chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Drug administered to patient of inappropriate age, Influenza
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of Influenza vaccine (unspecified), manufacturer unspecified), FLULAVAL. Concurrent medication included unspecified antibiotics. She had a medical history of rash on the face and neck. On an unspecified date in 2010 the subject received a dose of Influenza vaccine (unspecified, manufacturer unknown). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza. Outcome and attribution of the event to vaccination with Influenza vaccine was not known. On 31 August 2011 at 12:00 the 8 year old subject received a dose (dose 1 for 2011) of FLULAVAL at 0.5 ml in the left arm. This was the wrong vaccine for administration as FLULAVAL is not indicated for use in subjects under the age of 18. No additional details were provided. It was reported that this event occurred in three siblings. See linked sibling cases A0943409A and A0943422A.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 3 October 2011 the subject received a dose of FLUARIX (.5 ml, unknown route, left deltoid) at her place of work. On 4 October 2011, 1 day after vaccination with FLUARIX, the subject experienced a 3 inch area of swelling at injection site. The subject also experienced erythema. The subject was treated with cool compress (cold compress) and BENADRYL. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLUARIX. The healthcare professional commented that a similar reaction was observed in a "couple of patients". No details regarding any additional subjects was provided.
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site hives in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to Amoxicillin. On 25 September 2011 at 12:00 the subject received a dose of FLUARIX at 0.5 ml. On 26 September 2011, 1 day after vaccination with FLUARIX, the subject experienced injection site hives and injection site rash which progressed to generalized hives. The subject was treated with over the counter BENADRYL. The events were unresolved as of 27 September 2011.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia
Clinical narrative: This case was reported by a consumer (also the subject) and described the occurrence of sudden weakness in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received a dose of FLUARIX (details unknown). Immediately after vaccination with FLUARIX, the subject experienced sudden weakness. At the time of reporting the outcome of the event was unspecified. The consumer refused to provide any further information.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Contusion, Full blood count, Lip haemorrhage, Mouth haemorrhage, Platelet count decreased
Clinical narrative: Three days after ZOSTAVAX (shingle vaccine), life threatening drop in platelet count of less than 9K occurred. The only medication taken for 3 years prior to this event was simvastatin at 40mg. All data attached fully describes this episode. All this info is now sent to Merck National Svce Center, their reference SR#1-5391474323. The purpose of this writing is to confirm, assist and guide Merck team the opportunity to investigate any possible adverse reaction between ZOSTAVAX and simvastatin. It must be noted that the only medication taken for 3 years prior to the June 11, 2012 ZOSTAVAX injection was simvastatin. Three days after this injection, all the symptoms of thrombocytopenia developed (oral/lip bleeding and skin surface bruise marks) along with a life threatening drop in platelet count of less than 9K.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Thrombocytopenia
Clinical narrative: Three days after ZOSTAVAX (shingle vaccine), life threatening drop in platelet count of less than 9K occurred. The only medication taken for 3 years prior to this event was simvastatin at 40mg. All data attached fully describes this episode. All this info is now sent to Merck National Svce Center, their reference SR#1-5391474323. The purpose of this writing is to confirm, assist and guide Merck team the opportunity to investigate any possible adverse reaction between ZOSTAVAX and simvastatin. It must be noted that the only medication taken for 3 years prior to the June 11, 2012 ZOSTAVAX injection was simvastatin. Three days after this injection, all the symptoms of thrombocytopenia developed (oral/lip bleeding and skin surface bruise marks) along with a life threatening drop in platelet count of less than 9K.
Age: 77.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Platelet count decreased
Clinical narrative: Three days after ZOSTAVAX (shingle vaccine), life threatening drop in platelet count of less than 9K occurred. The only medication taken for 3 years prior to this event was simvastatin at 40mg. All data attached fully describes this episode. All this info is now sent to Merck National Svce Center, their reference SR#1-5391474323. The purpose of this writing is to confirm, assist and guide Merck team the opportunity to investigate any possible adverse reaction between ZOSTAVAX and simvastatin. It must be noted that the only medication taken for 3 years prior to the June 11, 2012 ZOSTAVAX injection was simvastatin. Three days after this injection, all the symptoms of thrombocytopenia developed (oral/lip bleeding and skin surface bruise marks) along with a life threatening drop in platelet count of less than 9K.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of unspecified patients who on unknown dates might have received improperly stored dose of M-M-R II (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports received from the same source. 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 a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and injection site were not known) on unspecified date 2 years ago, in August 2010. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient was "in the office now to receive 2 dose of GARDASIL which will be late." There were no symptoms reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Dyskinesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 16 years old female patient. The patient was vaccinated with dose 1 GARDASIL on 20-JUN-2012. Other suspect therapies included VARIVAX (Merck) on 20-JUN-2012. Concomitant medications included BOOSTRIX, HAVRIX and MENACTRA. On 20-JUN-2012 the patient experienced dyskinesia, 1 day after onset of therapy and dizziness. No treatment information was reported. The outcome of dyskinesia and dizziness is unknown. The relatedness for dizziness is unknown for GARDASIL. The relatedness for dyskinesia is unknown for VARIVAX (Merck) and GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of unspecified patients who on unknown dates might have received improperly stored dose of RECOMBIVAX HB (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified number of unspecified patients who on unknown dates might have received improperly stored dose of GARDASIL (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: This spontaneous report was received from a office manager concerning a 30 year old female consumer with no pertinent medical history or drug reactions/allergies who on 29-JUN-2012 was vaccinated with the first dose of VARIVAX (Merck), 0.5 mL, SQ left arm (lot # 0415AE, expiration date unknown). No other co-suspects were reported. No concomitant medications were reported. On 08-JUL-2012, the patient developed redness, itching and stiffness at the injection site. No laboratory tests were performed. No treatment was given for the events. At the time of the report, the patient had not recovered from the events. The patient sought medical attention called the office. The relatedness for stiffness, itching and redness at the injection site was unknown for VARIVAX (Merck). Additional information has been requested.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old male patient. The patient was vaccinated with a dose of ZOSTAVAX (lot # reported as "0257AE", exp date: 15-MAR-2012) on 24-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient came into the pharmacy on 02-AUG-2012 to report the adverse event. The patient developed rash and soreness at the injection site, unspecified, and fatigue. No treatment information was reported. The outcome of fatigue, soreness and rash at the injection site was reported as recovering/resolving. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Fatigue, Influenza, Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with sulfur allergies, who on 14-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not reported) lot # (671075/1197AA). Concomitant medications included DECAVAC administered on 15-JUL-2012. On 15-JUL-2012 the patient experienced small flat red rash, oval shaped at the injection site. The patient also had a lump under her arm on the right side, and experienced fatigue and flu symptoms and additional redness at the injection site. On 17-JUL-2012 the pharmacist reported that patient's lymph node, right armpit area, was swollen and the size of lymph node was as big as her hand. The treatment was given for events: ibuprofen and BENADRYL. No adverse event was reported regarding the DECAVAC. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with sulfur allergies, who on 14-JUL-2012 was vaccinated with a dose of ZOSTAVAX (dose and route not reported) lot # (671075/1197AA). Concomitant medications included DECAVAC administered on 15-JUL-2012. On 15-JUL-2012 the patient experienced small flat red rash, oval shaped at the injection site. The patient also had a lump under her arm on the right side, and experienced fatigue and flu symptoms and additional redness at the injection site. On 17-JUL-2012 the pharmacist reported that patient's lymph node, right armpit area, was swollen and the size of lymph node was as big as her hand. The treatment was given for events: ibuprofen and BENADRYL. No adverse event was reported regarding the DECAVAC. The outcome of the events was reported as not recovered/not resolved. 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 nurse (L.P.N.) refers to unspecified patients who were vaccinated with improperly stored RECOMBIVAX HB. It was reported that the first excursion occurred in May, 2011 where RECOMBIVAX HB were exposed to 31 F to 4 hours and the second excursion occurred on 29-MAY-2012 where RECOMBIVAX HB were exposed to 30F for 12 hours. No adverse effects reported. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 9 weeks old female patient. The patient was vaccinated intramuscularly in right deltoid with 0.5 ml PNEUMOVAX23 (lot number 0087AE, expire date 18-AUG-2013) instead of PREVNAR on 31-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. Pharmacist stated staff error only. No adverse effects reported at the reporting time. Pharmacist stated parents of the child have been contacted. Parent would bring child back in one month time for PREVNAR and for a follow up. This is one of several reports received from the same source. The adverse event for twin was captured in 1208USA002357. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 14 patients of unknown age. The nurse reported that 14 patients received a dose of VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect reported. It was unspecified if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous
Clinical narrative: Information has been received from a registered pharmacist concerning a 60 year old female patient with allergy to aspirin and IV dye and no pertinent medical history, who on 25-APR-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 1861AA expiration date 28-FEB-2013) SQ. Concomitant therapy included amitriptyline hydrochloride and PROZAC. The pharmacist reported that on 02-MAY-2012 the patient developed an injection site reaction after getting a dose of ZOSTAVAX (Merck). The reaction was raised and the redness was about the size of "50 cents" coin. The patient saw the pharmacist. No treatment was given for the adverse events. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from pharmacist refers to a 60 year old retired female patient with none illness at time of vaccination and none pre-existing allergies and medical conditions (previously reported that patient had allergy to aspirin and IV dye). It was reported that there was no reaction at time of vaccination. Several days later (date not reported) a red raised rash about the size of 50 C piece appeared. None lab diagnostic test were performed. It was reported that red raised rash went away after 3 days (date of recovery not reported). Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from 67 years old female diabetic consumer with no drug reactions or allergies reporting on herself. Consumer reported that on 26-JUL-2012, she was vaccinated with a one shot of ZOSTAVAX 0.65ml, subcutaneously (lot number not reported). No other co-suspects were reported. Concomitant medications included metformin, LIPITOR and DIOVAN. Consumer reported that on 26-JUL-2012, she had redness at the injection site which was getting better every day. No treatment was given for the patient's event. No lab diagnostics studies were performed. Consumer did not seek medical attention. Consumer reported that she received the vaccine in the drug store and said that "outsourced" clinician gave her the shot (no details provided). At the time of report, the outcome of the patient's event was reported as recovering/resolving. The relatedness for the patient's event was not reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to 10 patients of unknown age. The patients were vaccinated with ZOSTAVAX (lot#not provide). No other co-suspects were reported. No concomitant medications were reported. The physician stated that since December 2011 to 23-JUL-2012, there had been 10 patients who received ZOSTAVAX stored between -3C to 1C. Physician was still doing research to determine length of time ZOSTAVAX were stored this way before given to patients. The patients were not experiencing any known symptoms. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to very few patients of unknown age. The patients were vaccinated with VARIVAX (merck) (lot#not provide). No other co-suspects were reported. No concomitant medications were reported. The physician stated that since September 2009 to November 2011, there had been very few patients who received VARIVAX (merck) stored between -3C to 1C. Physician was still doing research to determine length of time VARIVAX (merck) were stored this way before given to patients. The patients were not experiencing any known symptoms. No treatment information was reported. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. The patients were vaccinated with ZOSTAVAX (lot# not provide). No other co-suspects were reported. No concomitant medications were reported. The physician stated that since September 2009 to November 2011, there had been an unknown number of patients who received ZOSTAVAX stored between -3C to 1C. Physician was still doing research to determine length of time ZOSTAVAX were stored this way before given to patients. The patients were not experiencing any known symptoms. This is one of several reports received from the same source. 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 an other health professional refers to unknown number of unknown age. The patients were vaccinated with GARDASIL (lot number not reported) which was stored as low as 24F on multiple occasions. No adverse effect reported. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. All telephone attempts to obtain follow-up information have been unsuccessful.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear infection
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old male patient with no drug reactions/allergies, who on 19-JUN-2012 was vaccinated with a dose of ZOSTAVAX 0.65mL, S.Q. in his left arm (lot number 672559/1657AA). Concomitant therapy included unspecified blood pressure medication and simvastatin (manufacturer unspecified). The reporter stated that the patient who received ZOSTAVAX had an ear infection. The treatment was given for an AE: prednisone. The patient sought medical attention - office visit. At the time of the report the patient's outcome was not recovered. Follow up information has been received from pharmacist refers to a 82 year male patient who on 19-JUN-2012 was vaccinated subcutaneously with a second dose of ZOSTAVAX (dose not reported, Lot # 672559/1657AA). It was reported that on 21-JUN-2012 patient developed ear infection. The patient received prednisone 20 mg for 9 days, for adverse event treatment. 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 registered nurse (R.N) refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot # not reported) on an unspecified date in September 2011 and the second dose of GARDASIL (lot # not reported) on 02-AUG-2012. No adverse effect reported. Whether the patient sought medical attention was not reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (0.5 ml) (lot number, injection site were not reported) intramuscular in July 2011. No other co-suspects were reported. No concomitant medications were reported. On 02-AUG-2012 the patient was "in office today to receive second dose of GARDASIL". There was no adverse event reported. The outcome was unknown at the time of report. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy cervix abnormal, Cervical conisation, Dysplasia, High risk sexual behaviour, Papilloma viral infection
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with morphine allergy and history of sinusitis, tonsillitis and gall bladder removed who was vaccinated with three 0.5 ml doses of GARDASIL on 0/2/6 months respectively. There was no concomitant medication. In summer of 2010, when the patient had a pap smear, it was found that she had dysplasia. She returned for cone removal and found to have HPV 16/18. The patient has all 3 shots and they wait and see if she would clean the virus. She also didn't use condoms. There were labs diagnostics studies performed. Unspecified treatments were given to the patient for AE and she was being closely monitored. It was also reported that GARDASIL was discontinued and was not reintroduced. At the time of reporting, the patient had not recovered. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse refers to the 17 years old female patient. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot # 654389/0961F, route unspecified) on 17-JAN-2006, second dose (0.5 ml, lot #0243G, route unspecified) on 19-MAR-2007 and third dose (0.5 ml, lot #, route unspecified) on 17-JUL-2007. The patient had a "cone biopsy" of her cervix, and the results were pending. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter with morphine allergy and history of sinusitis, tonsillitis and gall bladder removed who was vaccinated with three 0.5 ml doses of GARDASIL on 0/2/6 months respectively. There was no concomitant medication. In summer of 2010, when the patient had a pap smear, it was found that she had dysplasia. She returned for cone removal and found to have HPV 16/18. The patient has all 3 shots and they wait and see if she would clean the virus. She also didn't use condoms. There were labs diagnostics studies performed. Unspecified treatments were given to the patient for AE and she was being closely monitored. It was also reported that GARDASIL was discontinued and was not reintroduced. At the time of reporting, the patient had not recovered. The patient had sought unspecified medical attention. Follow-up information has been received from a registered nurse refers to the 17 years old female patient. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot # 654389/0961F, route unspecified) on 17-JAN-2006, second dose (0.5 ml, lot #0243G, route unspecified) on 19-MAR-2007 and third dose (0.5 ml, lot #, route unspecified) on 17-JUL-2007. The patient had a "cone biopsy" of her cervix, and the results were pending. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 months old male patient with no pertinent medical history. The patient was vaccinated with a dose of VARIVAX (merck) on 05-JUN-2012 (Lot# reported as 0262AE, dose and route not reported). Other suspect therapies included M-M-R II and VAQTA. Concomitant medications included: PREVNAR 13. On 11-JUL-2012 the patient developed less than 50 vesicular rashes on legs, trunk and arms. The patient had no fever. The patient saw a physician for medical attention. No lab diagnostics studies were performed. No treatment was given. At the time of this report the patient was recovering. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash pustular, Rash vesicular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 16 year old patient who on 17-MAY-2004 was vaccinated with the first dose of VARIVAX (Merck) (lot# unspecified). On 28-SEP-2007 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 654807/1066F). The nurse mentioned that on 01-FEB-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 16 year old male patient with anemia and no illness at time of vaccination who on 17-MAY-2004, was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). On 28-SEP-2007 at 18:30, the patient was vaccinated IM in the left arm with the second dose of VARIVAX (Merck) (lot# 654807/1066F). The nurse reported that the patient went to the clinic on 01-FEB-2012, with a rash described as "vesicular, with very few pustules, erythematic, non confluent, asymmetrical, irregular with no swelling", diagnosed with varicella. At the time of the report, the patient's outcome was unknown. The patient did not have testing done. A lot check has been initiated. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient who in February 2012, was vaccinated with her first dose of 0.5 ml GARDASIL (route, lot # not reported). On 14-MAY-2012, the patient was vaccinated with her second dose of 0.5 ml GARDASIL (route, lot # not reported). Concomitant therapy included SEASONIQUE. On 14-MAY-2012 ("the evening after receiving the second dose") the patient experienced fainting when she got to work and became nauseous, feverish and light-headed upon recovering from the faint. The next day she continued to experience light-headedness and dizziness. The patient had sought medical attention by calling the office. No treatment was given to the patient. At the time of the report, the events improved but the reporter was unsure if the patient would receive the third vaccination. Follow-up information was received from physician's office worker refers to a 23 years old female patient with Human papillomavirus (HPV) who was stressed at the time of vaccination. On 14-MAY-2012 at 10:15 AM, the patient was vaccinated with the second dose of GARDASIL, lot number 670049/1171AA, 0.5ml, intramuscularly in left deltoid. No other co-suspects were reported. On 14-MAY-2012 at 12:00 PM, the patient experienced light-headed, dizziness, feverish, nauseous, fainting. It was reported that the patient stated on 11-JUN-2012, after the injection, she felt tired, later at work she passed out (which the nurse felt was the same as the patient "fainted"). She went home and was dizzy. light-headed and nauseous, also stated she had a fever. It was reported that the patient had no symptoms after this event. The patient's outcome was recovered on 14-MAY-2012. The patient did not seek medical attention/intervention. The relatedness that patient's adverse events was not reported for GARDASIL. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a nurse concerning a 23 year old female patient who in February 2012, was vaccinated with her first dose of 0.5 ml GARDASIL (route, lot # not reported). On 14-MAY-2012, the patient was vaccinated with her second dose of 0.5 ml GARDASIL (route, lot # not reported). Concomitant therapy included SEASONIQUE. On 14-MAY-2012 ("the evening after receiving the second dose") the patient experienced fainting when she got to work and became nauseous, feverish and light-headed upon recovering from the faint. The next day she continued to experience light-headedness and dizziness. The patient had sought medical attention by calling the office. No treatment was given to the patient. At the time of the report, the events improved but the reporter was unsure if the patient would receive the third vaccination. Follow-up information was received from physician's office worker refers to a 23 years old female patient with Human papillomavirus (HPV) who was stressed at the time of vaccination. On 14-MAY-2012 at 10:15 AM, the patient was vaccinated with the second dose of GARDASIL, lot number 670049/1171AA, 0.5ml, intramuscularly in left deltoid. No other co-suspects were reported. On 14-MAY-2012 at 12:00 PM, the patient experienced light-headed, dizziness, feverish, nauseous, fainting. It was reported that the patient stated on 11-JUN-2012, after the injection, she felt tired, later at work she passed out (which the nurse felt was the same as the patient "fainted"). She went home and was dizzy. light-headed and nauseous, also stated she had a fever. It was reported that the patient had no symptoms after this event. The patient's outcome was recovered on 14-MAY-2012. The patient did not seek medical attention/intervention. The relatedness that patient's adverse events was not reported for GARDASIL. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 06-APR-2009, was vaccinated with the first dose GARDASIL and today, on 26-JUL-2012, was in the office to receive the second dose of GARDASIL (doses, routes and lot numbers not reported). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a consumer (who is a physician) refers to his 18 years old son with no pertinent medical history and no known drug reactions or allergies, who on 21-JUL-2012, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 25-JUL-2012, his son developed a fever (unspecified) and congestion, along with a runny nose. TYLENOL was given as a treatment for the experience. The consumer reported that today, on 26-JUL-2012, his son was still febrile and congested. At the time of the report the outcome of the patient was not recovered. The patient sought medical attention by consulting his father. The relatedness for patient developed fever, runny nose congestion was unknown for GARDASIL. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a currently 33 years old female patient. The patient was vaccinated with a dose of MMR-II (lot #, dose an route not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date, the patient broke out in hives following vaccination with a dose of MMR-II in early childhood. No treatment information was reported. At the time of the report, the patient's outcome was unknown. It was unspecified if the patient sought medical attention. The relatedness for broke out in hives was unknown for MMR-II. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was accidentally vaccinated with a dose of VARIVAX (lot number not provided) subcutaneous instead of ZOSTAVAX on 02-AUG-2012 by the physician's nurse. No other co-suspects were reported. No concomitant medications were reported. No by the physician's nurse. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought medical attention. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 months old female patient. The patient was vaccinated intramuscularly into the right deltoid with 0.5 ml PNEUMOVAX 23 (lot number 0087AE, expiration date 18-AUG-2013) on 31-JUL-2012. No other co-suspects or concomitant medications were reported. On 31-JUL-2012 the patient was inadvertently vaccinated with PNEUMOVAX 23 instead of PREVNAR. No adverse effects reported at the time of report. Pharmacist stated parents of the child had been contacted. Parents would bring child back in one month for the PREVNAR and for a follow up. The patient's sibling case was captured in MARRS# 1208USA002354. Additional information has been requested.
Sex: U
Vaccine: MMR
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 age. The nurse stated that on an unknown date, the patient was vaccinated SC with was 0.5 ml M-M-R II (lot# not provided) two weeks early. Nurse was not sure exactly when the first dose was given, but was sure the second dose was give too early. No other co-suspects were reported. No concomitant medications were reported. The patient did not sought medical attention. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to 3 patients. The patient were vaccinated with PNEUMOVAX23 (lot number 0491AE, expiration date 15-SEP-2013) (route, site, dose not reported) and had the following injection site reactions: redness of the arm, pain at the injection site extended down to the elbow and tenderness. This occurred over the last 2 weeks approximately in July 2012 with same lot 0491AE, expiration date 15-SEP-2013. Pharmacist would like a lot check for lot 0491AE, expiration date 15-SEP-2013. The patients had sought unspecified medical attention. No treatment information was reported. The outcome was unknown. Lot number 0491AE is an invalid lot number for PNEUMOVAX23. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 13 month old patient who on 27-APR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 670169/1574AA). The nurse mentioned that on 04-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of several reports from the same source. A lot check has been initiated. This is one of the same reporter link. The F/U information has been received from a physician refers to a 13 months old male patient with a weight 24 lbs and height 30 in, no sibling information reported, no pre-existing allergies, birthday defects and medical conditions were reported. The patient was subcutaneously vaccinated with lot # (670169/1574AA) dose 1 VARIVAX (merck) at right leg on 27-APR-2012. On 04-JUN-2012 the patient "to clinic with a rash described as'across upper back and upper chest are multiple erythematous areas with small clear vesicles, some died lesions are noted on the upper extremities". Diagnosed with Chickenpox, no testing was done, no illness at the time of vaccination. The outcome of patient had outbreaks of varicella was reported as recover/resolved, on 28-Jun-2012 as"no rash noted". Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 78 years old female patient. The patient was vaccinated with ZOSTAVAX (Lot#, dose number, dose and route were unspecified) on 07-DEC-2007. No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date the patient showed up at the physicians office with shingles even though the patient received the vaccine in 2007. The patient had a rash around her waist area and no pain issues. The patient had sought medical attention via visiting physician office. No treatment was given for the AE. The outcome was reported as not recovered/not resolved. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report has been received from a physician refers to a 67 years old female patient with hypertension. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX on an unspecified day in 2009. Concomitant medications included Hypertension medications. On approximately 20-JUL-2012 (reported as this past weekend) the patient experienced shingles. The patient sought medical attention and antiviral was given for the treatment of shingles. There was no lab diagnostic study was performed. The outcome of shingles was reported as not recovered/not resolved. Additional information is not available.
Age: 59.0
Sex: F
Vaccine: DTAP, PPV, VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 years old female patient with blood pressure abnormal. The patient's medical history included shingles. The patient was vaccinated with 0.65 ml ZOSTAVAX (subcutaneous in the right arm, Lot# and duration were unspecified) on 18-JUL-2012. Secondary suspect therapies included PNEUMOVAX23 (subcutaneous in the left arm, 0.5ml, Lot# and duration were unspecified) on 18-JUL-2012. Concomitant medications included: DTAP, unspecified pressure medication and other medications(specific names are unknown). It was reported that the patient received ZOSTAVAX in the right arm at the physician's office and experienced a rash at the injection site that was the size of a hand and it was really red and inflamed. It also reported that the patient had an outbreak if shingles 1 and 1/2 years ago in the brain. The patient had sought medical attention via pharmacy visit. No lab diagnostics studies performed. No treatment was given for the AE. The outcome was reported as recovering/resolving. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and a healthcare worker refers to a female patient of unknown age. The patient was vaccinated with dose 1, dose 2 and dose 3 GARDASIL (lot # 673256/0629AE, exp date 16-DEC-2014, reported by a healthcare worker) on 20-JAN-2012, 24-MAY-2012 and 20-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. This is one of two reports concerning a couple of twin sisters received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 02-AUG-2012, the patient was vaccinated with expired MMR II (lot #667735/1202AA, expire date 19-May-2012) as the first dose. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Balance disorder, Blood test normal, CSF test normal, Computerised tomogram normal, Gait disturbance
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  An unknown aged female patient with ingrown toenail at time of vaccination and amoxicillin allergy vaccinated intramuscularly into right arm with the second dose of GARDASIL (lot # 668261/1397AA) on an unknown date. Four days post vaccination with GARDASIL, the patient developed status migrainosus, subsequent muscle rigidity, visual disturbance, balance/gait disturbance, diffuse muscle pain. There was CSF (-) for infection, blood work and CT/MRI (-) performed. No further information is available. The original reporting source was not provided. The VAERS ID # is 451251-1.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Muscle rigidity, Myalgia, Nuclear magnetic resonance imaging normal, Status migrainosus, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act.  An unknown aged female patient with ingrown toenail at time of vaccination and amoxicillin allergy vaccinated intramuscularly into right arm with the second dose of GARDASIL (lot # 668261/1397AA) on an unknown date. Four days post vaccination with GARDASIL, the patient developed status migrainosus, subsequent muscle rigidity, visual disturbance, balance/gait disturbance, diffuse muscle pain. There was CSF (-) for infection, blood work and CT/MRI (-) performed. No further information is available. The original reporting source was not provided. The VAERS ID # is 451251-1.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Fall, Musculoskeletal stiffness, Skin discolouration, Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female patient with no pre-existing illness was vaccinated IM into the left leg with the first dose of GARDASIL (lot # (671994/1537AA) and expiration date 21-JUN-2012 00:00) on 23-MAR-2012. Concomitant medications included: ADACEL (lot # U4088AA, sanofi pasteur) and MENVEO (lot#A10132, novartis vaccines and diagnostics). On 23-MAR-2012 the patient fainted and fell to the ground. Was slightly stiff upper extremities, dusky in color, episode lasted <2 minutes. 911 called patient sent to local E.R. Vomiting *1. No treatment information was reported. The outcome of adverse events were unknown. The original reporting source was not provided. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Fall, Musculoskeletal stiffness, Skin discolouration, Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old female patient with no pre-existing illness was vaccinated IM into the left leg with the first dose of GARDASIL (lot # (671994/1537AA) and expiration date 21-JUN-2014 00:00) on 23-MAR-2012. Concomitant medications included: ADACEL (lot # U4088AA, sanofi pasteur) and MENVEO (lot #A10132, novartis vaccines and diagnostics). On 23-MAR-2012 the patient fainted and fell to the ground. Was slightly stiff in upper extremities, dusky in color, episode lasted <2 minutes. 911 called patient sent to local E.R. Vomiting*1. No treatment information was reported. The outcome of adverse events were unknown. The original reporting source was not provided. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 14 years old female patient was vaccinated IM into left arm with first dose of GARDASIL (lot # 668261/1397AA, expired date 09-APR-2013) on 19-MAR-2012. No other co-suspects were reported. No concomitant medications were reported. On 20-MAR-2012 the patient experienced rash and hives 12-24 hours after vaccination. The patient was treated with antihistamines. At the time of the report, the outcome of the patient was unknown. This report was considered not serious, no conditions by the agency. The original reporting source was not provided. The VAERS ID # is 452545-1. No further information is available.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 11 years old male patient treated intramuscularly into right arm with the first dose of GARDASIL (lot #: 668819/0477AA) on 23-MAR-2012. Concomitant medications included BOOSTRIX, MENACTRA, HAVRIX, CLARITIN and FLOVENT. The patient experienced syncope about 2 minutes after administration of vaccines. At time of the report, the patient's outcome was unknown. No further information is available. The original reporting source was not provided. The VAERS ID # is 452574-1.