX, was far worse than the shingles itself.  At the time of the report, the patient had not recovered.  The patient sought medical attention.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness
Clinical narrative: Information has been received from a 66 year old female who in May 2008, was vaccinated with ZOSTER (Oka/Merck).  Concomitant therapy included vitamins (unspecified).  In May 2008, after receiving ZOSTER vaccine (Oka/Merck), the patient experienced dizziness and felt like her balance was off.  In June 2008, the patient recovered.  The patient did not seek medical attention.  Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 78 year old male who on 21-MAR-2007 was vaccinated with ZOSTER (Oka/Merck), one dose, subcutaneously.  On 23-JUN-2008, the patient experienced a severe case of shingles.  The patient also had pain.  The patient's present status is not recovered.  The patient sought medical attention at the office.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a 55 year old nurse practitioner with a history of chickenpox who reported that she was preparing to administer ZOSTER (Oka/Merck) to a patient "a few days ago when a few drops of the vaccine flew into the air as she processed up on the plunger to remove air from the syringe.  The drops of ZOSTER (Oka/Merck), landed on her desk.  She was not aware of any topical exposure to the ZOSTER (Oka/Merck) at the time.  On 27-AUG-2008, the nurse practitioner noticed she had developed two clusters of vesicular lesions on her left forearm.  She then reported that the lesions were two clusters/rash of red, raised shiny bumps on her left forearm.  There was no vesicular fluid.  Later on 28-AUG-2008 the NP reported that her lesions were starting to vesiculate.  At the time of the report, the patient's vesicular lesions persisted.  The NP agreed to participate in the VZVIP program.  No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Headache, Thirst
Clinical narrative: Information has been received from a 65 year old female with asthma who on 26-Aug-2008 was vaccinated with a dose of ZOSTAVAX. concomitant therapy included cyanocobalamin injection, Montelukast sodium, inhalers, losartan potassium and metoprolol succinate. On 26-Aug-2008 after the vaccination, the patient experienced headaches, a severe dry mouth which caused her to be thirsty. the patient's events were recovering. No futher information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a certified medical assistant concerning a 61 year old female with no drug allergies or drug reactions, with hypertension and hypercholesterolamia, osteopenia and gastroooesophageal reflux disease who on 19-NOV-2007 was vaccinated with ZOSTER (Oka/Merck) (lot # 658361/1090U), 0.65ml, subcutaneous.  Concomitant therapy included hydrochlorothiazide, LIPITOR, NEXIUM and MSD.  Subsequently, the patient had been diagnosed with shingles.  Medical attention was sought via office visit.  No lab diagnostics studies were performed.   The outcome of shingles was not specified at the time of reporting.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Incorrect route of drug administration, Rheumatoid arthritis, Underdose
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 15-JAN-2008 was vaccinated subcutaneous with a 0.65 ml full dose ("may have gotten") of ZOSTAVAX (Merck) minus one small drop.  It was also reported some of the vaccine dripped down the patient's arm.  No adverse event reported.  Teh patient sought medical attention via an office visit.  A product quality complaint was not involved.  Follow-up information received from the patient indicated her "shot may have been given intramuscular (IM) instead of subcutaneous".  Follow-up information was received from the patient.  The patient had been diagnosed with rheumatoid arthritis after getting ZOSTAVAX (Merck).  Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 6 year old female who on 29-JUL-2008 was vaccinated with ZOSTAVAX (Merck).  No adverse event was reported.  Follow up information has been received from the medical assistant, who reported that the reason for the confusion was that both vaccines were stored in the same freezer and that the packaging looked very similar.  It was an error of hers not to check twice and make sure that she was administering the correct vaccine.  Follow-up information was received which reported that the patient did not have adverse experience, was scheduled to received VARIVAX (Merck) and was administered ZOSTAVAX (Merck) MSD in error.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female with blood pressure high, who on 13-MAR-2008 was vaccinated with ZOSTER (Merck).  Concomitant therapy included unspecified blood pressure medication.  About a month after vaccination, in April 2008, the patient developed welt like marks on the same arm as the injection site.  The patient sought medical attention at an office visit.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Nausea, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a 75 year old female with no medical history, no known allergies, who on the first week of June 2008 was vaccinated with a dose of ZOSTER (Oka/Merck).  Concomitant therapy included unspecified blood pressure medication.  In approximately June 2008, shortly after receiving ZOSTER (Oka-Merck) the patient experienced a case of shingles on her head.  She had maybe one or two break-outs, however she was experiencing bad headaches and a little bit of nausea.  An MRI was performed: results not provided.  Unspecified medical attention was sought.  At the time of reporting the patient was recovering.  There was no product quality complaint  No additional information is expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cataract, Eye pain, Herpes zoster
Clinical narrative: Information has been received from a nurse concerning two female patient's in their early 70's who were vaccinated subcutaneously with ZOSTAVAX and developed shingles after receiving the vaccine. Follow-up information was received from a physician which reported that a 73 year old white female patient with allergies to Lyrica, Ceftin, Vancomycin and Sulfanoamides who on 13-SEP-2006, was vaccinated subcutaneously into the left arm with ZOSTAVAX. On 25-AUG-2008, the patient developed a cataract in her left eye and developed eye pain and saw an ophthalmologist and was diagnosed with shingles at her right temple and eye brow area, treated with acyclovir. This is one of several reports from the same source. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 64 year old female with hypertension, hypothyroidism, cholesterol high and history of shingles who on 01-AUG-2008 was vaccinated with a 0.65mL dose of ZOSTAVAX subcutaneously. Concomitant therapy included Atenolol, Lisinopril, Hydrochlorothiazide and Crestor. On 02-AUG-2008 the patient experienced site reaction of swelling and redness. She also had headache for a few days. The patient sought unspecified medical attention. The patient recovered on 09-AUG-2008 on therapy. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash
Clinical narrative: Information has been received from a 69 year old female with no allergy who in June 2008, was vaccinated with ZOSTAVAX 0.65 ml (lot # not provided). Concomitant therapy included Metoprolol, Crestor, Actonel. In June 2008, within couple days, the patient experienced rash at injection site and headache after vaccination. The patient's rash at injection site and headache persisted. The patient sought medical attention. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous, Rash papular
Clinical narrative: Initial information has been received from an 86 year old male physician with no illness at the time of vaccination or pertinent medical history or allergies, who is also the patient and follow-up information was received from a physician.  On 10-JUN-2008 at 9:25 AM the patient was vaccinated into the left deltoid with the first dose of ZOSTAVAX (Merck) (lot # 659407/0295X).  Concomitant therapy included NORVASC.  On 25-AUG-2008 the patient developed erythematous papular lesions on his chest.  The patient further stated that the above lesions were confined to one dermatome.  The physician reported in follow up that the patient called to report that he had developed shingles rash.  The patient was treating with VALTREX.  The outcome was unknown.  Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Medication error, No adverse event
Clinical narrative: A non-serious, spontaneous report of "received FLUMIST in a single nostril" in a four-year old female patient was received from a nurse. No medical history or concomitant medications were reported. FLUMIST was administered in one nostril; second half of the dose (0.1 ml) was also given in the same nostril. The patient wiped her nose after the dose was given. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Body temperature increased, Cough, Diarrhoea, Ear disorder, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 week old male with a history of cradle cap, circumcision, constipation and candidiasis who on 17-JUN-2008, 18-AUG-2008 and 20-OCT-2008 was vaccinated with the first second and third doses of ROTATEQ.  Suspect therapy included PEDVAX HIB (17-JUN-2008 and 18-AUG-2008) only first two doses given.  It was reported that on 20-OCT-2008 PEDVAX HIB was not given due to vaccine PEDIATRIX.  On 29-JUL-2008 the patient experienced viral pharyngitis.  On approximately 18-AUG-2008 during a well baby visit it was noted that the ear, nose and throat exam were normal and the entire physical exam was "unremarkable."  On 18-SEP-2008 the patient was treated for cold symptoms of nose congestion, cough, runny nose, a fever of 99.1F and one episode of diarrhea.  On 20-OCT-2008 the patient presented for a well exam.  Examination revealed a small cartilege protrusion on the inside of his left ear, otherwise the exam was unremarkable.  No further information is available.
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Nasal congestion, Nasopharyngitis, Pyrexia, Rhinorrhoea, Viral pharyngitis
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 week old male with a history of cradle cap, circumcision, constipation and candidiasis who on 17-JUN-2008, 18-AUG-2008 and 20-OCT-2008 was vaccinated with the first second and third doses of ROTATEQ.  Suspect therapy included PEDVAX HIB (17-JUN-2008 and 18-AUG-2008) only first two doses given.  It was reported that on 20-OCT-2008 PEDVAX HIB was not given due to vaccine PEDIATRIX.  On 29-JUL-2008 the patient experienced viral pharyngitis.  On approximately 18-AUG-2008 during a well baby visit it was noted that the ear, nose and throat exam were normal and the entire physical exam was "unremarkable."  On 18-SEP-2008 the patient was treated for cold symptoms of nose congestion, cough, runny nose, a fever of 99.1F and one episode of diarrhea.  On 20-OCT-2008 the patient presented for a well exam.  Examination revealed a small cartilege protrusion on the inside of his left ear, otherwise the exam was unremarkable.  No further information is available.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Appendicectomy, Haematochezia, Intussusception, Surgery, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. Concerning a 20 weeks old male on 29-JUL-2008 was vaccinated with the third dose of ROTATEQ (lot # 660376/0019X) by mouth. Concomitant therapy included the third dose of PREVNAR (lot # C65935) I.M. route, and the third dose of PEDIARIX (lot # AC21B110AB) I.M. route. On 22-SEP-2008 the patient was seen in hospital for repeated vomiting and blood in the stool, he was taken to gastrointestinal floor where a barium enema was attempted for reduction of intussusception and was unsuccessful and emergency surgery was performed to reduce the intussusception and an appendicectomy was performed. Reviewed hospital medical records of 22-24-SEP-2008. Final diagnostic: Intussusception surgically reduced. Records reveal patient experienced vomiting, crampy abdominal pain and bloody stool. Emergent surgery to reduce IS and appendectomy. Progressed well and was discharged to home with primary care physician and surgery clinic follow-up. Reviewed primary care physician medical records of 21-FEB-2008 and 06-OCT-2008. Final diagnostic: intussusception surgically reduced. Records reveal patient experienced good health on day of vaccination. Developed IS late in September-2008. The patient did well postoperatively. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. This was originally reported by a consumer. The VAER # ID is 326995. A standard lot check investigation was performed. All in-process quality checks for the lot # 660376/0019X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. No further information is expected.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Barium enema abnormal, Intussusception, Surgery, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. Concerning a 20 weeks old male on 29-JUL-2008 was vaccinated with the third dose of ROTATEQ (lot # 660376/0019X) by mouth. Concomitant therapy included the third dose of PREVNAR (lot # C65935) I.M. route, and the third dose of PEDIARIX (lot # AC21B110AB) I.M. route. On 22-SEP-2008 the patient was seen in hospital for repeated vomiting and blood in the stool, he was taken to gastrointestinal floor where a barium enema was attempted for reduction of intussusception and was unsuccessful and emergency surgery was performed to reduce the intussusception and an appendicectomy was performed. Reviewed hospital medical records of 22-24-SEP-2008. Final diagnostic: Intussusception surgically reduced. Records reveal patient experienced vomiting, crampy abdominal pain and bloody stool. Emergent surgery to reduce IS and appendectomy. Progressed well and was discharged to home with primary care physician and surgery clinic follow-up. Reviewed primary care physician medical records of 21-FEB-2008 and 06-OCT-2008. Final diagnostic: intussusception surgically reduced. Records reveal patient experienced good health on day of vaccination. Developed IS late in September-2008. The patient did well postoperatively. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. This was originally reported by a consumer. The VAER # ID is 326995. A standard lot check investigation was performed. All in-process quality checks for the lot # 660376/0019X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. No further information is expected.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Abdominal pain, Appendicectomy, Barium enema, Enema administration, Haematochezia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. Concerning a 20 weeks old male on 29-JUL-2008 was vaccinated with the third dose of ROTATEQ (lot # 660376/0019X) by mouth. Concomitant therapy included the third dose of PREVNAR (lot # C65935) I.M. route, and the third dose of PEDIARIX (lot # AC21B110AB) I.M. route. On 22-SEP-2008 the patient was seen in hospital for repeated vomiting and blood in the stool, he was taken to gastrointestinal floor where a barium enema was attempted for reduction of intussusception and was unsuccessful and emergency surgery was performed to reduce the intussusception and an appendicectomy was performed. Reviewed hospital medical records of 22-24-SEP-2008. Final diagnostic: Intussusception surgically reduced. Records reveal patient experienced vomiting, crampy abdominal pain and bloody stool. Emergent surgery to reduce IS and appendectomy. Progressed well and was discharged to home with primary care physician and surgery clinic follow-up. Reviewed primary care physician medical records of 21-FEB-2008 and 06-OCT-2008. Final diagnostic: intussusception surgically reduced. Records reveal patient experienced good health on day of vaccination. Developed IS late in September-2008. The patient did well postoperatively. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. This was originally reported by a consumer. The VAER # ID is 326995. A standard lot check investigation was performed. All in-process quality checks for the lot # 660376/0019X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. No further information is expected.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC, RV5
Symptoms: Intussusception, Surgery, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. Concerning a 20 weeks old male on 29-JUL-2008 was vaccinated with the third dose of ROTATEQ (lot # 660376/0019X) by mouth. Concomitant therapy included the third dose of PREVNAR (lot # C65935) I.M. route, and the third dose of PEDIARIX (lot # AC21B110AB) I.M. route. On 22-SEP-2008 the patient was seen in hospital for repeated vomiting and blood in the stool, he was taken to gastrointestinal floor where a barium enema was attempted for reduction of intussusception and was unsuccessful and emergency surgery was performed to reduce the intussusception and an appendicectomy was performed. Reviewed hospital medical records of 22-24-SEP-2008. Final diagnostic: Intussusception surgically reduced. Records reveal patient experienced vomiting, crampy abdominal pain and bloody stool. Emergent surgery to reduce IS and appendectomy. Progressed well and was discharged to home with primary care physician and surgery clinic follow-up. Reviewed primary care physician medical records of 21-FEB-2008 and 06-OCT-2008. Final diagnostic: intussusception surgically reduced. Records reveal patient experienced good health on day of vaccination. Developed IS late in September-2008. The patient did well postoperatively. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. This was originally reported by a consumer. The VAER # ID is 326995. A standard lot check investigation was performed. All in-process quality checks for the lot # 660376/0019X were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Agency and was released. No further information is expected.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Gait disturbance, Gaze palsy, Malaise
Clinical narrative: Initial information was received on 17 December 2008 from a health care professional. An 18 year old male patient with a history of pneumonia (01 December 2008) treated with CIPRO, received an injection of FLUZONE SV 2008-2009 (lot number U2853AB) intramusculary in the deltoid on 15 December 2008 at 12:30 PM. On 15 December 2008, at 5:00 PM the patient became dizzy, was stumbling and had trouble walking. At 5:30 PM felt eyes rolling to back of his head and were fluttering for 5 minutes. He felt extreme malaise and fell asleep. The next morning he felt fine. The patient's parent reported that the patient had a seizure. The patient recovered. No further information was provided. Documents held by sender: None.
Age: 18.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Convulsion, Dizziness, Gait disturbance, Gaze palsy, Malaise
Clinical narrative: Initial information was received on 17 December 2008 from a health care professional. An 18 year old male patient with a history of pneumonia (01 December 2008) treated with CIPRO, received an injection of FLUZONE SV 2008-2009 (lot number U2853AB) intramusculary in the deltoid on 15 December 2008 at 12:30 PM. On 15 December 2008, at 5:00 PM the patient became dizzy, was stumbling and had trouble walking. At 5:30 PM felt eyes rolling to back of his head and were fluttering for 5 minutes. He felt extreme malaise and fell asleep. The next morning he felt fine. The patient's parent reported that the patient had a seizure. The patient recovered. No further information was provided. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, FLU3, MNQ, TDAP
Symptoms: Muscular weakness
Clinical narrative: An 12 year old male patient with a history of allergic rhinitis received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2808AA) in the left thigh, MENACTRA (lot number U20808AA) in the left thigh, and BOOSTRIX (lot number AC52B028AA) in the right thigh on 3 November 2008. On 17 December 2008 the patient presented to the doctor's office with complaints of bilateral weakness in the upper and lower extremities. The patient was diagnosed with possible GBS (GUILLAIN BARRE syndrome) and was sent to the hospital. The patient was not recovered at the time of the report. Documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP, FLU3, MNQ, TDAP
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: An 12 year old male patient with a history of allergic rhinitis received an intramuscular injection of FLUZONE SV 2008-2009 (lot number U2808AA) in the left thigh, MENACTRA (lot number U20808AA) in the left thigh, and BOOSTRIX (lot number AC52B028AA) in the right thigh on 3 November 2008. On 17 December 2008 the patient presented to the doctor's office with complaints of bilateral weakness in the upper and lower extremities. The patient was diagnosed with possible GBS (GUILLAIN BARRE syndrome) and was sent to the hospital. The patient was not recovered at the time of the report. Documents held by sender: none.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Pt. received Tdap postpartum on 12/27/08 @ hospital.  Returned 12/29/08 to clinic with painful L arm; red, slightly swollen and hardened. Instructed to ice site.  Seen at health center today with increased swelling and redness to site.  Keflex ordered and instructed to return to clinic on 1/2/09 if swelling does not decrease.
Age: 23.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pt. received Tdap postpartum on 12/27/08 @ hospital.  Returned 12/29/08 to clinic with painful L arm; red, slightly swollen and hardened. Instructed to ice site.  Seen at health center today with increased swelling and redness to site.  Keflex ordered and instructed to return to clinic on 1/2/09 if swelling does not decrease.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Headache, Herpes zoster
Clinical narrative: Same day as injection, Headache; 3 days after injection, shingles outbreak (22 spots) on same side of abdomen as injection (left arm) but on opposite side from previous outbreak 2 mos ago.  Headache medicine only.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Breast cancer, Chemotherapy, Lymphadenectomy, Mastectomy, Radiotherapy
Clinical narrative: Information has been received from a Nurse practitioner concerning a 25 year old female patient who on 18-APR-2008 was vaccinated with the first dose of GARDASIL. After receiving the first dose of GARDASIL the patient was diagnosed with right breast cancer (2008). In November 2008, the patient had a right segmental mastectomy and lymph node dissection. As per the oncologist the breast cancer is not related to the GARDASIL. The patient was continuing on HERCEPTIN chemotherapy treatments until May 2009. She was also currently receiving radiation therapy. Upon internal review, breast cancer was considered to be an Other Important Medical Event. Additional information has been requested.  1/19/09 Reviewed PCP medical records of 11/14/2008. FINAL DX: right breast cancer, clinical stage T1C N0 M0; ER-positive, HER-2-positive; neoadjuvant chemotherapy; BRCA1 & 2 gene negative; right segmental mastectomy & sentinel lymph node biopsy 11/5/08.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Drug exposure during pregnancy, Foetal disorder, Gestational diabetes, Ultrasound scan normal
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N) through the Merck pregnancy registry concerning a 22 year old female with cardiac murmur with a history of 2 pregnancies and 2 live births and a history of hypothyroidism who on 27-FEB-2008 was vaccinated with the first dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included FLINTSTONES Multivitamin. The patient was pregnant. The reporter stated that the patient's last menstrual period was 16-FEB-2008. The estimated conception date was 02-MAR-2008. The patient was in for first obstetrics (OB) visit on 10-JUN-2008 and urine pregnancy test was positive and ultrasound due date was 24-NOV-2008. On 02-JUL-2008 ultrasound was performed for size and dating. The result was within normal limits (MNL) and the estimated delivery date was 23-NOV-2008. No product quality complaint was involved. Follow-up information on 19-DEC-2008 was received from a licensed practical nurse (L.P.N) concerning a 23 year old patient who was a smoker, on 27-FEB-2008 at 1535 was vaccinated intramuscularly into left deltoid with the first dose of GARDASIL (lot # 659653/1448U). Ferrous sulfate, FLINTSTONES Multivitamin and omeprazole were used during pregnancy. On 12-NOV-2008, the patient delivered a female baby with congenital anomaly weighing 3103gm (weeks from LMP: 38). Length: 20 inch. Apgar score: 8/9. The baby had a cleft palate. There were no other complications or abnormalities. The complications during pregnancy included gestational diabetes and anemia. Ferrous sulfate was taken for the treatment of anemia. At the time of reporting, the outcomes for cleft palate, gestational diabetes and anemia were unknown. Additional information has been requested.