chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral candidiasis, Ultrasound Doppler, Ultrasound Doppler normal, Vaccination complication, Vision blurred
Clinical narrative: The first reaction was to the site of injection, which I understand is common to be red, but 3 or 4 days my under arm was swollen almost to my elbow. The pharmacist said it should subside usually around 5 days. The reaction to my arm did subside around 10-19-13. On 10-20, 10-21-13 I started having problems with numbness of my tongue, mouth, upper and lower lips, and facial numbness around my chin. I saw my PCP on 10-24-13, the only thing he could see was a few patches on the back of my tongue which resembled thrush, so he gave me a prescription for lozengers. I went back to him on 11-1-13, the patches were gone, but I still had all of the numbness, plus he noticed I was having an issue with my eye focusing looking to the left. So he ordered an MRI of the brain to rule out a stroke, and also an ultrasound of my carotid arteries on 11-06-13. MRI showed no strokes and ultrasound was good. So he recommended seeing a neurologist for a second opinion. I saw a neurologist on 11-18-13, she ordered a LP to rule out MS, but before the procedure could be done all my symptoms subsided, and I have not had any more symptoms. I had a follow up visit with my neurologist on 12-11-13, and in her medical opinion she believes that I had an adverse reaction to the ZOSTAVAX vaccine.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 25-NOV-2013, the patient was vaccinated in the upper right arm with the first dose of PNEUMOVAX 23 (dose, strength and lot # were not provided). There was no concomitant medication reported. Pharmacist stated post vaccination with PNEUMOVAX 23, the patient developed swelling of the right arm that extended down to her right elbow (approximately in the 2013). Patient's present status was reported as "fine now". There was not treatment given to the patient. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse, for GARDASIL, a Pregnancy Registry product, with no drug allergy and no pertinent medical history concerning a 16 year old female patient with no who on 28-OCT-2011 and 19-JAN-2012 was vaccinated IM with her first and second dose of 0.5 ml GARDASIL (both lot # not reported) at another facility, respectively. On 19-JUN-2012, the patient was vaccinated with the third dose (lot # 667194/1271Z, expiration date 11-DEC-2012). There was no concomitant medication. Subsequently the patient took a home pregnancy test which showed that she was approximately 7 weeks pregnant. Her last menstrual period (LMP) was approximately on 09-MAY-2012, and estimated delivery date (EDD) was on 13-FEB-2013. The patient had sought medical attention by contacting the physician(method unknown). All telephone attempts to obtain follow-up information have been unsuccessful. Three attempts were made for pregnancy outcome with no response (2 phone calls and 1 fax). The case is lost to follow up. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pallor, Local swelling
Clinical narrative: This spontaneous report as received from a other health professional refers to a 67 year old female patient. On 04-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 (lot # J009833, expiration date: 25-JAN-2015), 0.5 ml, intramuscular in the left arm for vaccination. On 04-DEC-2013, the patient experienced swollen left arm, white colored at the injection site, and red around the edges of the injection site. The patient sought medical attention in the office doctor. The patient received treatment over the counter with oral BENADRYL (manufacturer unknown). The reporter stated that the patient's arm was still swollen but "going down" she was on the mend, and feeling good. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. The medical assistant reported that GARDASIL (MARRS# 1312USA002103), PNEUMOVAX 23, RECOMBIVAX (MARRS# 1312USA005448), and VAQTA (MARRS# 1312USA005449) were improperly stored. On unknown date unspecified patients vaccined with improperly stored RECOMBIVAX. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of four cases from the same reporter. Additional information has been requested. This is correction information. The LLT and PT of the primary event was recorded to Incorrect storage of drug.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. The medical assistant reported that GARDASIL, PNEUMOVAX23 (MARRS# 1312USA005447), RECOMBIVAX (MARRS# 1312USA005448) and VAQTA (MARRS# 1312USA005449) were improperly stored. On unknown date unspecified patients vaccinated with improperly stored GARDASIL. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of four cases from the same reporter. Additional information has been requested. This is correction information. The LLT and PT of the primary event was recoded to incorrect storage of drug.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. The medical assistant reported that GARDASIL (MARRS# 1312USA002103), PNEUMOVAX 23 (MARRS# 1312USA005447), RECOMBIVAX (MARRS# 1312USA005448) and VAQTA were improperly stored. On unknown date unspecified patients vaccined with improperly stored RECOMBIVAX. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of four cases from the same reporter. Additional information has been requested. This is correction information. The LLT and PT of the primary event was recorded to Incorrect storage of drug.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age. The medical assistant reported that GARDASIL (MARRS# 1312USA002103), PNEUMOVAX 23 (MARRS# 1312USA005447), RECOMBIVAX and VAQTA (MARRS# 1312USA005449) were improperly stored. On unknown date unspecified patients vaccined with improperly stored RECOMBIVAX. No adverse effects reported. It was unknown if the patient had sought medical attention. This is one of four cases from the same reporter. Additional information has been requested. This is correction information. The LLT and PT of the primary event was recorded to Incorrect storage of drug.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Grand mal convulsion
Clinical narrative: Case number PHHY2013US127889 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 500814) web site on 11 Nov 2013, with a follow up received from the Quality Assurance (QA ref: 263765) department on 04 Dec 2013. This report refers to an 18-year-old male patient. His medical history included attention deficit disorder (ADD) and seizures and concomitant medications were CONCERTA and LAMICTAL. He was vaccinated with MENVEO (batch number: M12093, expiry date: Apr 2014) and GARDASIL (other manufacturer, batch number: H021608); both vaccines administered in the left arm on 26 Jul 2013. On 28 Jul 2013, he had a two and a half minute grand mal seizure. He was at home and remained there. He consulted a neurologist and it was reported that the neurologist reported that the event was because of human papilloma virus vaccine. The outcome of the events was reported as complete recovery as of 26 Aug 2013. Based on the batch review, it was stated that the concerned MENVEO batch number M12093 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up received from the QA department on 04 Dec 2013: Updated Batch report.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Local swelling
Clinical narrative: Inflamed. Swelling. Pain. Antibiotics taken. Arm hurts when raising. Went to doctor on 4th day.
Age: 83.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Inflammation, Pain, Pain in extremity, Swelling
Clinical narrative: Inflamed. Swelling. Pain. Antibiotics taken. Arm hurts when raising. Went to doctor on 4th day.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Malaise
Clinical narrative: Fever, chills, vomiting.
Age: 71.0
Sex: M
Vaccine: FLU3, FLU3, FLU3
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: CSF protein increased, Gait disturbance, Headache, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Numbness of the toes and.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pain in jaw, Paraesthesia
Clinical narrative: Numbness of the toes and.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Ataxia, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Dysarthria
Clinical narrative: Numbness of the toes and.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Fatigue, Gait disturbance, Muscular weakness, Myalgia, Nuclear magnetic resonance imaging brain
Clinical narrative: Numbness of the toes and.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Nuclear magnetic resonance imaging spinal, Paraesthesia, Red blood cells CSF positive
Clinical narrative: Numbness of the toes and.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, FLU3, MNQ, FLU3, MEN
Symptoms: Blood test, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal, Nuclear magnetic resonance imaging
Clinical narrative: Numbness of the toes and.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Dizziness, Erythema, Local swelling, Poor quality sleep, Tenderness
Clinical narrative: On 11/21/2013 Thursday even. didn't feel well after shots. Friday morn. 11/22/2013 called into work feeling nauseous, dizzy, disoriented, loss of appetite (didn't go to work) at that time noticed extreme discomfort of swollen, inflamed, hard bumpy areas - radiating into (L) side of trunk and shoulder (under armpit). On Friday stayed home couldn't drive (I was out of it), skin on lips were peeling, (felt fever) on 11/23/13 Sat. called Dr. twice, I explained what I was experiencing and asked if I had streaks down my arm (I said no) and if I had swollen lips (I said no) and he said take ADVIL. I didn't have ADVIL I took ibuprofen instead. Dr. said ice your (L) arm. I said I couldn't lift my arm. I asked is there something that can reverse this reaction or do I just wait it out? And he said yes - wait it out, there's nothing I can do. Dr, the on call doctor said good luck. I was looking for help because I was so sick. I felt I was really in trouble when he said good luck. On 11/24/2013 - Sun I still wasn't feeling out of the woods, not feeling myself, not back to normal - like I was in a fog - didn't attend church in morning. Didn't go to work Mon. 11/25/2013 - still wasn't feeling on top of everything so they said at work that they really didn't need me - you can take it off if you want. Today - Dec. 9, 2013 - Mon, I've noticed I've lost appetite and have lost about 10 lbs. Now - will follow-up with primary doctor before anymore shots. Dr. did say not to have anymore shots and to make sure my vaccine records are updated.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Decreased appetite, Discomfort, Disorientation, Dizziness, Feeling abnormal
Clinical narrative: On 11/21/2013 Thursday even. didn't feel well after shots. Friday morn. 11/22/2013 called into work feeling nauseous, dizzy, disoriented, loss of appetite (didn't go to work) at that time noticed extreme discomfort of swollen, inflamed, hard bumpy areas - radiating into (L) side of trunk and shoulder (under armpit). On Friday stayed home couldn't drive (I was out of it), skin on lips were peeling, (felt fever) on 11/23/13 Sat. called Dr. twice, I explained what I was experiencing and asked if I had streaks down my arm (I said no) and if I had swollen lips (I said no) and he said take ADVIL. I didn't have ADVIL I took ibuprofen instead. Dr. said ice your (L) arm. I said I couldn't lift my arm. I asked is there something that can reverse this reaction or do I just wait it out? And he said yes - wait it out, there's nothing I can do. Dr, the on call doctor said good luck. I was looking for help because I was so sick. I felt I was really in trouble when he said good luck. On 11/24/2013 - Sun I still wasn't feeling out of the woods, not feeling myself, not back to normal - like I was in a fog - didn't attend church in morning. Didn't go to work Mon. 11/25/2013 - still wasn't feeling on top of everything so they said at work that they really didn't need me - you can take it off if you want. Today - Dec. 9, 2013 - Mon, I've noticed I've lost appetite and have lost about 10 lbs. Now - will follow-up with primary doctor before anymore shots. Dr. did say not to have anymore shots and to make sure my vaccine records are updated.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Impaired driving ability, Induration, Lip exfoliation, Local swelling, Mobility decreased
Clinical narrative: On 11/21/2013 Thursday even. didn't feel well after shots. Friday morn. 11/22/2013 called into work feeling nauseous, dizzy, disoriented, loss of appetite (didn't go to work) at that time noticed extreme discomfort of swollen, inflamed, hard bumpy areas - radiating into (L) side of trunk and shoulder (under armpit). On Friday stayed home couldn't drive (I was out of it), skin on lips were peeling, (felt fever) on 11/23/13 Sat. called Dr. twice, I explained what I was experiencing and asked if I had streaks down my arm (I said no) and if I had swollen lips (I said no) and he said take ADVIL. I didn't have ADVIL I took ibuprofen instead. Dr. said ice your (L) arm. I said I couldn't lift my arm. I asked is there something that can reverse this reaction or do I just wait it out? And he said yes - wait it out, there's nothing I can do. Dr, the on call doctor said good luck. I was looking for help because I was so sick. I felt I was really in trouble when he said good luck. On 11/24/2013 - Sun I still wasn't feeling out of the woods, not feeling myself, not back to normal - like I was in a fog - didn't attend church in morning. Didn't go to work Mon. 11/25/2013 - still wasn't feeling on top of everything so they said at work that they really didn't need me - you can take it off if you want. Today - Dec. 9, 2013 - Mon, I've noticed I've lost appetite and have lost about 10 lbs. Now - will follow-up with primary doctor before anymore shots. Dr. did say not to have anymore shots and to make sure my vaccine records are updated.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Nausea, Pyrexia, Weight decreased
Clinical narrative: On 11/21/2013 Thursday even. didn't feel well after shots. Friday morn. 11/22/2013 called into work feeling nauseous, dizzy, disoriented, loss of appetite (didn't go to work) at that time noticed extreme discomfort of swollen, inflamed, hard bumpy areas - radiating into (L) side of trunk and shoulder (under armpit). On Friday stayed home couldn't drive (I was out of it), skin on lips were peeling, (felt fever) on 11/23/13 Sat. called Dr. twice, I explained what I was experiencing and asked if I had streaks down my arm (I said no) and if I had swollen lips (I said no) and he said take ADVIL. I didn't have ADVIL I took ibuprofen instead. Dr. said ice your (L) arm. I said I couldn't lift my arm. I asked is there something that can reverse this reaction or do I just wait it out? And he said yes - wait it out, there's nothing I can do. Dr, the on call doctor said good luck. I was looking for help because I was so sick. I felt I was really in trouble when he said good luck. On 11/24/2013 - Sun I still wasn't feeling out of the woods, not feeling myself, not back to normal - like I was in a fog - didn't attend church in morning. Didn't go to work Mon. 11/25/2013 - still wasn't feeling on top of everything so they said at work that they really didn't need me - you can take it off if you want. Today - Dec. 9, 2013 - Mon, I've noticed I've lost appetite and have lost about 10 lbs. Now - will follow-up with primary doctor before anymore shots. Dr. did say not to have anymore shots and to make sure my vaccine records are updated.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: This spontaneous report refers to a 68 year old male patient. There is no pertinent medical history or drug allergies/reaction. On 12-OCT-2013 the patient was vaccinated with ZOSTAVAX, dose 0.65 milliliters, subcutaneous. Concomitant medication included unspecified diabetes medication. Lot number and expiry date were unknown. On 18-OCT-2013, the patient had a break out in hives on all parts of his body excluding his back, starting on his fingers. There were red welts that itched. The hives on his neck were the most severe. The outcome of events was reported as not resolved. Treatment given for events was unspecified generic antihistamine pill, unspecified hydrocortisone cream. Lab diagnostic studies performed with chem. 20 blood work, result was unknown. The patient had sought medical attention via phone call. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Laboratory test, Pruritus, Urticaria
Clinical narrative: This spontaneous report refers to a 68 year old male patient. There is no pertinent medical history or drug allergies/reaction. On 12-OCT-2013 the patient was vaccinated with ZOSTAVAX, dose 0.65 milliliters, subcutaneous. Concomitant medication included unspecified diabetes medication. Lot number and expiry date were unknown. On 18-OCT-2013, the patient had a break out in hives on all parts of his body excluding his back, starting on his fingers. There were red welts that itched. The hives on his neck were the most severe. The outcome of events was reported as not resolved. Treatment given for events was unspecified generic antihistamine pill, unspecified hydrocortisone cream. Lab diagnostic studies performed with chem. 20 blood work, result was unknown. The patient had sought medical attention via phone call. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Depression, Dizziness
Clinical narrative: Severe menstrual cramping and start of menstruation and should not have this due to being on birth control. Have had nausea, vomiting, headaches, muscle aches and pains, weakness, insomnia, stomach cramps, loss of appetite, heart palpitations, dizzy spells, near syncopal, loss of energy, and depression. This has all been happing over the course of the last 10 days.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Headache, Insomnia, Menstrual disorder, Myalgia
Clinical narrative: Severe menstrual cramping and start of menstruation and should not have this due to being on birth control. Have had nausea, vomiting, headaches, muscle aches and pains, weakness, insomnia, stomach cramps, loss of appetite, heart palpitations, dizzy spells, near syncopal, loss of energy, and depression. This has all been happing over the course of the last 10 days.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Palpitations, Presyncope, Vomiting
Clinical narrative: Severe menstrual cramping and start of menstruation and should not have this due to being on birth control. Have had nausea, vomiting, headaches, muscle aches and pains, weakness, insomnia, stomach cramps, loss of appetite, heart palpitations, dizzy spells, near syncopal, loss of energy, and depression. This has all been happing over the course of the last 10 days.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Blood iron, Blood test, Borrelia test, Fatigue
Clinical narrative: This spontaneous report as received from a consumer (the patient's father) refers to a 23 year old female patient with OCD. In 2010, the patient received the first vaccination with GARDASIL, administered via intramuscular injection. On unspecified dates, the patient received the second and third dose of GARDASIL. Concomitantly, the patient received unspecified OCD medication. Since the administration of GARDASIL, also reported with a start date of 16-DEC-2012, the patient had been experiencing extreme fatigue, malaise and lack of energy, that "interferes with her quality of life and ability to work in her chosen field" (as stated by the patient's father). In addition, muscle aches were reported with an unspecified start date. The patient's father also reported that his daughter's adverse experience began on an unspecified date with fever and sore throat, after completion of the series. While fever and sore throat diminished, the extreme fatigue, tiredness and muscle aches continued. No treatment was given for the adverse events. On an unspecified date, the patient visited the doctor because of the adverse events. On an unspecified date, blood work for Lyme disease, hormonal imbalance, iron and other unspecified tests were performed. The results of the tests were unknown. The patient's father wanted to know if there had been other reports of similar experience and how best to deal with it. A causality assessment was not provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability, Laboratory test, Malaise, Myalgia, Oropharyngeal pain
Clinical narrative: This spontaneous report as received from a consumer (the patient's father) refers to a 23 year old female patient with OCD. In 2010, the patient received the first vaccination with GARDASIL, administered via intramuscular injection. On unspecified dates, the patient received the second and third dose of GARDASIL. Concomitantly, the patient received unspecified OCD medication. Since the administration of GARDASIL, also reported with a start date of 16-DEC-2012, the patient had been experiencing extreme fatigue, malaise and lack of energy, that "interferes with her quality of life and ability to work in her chosen field" (as stated by the patient's father). In addition, muscle aches were reported with an unspecified start date. The patient's father also reported that his daughter's adverse experience began on an unspecified date with fever and sore throat, after completion of the series. While fever and sore throat diminished, the extreme fatigue, tiredness and muscle aches continued. No treatment was given for the adverse events. On an unspecified date, the patient visited the doctor because of the adverse events. On an unspecified date, blood work for Lyme disease, hormonal imbalance, iron and other unspecified tests were performed. The results of the tests were unknown. The patient's father wanted to know if there had been other reports of similar experience and how best to deal with it. A causality assessment was not provided. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia, Quality of life decreased
Clinical narrative: This spontaneous report as received from a consumer (the patient's father) refers to a 23 year old female patient with OCD. In 2010, the patient received the first vaccination with GARDASIL, administered via intramuscular injection. On unspecified dates, the patient received the second and third dose of GARDASIL. Concomitantly, the patient received unspecified OCD medication. Since the administration of GARDASIL, also reported with a start date of 16-DEC-2012, the patient had been experiencing extreme fatigue, malaise and lack of energy, that "interferes with her quality of life and ability to work in her chosen field" (as stated by the patient's father). In addition, muscle aches were reported with an unspecified start date. The patient's father also reported that his daughter's adverse experience began on an unspecified date with fever and sore throat, after completion of the series. While fever and sore throat diminished, the extreme fatigue, tiredness and muscle aches continued. No treatment was given for the adverse events. On an unspecified date, the patient visited the doctor because of the adverse events. On an unspecified date, blood work for Lyme disease, hormonal imbalance, iron and other unspecified tests were performed. The results of the tests were unknown. The patient's father wanted to know if there had been other reports of similar experience and how best to deal with it. A causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from a nurse refers to a female patients 2 cousins of unknown age. On an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient experienced premature ovarian failure. The event of premature ovarian failure was considered as serious due to significant disability or incapacity. It was reported that when the response was requested, the representative stated that premature ovarian failure could present incapacity to become pregnant, at least temporarily for each patient. The outcome of the event premature ovarian failure was unknown. The reporter did not provide the causality between the event and the suspect drug. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report was received from a nurse refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL. On an unknown date, the patient experienced premature ovarian failure. The patient reported that 2 of her cousins also experienced premature ovarian failure some time after receiving GARDASIL. The event of premature ovarian failure was considered as serious due to significant disability or incapacity. It was reported that when the response was requested, the representative stated that premature ovarian failure could present incapacity to become pregnant, at least temporarily for each patient. The outcome of the event premature ovarian failure was unknown. The reporter did not provide the causality between the event and the suspect drug. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed visited nurse concerning to a patient of unknown age and gender. Current conditions and medical history were not reported. On 23-JUL-2008, the patient was vaccinated with a first dose of hepatitis a vaccine, inactivated (manufacturer unknown), (dose, lot# and route not reported) administration at another facility. On 13-JAN-2009, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated (manufacturer unknown), (dose, lot# and route not reported) administered at another facility. Concomitant medication was not reported. No adverse event reported. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 15 month old patient. On 12-DEC-2013 the patient was vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneously. Other suspect therapies included PROQUAD (Merck). On 12-DEC-2013, the patient was inadvertently administered a 0.5 ml SQ dose of PROQUAD and a 0.5 ml SQ dose of VARIVAX. The outcome of event is unknown. No adverse effect was reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Exposure during pregnancy, Pregnancy test urine positive, Ultrasound antenatal screen
Clinical narrative: Information has been received from a pharmacist for GARDASIL a Pregnancy Registry Product, concerning a 20 year old female with allergies (unspecified) and no drug reactions/allergies. On 13-JAN-2012 was vaccinated, with first dose of GARDASIL (lot # unspecified), 0.5 ml, injection, intramuscularly (IM). On 23-MAR-2012 the patient was vaccinated with the second dose of GARDASIL (lot # unspecified), 0.5 ml, IM. Concomitant therapy included omeprazole (manufacturer unknown) and CLARITIN taken as needed. On an unspecified date, the patient became pregnant. The patient mentioned after receiving the 2nd dose of GARDASIL that she did not have a period since December 2011. The patient was given a urine pregnancy test in the office visit on 23-MAR-2012 which was positive for pregnancy. No treatment was given. The patient's Last Menstrual Period (LMP) was in December 2011 and her estimated delivery date (EDD) was 06-SEP-2012. At the time of report, the outcome was unknown. Follow up information has been received on 14-DEC-2013 from a pharmacist. It was reported that the patient terminated pregnancy electively at 20 weeks (in 2012). Fetal outcome was unknown. It was also reported that anatomy ultrasound prior to termination (date unknown) did not indicated any abnormalities. Relatedness between elective termination and GARDASIL was not assessed. Upon internal review elective termination was considered to be medically significant. Additional information is not expected.
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: This spontaneous report as received from a a male patient of unknown age regarding himself. On an unknown date the patient was vaccinated with PNEUMOVAX23, subcutaneous. The patient reported that he "received 2 subcutaneous injections of PNEUMOVAX 23 (dates unknown)." The patient also reported that he has developed "aches all over the body" after receiving the second subcutaneous injection site of PNEUMOVAX 23 (date unknown). It is unclear as to whether the patient received these 2 injections at the same time. All dates are unknown. The outcome of aches all over the body is unknown. Causality was also unknown. 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 nurse refers to a patient of unknown age. The nurse reported that a patient was vaccinated with a dose of expired ZOSTAVAX (lot# H012521, expired date 09-OCT-2013) on 02-DEC-2013, subcutaneously, 0.65 ml. No adverse event was reported. No product quality Complaint. Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Muscle tightness, Pharyngeal oedema, Pruritus
Clinical narrative: Neck tightening, throat swelling, itchy tongue rated 7/10 for severity. Gave Benadryl liquid 10ml - immediate relief.  Second dose 4 hrs later at 10ml.  Third dose 10ml - 6 hrs later for maintenance.  No further dose needed.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Erythema, Flushing, Lip swelling, Pruritus
Clinical narrative: Face was red and flushed throughout the entire day.  The next day when she woke up (approx 20 hours after vaccine) her upper lip was severely swollen 7/10 for severity.  noted itching and discomfort.  Given Benadryl liquid 10ml and ice - reduced swelling over 4 hours time. Second dose 4 hrs later for maintenance at 10ml.  No further dose required.  Follow up instructions given.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Papule
Clinical narrative: Herpes zoster rash which fully erupted on 11/17/13; there were a few skin papules present the day after vaccine.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling/Numbness in right thumb.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Nasopharyngitis, Pyrexia, Rash, Upper respiratory tract infection
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 year old female patient with unspecified multiple allergies and AUGMENTIN allergy. On 09-AUG-2013, the patient was vaccinated with a dose of GARDASIL (lot # J003727, expiry date was 07-NOV-2015) intramuscular and Tdap. Concomitant therapies included ZYRTEC, SINGULAIR, NASONEX, ADVAIR and PROAIR. On 15-OCT-2013, the patient experienced fever, rash and upper respiratory infection for which she went to the physician's office and the emergency room on 15-OCT-2013 and sought medical attention. Also the physician reported that the patient went for a second emergency room visit at an unspecified time. On 21-OCT-2013, the patient came to the physician's office for cold symptoms and possible pneumonia. Again on 22-NOV-2013, the patient came to the physician's office for vomiting and stomach pain and was prescribed ZOFRAN. The patient was treated with PEPCID, prednisone and BENADRYL. As of 02-DEC-2013, the patient was still vomiting. At the time of this report, the outcome of rash, vomiting, fever, stomach pain, cold symptoms, upper respiratory infection and possible pneumonia was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 year old female patient with unspecified multiple allergies and AUGMENTIN allergy. On 09-AUG-2013, the patient was vaccinated with a dose of GARDASIL (lot # J003727, expiry date was 07-NOV-2015) intramuscular and Tdap. Concomitant therapies included ZYRTEC, SINGULAIR, NASONEX, ADVAIR and PROAIR. On 15-OCT-2013, the patient experienced fever, rash and upper respiratory infection for which she went to the physician's office and the emergency room on 15-OCT-2013 and sought medical attention. Also the physician reported that the patient went for a second emergency room visit at an unspecified time. On 21-OCT-2013, the patient came to the physician's office for cold symptoms and possible pneumonia. Again on 22-NOV-2013, the patient came to the physician's office for vomiting and stomach pain and was prescribed ZOFRAN. The patient was treated with PEPCID, prednisone and BENADRYL. As of 02-DEC-2013, the patient was still vomiting. At the time of this report, the outcome of rash, vomiting, fever, stomach pain, cold symptoms, upper respiratory infection and possible pneumonia was unknown. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered, Wrong technique in drug usage process
Clinical narrative: This spontaneous report was received from a nurse refers to a 4 month old female child. On 09-DEC-2013, the patient was mistakenly vaccinated with a dose of VARIVAX, oral (dose and frequency unspecified) (Lot # J006356) instead of ROTARIX. Nurse stated that her colleague diluted VARIVAX (Merck) with the ROTARIX diluent and administered VARIVAX orally to the child. No adverse effects reported at this time. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative regarding an approximately 76 year old female patient. The patient did not have any pertinent medical conditions and previous drug allergies. On 05-DEC-2013, the patient was vaccinated with ZOSTAVAX 19400 PFU (Lot number J)08436, expiry date of 11-OCT-2014) (dose and frequency not provided) subcutaneously in the right arm for prevention of shingles. On an unknown date in December 2013, the patient experienced rash on her lower right arm. On 07-DEC-2013, the patient returned back to pharmacy with the rash. The patient sought medical attention by visiting pharmacy. Treatment to the event was provided using BENADRYL, TYLENOL, and warm compresses as needed. No lab diagnostic test were done. The outcome of rash on her lower right arm was unknown. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner and licensed practical nurse refers to a 24 year old female patient. On 07-FEB-2013, the patient was vaccinated with a first dose of VARIVAX (Merck) (lot #, expiry date, route of administration and dose were not reported) because the patient did not have immunity to ENGERIX-B. On 21-MAR-2013, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot #, expiry date, route of administration and dose were not reported) and ENGERIX-B. On 04-APR-2013, the patient found out that she was pregnant. The last menstrual period (LMP) and estimated date of conception (EDD) were not known. The patient sought medical attention, she visited the office but no treatment was given to the patient. The pregnancy outcome was lost to follow-up. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, expire date, route, dose, strength and indication not reported) in the arm. The nurse reported that the patient experienced pain at the injection site and "pain that shot all the way through their arm" at the same time of the injection. The outcome of pain at the injection site and "pain that shot all the way through their arm" at the time of the injection was unknown. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash
Clinical narrative: This spontaneous report refers to a 60 year old female patient. On 03-DEC-2013 reported as about one week ago, the patient was vaccinated with ZOSTAVAX. Dose, lot and expiry date were not reported. Concomitant medications included blood pressure medication and a statin. On 10-DEC-2013, 8 days after onset of therapy the patient experienced a rash on the right side of her head and burning at the site of the rash after receiving ZOSTAVAX, six inches by three inches in diameter (shingles). The outcome event is unknown. Anti-viral medication was prescribed as treatment for event. She has not visited her Nurse Practitioner yet but agreed to receive the packet to her. No PQC was reported. No additional AE information was provided. The patient had seen a physician at the healthcare facility where I work. No lab study was performed. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: FLU3, MMRV, PNC13
Symptoms: Flushing, Inflammation, Lymphadenopathy, Rash, Rash papular
Clinical narrative: Erythematous pap. pinpoint rash to MUNK, BUES and BLR, buttocks and cheeks, TMS flushed at LR PP eryth others, nose inflamed (+) post cervical lymphadenopathy, LS CTA, HR RRR - adverse reaction, exanthem to MMRV.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Blood test normal, Electrocardiogram abnormal, Loss of consciousness
Clinical narrative: Initial report received from a consumer (the patient) on 10 December 2013. A 80-year-old female patient, had received intramuscular dose of FLUZONE HD (lot number: unknown) in left deltoid on 29 October 2013. The patient had no illness at time of vaccination and was allergic to penicillin and sulfa. Concomitant medications were not reported. On 19 November 2013, the patient's blood pressure was increase 160/90, electrocardiogram abnormal and passed out for less than 1 minute. Relevant diagnostic tests/laboratory data: Normal blood work and electrocardiogram was abnormal corrective treatments was not reported. The outcome of the event was recovered on unspecified date. List of documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from medical assistant refers to a 58 year old female patient. The patient's medical history includes hypertension, skin cancer, seasonal rhinitis, migraines. The patient has a history of a drug reaction to PERCOCET (unspecified manufacturer) of nausea and vomiting and a history of a drug reaction to Sulfa (unspecified manufacturer) described as Idiopathic thrombocytopenic purpura (ITP). On 06-DEc-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, lot# J008432 expires on 11-OCT-2014, subcutaneous. Over the weekend on 07-DEC-2013 or 08-DEC-2013, the patient stated over the phone to physician that she experienced a large bump at the injection site which was located at the back of her left upper arm and was described as red, itchy and swollen. The patient sought medical attention at an unspecified clinic on 09-DEC-2013 where the patient was diagnosed with cellulitis at the injection site and prescribed KEFLEX 500 mg twice per day. The outcomes of the reported events were reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician's wife (medical assistant) and an office manager refers to a patient of unknown age. On 11-DEC-2013 the patient was vaccinated with an expired dose of oral ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012), dose unspecified, oral. This medical assistant noted this was the only dose of oral ROTATEQ this patient had been administered. No adverse effect reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from an unknown age male patient refers to himself. On an unknown date in November 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, route not reported) for prevention of shingles. On an unknown date the patient experienced shingles. The patient was treated with unspecified medications. The patient sought medical attention via office visit on an unknown date. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a female registered nurse of unknown age refers to herself. On 14-NOV-2013, the patient went to an unspecified pharmacy to receive an unspecified influenza vaccine, however, the unspecified pharmacist documented that she was vaccinated with a dose of PNEUMOVAX23 (lot number reported as J010396, expiration date 16-FEB-2015) (dose, route not reported). The patient had already received a dose of PNEUMOVAX23 on an unspecified date about a year ago (approximately in December 2012). No adverse effects reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site rash, Injection site vesicles, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to a 2 year old female patient with allergy to natural rubber, adhesive allergy and allergy to latex. The patient's medical history included chickenpox (CP), "PR" and seizure. On 25-OCT-2013 the patient was vaccinated with her first dose of VARIVAX (Merck) (lot number, dose, route and site of administration were not reported). Concomitant therapies included REGLAN, MAGNESIA, BACTOFEN, diazepam (manufacturer unknown), topiramate, KEPPRA, phenobarbital and KLONOPIN. On 13-NOV-2013, the patient experienced chickenpox with a couple of vesicles, mostly crusted (about 20) on legs, low abdomen and lower back. The rash "blister" occurred at the site of injection approximately 10 days post-vaccination on left thigh. In November 2013 the patient recovered from adverse events. The patient did not have recent exposure to chickenpox and shingles. The relatedness between vaccination with VARIVAX (Merck) and adverse event was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist reported that a patient was administered the first dose in GARDASIL (dose, lot #, expiration date and route for all doses not reported) series on an unspecified date in September 2012, the second dose in series on an unspecified date in November 2012 and was in the provider's office on 10-DEC-2013 for administration of the third dose in series. No adverse events were reported. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, Measles antibody negative
Clinical narrative: This spontaneous report has been received from a registered nurse concerning to a 48 year old female patient with almonds, pollen and mold allergies. The patient's medical history included acne. On an unknown date, the patient was vaccinated with the first dose of MMR II (dose, lot # and route not reported). On 15-DEC-2010, the patient was vaccinated with a second dose of MMR II (dose, lot # and route not reported). On 22-JUN-2013, titers were drawn with a negative result for measles. On 01-JUL-2013, the patient was vaccinated with a third dose of MMR II (dose, lot # and route not reported) and on 18-SEP-2013, the patient was vaccinated with a fourth dose of MMR II (dose, lot # and route not reported). On 06-AUG-2013 with a negative titer result for measles and on 26-NOV-2013 with a negative titer result for measles. Concomitant therapies included spironolactone (manufacturer unknown) and unspecified birth control medication. The outcome of measles antibody negative was unknown. Additional information is not expected.