chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Fever 102, nausea, 1 episode of vomiting.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: 6/13/13 7pm fever - 100.2, headache, fatigue, abdominal pain, nausea, and vomiting (2am, fever 102). 6/14/13 10am vomited once, no headache. 1:30pm seen in our office, normal exam. Normal vital signs, no headache feeling better.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vomiting
Clinical narrative: 6/13/13 7pm fever - 100.2, headache, fatigue, abdominal pain, nausea, and vomiting (2am, fever 102). 6/14/13 10am vomited once, no headache. 1:30pm seen in our office, normal exam. Normal vital signs, no headache feeling better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Hives covering upper torso, reaction to MMRV or KINRIX.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Poor quality sleep
Clinical narrative: Irritability, poor sleep at night: No sustained night sleep, abrupt cessation of day naps.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient received meningitis vaccine in office - was sitting in chair in office for observation after vaccine - felt faint, became pale, sweaty and temporary loss of consciousness due to fainting. Patient did not fall, no injuries. Pt. became responsive and was observed while lying down for 20 minutes - patient felt better. B/P/pulse returned to normal and was discharged home with parent from office.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Pt into clinic 6/20/13 for evaluation of c/o lt arm pain, swelling, and redness post PNEUMOVAX 6/18/13. The Dr and RN evaluated pt. Swelling noted approximately 3 inches above lt antecubital to 5 inches below injection site, area red and hot to touch, pt reports pain to touch. KEFLEX, ice, antihistamine.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Crying, Erythema, Feeling hot, Rash
Clinical narrative: 6/13 - arm very hot and red, pt crying all day. 6/14 - work up, still hot and red with rash almost to elbow (approx 4"). Doesn't think she had fever. Appt offered - "too far to come" may go to UC mom says its from the DTaP IZ.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous repor as received from the Healthcare worker refers to a 65 year old male patienr. On 13-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # 0069AE, expiration date 03-APR-2013) 0.65 ml, subcutanoeusly in the right arm. The Healthcare worker reported that two patients were vaccinated with expired ZOSTAVAX (related to MARRS case 1306USA007128). No adverse effects were reporred. This is one of two reports from the same source. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Varicella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose, frequency and route not reported). Concomitant medications were not reported. On an unknown date after receiving ZOSTAVAX the patient developed redness at the injection site. Also on an unspecified date, the patient was diagnosed with chickenpox by his physician. At the time of the report the patient's outcome was unknown. This case is related with MARRS # 1306USA009703. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose, frequency and route not reported). Concomitant medications were not reported. On an unknown date after receiving ZOSTAVAX the patient developed redness at the injection site. At the time of the report the patient's outcome was unknown. This case is related with MARRS # 1306USA006631. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hepatic enzyme increased, Laboratory test
Clinical narrative: This spontaneous report as received from a pharmacist refers to his 59 year old wife with penicillin allergy, lupus and seasonal allergies. The patient had a "physical examination and blood work" performed on an unspecified date before receiving ZOSTAVAX and "everything was fine other than an indication of high cholesterol". On approximately 03-MAY-2013, "about 6 weeks ago in early May", the patient was vaccinated with ZOSTAVAX. Concomitant therapy included ZYRTEC. The pharmacist reported that the patient "did not have any symptoms" however when she returned to the unspecified physician's office for a routine "physical examination and blood work" on 10-JUN-2013, her blood work showed "elevated liver enzymes". The pharmacist reported that the unspecified physician then performed "further studies and test" and "made an appointment for the patient" with an unspecified rheumatologist. The patient had not been seen by the rheumatologist as of 14-JUN-2013. The pharmacist reported that the patient "is doing fine except that she is very tired". No treatment was given. The patient was no recovered from events at reporting time. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a 62 year old female patient. On 13-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # 0741AA, expiration date 17-AUG-2012) 0.65 ml, subcutaneously in the right arm. The Healthcare worker reported that two patients were vaccinated with expired ZOSTAVAX (related to MARRS case 1306USA009891). No adverse effects were reported. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician's assistant, via a company representative, refers to a female patient of unknown age, who "last week", on 04-JUN-2013 was vaccinated with a dose of ZOSTAVAX (dose and route were not reported). Concomitant medications were not provided. The last week, on 04-JUN-2013, the patient had an injection site reaction after receiving the ZOSTAVAX. The physician's assistant noticed a shingles like rash around the injection site. The outcome of shingles like rash around the injection site and injection site reaction was unknown. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect dose administered, No therapeutic response
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The physician reported that on an unknown date patients were vaccinated with (Merck) VARIVAX (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). Physician stated that patients had received (merck) VARIVAX two and three times (unspecified dates) and were showing negative titers (unknown date) using standard lab varicella testing. At the time of the report, the outcome of patients was unknown. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a 79 year old female patient (reporting on herself). On 01-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose, frequency and route not reported). Concomitant therapy was not reported. It was reported that 2 weeks after she had the vaccine, on 15-APR-2013, the patient had shingles. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 64 years old patient. On 11-JUN-2013 the patient inadvertently received (Merck) VARIVAX (lot # H016600, expiry date unspecified) instead of ZOSTAVAX which was planned for shingles prevention. No adverse effects reported. The reporter stated physician intended to revaccinate with ZOSTAVAX at an unspecified time in the future. It was unspecified if the patient had sought medical attention. This is one of several reports from same source. Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 51 years old patient. On 11-JUN-2013 the patient inadvertently received VARIVAX (Merck) (0.5ml, once) (lot # H016600, expiry date 05-SEP-2014) subcutaneously instead of ZOSTAVAX which was planned. No adverse effects reported. The reporter stated physician intended to revaccinate with ZOSTAVAX at an unspecified time in the future. It was unspecified if the patient had sought medical attention. This is one of several reports from same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. Pharmacist was informed by an unspecified nurse that the patient received the first two doses of GARDASIL "approximately six years ago.", approximately June 2007 (dose, route and lot # unknown). Pharmacist was unsure if the patient was in the physician's office "now" 13-JUN-2013 to receive the third dose. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 13-JUN-2013 the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # reported as 0068AE, Exp 03-APR-2013). No adverse effect 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 registered nurse refers to a patient of unknown age. The nurse reported that the unspecified patient was administered the first dose of GARDASIL on an unspecified date "about a year ago", in approximately June 2012, (dose, route and lot # unknown) and the patient was "currently" in the physician's office, on 13-JUN-2013, and about to receive the second dose of GARDASIL (dose, route and lot # unknown). No adverse effect reported, Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received via a company representative from a 68 year old female patient refers to herself. Two weeks ago, on 29-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). The patient stopped the company representative to show her a rash that had appeared on her leg a week ago, on 05-JUN-2013. The patient had not yet contacted her primary physician who prescribed the ZOSTAVAX or the pharmacy where she received the vaccine. She stated she would ask the physician for whom she works to take a look to determine if it was in fact a rash or bug bites. She would contact her primary physician as well as the pharmacy (no specified timeframe was given). At the time of the report the patient had not recovered. The causal relationship was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 14-JUN-2013, the patient was vaccinated with a dose of MMR II (Lot # reported as H014978, expiration date 09-AUG-2014) and a dose of VARIVAX (Merck) (Lot # reported as H019449, expiration date 15-OCT-2014) that were exposed to unknown temperatures during a 4 hour power outage. The nurse reported that after additional excursion information was provided and evaluated, VARIVAX (Merck) was supported for 3 months and MMR II was supported until date of expiration. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date, when the patient was a baby, they were vaccinated with three dose series of RECOMBIVAX HB (dose, route and lot number not reported). It was reported, that recently, in 2013, the patient had the blood work completed to test for protective antibody levels for hepatitis B. The blood work came back as "non-reactive". The outcome of the adverse event was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Information was received from a consumer regarding concerning his 27 year-old wife, who on 13-JUN-2013 was vaccinated with GARDASIL (dosage, route and site of administration not provided). The patient received the vaccine while pregnant. Initial exposure to GARDASIL was at 29 weeks (calculated LMP of 22-NOV-2012 and EDD of 29-AUG-2013 based on gestational age provided of 29 weeks). The patient's husband reported that the 27 year-old female was accidentally administered GARDASIL, but did not mention what vaccine the patient was supposed to receive. The pregnancy outcome is pending. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, No therapeutic response, Rubella antibody positive
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a female not pregnant patient in her 40's. On an unknown date, in the past, the patient was vaccinated with a dose of M-M-R II (dose, route, lot number not reported). On an unknown date in 2013, recently the patient had titer test that revealed positive for rubella but negative for measles. The patient's outcome was unknown. The patient sought medical attention, saw a nurse. The relationship between adverse event and M-M-R II was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4, MMR, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a an unknown number of patient of unknown age. The reporter stated that on an unknown date: M-M-R II injection (lot# and exp date unspecified), GARDASIL (lot # and exp date unspecified) and ROTATEQ (lot # and exp date unspecified) were exposed to 49F for 168  hours over 2 months. The reporter stated that M-M-R II, GARDASIL and ROTATEQ were administered to patients during this time (dose, route, application site unspecified). No adverse effects reported. The patients outcome was not reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash, Swelling
Clinical narrative: This spontaneous report as received from a 60 year old female patient with multiple sclerosis, arthritis, brain damage, methicillin-resistant staphylococcus aureus and pancreatitis refers to herself. Patient had no drug allergies. On 11-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified), subcutaneous. Concomitant therapies included XANAX, mirtazepine (manufacturer unknown) and VICODIN. On 12-JUN-2013, the patient experienced feet broke out in a rash, swelled and had tingling sensation. The outcome of the events was reported as not recovered. No treatment was given. No lab tests were performed. The patient had not sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received via a company representative from a physician refers to a patient of unknown age and gender with no reported medical history. On an unknown date the patient (at age of 1 year) was vaccinated with VAQTA, dose 1, 25 U/0.5 ml (route unknown). On an unknown date the patient (now at age of 15 months) was vaccinated with VAQTA dose 2, 25 U/0.5 ml (route unknown). No other suspect therapy or concomitant medication was reported. On an unknown date the patient experienced received first dose of VAQTA at the one year of age and the second dose at the 15 month of age (medication error). No adverse effect was reported. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: Fever of 102.8, site pain, feeling bad.
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, second and third dose of GARDASIL (lot # unspecified) respectively in July 2009, October 2009 and August 2010 for prophylaxis. No adverse effect reported. Physician reported GARDASIL was not administered in his office. Additional information is not expected.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site induration
Clinical narrative: Tender knot to (L) thigh, no fever.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Diarrhoea, Dysstasia, Hypersomnia, Hypokinesia
Clinical narrative: Case number PHHY2013US056722 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486413) website on 05 Jun 2013, and with a follow up report received from QA department on 18 Jun 2013. This is also a quality complaint (QA ref: 233210). This report refers to a 49-year-old female patient. Her medical history included allergy to Sulfa, penicillin and BENADRYL drugs. Her vaccination history included administration of INFLUENZA (manufacturer and batch number: unknown, date unspecified) and had experienced events such as could not move without any assistance, could not stand and weakness. Current condition included full blown AIDS (acquired immune deficiency syndrome) but was very active and lively; Currently, she was in dialysis center undergoing dialysis of kidney. At dialysis center, this poly-medicated patient was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly into left arm on 14 Sep 2012. One hour post vaccination, she experienced nausea, vomiting, diarrhea and could not move or stand without assistance to go to bathroom. On 15 Sep 2012, she stated that she was not feeling well (reporter thought it was from dialysis treatment). She went to sleep and slept for longer time than normal. She tried to eat, but had vomiting. She refused to go to hospital and kept on saying that she was sick. She was very lethargic, and had no fever. She could not move off couch to bed and could not walk. She visited emergency room. Intensive care unit (ICU) and coronary care unit (CCU). She did not recover from the events. The reporter considered these events as life threatening. On 01 Oct 2012, 16 days after vaccination, she died (cause of death was not provided). No causality assessment was provided. Based on the review, it ws stated that the concerned vaccine FLUVIRIN batch number 1204601 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up report received from QA department on 18 Jun 2013. Updated batch review report.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Intensive care, Lethargy, Malaise, Vomiting
Clinical narrative: Case number PHHY2013US056722 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486413) website on 05 Jun 2013, and with a follow up report received from QA department on 18 Jun 2013. This is also a quality complaint (QA ref: 233210). This report refers to a 49-year-old female patient. Her medical history included allergy to Sulfa, penicillin and BENADRYL drugs. Her vaccination history included administration of INFLUENZA (manufacturer and batch number: unknown, date unspecified) and had experienced events such as could not move without any assistance, could not stand and weakness. Current condition included full blown AIDS (acquired immune deficiency syndrome) but was very active and lively; Currently, she was in dialysis center undergoing dialysis of kidney. At dialysis center, this poly-medicated patient was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly into left arm on 14 Sep 2012. One hour post vaccination, she experienced nausea, vomiting, diarrhea and could not move or stand without assistance to go to bathroom. On 15 Sep 2012, she stated that she was not feeling well (reporter thought it was from dialysis treatment). She went to sleep and slept for longer time than normal. She tried to eat, but had vomiting. She refused to go to hospital and kept on saying that she was sick. She was very lethargic, and had no fever. She could not move off couch to bed and could not walk. She visited emergency room. Intensive care unit (ICU) and coronary care unit (CCU). She did not recover from the events. The reporter considered these events as life threatening. On 01 Oct 2012, 16 days after vaccination, she died (cause of death was not provided). No causality assessment was provided. Based on the review, it ws stated that the concerned vaccine FLUVIRIN batch number 1204601 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up report received from QA department on 18 Jun 2013. Updated batch review report.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abasia, Asthenia, Death, Diarrhoea, Dysstasia
Clinical narrative: Case number PHHY2013US056722 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486413) website on 05 Jun 2013, and with a follow up report received from QA department on 18 Jun 2013. This is also a quality complaint (QA ref: 233210). This report refers to a 49-year-old female patient. Her medical history included allergy to Sulfa, penicillin and BENADRYL drugs. Her vaccination history included administration of INFLUENZA (manufacturer and batch number: unknown, date unspecified) and had experienced events such as could not move without any assistance, could not stand and weakness. Current condition included full blown AIDS (acquired immune deficiency syndrome) but was very active and lively; Currently, she was in dialysis center undergoing dialysis of kidney. At dialysis center, this poly-medicated patient was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly into left arm on 14 Sep 2012. One hour post vaccination, she experienced nausea, vomiting, diarrhea and could not move or stand without assistance to go to bathroom. On 15 Sep 2012, she stated that she was not feeling well (reporter thought it was from dialysis treatment). She went to sleep and slept for longer time than normal. She tried to eat, but had vomiting. She refused to go to hospital and kept on saying that she was sick. She was very lethargic, and had no fever. She could not move off couch to bed and could not walk. She visited emergency room. Intensive care unit (ICU) and coronary care unit (CCU). She did not recover from the events. The reporter considered these events as life threatening. On 01 Oct 2012, 16 days after vaccination, she died (cause of death was not provided). No causality assessment was provided. Based on the review, it ws stated that the concerned vaccine FLUVIRIN batch number 1204601 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up report received from QA department on 18 Jun 2013. Updated batch review report.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypersomnia, Intensive care, Lethargy, Malaise, Mobility decreased
Clinical narrative: Case number PHHY2013US056722 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486413) website on 05 Jun 2013, and with a follow up report received from QA department on 18 Jun 2013. This is also a quality complaint (QA ref: 233210). This report refers to a 49-year-old female patient. Her medical history included allergy to Sulfa, penicillin and BENADRYL drugs. Her vaccination history included administration of INFLUENZA (manufacturer and batch number: unknown, date unspecified) and had experienced events such as could not move without any assistance, could not stand and weakness. Current condition included full blown AIDS (acquired immune deficiency syndrome) but was very active and lively; Currently, she was in dialysis center undergoing dialysis of kidney. At dialysis center, this poly-medicated patient was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly into left arm on 14 Sep 2012. One hour post vaccination, she experienced nausea, vomiting, diarrhea and could not move or stand without assistance to go to bathroom. On 15 Sep 2012, she stated that she was not feeling well (reporter thought it was from dialysis treatment). She went to sleep and slept for longer time than normal. She tried to eat, but had vomiting. She refused to go to hospital and kept on saying that she was sick. She was very lethargic, and had no fever. She could not move off couch to bed and could not walk. She visited emergency room. Intensive care unit (ICU) and coronary care unit (CCU). She did not recover from the events. The reporter considered these events as life threatening. On 01 Oct 2012, 16 days after vaccination, she died (cause of death was not provided). No causality assessment was provided. Based on the review, it ws stated that the concerned vaccine FLUVIRIN batch number 1204601 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up report received from QA department on 18 Jun 2013. Updated batch review report.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nausea, Product quality issue, Vomiting
Clinical narrative: Case number PHHY2013US056722 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 486413) website on 05 Jun 2013, and with a follow up report received from QA department on 18 Jun 2013. This is also a quality complaint (QA ref: 233210). This report refers to a 49-year-old female patient. Her medical history included allergy to Sulfa, penicillin and BENADRYL drugs. Her vaccination history included administration of INFLUENZA (manufacturer and batch number: unknown, date unspecified) and had experienced events such as could not move without any assistance, could not stand and weakness. Current condition included full blown AIDS (acquired immune deficiency syndrome) but was very active and lively; Currently, she was in dialysis center undergoing dialysis of kidney. At dialysis center, this poly-medicated patient was vaccinated with FLUVIRIN (batch number: 1204601) intramuscularly into left arm on 14 Sep 2012. One hour post vaccination, she experienced nausea, vomiting, diarrhea and could not move or stand without assistance to go to bathroom. On 15 Sep 2012, she stated that she was not feeling well (reporter thought it was from dialysis treatment). She went to sleep and slept for longer time than normal. She tried to eat, but had vomiting. She refused to go to hospital and kept on saying that she was sick. She was very lethargic, and had no fever. She could not move off couch to bed and could not walk. She visited emergency room. Intensive care unit (ICU) and coronary care unit (CCU). She did not recover from the events. The reporter considered these events as life threatening. On 01 Oct 2012, 16 days after vaccination, she died (cause of death was not provided). No causality assessment was provided. Based on the review, it ws stated that the concerned vaccine FLUVIRIN batch number 1204601 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Follow up report received from QA department on 18 Jun 2013. Updated batch review report.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Deep vein thrombosis, Optic neuritis, Retinal haemorrhage, Retinitis, Varicella virus test positive
Clinical narrative: (1) Pronounced hearing loss in right ear as measured by pre- and post- immunization by licensed audiologist. (2) Neuritis/retinitis of right eye.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram, Deafness unilateral, Ophthalmological examination abnormal, Optic neuritis, Retinitis
Clinical narrative: (1) Pronounced hearing loss in right ear as measured by pre- and post- immunization by licensed audiologist. (2) Neuritis/retinitis of right eye.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: (1) Pronounced hearing loss in right ear as measured by pre- and post- immunization by licensed audiologist. (2) Neuritis/retinitis of right eye.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Altered state of consciousness, Gaze palsy, Joint contracture, Malaise, Opisthotonus
Clinical narrative: Initial report received from a nurse on 10 June 2013. A 13-year-old female patient with no concurrent illnesses, and medical history of allergy to latex, had received on 10 June 2013 the following vaccinations: MENACTRA vaccine (lot number U4418AA, dose 1, IM, Left Deltoid): Hepatitis A vaccine (Merck, lot number 0535AE, dose 1, right deltoid); and HPV vaccine (Merck, lot number H021608, dose 1, right deltoid). At an unspecified amount of time after receiving the vaccinations the patient started feeling sick to her stomach. She lay down on the exam table, felt better and was going to check out of the clinic when she said she felt sick to her stomach again. She sat down and at that time turned white, arched her back and her head flew forward and bobbed. Her hands turned inward (posturing), and her eyes rolled back. She was incontinent of urine and unresponsive. The episode lasted for 2-3 minutes. Per the reporter, there was no convulsion and the doctor was present. The patient then experienced a second episode lasting 1 minute where she turned pale and her hand turned inward again (posturing). The doctor carried her to the exam table from a chair and she woke up and started talking after 10-15 minutes. The patient did not remember the episodes. She was sent by wheelchair to an emergency room (ER) located in the building and was then transferred to the pediatric trauma unit at a hospital (hospitalization was not reported). The father subsequently reported that the patient had a third episode in the ER. Recovery status was reported as "unknown." Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Pallor, Posture abnormal, Urinary incontinence
Clinical narrative: Initial report received from a nurse on 10 June 2013. A 13-year-old female patient with no concurrent illnesses, and medical history of allergy to latex, had received on 10 June 2013 the following vaccinations: MENACTRA vaccine (lot number U4418AA, dose 1, IM, Left Deltoid): Hepatitis A vaccine (Merck, lot number 0535AE, dose 1, right deltoid); and HPV vaccine (Merck, lot number H021608, dose 1, right deltoid). At an unspecified amount of time after receiving the vaccinations the patient started feeling sick to her stomach. She lay down on the exam table, felt better and was going to check out of the clinic when she said she felt sick to her stomach again. She sat down and at that time turned white, arched her back and her head flew forward and bobbed. Her hands turned inward (posturing), and her eyes rolled back. She was incontinent of urine and unresponsive. The episode lasted for 2-3 minutes. Per the reporter, there was no convulsion and the doctor was present. The patient then experienced a second episode lasting 1 minute where she turned pale and her hand turned inward again (posturing). The doctor carried her to the exam table from a chair and she woke up and started talking after 10-15 minutes. The patient did not remember the episodes. She was sent by wheelchair to an emergency room (ER) located in the building and was then transferred to the pediatric trauma unit at a hospital (hospitalization was not reported). The father subsequently reported that the patient had a third episode in the ER. Recovery status was reported as "unknown." Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Convulsion, Culture urine
Clinical narrative: Initial report received from a nurse on 10 June 2013. A 13-year-old female patient with no concurrent illnesses, and medical history of allergy to latex, had received on 10 June 2013 the following vaccinations: MENACTRA vaccine (lot number U4418AA, dose 1, IM, Left Deltoid): Hepatitis A vaccine (Merck, lot number 0535AE, dose 1, right deltoid); and HPV vaccine (Merck, lot number H021608, dose 1, right deltoid). At an unspecified amount of time after receiving the vaccinations the patient started feeling sick to her stomach. She lay down on the exam table, felt better and was going to check out of the clinic when she said she felt sick to her stomach again. She sat down and at that time turned white, arched her back and her head flew forward and bobbed. Her hands turned inward (posturing), and her eyes rolled back. She was incontinent of urine and unresponsive. The episode lasted for 2-3 minutes. Per the reporter, there was no convulsion and the doctor was present. The patient then experienced a second episode lasting 1 minute where she turned pale and her hand turned inward again (posturing). The doctor carried her to the exam table from a chair and she woke up and started talking after 10-15 minutes. The patient did not remember the episodes. She was sent by wheelchair to an emergency room (ER) located in the building and was then transferred to the pediatric trauma unit at a hospital (hospitalization was not reported). The father subsequently reported that the patient had a third episode in the ER. Recovery status was reported as "unknown." Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Joint contracture, Opisthotonus, Pallor, Posture abnormal
Clinical narrative: Initial report received from a nurse on 10 June 2013. A 13-year-old female patient with no concurrent illnesses, and medical history of allergy to latex, had received on 10 June 2013 the following vaccinations: MENACTRA vaccine (lot number U4418AA, dose 1, IM, Left Deltoid): Hepatitis A vaccine (Merck, lot number 0535AE, dose 1, right deltoid); and HPV vaccine (Merck, lot number H021608, dose 1, right deltoid). At an unspecified amount of time after receiving the vaccinations the patient started feeling sick to her stomach. She lay down on the exam table, felt better and was going to check out of the clinic when she said she felt sick to her stomach again. She sat down and at that time turned white, arched her back and her head flew forward and bobbed. Her hands turned inward (posturing), and her eyes rolled back. She was incontinent of urine and unresponsive. The episode lasted for 2-3 minutes. Per the reporter, there was no convulsion and the doctor was present. The patient then experienced a second episode lasting 1 minute where she turned pale and her hand turned inward again (posturing). The doctor carried her to the exam table from a chair and she woke up and started talking after 10-15 minutes. The patient did not remember the episodes. She was sent by wheelchair to an emergency room (ER) located in the building and was then transferred to the pediatric trauma unit at a hospital (hospitalization was not reported). The father subsequently reported that the patient had a third episode in the ER. Recovery status was reported as "unknown." Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Tremor, Urinary incontinence
Clinical narrative: Initial report received from a nurse on 10 June 2013. A 13-year-old female patient with no concurrent illnesses, and medical history of allergy to latex, had received on 10 June 2013 the following vaccinations: MENACTRA vaccine (lot number U4418AA, dose 1, IM, Left Deltoid): Hepatitis A vaccine (Merck, lot number 0535AE, dose 1, right deltoid); and HPV vaccine (Merck, lot number H021608, dose 1, right deltoid). At an unspecified amount of time after receiving the vaccinations the patient started feeling sick to her stomach. She lay down on the exam table, felt better and was going to check out of the clinic when she said she felt sick to her stomach again. She sat down and at that time turned white, arched her back and her head flew forward and bobbed. Her hands turned inward (posturing), and her eyes rolled back. She was incontinent of urine and unresponsive. The episode lasted for 2-3 minutes. Per the reporter, there was no convulsion and the doctor was present. The patient then experienced a second episode lasting 1 minute where she turned pale and her hand turned inward again (posturing). The doctor carried her to the exam table from a chair and she woke up and started talking after 10-15 minutes. The patient did not remember the episodes. She was sent by wheelchair to an emergency room (ER) located in the building and was then transferred to the pediatric trauma unit at a hospital (hospitalization was not reported). The father subsequently reported that the patient had a third episode in the ER. Recovery status was reported as "unknown." Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Gaze palsy, Nausea, Opisthotonus, Pallor, Posture abnormal
Clinical narrative: Initial report received from a nurse on 10 June 2013. A 13-year-old female patient with no concurrent illnesses, and medical history of allergy to latex, had received on 10 June 2013 the following vaccinations: MENACTRA vaccine (lot number U4418AA, dose 1, IM, Left Deltoid): Hepatitis A vaccine (Merck, lot number 0535AE, dose 1, right deltoid); and HPV vaccine (Merck, lot number H021608, dose 1, right deltoid). At an unspecified amount of time after receiving the vaccinations the patient started feeling sick to her stomach. She lay down on the exam table, felt better and was going to check out of the clinic when she said she felt sick to her stomach again. She sat down and at that time turned white, arched her back and her head flew forward and bobbed. Her hands turned inward (posturing), and her eyes rolled back. She was incontinent of urine and unresponsive. The episode lasted for 2-3 minutes. Per the reporter, there was no convulsion and the doctor was present. The patient then experienced a second episode lasting 1 minute where she turned pale and her hand turned inward again (posturing). The doctor carried her to the exam table from a chair and she woke up and started talking after 10-15 minutes. The patient did not remember the episodes. She was sent by wheelchair to an emergency room (ER) located in the building and was then transferred to the pediatric trauma unit at a hospital (hospitalization was not reported). The father subsequently reported that the patient had a third episode in the ER. Recovery status was reported as "unknown." Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, HEPA, HPV4, HEPA, HPV4, MNQ
Symptoms: Posturing, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Initial report received from a nurse on 10 June 2013. A 13-year-old female patient with no concurrent illnesses, and medical history of allergy to latex, had received on 10 June 2013 the following vaccinations: MENACTRA vaccine (lot number U4418AA, dose 1, IM, Left Deltoid): Hepatitis A vaccine (Merck, lot number 0535AE, dose 1, right deltoid); and HPV vaccine (Merck, lot number H021608, dose 1, right deltoid). At an unspecified amount of time after receiving the vaccinations the patient started feeling sick to her stomach. She lay down on the exam table, felt better and was going to check out of the clinic when she said she felt sick to her stomach again. She sat down and at that time turned white, arched her back and her head flew forward and bobbed. Her hands turned inward (posturing), and her eyes rolled back. She was incontinent of urine and unresponsive. The episode lasted for 2-3 minutes. Per the reporter, there was no convulsion and the doctor was present. The patient then experienced a second episode lasting 1 minute where she turned pale and her hand turned inward again (posturing). The doctor carried her to the exam table from a chair and she woke up and started talking after 10-15 minutes. The patient did not remember the episodes. She was sent by wheelchair to an emergency room (ER) located in the building and was then transferred to the pediatric trauma unit at a hospital (hospitalization was not reported). The father subsequently reported that the patient had a third episode in the ER. Recovery status was reported as "unknown." Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Blood test abnormal, Computerised tomogram normal, Infection, Local swelling, Trismus
Clinical narrative: Mother said child had "Lock jaw". Couldn't open his mouth also swelling neck area, Was directed by PMD to go to ER. Was given steroids, blood tests, CAT scan, was placed on antibiotic. Now has an appt with oral surgeon.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, VARCEL, HPV4, MNQ, VARCEL
Symptoms: Computerised tomogram normal, Laboratory test normal, Local swelling, Streptococcus test negative, Trismus
Clinical narrative: Mother said child had "Lock jaw". Couldn't open his mouth also swelling neck area, Was directed by PMD to go to ER. Was given steroids, blood tests, CAT scan, was placed on antibiotic. Now has an appt with oral surgeon.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Tiredness, light-headed, Nausea. Severe headache (10 on scale from 1-10) starting around 5pm lasting through the night into the morning.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 10cm x 8cm area of erythema (R) upper arm.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swelling at injection site swollen/red area 5 x 5.5cm.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Discomfort, Feeling hot
Clinical narrative: Patient took 1st dose of oral Typhoid 6/11/13 at 7pm and began to have abd. pain and "tightness" of abdomen 6/12/13 (Wed) accompanied by cramping and general "uncomfortableness". Took 2nd dose Thurs at 10:30 pm with "lots of water" and at 01:00 am had severe stomach pain, backache, and mom states she was "doubled over" by 4am. Was "hot with waves of pain". Went to MD that morning - blood work done but mom doesn't know which labs were drawn. She was also dx with UTI and was having her menstrual cycle. Her mom believes all 3 things most likely contributed to her symptoms. She was put on antibiotics, encouraged to eat something and eventually felt better that day and slept approx 15 hrs. Call on 6/18 to mom, and she said patient is fine now.
Age: 15.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Urinary tract infection
Clinical narrative: Patient took 1st dose of oral Typhoid 6/11/13 at 7pm and began to have abd. pain and "tightness" of abdomen 6/12/13 (Wed) accompanied by cramping and general "uncomfortableness". Took 2nd dose Thurs at 10:30 pm with "lots of water" and at 01:00 am had severe stomach pain, backache, and mom states she was "doubled over" by 4am. Was "hot with waves of pain". Went to MD that morning - blood work done but mom doesn't know which labs were drawn. She was also dx with UTI and was having her menstrual cycle. Her mom believes all 3 things most likely contributed to her symptoms. She was put on antibiotics, encouraged to eat something and eventually felt better that day and slept approx 15 hrs. Call on 6/18 to mom, and she said patient is fine now.
Age: 19.0
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 19 year old patient. On 19-JUN-2013, the patient was vaccinated with an expired dose of 0.5 ml GARDASIL, (lot # 1569Z, expiry date 05-APR-2013). Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On 07-JUN-2013 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot # J001010, expiry date 24-APR-2014) subcutaneous to the "upper arm". Approximately on 07-JUN-2013, the patient experienced "redness, 10 cm by 5cm, in an oval shape" at the injection site and the redness has lasted "about 7 days now (14-JUN-2013)". There were no lesions or vesicles with the redness. Warm compress was given as a treatment. The patient had sought medical attention via contact pharmacy. The outcome of the patient's adverse events was reported as not recovered/not resolved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a Nurse Practitioner via a representative refers to a patient of unknown age and gender. No medical history was reported. On an unknown date in 2009, the patient was vaccinated with dose 1 of GARDASIL (lot#, expiry not reported) and received the second dose on an unknown date in 2010. No concomitant medications were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. On 01-JAN-2013 the patient was vaccinated with ZOSTAVAX (route, dose and lot # were unknown). The patient developed shingles after 6 months(in June 2013) of having the shot. The outcome of event was unknown. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a 22 year old female patient. No medical history was reported. The healthcare worker reported that the patient was in office on 19-JUN-2013, to receive the third dose of GARDASIL (lot#, expiry not reported). On 12-JUN-2012, the patient received dose 1 of GARDASIL (lot #, expiry not reported) and on 17-AUG-2012, patient received the second dose of GARDASIL 0.5 ml, intramuscularly. No adverse effect reported. Additional information has been requested.