chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Patient c/o lightheaded and nausea on 7/10/12 and c/o redness, swelling, warmth to injection side (L) arm. Took BENADRYL, ibuprofen, and ice which helped subside symptoms. I saw patient on 7/11/12 and symptoms improved. No rash or respiratory distress noted.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: After pt received the last vaccine he fainted, lost consciousness for 10-15 seconds and had urinary incontinence. Patient fell, hitting his head on the floor and for that reason was sent to the ER for further evaluation.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt woke up on 7/13/2012 with redness and swelling at area of injection. Pt denied pain, itching or fever. Advised to use cool compresses and TYLENOL or MOTRIN for relief.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Haematemesis, Pyrexia, Vomiting
Clinical narrative: ROTATEQ given & patient vomited for weeks & some initial vomiting was tinged with blood & ran fever.
Age: 57.0
Sex: F
Vaccine: YF
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: The injection site became itchy on Thursday (7/12/12) evening & started to swell on Friday & Saturday. The swelling started to go down on Sunday but the itchiness remained through Monday.
Age: 1.12
Sex: F
Vaccine: DTAP, HEPA, PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: Vaccine administered on 5/25/11. Dark red hives started to appear on evening of 5/25/11 and by 5/26/11 AM they were all over her body. Mother took her to ER. They administered high dose allergy med. Hives went away by two days later.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Malaise, Skin infection
Clinical narrative: Pt. developed swelling and erythema on (L) deltoid, erythema measured 4 cm in diameter. Mom reported, child c/o malaise. So brought in to clinic Pt. had been prescribed amoxicillin 2 days ago for an infected, abraded legion on (R) leg.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report as received from a registered pharmacist referred to a 63 years old female patient. The patient was vaccinated with a dose of lot # (669863/0365AA) ZOSTAVAX on 19-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. On 19-MAY-2012, after ZOSTAVAX injection, the patient experienced an injection site reaction that was painful, itchy and red. The patient visited physician's office for medical attention. No treatment information was reported. The outcome of injection site painful, itchy and red reaction was unknown. The relatedness for of injection site painful, itchy and red reaction was unknown for ZOSTAVAX. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Information has been received from a health professional at a physician's office, a physician and two company representatives concerning a 54 year old male patient. The patient was vaccinated with .65 ml ZOSTAVAX on 05-JUN-2012 (also reported as 25-JUN-2012). No other co-suspects were reported. No concomitant medications were reported. It was reported 5 days after getting the vaccine, the patient called the doctor's office because he had experienced a fever and a sore throat and requested an antibiotic, which the physician did not prescribe. It was reported the patient was very sick for three weeks after getting the vaccine. The physician reported "this patient may have to have his tonsils out". Treatment included over the counter medications (not specified). The outcome of sore throat and fever was reported as recovering/resolving. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Oral herpes
Clinical narrative: This spontaneous report as received from a physician refers to a 17 years old female patient with acne. The patient was vaccinated with dose 1 GARDASIL (Lot # 0313AE expiration date 26-OCT-2014). Concomitant medications included: minocycline. The physician reported that on 30-JUN-2012, the patient developed fever blisters. The patient was seen in the office and was treated with ZOVIRAX. At the time of the report, the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Coxsackie viral infection, Coxsackie virus test positive, Pyrexia, Rash generalised, Varicella post vaccine
Clinical narrative: This spontaneous report was given from a Nurse Practitioner concerning her 4 year old granddaughter with no pertinent medical history or drug reactions/allergies who on 13-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (dose and route not provided) (lot# 663819/0336Y, expiration date on 13-MAR-2011) and on 12-AUG-2009 received the second dose of VARIVAX (Merck) (dose and route not provided) (VARIVAX) (lot # 0803Y). There were no concomitant medications. The nurse reported that "early last week" on approximately 25-JUN-2012 her granddaughter was diagnosed with severe widespread chickenpox. The patient developed a fever of 102. The nurse indicated that the chickenpox rashes were "everywhere" on her granddaughter, including between toes and around genitalia. She was treated with CALADRYL lotion to the lesions and a topical mixture of MYLANTA and BENADRYL to the oral lesions. No laboratory test were performed. At the time of the report, the patient had not recovered from the event. The patient sought medical attention at the physician's office. Additional information received from the nurse practitioner revealed that her granddaughter was tested and it turns out that she had "coxsackie virus". The patient's outcome for "coxsackie virus" was not provided. It was noted that the nurse practitioner daughter also developed lesions and was tested and it turns out that she had "coxsackie virus" too. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Coxsackie viral infection, Coxsackie virus test positive, Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report was given from a Nurse Practitioner concerning her 4 year old granddaughter with no pertinent medical history or drug reactions/allergies who on 13-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (dose and route not provided) (lot# 663819/0336Y, expiration date on 13-MAR-2011) and on 12-AUG-2009 received the second dose of VARIVAX (Merck) (dose and route not provided) (VARIVAX) (lot # 0803Y). There were no concomitant medications. The nurse reported that "early last week" on approximately 25-JUN-2012 her granddaughter was diagnosed with severe widespread chickenpox. The patient developed a fever of 102. The nurse indicated that the chickenpox rashes were "everywhere" on her granddaughter, including between toes and around genitalia. She was treated with CALADRYL lotion to the lesions and a topical mixture of MYLANTA and BENADRYL to the oral lesions. No laboratory test were performed. At the time of the report, the patient had not recovered from the event. The patient sought medical attention at the physician's office. Additional information received from the nurse practitioner revealed that her granddaughter was tested and it turns out that she had "coxsackie virus". The patient's outcome for "coxsackie virus" was not provided. It was noted that the nurse practitioner daughter also developed lesions and was tested and it turns out that she had "coxsackie virus" too. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Coxsackie viral infection, Coxsackie virus test positive, Pyrexia, Rash generalised, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a Nurse Practitioner concerning her 4 year old granddaughter with no pertinent medical history or drug reactions/allergies who on 13-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (dose and route not provided) (lot # 663819/0336Y, expiration date 13-MAR-2011) and on 12-AUG-2009 received the second dose of VARIVAX (Merck) (dose and route not provided) (lot # 0803Y). There were no concomitant medications. The nurse reported that in June 2012 "early last week" her granddaughter was diagnosed with severe widespread chickenpox. The patient developed a fever of 102. The nurse indicated that the chickenpox rashes were "everywhere" on her granddaughter, including between toes and around genitalia. She was treated with CALADRYL lotion to the lesions and a topical mixture of MYLANTA and BENADRYL to the oral lesions. No laboratory test were performed. At the time of the report, the patient had not recovered from the event. The patient sought medical attention at the physician's office. Additional information received from the nurse practitioner revealed that her granddaughter was tested and it turns out that she had "Coxsackie virus". The patient's outcome for "Coxsackie virus" was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Coxsackie viral infection, Coxsackie virus test positive, Pyrexia, Varicella post vaccine
Clinical narrative: This spontaneous report was received from a Nurse Practitioner concerning her 4 year old granddaughter with no pertinent medical history or drug reactions/allergies who on 13-MAY-2009 was vaccinated with the first dose of VARIVAX (Merck) (dose and route not provided) (lot # 663819/0336Y, expiration date 13-MAR-2011) and on 12-AUG-2009 received the second dose of VARIVAX (Merck) (dose and route not provided) (lot # 0803Y). There were no concomitant medications. The nurse reported that in June 2012 "early last week" her granddaughter was diagnosed with severe widespread chickenpox. The patient developed a fever of 102. The nurse indicated that the chickenpox rashes were "everywhere" on her granddaughter, including between toes and around genitalia. She was treated with CALADRYL lotion to the lesions and a topical mixture of MYLANTA and BENADRYL to the oral lesions. No laboratory test were performed. At the time of the report, the patient had not recovered from the event. The patient sought medical attention at the physician's office. Additional information received from the nurse practitioner revealed that her granddaughter was tested and it turns out that she had "Coxsackie virus". The patient's outcome for "Coxsackie virus" was not provided. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years and 11 months old female patient. The patient was vaccinated with dose 1, dose 2 and dose 3 of LIQUID PEDVAXHIB in 2000 (lot #, dose and route not reported). On 03-JUL-2012 the patient was inadvertently vaccinated intramuscularly with a fourth 0.5 ml dose of LIQUID PEDVAXHIB, instead of GARDASIL. At the time of the report no adverse effects were reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Injection site pain, Muscle spasms, Pain
Clinical narrative: Information has been received from a consumer concerning her 81 year old mother with a history of mitral valve condition and no drug allergies/reactions who on 01-MAY-2012, was vaccinated subcutaneously in right arm with a 0.65 ml dose of ZOSTAVAX (Merck, (Lot# not reported). Concomitant therapy included LYRICA, TYLENOL WITH CODEINE, ATIVAN and NEURONTIN. On 02-MAY-2012, the patient's right arm was hurt at the injection site. On 03-MAY-2012 (reported as the next day) the patient experienced whole body ached, toes and fingers were tingling, the patient had cramping and was feeling week. The reporter sated that the patient had been seen by several doctors and also she was seen at the ER and was put on VICODIN for pain. The patient underwent unspecified 'blood work" (results unknown). The adverse event did not improve. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her 81 year old mother with a history of mitral valve condition and no drug allergies/reactions who on 01-MAY-2012, was vaccinated subcutaneously in right arm with a 0.65 ml dose of ZOSTAVAX (Merck, (Lot# not reported). Concomitant therapy included LYRICA, TYLENOL WITH CODEINE, ATIVAN and NEURONTIN. On 02-MAY-2012, the patient's right arm was hurt at the injection site. On 03-MAY-2012 (reported as the next day) the patient experienced whole body ached, toes and fingers were tingling, the patient had cramping and was feeling week. The reporter sated that the patient had been seen by several doctors and also she was seen at the ER and was put on VICODIN for pain. The patient underwent unspecified 'blood work" (results unknown). The adverse event did not improve. At the time of the report the patient's status was not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot # not reported expiration date 09-JUN-2012) on 11-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. 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 secretary referred to a patient of unknown age. The patient was vaccinated with dose 1 and 2 of GARDASIL, two years ago, in 2009 and with dose 3 on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. No treatment information was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date, was vaccinated with 0.65 ml dose of ZOSTAVAX (lot# not reported). The physician stated that the patient developed shingles after having been vaccinated with ZOSTAVAX. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 669692/0615 expiration date 02-JUL-2012) that was expired on 05-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The report was received from the same reporter with other 3 cases, and their MARRS# are 1207USA002230, 1207USA003758, 1207USA003760, respectively. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an 86 year old female patient with penicillin allergy and sulfa allergy who on 12-APR-2012 was vaccinated SQ with a 0.65mL single dose of ZOSTAVAX (Merck). The physician reported that on 08-MAY-2012 the patient experienced a swollen, hot and itchy arm, from the injection site down to the elbow. It was reported that an unspecified physician prescribed an unspecified antiviral cream, and that symptoms subsequently resolved on an unspecified date. Follow up information was received from the physician who indicated that they were unable to get in touch with the patient. Additional information is not expected.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site dryness, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 40 year old female patient, with multiple sclerosis, who on 12-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#, dose and route did not reported). Concomitant therapy included REBIF. No adverse effects reported. Follow-up information has been received from the pharmacist via a vaccine adverse experience report concerning the patient. The patient was vaccinated on 12-JUN-2012 4:30 PM (lot #: 1659AA, SQ, 1 dose). The patient experienced redness, swelling, or burning sensation at injection site starting day after vaccination lasting 3 to 4 days, she states rash measured 4 inches wide by 10-12 inches long, Rash healed but dry spot still at site, 07-JUL-2012. At time of the report, the patient had recovered. It was reported that the patient didn't require emergency room/doctor visit. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative, No adverse event, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old male who had been given "at least one dose of MMR II in the past and now had negative titers." At the time of the report, the patient's outcome was unknown. Follow up has been received from the registered nurse who stated that the patient had documentation of two doses of MMR II (lot# not reported) and negative serum titers. He stated that there was no adverse experience besides negative titers: no evidence of disease or any other disorder. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Rash vesicular, Secondary transmission, Skin lesion, Varicella
Clinical narrative: Information has been received from a published article. BACKGROUND: Transmission of vaccine-strain varicella-zoster-virus (VZV) had rarely been documented, with only 10 published laboratory-confirmed cases, all of which occurred among close contacts of vaccine recipients who developed post-vaccination rash. The authors described a unique case of vaccine-strain varicella resulting from exposure to a vaccinated individual who reported no rash post vaccination. RESULTS: A 25-day-old healthy female infant developed varicella 22 days after her mother was vaccinated in the immediate postpartum period. The infant developed a vesicular rash with 50-60 lesions. She was afebrile, had no complications was not hospitalized, and recovered completely. Infection with vaccine-strain VZV was confirmed by strain-specific PCR of cutaneous lesions. Her mother had no post-vaccination symptoms, rash or itching. The infant had no known contact with other persons with rash (varicella or zoster) or recent varicella vaccination other than her mother. CONCLUSIONS: This was the first reported case of secondary transmission of vaccine-strain VZV from a vaccine recipient who developed no rash illness. Possible mechanisms for transmission included aerosolization of the vaccine during administration, transference of vaccine fluid from the mother's arm to the infant's mucosa immediately after vaccination, passage through break milk or transmission through maternal respiratory secretions. The possibility of rare transmission of vaccine-strain VZV to a neonate should not discourage post-partum vaccination programs as the risk of complications from wild-type VZV illness greatly exceeds the risk of neonatal infection by vaccine-strain VZV. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received from a published article. BACKGROUND: Transmission of vaccine-strain varicella-zoster-virus (VZV) had rarely been documented, with only 10 published laboratory-confirmed cases, all of which occurred among close contacts of vaccine recipients who developed post-vaccination rash. The authors described a unique case of vaccine-strain varicella resulting from exposure to a vaccinated individual who reported no rash post vaccination. RESULTS: A 25-day-old healthy female infant developed varicella 22 days after her mother was vaccinated in the immediate postpartum period. The infant developed a vesicular rash with 50-60 lesions. She was afebrile, had no complications was not hospitalized, and recovered completely. Infection with vaccine-strain VZV was confirmed by strain-specific PCR of cutaneous lesions. Her mother had no post-vaccination symptoms, rash or itching. The infant had no known contact with other persons with rash (varicella or zoster) or recent varicella vaccination other than her mother. CONCLUSIONS: This was the first reported case of secondary transmission of vaccine-strain VZV from a vaccine recipient who developed no rash illness. Possible mechanisms for transmission included aerosolization of the vaccine during administration, transference of vaccine fluid from the mother's arm to the infant's mucosa immediately after vaccination, passage through break milk or transmission through maternal respiratory secretions. The possibility of rare transmission of vaccine-strain VZV to a neonate should not discourage post-partum vaccination programs as the risk of complications from wild-type VZV illness greatly exceeds the risk of neonatal infection by vaccine-strain VZV. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old male patient with depression, high cholesterol and no drug allergy. On 03-JUL-2012, the patient was vaccinated with ZOSTAVAX (lot #671780/0170AE, exp date 06-MAR-2013). No other co-suspects were reported. Concomitant medications included sertraline hydrochloride and Atorvastatin. On 04-JUL-2012, the patient developed a "red hard lump at the site of injection, that itched and burned. It was 2 inches by 3 inches in size. It looked like a rash." The patient had sought medical attention via came into the pharmacy. There was no treatment information for the event and no laboratory performed. At the time of report, the patient had not yet recovered. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old male patient with depression, high cholesterol and no drug allergy. On 03-JUL-2012, the patient was vaccinated with ZOSTAVAX (lot #671780/0170AE, exp date 06-MAR-2013). No other co-suspects were reported. Concomitant medications included sertraline hydrochloride and Atorvastatin. On 04-JUL-2012, the patient developed a "red hard lump at the site of injection, that itched and burned. It was 2 inches by 3 inches in size. It looked like a rash." The patient had sought medical attention via came into the pharmacy. There was no treatment information for the event and no laboratory performed. At the time of report, the patient had not yet recovered. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 66 year old female who on 09-MAY-2012 was vaccinated subcutaneously with ZOSTAVAX (Merck) (Lot #: 672868/0239AE). The pharmacist stated that on 09-MAY-2012 the patient experienced a 4 inch rash at the injection site with swelling. 50 mg BENADRYL had been given for AE. The patient did not seek medical attention. At the time of reporting, the patient was recovering. Follow up information was received from a registered pharmacist concerning 66 year old mother patient who on 09-MAY-2012 at p.m., was vaccinated with the first dose of ZOSTAVAX (lot #672868/0239AE) at pharmacy. It was reported that on 20-MAY-2012 at a.m., the patient experienced itching and redness extending beyond injection site by 4 inches all around. No serious illness noted from vaccine. At the time of the report, the patient's outcome regarding itching and redness extending beyond injection site by 4 inches all around was unknown. The patient did not seek medical attention. The relatedness for itching and redness extending beyond injection site by 4 inches all around was unknown for ZOSTAVAX. Additional information has been requested.
Age: 27.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a health care professional refers to a 27 years old patient. The patient was vaccinated with the third 0.5 ml dose of GARDASIL (Lot # not reported) IM. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot #669692/0615AA expiration date 02-JUL-2012) that was expired on 03-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The report was received from the same reporter with the other 3 cases, and their MARRS# are 1207USA003758, 1207USA003759, 1207USA003760, respectively. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Information has been received from a nurse (L.P.N) concerning her approximately 20 year old daughter with a history of bronchitis and without pregnant, concomitant medication or drug reactions/allergies, who in her 4, or 5, or 6 years old was vaccinated subcutaneously with a dose of 0.5 ml VARIVAX (Merck). It was reported that the patient developed chickenpox after receiving VARIVAX (Merck). The patient developed rash 2-3 years ago, in approximately 2009. The rash appeared on her back, chest, trunk, and face. BENADRYL was given for treatment. There was no lab diagnostics performed. The patient was recovered in 7 days after developing rash. The patient sought medical attention by seeing the physician. Follow up information has been received from a physician who indicated that this patient did not belong to the physician reported. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Pyrexia, Somnambulism, Vomiting
Clinical narrative: This spontaneous report as received from a 41 year old registered pharmacist reporting on herself, who on 29-JUN-2012 was vaccinated with two pediatric doses of RECOMBIVAX HB to equal one adult dose. No other co-suspects were reported. No concomitant medications were reported. The registered pharmacist stated that two hours after RECOMBIVAX HB was given on 29-JUN-2012, she began feeling extremely tired. She stated that she was so tired that she began to fall asleep driving as her eyes just kept closing. She also stated that she had a mild fever and vomited yesterday on 02-JUL-2012. Today, on 03-JUL-2012, she reported feeling light headed but had not vomiting and was not as tired as she had been. No treatment was given for the experience. At the time of the report, the registered pharmacist was recovering. The relatedness for began feeling extremely tired, feeling light headed, she had vomited and mild fever was unknown for RECOMBIVAX HB. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 669692/0615AA expiration date 02-JUL-2012) that was expired on 06-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The report was received from the same reporter with the 3 other cases, and their MARRS# are 1207USA002230, 1207USA003758, 1207USA003759, respectively. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 669692/0615AA expiration date 02-JUL-2012) that was expired on 05-JUL-2012. No adverse event reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. The reported was received from the same reporter with the other 3 cases, and their MARRS# are 1207USA002230, 1207USA003759, 1207USA003760, respectively. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with expired ZOSTAVAX (lot #: 669639/0613AA, exp date: 30-JUN-2012) on 03-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated in error with a dose of VARIVAX (Lot # not reported) SQ on 10-JUL-2012. No unknown adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a consumer refers to her daughter a female patient of unknown age with asthma. The patient was vaccinated with dose 1 and dose 2 GARDASIL on 06-JAN-2012 and 21-MAR-2012 respectively (Lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient did not received her second dose of GARDASIL "on schedule" because at the time the second dose was originally scheduled the patient experienced an exacerbation of a pre-existing condition of asthma. It was not known if the patient sought for medical attention. No treatment information was reported. The physician who was treating the patient determined that the patient's second dose should be postponed until her asthma exacerbation had subsided. The reported stated that her daughter was not experiencing an adverse effect of GARDASIL. The patient's present status was not reported. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling
Clinical narrative: This spontaneous report as received from an 82 years old female consumer reporting on herself, with no pertinent medical history and no known drug reactions/allergies. The patient was vaccinated with a dose of ZOSTAVAX in April 2011. No other co-suspects were reported. Concomitant medications included: DEXAMETHAZON. In May 2011 the patient experienced that her ankle began to swell and had been swollen since then. The patient sought unspecified medical attention. No treatment information was reported. The outcome of her ankle began to swell and has been swollen was reported as "NA" (also reported "has been swollen since then"). The relatedness for her ankle began to swell and has been swollen was unknown for ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vaginal ulceration
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 12 years old female patient. The patient had a history of low grade fever approximately 1 week before receiving the vaccine. On an unspecified date, the patient was vaccinated intramuscularly with dose 1, 0.5 ml GARDASIL (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that 2 weeks after receiving her first dose of GARDASIL, the patient developed a vaginal ulcer. The patient went to an unspecified ER, was seen and sent back to her primary physician. GARDASIL was discontinued. The outcome of vaginal ulcer was reported as recovered/resolved. No further information is available.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Lip swelling, Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse referred to a 15 years old female patient, with no known drug reactions/allergies and no other pertinent medical history. The patient was vaccinated with dose 1, of 0.5 ml GARDASIL (lot # 0022AC) on 06-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 07-JUL-2012 the patient experienced feeling hot and itching, 24 hours after onset of therapy. 48 hours later the patient experienced lips swelled up and and still itching. 72 hours later the patient still had hives. The patient contacted physician for medical attention. The patient was given BENADRYL by her mother, as a treatment for the AE. The outcome of itching, hives, lips swelled up and feeling hot was reported as recovering/resolving. The relatedness for feeling hot, hives, lips swelled up and itching was unknown for GARDASIL. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Vaccination failure
Clinical narrative: This spontaneous report as received from a consumer referred to her 19 years old daughter. the patient was vaccinated with the three shots of GARDASIL back in 2007. No other co-suspects were reported. No concomitant medications were reported. About a year and a half ago, in JAN-2011 the patient got human papillomavirus (HPV). The patient sought medical attention by an office visit. No treatment information was reported. The outcome of the patient was unknown. The relatedness for the patient's HPV was unknown for GARDASIL. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Fatigue, Injection site erythema
Clinical narrative: Information has been received from a doctor of pharmacy and a consumer concerning a 83 year old female patient with drug reactions or allergies to erythromycin, FELDENE, MOTRIN, FOSAMAX (WAES # 1205USA04952), CELEBREX and high blood pressure and high cholesterol who on 17-MAY-2012, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously (lot number 671662/1160AA, expiration date 18-OCT-2012). There was no concomitant medication. On 17-MAY-2012, since receiving ZOSTAVAX (Merck), the patient had been very tired, dragging and exhausted. The patient was so tired she had to cancel her plans for the day. The pharmacist also reported that the patient had injection site redness "the size of a half dollar". There was no treatment given for being very tired, dragging and exhausted and injection site redness "the size of a half dollar". At the time of the report the patient not recovered. The patient sought medical attention, called the pharmacy. Follow up information has been received from the physician concerning the patient. The physician reported that he prescribed but he did not administer the vaccine. The physician stated that he was not aware of any adverse effect. The patient had a history of swollen arm while on prior therapy with PNEUMOVAX 23 (manufacturer unknown) (WAES # 1205USA04951). No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from an office manager refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with, 0.65 ml ZOSTAVAX (lot# and route not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced hair falling out. "The patient's hair grew back but in patches", so the representative felt that this adverse event happened a while back go. The office manager thought that the patient had not sought medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information was received from a physician regarding a 69 year old female patient who 5 years ago "in 2007", was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not provided). The physician reported that the patient went back to her office last week "in June 2012" with shingles. The physician stated that the shingles were mild and the patient had no symptoms. At the time of the report, the patient recovered. The patient sought medical attention, by office visit of physician. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a licensed practice nurse concerning a 19 year old male patient with no pre-existing allergies and no medical conditions who on 09-JUN-2012 was vaccinated into left arm with a dose of GARDASIL (lot # 672834/0131AE). Concomitant therapy included a second dose of MENACTRA (lot # U3906AA, into left arm) given on the same day. No other concomitant therapy. On 09-JUN-2012 the patient fainted within 1 minute after administration with vaccine. Head and feet were elevated. Ice pack was applied. Ammonia inhalant was used to bring patient aware. Blood pressure was 100/60 and pulse was 60 at AM 8:55. Patient escorted to exam room and monitored with head and feet elevated for additional 20 minutes. Blood pressure was 112/73 at 9:15 AM, patient was examined by doctor. Then patient was OK to leave facility without complaints of discomfort. Patient stated he was OK. Patient called office when he arrived home. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 4 year old male patient who on 26-MAY-2009 was vaccinated SC with the first dose of VARIVAX (Merck) (Lot #: 662382/1758X). The physician reported that on 29-FEB-2012 the patient was diagnosed with shingles of the right leg. The patient was then treated by the primary physician. Treatment given for the event included ZOVIRAX 200 mg/5ml - 8 ml by mouth 4 times a day, and BENADRYL (unspecified dose). At the time of the report, the patient was recovering. Follow-up information has been received from a medical assistant refers to the patient. The patient was vaccinated with the first dose of (Merck) VARIVAX (lot number 662382/18758X) subcutaneous on 26-MAY-2009 and developed shingles after his 4 years old brother had chickenpox. The patient did have a second dose of (Merck) VARIVAX after his episode of shingles at unspecified time. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a pharmacist concerning an approximately 87 year old male who in June 2008 ("4 years ago"), was vaccinated with a ZOSTAVAX (Merck) (Lot#, dose and route not reported). In about 2011 ("about 1 year ago"), the patient experienced shingles. The patient sought medical attention by speaking to the physician. On an unknown date, the patient recovered from shingles. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Muscle twitching, Surgery
Clinical narrative: Information has been received from a 75 year old female consumer reporting on herself with a medical drug of ZOSTAVAX (lot # not provided) given in September 2011. On 07-MAR-2012, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not provided). The patient said she had experienced twitching since receiving the vaccine on 07-MAR-2012. The patient said she had "female" surgery on 15-MAR-2012 and thought the twitching may be from the surgery. The patient did not receive any treatment. At the time of the report, the patient was recovering. She did not seek medical attention. The relatedness for "female" surgery and twitching were unknown for PNEUMOVAX 23. Follow up information indicated that the patient did not received the ZOSTAVAX; it was just a clerical error. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (lot # 669405/1416Z expiration date 21-JAN-2012) subcutaneously on 10-JUL-2012. No known adverse effects were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 03-JUL-2012 the patient was vaccinated IM with a 0.5 ml dose of GARDASIL which was exposed to temperatures that they could not support. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug label confusion, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old female patient who on an unknown date was inadvertently vaccinated with VARIVAX (Merck) (dose, route and lot number not reported) instead of ZOSTAVAX (Merck). No adverse effect reported. Follow up information has been received from the pharmacist who stated that the patient received the VARIVAX vaccine (lot # 670801/0816AA) on 11-JUN-2012. The patient did not receive any other vaccines that day. The pharmacist stated that the patient had not experienced any adverse event at that time. The pharmacist stated that the wrong vaccine was administered due to the VARIVAX and ZOSTAVAX (Merck) vaccines having similar labels, both with the word "varicella". The pharmacist stated that the VARIVAX (Merck) and ZOSTAVAX (Merck) vaccine were stored in the same refrigerator and assessed through a Pyxis system. The Pyxis system allowed access to the VARIVAX (Merck) and ZOSTAVAX (Merck) vaccines at the same time. The pharmacist stated that the nurse who administered the vaccine saw "varicella" on the box of vaccines. The nurse failed to double check the label of the vaccine. The pharmacist stated that both the nurse and the patient had been notified that the wrong vaccine had been administered. The patient was asked to return 28 days from 11-JUN-2012 to be vaccinated with the ZOSTAVAX (Merck) vaccine. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site ulcer, Injection site warmth
Clinical narrative: This spontaneous report was received from a consumer reporting on his 68 years old with no medical history or drug reactions/allergies who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). There were no concomitant medications. On an unknown date, the patient developed an oozing red and hot sore at the injection site. No treatment was given for the events and no laboratory tests were performed. On an unknown date, the patient recovered from the events. The patient did not seek medical attention. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, Pneumonia
Clinical narrative: This spontaneous report as received from a 73 years old female patient without drug reactions or allergies. The pertinent history of the patient was "blood pressure and thyroid hormone". The patient was vaccinated by her physician with PNEUMOVAX 23 (lot number 643784/0676M: expire date 22-MAY-2004) (dosage, injection site and route were not reported) on 04-NOV-2005 "but it was expired and the expired date was 22-MAY-2004". No other co-suspects were reported. Concomitant medications were given but the patient declined the specified the names. On 09-JUN-2012 the patient was diagnosed with pneumonia. "The physician listed was the one who provided the vaccine but she no longer sees him". No laboratory diagnostics studies were performed. Treatment LEVAQUIN was given. The adverse event was improved on therapy. On 09-JUL-2012 the patient was recovered. The patient has sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant (MA) referred to a patient of unknown age. The patient was vaccinated with dose 1, 2, 3 and an extra 4 dose of GARDASIL on 29-JUN-2007, on 08-SEP-2008, on 30-APR-2012 and on 02-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. The patient experienced no known adverse effects. No treatment information was reported. The outcome of patient was unknown. The events were not related to GARDASIL. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Paraesthesia, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a 60 year old female pharmacy technician reporting on herself. The patent was vaccinated with a dose of ZOSTAVAX in January 2012 (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist technician stated she developed a rash around her ankles 1 day after she was given the vaccine. She saw a physician who started her on prednisone (manufacturer unknown) and the rash went away, but the rash had returned. The rash began on both legs around her ankles and was itchy, tingles and was stinging. Furthermore the rash had bumps which when she itched, they would break open and create a hole in her leg. The outcome of the events was reported as not recovered. The relatedness for the reported events was not reported for ZOSTAVAX. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a 30 year old female patient who on 24-FEB-2012, was vaccinated IM with 0.5 ml first dose of GARDASIL (lot # not reported). On 25-APR-2012, the patient was vaccinated IM with the second dose of GARDASIL (lot # not reported). On 03-JUL-2012, the patient was vaccinated IM in the left deltoid with the third dose of GARDASIL (lot # not reported). The nurse stated that the patient got her third dose of GARDASIL too early. No adverse effects were reported. No further information is available.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 74 years old male patient with diabetes, hypertension, hyperlipidemia and penicillin allergy. The patient was intramuscularly vaccinated on left arm with lot # (672673/0492AE), 0.5 ml PNEUMOVAX23 on 10-JUL-2012. Concomitant medications included METFORMIN, COLACE, ASPIRIN, PRILOSEC and ZOCOR. On 11-JUL-2012 the patient developed fever 101.9F, swelling, pain and redness. The patient called the office and was advised to apply ice compresses to the area of the reaction, to take antihistamines and TYLENOL. The outcome of redness, pain, fever and swelling was reported as not recovered/not recovered. No lab diagnostics study was performed. The nurse was requesting a lot check. This is one of several reports from the same source (MARRS#1207USA002940). Additional information has been requested.