chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Dry skin, Urticaria
Clinical narrative: This case was reported by a consumer and described the occurrence of hive in a 65-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure, high pressure in eye, sulfa allergy and tomato allergy. Concurrent medications included lisinopril and XALATAN. On 9 October 2012 at 10:30 the subject received 1st dose of FLULAVAL (unknown, left arm). On 12 October 2012, 3 days after vaccination with FLULAVAL, the subject experienced hives, bruising and dry skin. The subject reported that she was taking BENADRYL to help with her hives. The subject reported that she received the injection at her place of employment, but planned to follow-up with her own physician on an unknown date. The hives resolved on 12 October 2012 and the dry skin resolved on 15 October 2012. At the time of reporting the bruising had improved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site swollen in possibly 10 or more subjects of unspecified ages and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). In 2012 the subjects received unspecified dose of FLULAVAL (.5 unknown, intramuscular). At unspecified times after vaccination with FLULAVAL, the subjects experienced injection site swollen, injection site pain, injection site induration and injection site reaction. The healthcare professional reported the office had up to 10 subjects or possibly more, with complaints of injection site swelling, soreness and pain, in some cases induration size of coin and injection site reaction. At the time of reporting the outcome of the injection site swollen, injection site pain, injection site induration and injection site reaction were unspecified. The healthcare professional reported another case regarding FLULAVAL; please see case A0996318A.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2012 the subject received a dose of FLULAVAL (unknown details). In 2012, less than a year after vaccination with FLULAVAL, the subject experienced rash. The physician reported that the subject "left the clinic covered in rash after receiving the FLULAVAL vaccine." At the time of reporting the outcome of the event was unspecified. The physician also stated "that he has seen more allergies to the flu vaccine this year than what he has seen in the past." The physician previously reported a case with unspecified number of subjects with reactions to the flu vaccine earlier in October 2012. See case A0997357A for details.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash, Rash vesicular
Clinical narrative: "Shingles like" rash on cheek under right eye. Slight burning, but otherwise painless. Appeared on 02/10/13 in morning.
Age: 60.0
Sex: F
Vaccine: UNK
Symptoms: Induration, Rash erythematous, Skin warm, Tenderness
Clinical narrative: 6 inch erythematous patch, hot, indurated, tender.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Underdose
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site redness in a 33-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On the morning of 12 November 2012 the subject received a dose of FLULAVAL (.1 ml, intradermal, left arm) and experienced inappropriate route of vaccination and vaccine underdose. FLULAVAL is indicated as a single dose of 0.5mL administered intramuscularly. On 12 November 2012 at 10:30, less than one day after vaccination with FLULAVAL, the subject experienced injection site redness. At the time of reporting the event was unresolved. The pharmacist considered the event of injection site redness was probably related to vaccination with FLULAVAL. Follow up was received on 8 January 2013 from pharmacist. The pharmacist stated that she was a "poison specialist who was called by the nurse practitioner who administered the FLULAVAL." On 12 November 2012, the subject experienced injection site redness minutes after vaccination with FLULAVAL. On 12 November 2012, 39 minutes after vaccination with FLULAVAL, the injection site redness had resolved. The pharmacist stated "per the nurse practitioner who re-evaluated the patient, by 11:09 on 12 November 2012, the symptoms of redness had resolved. The patient had no induration at the injection site." The pharmacist did not consider the event to be serious.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of arm soreness at injection site in a 8-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 29 November 2012 at 17:00 the subject received 1st dose of FLULAVAL (.5 ml, unknown route, right deltoid) and experienced inappropriate age at vaccine administration. The subject was younger than the indicated age for FLULAVAL. In 2012, less than one week after vaccination with FLULAVAL, the subject experienced arm soreness at injection site. At the time of reporting the outcome of the event was unspecified.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in a 25-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 November 2012 at 15:00 the subject received unspecified dose of FLULAVAL (.1 ml, unknown, right arm) and experienced wrong vaccine administered. On 7 November 2012, within a week of the vaccination with FLULAVAL, the subject experienced wrong vaccine administered, injection site redness, injection site swollen and hotness at injection site. The subject was supposed to receive a Tb test, but 0.1 ml of FLULAVAL was placed in the right arm instead of Tb test. The subject's arm was red, swollen and hot, like it would occur with a concentrated reaction at the site of administration. The reporter could not provide any additional details. At the time of reporting the outcome of the injection site redness, injection site swollen and hotness at injection site were unspecified. Follow up was received from the healthcare professional (occupational health nurse) on 8 January 2013. The nurse reported that on 10 November 2012, the events of injection site redness, injection site swollen, and hotness at injection site had resolved. The nurse did not consider these events serious. The nurse stated that these events were the result of erroneous administration where they "administered flu vaccine instead of PPD."
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 35-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included sulfa allergy. On 6 November 2012 at 12:15 the subject received a dose of FLULAVAL (3.5 ml, intramuscular, left deltoid) and experienced overdose. The recommended dose is 0.5ml of FLULAVAL. The subject was treated with TYLENOL. At the time of reporting the outcome of the injection site pain was unspecified.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). There were no concurrent medications. On 25 October 2011 (morning 08:30 - 11:30) the subject received a dose of FLULAVAL in the right arm. Less than one year after vaccination with FLULAVAL, the subject experienced allergic reaction (prior to reporting on 09 January 2012). At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via Merck and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced rash. A pharmacist reported that the subject developed a rash after possibly receiving FLULAVAL. At the time of the report no other information was available. At the time of reporting the outcome of the event was unspecified.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Received MMR #1 on 1/31/13 - developed fever within 24 hours then had febrile seizure within 48 hours. Fever 101.
Sex: F
Vaccine: FLU3
Symptoms: Drug screen positive, Opiates positive
Clinical narrative: This case was reported by a pharmacist and described the occurrence of urine drug screen positive for opiates in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2012 the subject received a dose of FLULAVAL (unknown details). In 2012, less than a year after vaccination with FLULAVAL, the subject experienced urine drug screen positive for opiates. The pharmacist was "calling to ask if FLULAVAL could potentially cause a false positive on a drug screen." At the time of reporting the outcome of the event was unspecified.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash on neck, trunk, arms, legs & face.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Bacterial test positive, Full blood count normal, Rash pruritic, Urine leukocyte esterase positive, White blood cells urine positive
Clinical narrative: Maculopapular rash on neck, trunk, arms, legs & face.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Arm became hot & swollen about 3" below location of injection. Applied ice & took antihistamine, resolved after 5 days.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Syncope
Clinical narrative: Patient experienced syncope, was sitting at time. Nurse laid table down and put cool cloths on patient, observed him for 15-20 mins until he felt better.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Rash
Clinical narrative: Pt. developed a rash in upper torso and painful injection site.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Arthropathy, Dizziness, Immediate post-injection reaction, Nervousness, Pallor
Clinical narrative: Immediately after shot patient lightheaded, pale, no LOC, no nausea, but felt shaky. Given orange juice and better but reported 7-10 minutes post vaccine a "strong sensation" (R) hand side of vaccination. No paresthesias or weakness. Left office on own.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUN3, MMR
Symptoms: Pyrexia
Clinical narrative: High fever - 106 max, onset 10 days after MMR. Fever lasted 4-5 days, requiring multiple doses TYLENOL & ibuprofen & cooling baths. No rash. Mom felt child had no other illness at that time.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The physician reported that the patient received the first dose of GARDASIL (lot #, expiration date, dose and route not reported) on an unspecified date one and one half year ago and was in the office on 31-JAN-2013 to receive the second dose of GARDASIL (lot #, expiration date, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. No treatment information was reported. The outcome of the patient was unknown. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: Pt. given varicella in back of Rt. arm. Next morning noted red and itching. Only hurt when scratched or rubbed to relieve itch. No fever. No breathing prob. Advised to take BENADRYL. Can use cold moist to relieve sx - anti itch cream. Feb 8th at 4pm 40 mm x 50 mm red, warm to touch.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 3cm x 3cm red raised area rt thigh. Onset 5 days receiving VARIVAX in rt thigh.
Age: 4.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Pt. received MMRV and Hep A in Rt arm. Developed hives in Rt arm which quickly spread throughout entire body.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Complaints ongoing continuous pain and intermittent tingling at (R) deltoid injection site, radiating down to fingertips when performing daily routines. Incident not reported until 2/7/13. Denies being seen at ER for treatment.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to a patient of 9 year old (gender unspecified). On 31-JAN-2013, the patient was inadvertently vaccinated with an extra third dose of 0.5ML(milliliter), M-M-R II (lot number was reported as 0680AE, expiry date 02-APR-2014, route subcutaneous). No adverse effects was reported. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 18 year old patient(unspecified gender). The patient had no prior vaccination history. On an unknown date, the patient was vaccinated with a first dose PROQUAD (merck), (lot number, expiration date and route was not provided). No concomitant medications reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccination complication
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 years old female patient. On an unspecified date the patient was vaccinated with ZOSTAVAX "a shingles shot" (manufacturer unknown) (dose, lot and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient reported that she had a bad reaction to a shingles shot and that she had a rash on her arm because of the shot. No treatment information was reported. The outcome of the patient events was unknown. The relation between a bad reaction to a shingles shot and rash on her arm because of the shot and ZOSTAVAX is unknown. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients who on 04-FEB-2013 were vaccinated with doses of GARDASIL (from lot # H017698, expiry on 02-JUL-2015) or M-M-R II (from either lot# 0425AE, expiry on 27-FEB-2014 or from lot# 0367AE, expiry on 15-FEB-2014) that were exposed to an unsupported temperature excursion. No patient specific information was provided. It was unknown if any patients received both GARDASIL and M-M-R II. No adverse effects were reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients who on 04-FEB-2013 were vaccinated with doses of GARDASIL (from lot # H017698, expiry on 02-JUL-2015), M-M-R II (from either lot# 0425AE, expiry on 27-FEB-2014 or from lot# 0367AE, expiry on 15-FEB-2014) that were exposed to an unsupported temperatured excursion. No patient specific information was provided. It was unknown if any patients received both GARDASIL and M-M-R II. No adverse effects were reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients who on 04-FEB-2013 were vaccinated with doses of GARDASIL (from lot # H017698, expiry on 02-JUL-2015) or M-M-R II (from either lot# 0425AE, expiry on 27-FEB-2014 or from lot# 0367AE, expiry on 15-FEB-2014) that were exposed to an unsupported temperatured excursion. No patient specific information was provided. It was unknown if any patients received both GARDASIL and M-M-R II. No adverse effects were reported. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL(lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of RECOMBIVAX HB (lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient. On 06-FEB-2013, the patient was vaccinated with a dose of PROQUAD (merck) (Lot # not reported). No adverse event was reported. The nurse also stated that the patient had received the first dose of M-M-R II on 16-OCT-2002 and the first dose of VARIVAX (Merck) on 12-MAY-1999. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Fungal infection, Pregnancy test urine positive, Ultrasound antenatal screen normal, Urinary tract infection
Clinical narrative: This spontaneous prospective pregnancy report has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 15 years old female patient, with no drug/reactions/allergies and no pertinent medical history, who received GARDASIL while pregnant. There was no concomitant medications. The patient's history of previous pregnancies and live births is not known. The patient received the first dose of GARDASIL (lot # 668261/1397AA, Exp: 09-APR-2013) on 24-JAN-2012. The second dose of GARDASIL (lot # 668261/1397AA, Exp: 09-APR-2013) on 11-APR-2012, and the third dose on 15-AUG-2012 (Lot # 672721/0101AE, Exp: 10-OCT-2012) (doses and routes not reported). The patient was found to be pregnant on 15-AUG-2012 after she was vaccinated with the third dose of GARDASIL. The patient had a urine pregnancy test on 15-AUG-2012 prior to starting birth control and was found to be pregnant. The patient then stated that her LMP was on 29-APR-2012. EDD would be on 03-FEB-13. The patient was exposed to GARDASIL during trimester 1 and 2. No adverse event reported outside of the pregnancy. No treatment was given. The patient sought medical attention via office contact. Follow up information as received from a licensed practical nurse refers to a 16 years old (currently) female patient with no previous pregnancies who on 26-JAN-2012 at 09:12 am, was vaccinated with of first dose of GARDASIL (lot # 668261/1397AA, Expiration date: 09-APR-2013) in left deltoid. On 11-APR-2012 at 04:07 pm, was vaccinated with of second dose of GARDASIL in left deltoid (lot # 668261/1397AA, Expiration date: 09-APR-2013) and on 15-AUG-2012 at 03:10 pm, was vaccinated of the third dose of GARDASIL in left deltoid (Lot # 672721/0101AE, Expiration date: 10-OCT-2012) (doses not reported). Concomitant medications included ascorbic acid, cholecalciferol, folic acid, magnesium oxide, polysaccharide iron complex, vitamin A, vitamin B complex, vitamin E, SELECT OB, FLAGYL, DIFLUCAN and nitrofurantoin. Subsequently, the patient became pregnant; date of last menstrual period (LMP) was 03-APR-2012 and an estimated delivery date (EDD) of 08-JAN-2013. On 06-SEP-2012, the ultrasound prenatal was performed with a result within normal limits. On an unknown date, the patient experienced urinary tract infection treated with nitrofurantoin (08-OCT-2012); bacterial vaginosis (date unknown) treated with FLAGYL (11-OCT-2012); and yeast infection (date unknown) treated with DIFLUCAN (11-OCT-2012). The patient's outcome for urinary tract infection, yeast infection and bacterial vaginosis were unknown. The relatedness for urinary tract infection, yeast infection and bacterial vaginosis was unknown for GARDASIL. On 03-JAN-2013, the patient delivered a female infant, weighing 6.7; with a length 20 inches. The infant's APGAR scores were 9/9.Upon delivery, the infant was noted to be a normal there were no congenital anomalies healthy newborn. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginitis bacterial
Clinical narrative: This spontaneous prospective pregnancy report has been received from a licensed practical nurse for GARDASIL, a Pregnancy Registry product, concerning a 15 years old female patient, with no drug/reactions/allergies and no pertinent medical history, who received GARDASIL while pregnant. There was no concomitant medications. The patient's history of previous pregnancies and live births is not known. The patient received the first dose of GARDASIL (lot # 668261/1397AA, Exp: 09-APR-2013) on 24-JAN-2012. The second dose of GARDASIL (lot # 668261/1397AA, Exp: 09-APR-2013) on 11-APR-2012, and the third dose on 15-AUG-2012 (Lot # 672721/0101AE, Exp: 10-OCT-2012) (doses and routes not reported). The patient was found to be pregnant on 15-AUG-2012 after she was vaccinated with the third dose of GARDASIL. The patient had a urine pregnancy test on 15-AUG-2012 prior to starting birth control and was found to be pregnant. The patient then stated that her LMP was on 29-APR-2012. EDD would be on 03-FEB-13. The patient was exposed to GARDASIL during trimester 1 and 2. No adverse event reported outside of the pregnancy. No treatment was given. The patient sought medical attention via office contact. Follow up information as received from a licensed practical nurse refers to a 16 years old (currently) female patient with no previous pregnancies who on 26-JAN-2012 at 09:12 am, was vaccinated with of first dose of GARDASIL (lot # 668261/1397AA, Expiration date: 09-APR-2013) in left deltoid. On 11-APR-2012 at 04:07 pm, was vaccinated with of second dose of GARDASIL in left deltoid (lot # 668261/1397AA, Expiration date: 09-APR-2013) and on 15-AUG-2012 at 03:10 pm, was vaccinated of the third dose of GARDASIL in left deltoid (Lot # 672721/0101AE, Expiration date: 10-OCT-2012) (doses not reported). Concomitant medications included ascorbic acid, cholecalciferol, folic acid, magnesium oxide, polysaccharide iron complex, vitamin A, vitamin B complex, vitamin E, SELECT OB, FLAGYL, DIFLUCAN and nitrofurantoin. Subsequently, the patient became pregnant; date of last menstrual period (LMP) was 03-APR-2012 and an estimated delivery date (EDD) of 08-JAN-2013. On 06-SEP-2012, the ultrasound prenatal was performed with a result within normal limits. On an unknown date, the patient experienced urinary tract infection treated with nitrofurantoin (08-OCT-2012); bacterial vaginosis (date unknown) treated with FLAGYL (11-OCT-2012); and yeast infection (date unknown) treated with DIFLUCAN (11-OCT-2012). The patient's outcome for urinary tract infection, yeast infection and bacterial vaginosis were unknown. The relatedness for urinary tract infection, yeast infection and bacterial vaginosis was unknown for GARDASIL. On 03-JAN-2013, the patient delivered a female infant, weighing 6.7; with a length 20 inches. The infant's APGAR scores were 9/9.Upon delivery, the infant was noted to be a normal there were no congenital anomalies healthy newborn. 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 refers to unspecified number of patients. On an unknown dates, the patients were vaccinated with their second and third doses of GARDASIL (Lot # not reported) off schedule. No adverse symptoms were reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a physician refers to a late 60 years old female patient. On approximately January 2013, the patient was vaccinated with ZOSTAVAX (lot#, dose and route not reported). The patient stated that on an unknown date, after receiving ZOSTAVAX she developed pain in both her sides of her trunk. The patient sought medical attention. The patient was treated with XANAX. The outcome of the event was not provided. The relatedness of the event with ZOSTAVAX was not provided. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: This spontaneous report as received from a physician refers to a 84 year old female patient. On 28-DEC-2012, the patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported) subcutaneously. The physician reported that on 07-JAN-2013, the patient experienced cellulitis. The patient saw the physician. The outcome of cellulitis was reported as recovered/resolved on an unspecified date. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Device leakage, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a female doctor of pharmacy of unknown age reporting on herself. On an unknown date, the pharmacist while attempting to withdrawal reconstituted ZOSTAVAX (dose, route, lot number not reported) the vial leaked and product got on her hands. No adverse effect reported. PQC filled. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Injected limb mobility decreased, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer reporting on herself a 42 year old female patient with frequent bronchitis and environmental allergies and medical history of sinusitis and pneumonia who on 01-FEB-2013, was vaccinated with PNEUMOVAX23, (lot # not provided) 0.5 ml in the left arm for low pneumococcal levels. Concomitant therapies included LEXAPRO, NASONEX and vitamins (unspecified). The patient stated that on 01-FEB-2013 the same evening that received PNEUMOVAX23, she started to experience pain in her injection arm. She states that over the following two days, her arm began to swell and turn red. She also began to experience a fever of 101 F and 102 F; there was an area of hardness that was about 5 inches by 3 inches, extending down towards her elbow on the injection arm. She reported that she had been having difficulty lifting the effected arm. Also she state, It got so bad that she called her physician's emergency number, and he prescribed KEFLEX. She reported that her symptoms have been improving since she has started taking the KEFLEX. AT the time of the report she was not fully recovered, and she would be going to her physician for a follow-up at an unspecified date. No additional information currently available. She was agreeable to contact with her physician for follow-up information. The relatedness for events were unknown for PNEUMOVAX23. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a consumer reporting on herself a 42 year old female patient with frequent bronchitis and environmental allergies and medical history of sinusitis and pneumonia who on 01-FEB-2013, was vaccinated with PNEUMOVAX23, (lot # not provided) 0.5 ml in the left arm for low pneumococcal levels. Concomitant therapies included LEXAPRO, NASONEX and vitamins (unspecified). The patient stated that on 01-FEB-2013 the same evening that received PNEUMOVAX23, she started to experience pain in her injection arm. She states that over the following two days, her arm began to swell and turn red. She also began to experience a fever of 101 F and 102 F; there was an area of hardness that was about 5 inches by 3 inches, extending down towards her elbow on the injection arm. She reported that she had been having difficulty lifting the effected arm. Also she state, It got so bad that she called her physician's emergency number, and he prescribed KEFLEX. She reported that her symptoms have been improving since she has started taking the KEFLEX. AT the time of the report she was not fully recovered, and she would be going to her physician for a follow-up at an unspecified date. No additional information currently available. She was agreeable to contact with her physician for follow-up information. The relatedness for events were unknown for PNEUMOVAX23. 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 registered nurse refers to a patient of unknown gender and age. The patient was vaccinated with GARDASIL, the first dose of GARDASIL on 23-aug-2011, the second dose of GARDASIL on 09-jan-2013 and the third dose of GARDASIL on 31-jan-2013. No adverse event was reported. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscle tightness, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a 63 year old female consumer refers to herself. The patient was vaccinated with 1 dose of ZOSTAVAX (dose, frequency and lot# not reported) in her left arm on 01-FEB-2013. The patient stated that she was experiencing side effects, half dollar sized red mark with itching and swelling with onset date of 02-FEB-2013 and on 03-FEB-2013 (Sunday) it got larger. On 04-FEB-2013 (Monday), the patient went to the doctor and the doctor gave her "something that relieved the itching". The patient also experienced muscle tension on 02-FEB-2013. At the time of reporting, the patient's outcome was unknown. The relatedness for all events was related for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date (recently), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient broke out with shingles after the vaccination. On an unknown date, the patient sought medical attention (saw the healthcare professional). The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a patient of unknown age and gender. On an unknown date (recently), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patient broke out with shingles after the vaccination. On an unknown date, the patient sought medical attention (saw the healthcare professional). The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus
Clinical narrative: This spontaneous report as received from a female consumer refers to herself of unknown age. The patient was vaccinated SC with a dose of 0.65 ml ZOSTAVAX (lot# not reported) in approximately February 2011 (reported as over 2 years ago). Concomitant medications included: acyclovir. On an unspecified date however the consumer still had two cases of shingles since receiving the ZOSTAVAX. The consumer stated that she also had Ramsey Hunt Syndrome however she did not mention if the Ramsey Hunt Syndrome occurred before or after the ZOSTAVAX was administered. At the time of reporting, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patient were vaccinated with a dose of PEDVAXHIB (lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a field representative referred to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose/frequency, route and duration were unspecified) for shingles vaccination. Then the patient experienced irritation, swelling, redness and tenderness at the injection site on an unknown date. The outcome of irritation, swelling, redness and tenderness at the injection site were unknown. The relatedness of irritation, swelling, redness and tenderness at the injection site were unknown for ZOSTAVAX. This was one of several reports that received from the same source. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a physician via a field representative referred to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose/frequency, route and duration were unspecified) for shingles vaccination. Then the patient experienced irritation, swelling, redness and tenderness at the injection site on an unknown date. The outcome of irritation, swelling, redness and tenderness at the injection site were unknown. The relatedness of irritation, swelling, redness and tenderness at the injection site were unknown for ZOSTAVAX. This was one of several reports that received from the same source. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female patient. The patient had none drug allergies. On 30-JAN-2013, the patient was vaccinated subcutaneous with 0.65 ml ZOSTAVAX (lot # reported as H019092, expiry date reported as 09-FEB-2014). "Two days later", on 01-FEB-2013, the patient developed a reddened area around the injection site, "about the size of a baseball" that was hot and itchy. The patient sought for medical attention by coming to the pharmacist and had not been to see healthcare provider. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was unknown. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Information was received from a Claims Examiner concerning a female who on an unspecified date, was vaccinated with ZOSTAVAX (lot number 0257AE). She was vaccinated at pharmacy. On 17-AUG-2012 she experienced an adverse reaction (not specified) after receiving the vaccination. The outcome was unknown. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Paremedics sent for pt who almost immediately developed rash, hives and itching and red face following injection.  Given Epi pen by nurse on  site and Benadryl 50mg IV by paremedics. 3pm vital signs: Pulse 85, Resp 20, BP 150/80, O2 Sats 96%.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with GARDASIL (lot # 666597/0768Z; expired date 17-OCT-2012) (dose, route, indication were not reported) on 06-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 06-NOV-2012 the patient was administered expired GARDASIL. No adverse reactions reported. There was no treatment given for adverse event. Action taken and outcome were not reported. The patient had not sought any medical attention. Follow up information has been received from the medical assistant refers to to the 20 year old female patient. The patient was vaccinated with the first dose of GARDASIL (lot # 666597/0768Z; expired date 17-OCT-2012) (dose was not reported, intramuscularly in the right deltoid) at 08:52 AM on 06-SEP-2012. At 09:57 AM on 06-NOV-2012 the patient was vaccinated with the second dose of GARDASIL (lot # 666597/0768Z; expired date 17-OCT-2012) (dose was not reported, intramuscularly in the right deltoid). The patient notified and had a repeat GARDASIL (lot number reported as H017019) (dose was not reported, intramuscularly in the right deltoid) at 10:24 AM on 07-DEC-2012. No adverse reactions reported. It was reported that the patient didn't require emergency room/doctor visit. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Blood test, Pruritus, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old male child. The mother of the child had been vaccinated with a single dose of 0.5 mL of PROQUAD (Merck) on an unknown date. The mother called the health department and said that on 04-FEB-2013 the child experienced fever and rash. The outcome of fever, rash and secondary transmission is unknown. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Pyrexia, Rash, Secondary transmission
Clinical narrative: This spontaneous report as received from a nurse refers to a 5 year old male child. The mother of the child had been vaccinated with a single dose of 0.5 mL of PROQUAD (Merck) on an unknown date. The mother called the health department and said that on 04-FEB-2013 the child experienced fever and rash. The outcome of fever, rash and secondary transmission is unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: PPV, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Rash pruritic
Clinical narrative: Small rash at injection site that grew to about 1x1. Several itchy bumps that have shown up over the past 24-48 hours (approximately 8 bumps) may vaccine related or other reason. Visited primary doctor due to itchiness at injection site and other bumps itching. Doctor suggested watching for further symptoms and reporting back and taking OTC meds for now.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient developed red, 2 inch wide whelp halfway around arm and lymph node of side of body which received shot. She said 4 days after shot she developed itching, which she treated with OTC cortisone cream. She consulted her Dr Tuesday (the day after the shot). Resolving as of 1/26/13.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation, Injection site pain, Pain
Clinical narrative: Pain at site and pain with use of arm.
Age: 37.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Bursitis, Injected limb mobility decreased, Injection site pain
Clinical narrative: The Flu shot (in right arm) and whooping cough/tetanus shot (left arm) were administered high on the arm. Shot hurt worse than before especially for right arm. That day I could not raise either arm above my head. Saw administering nurse approximately 3 weeks after. Then saw my general practitioner approximately 5 weeks after. She diagnosed me with shoulder bursitis in both shoulders. Right one is the worse one. Treatment included 2 weeks of NSAID (took approximately 4 weeks) & exercises. Pain continues to be present.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles (severe case) on 1/25/13.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient called 10 days after received flu shot and stated arm still sore, pain radiating down arm, shoulder sore. Pt. said has had pain since getting shot.
Age: 1.85
Sex: M
Vaccine: DTAP
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: A case of pertussis disease in a three year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3278AA received on 05 May 2009, dose two lot number C3292AA received on 01 July 2009 and dose three lot number C3431AA received on 01 September 2009 and one dose of TRIPEDIA, lot number U3009AA on 03 January 2011 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 17 June 2012, approximately 17 months after the last dose. On 17 June 2012, the subject developed a cough and paroxysmal cough on 01 July 2012 with a whoop. Laboratory testing included positive PCR on 28 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 June 2012 for five days. The subject was not hospitalized. At the time of final contact on 01 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 1.85
Sex: M
Vaccine: DTAP
Symptoms: Polymerase chain reaction
Clinical narrative: A case of pertussis disease in a three year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C3278AA received on 05 May 2009, dose two lot number C3292AA received on 01 July 2009 and dose three lot number C3431AA received on 01 September 2009 and one dose of TRIPEDIA, lot number U3009AA on 03 January 2011 (routes and sites of administration for all doses not reported). The subject developed cold-like symptoms on 17 June 2012, approximately 17 months after the last dose. On 17 June 2012, the subject developed a cough and paroxysmal cough on 01 July 2012 with a whoop. Laboratory testing included positive PCR on 28 June 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 June 2012 for five days. The subject was not hospitalized. At the time of final contact on 01 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test normal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 31 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; dose 1 received on 03 February 2012 (lot number not reported), dose 2 received on 04 April 2012 (lot number C4156AB) and dose 3 received on 14 June 2012 lot number C4277AC (routes and site of administration not reported). The subject developed cold-like symptoms and a cough on 26 September 2012, approximately three months after the last dose. On 27 September 2012, the subject developed a paroxysmal cough with a whoop. Laboratory testing included negative PCR on 28 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 September 2012 for five days. The subject was not hospitalized. At the time of final contact on 12 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Age: 0.53
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction
Clinical narrative: Initial report received on 31 January 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a nine-month-old male subject (initial not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; dose 1 received on 03 February 2012 (lot number not reported), dose 2 received on 04 April 2012 (lot number C4156AB) and dose 3 received on 14 June 2012 lot number C4277AC (routes and site of administration not reported). The subject developed cold-like symptoms and a cough on 26 September 2012, approximately three months after the last dose. On 27 September 2012, the subject developed a paroxysmal cough with a whoop. Laboratory testing included negative PCR on 28 September 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 28 September 2012 for five days. The subject was not hospitalized. At the time of final contact on 12 October 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.