chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 year old patient (unspecified gender). On 23-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: Information has been received from a Licensed Practical Nurse referring to a 21 year old female patient. On unknown dates the patient was vaccinated with all three doses of an unspecified Hepatitis B vaccine injection (manufacturer unknown) as a child. Then the patient had titers drawn on an unspecified date for Hepatitis B immunity. The titer results were negative for Hepatitis B. The patient did not seek medical attention. No treatment was given to the patient. At the time of this report, the event outcome was unknown. The causality between the event and the vaccination was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 6 unspecified infants of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On 01-JUL-2015, the patients were vaccinated with a dose of improperly stored RECOMBIVAX HB (doses and routes of administration were not reported, lot number K010535 and expiration date 27-AUG-2016, lot number K010535 and expiration date 27-AUG-2016, lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information about patient's pertinent medical history, concurrent medical conditions, concomitant medications, drug reactions or allergies was provided. On an unspecified date in 2012, the patient was vaccinated with the third dose of MMR II, lot # 0873aa, expiration date 06-JUN-2013 (dose and route were not reported). No adverse experience was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning unspecified patients of unknown age and gender. The reporter stated that on unspecified dates, since 11-MAY-2015, unspecified patients have been administered doses of improperly stored oral, ROTATEQ (dose, frequency and route of administration not reported) (lot # K004731, expiration date 10-DEC-2015; lot # K010221, expiration date 12-MAY-2016) exposed to temperatures outside of the recommended range. No adverse experience has been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 1 unspecified infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-JUL-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 and expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Since 23-JUN-2015, the patients were vaccinated with doses of GARDASIL lot # K009482, expiration date: 06-MAR-2017 which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient called 08/06/15 to complain of a rash on arms and took BENADRYL tabs and cortisone topical cream. Asked patient to watch if it progressed called 08/07/15 5pm contacted MD at once. 8/7/15 per MD- x2 tab 5mg x10D.
Age: 57.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient called 08/06/15 to complain of a rash on arms and took BENADRYL tabs and cortisone topical cream. Asked patient to watch if it progressed called 08/07/15 5pm contacted MD at once. 8/7/15 per MD- x2 tab 5mg x10D.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Pain in extremity
Clinical narrative: Patient presented with huge red area around shot area. Sent her to E.R. and she was given an antibiotic. Not sure if infected by flu shot or just adverse effect. Her arm became sore and red shortly after receiving vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Significant hives within 5 days of vaccinations required ER visit x1 and office visit.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Nausea, Peripheral swelling, Urticaria
Clinical narrative: Swelling and hives of upper arm. Dizziness and nausea. Treatment -> Prednisone 20mg (2 tabs po qd) x 5 days.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Pt received PREVNAR 13 injection at pharmacy on 8/11/15. She had already been immunized with PREVNAR 13, in the office, on 4-15-15.
Age: 0.44
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given to unrecommended age.
Age: 0.33
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to patient at 4 month well check but is not recommended in children under the age or 4 yrs.
Age: 0.34
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX was given at 4 month well check and is not recommended in children under 4 years of age.
Age: 0.42
Sex: F
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX given to patient at 4 month well check and is not recommended in children under the age of 4 years.
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: 8/8/15 low grade fever 100.2, muscle aches, headache, nausea, baseball sized lump at injection site-hard, hot and painful. 8/10/13-other symptoms resolved-only baseball sized lump, hard, hot and painful persists.
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: 8/8/15 low grade fever 100.2, muscle aches, headache, nausea, baseball sized lump at injection site-hard, hot and painful. 8/10/13-other symptoms resolved-only baseball sized lump, hard, hot and painful persists.
Age: 1.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema multiforme, Rash
Clinical narrative: Eruption. Erythema Multiforme present for 24 hours.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Syncope
Clinical narrative: Syncope and collapse after receiving vaccinations listed below. Patient was lightheaded as he stood up. Rested on floor after woken with ammonia salts for about 15 minutes. Appeared WNL after rest. Mom commented patient had nothing to eat all day and doesn't sleep well at night. Played basketball in 90 degree weather. Followed up with parents on 7/29/15 patient is okay.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Speech disorder
Clinical narrative: Felt dizzy not first 15 min but for 20 min after the 15 min initial wt time. Also c/o 10 min of difficulty vocalizing.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Nausea, Somnolence
Clinical narrative: Pt stated nausea, dizziness shortly followed by shortness of breath and extreme drowsiness.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 7.0
Sex: M
Vaccine: HEPA
Symptoms: Nodule, Urticaria
Clinical narrative: Mother called on-call nurse at 8:44 PM on 8/5/15 stating pt got Hep A in office and now has baseball size knot on back and whelps on face. No local reaction at injection site. Pt was otherwise fine.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant, referring to an unspecified number of patients of unknown age and gender. Neither medical history nor concurrent conditions were reported. On 17-JUL-2015, 20-JUL-2015 and 21-JUL-2015, the unspecified number of patients were vaccinated with improperly stored PROQUAD (Merck) (route unknown, lot # L008356, expiration date 11-SEP-2016 and lot # K023363, expiration date 20-MAY-2015). No adverse effects were reported. No product quality complaints were reported. No further information provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 1 unspecified infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 07-JUL-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 and expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning a 7-year-old patient of unknown gender and ethnicity. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with the first dose of GARDASIL (dose, lot number, expiration date and route of administration were not reported). The patient did not seek medical attention. The second and third dose of GARDASIL have not been administered to the patient. No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Within minutes patient became pale, diaphoretic, light headed.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 1 unspecified infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-JUL-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 and expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were administered doses of MMR II (lot # K015374, expiration date 18-SEP-2016 and lot# K007108, expiration date 16-MAY-2016) and MMR II albumin status unknown (lot/batch # reported as K005100 (not valid for MMR II), expiration date 04-APR-2016 (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 12-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported). Lot # of the M-M-R II the patient received could be one of the following numbers: lot # K014832 with expiration date: 14-SEP-2016, K021152 with expiration date: 02-NOV-2016 and K015375 with expiration date: 18-SEP-2016. But it was not specified which lot # the patient received. All the lot # had been verified to be a valid lot number for M-M-R II. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist referring to a 65 year old female patient. The patient's concurrent condition included spots found during breast reduction surgery in November 2014. The patient had no drug allergies. On 05-AUG-2015 the patient was vaccinated with ZOSTAVAX (lot # K020187 with expiration date of 27-JAN-2016, 0.65 ml, subcutaneous). Concomitant therapies included FOSAMAX. On 07-AUG-2015, the patient had a rash above her upper lip. No lab diagnostics studies were performed. The dermatologist prescribed VALTREX for the rash above her lip. The patient applied triple antibiotic ointment. The outcome of rash was recovering No product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unspecified day, these patients were vaccinated with improperly stored PEDVAXHIB (lot # L002867, expiration date: 11-NOV-2017; lot# L006546, expiration date: 27-NOV-2017; lot# J007097, expiration date: 14-MAR-2016; lot# J007414, expiration date: 14-MAR-2016; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unspecified day, these patients were vaccinated with improperly stored GARDASIL (lot # K007828, expiration date: 02-MAR-2017; lot# K011562, expiration date: 08-APR-2017; lot# J006850, expiration date: 31-MAR-2016; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 1 unspecified infant of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-JUL-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route of administration were not reported, lot number K010535 and expiration date 27-AUG-2016 or lot number K020216 and expiration date 17-SEP-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 15-JUN-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported). Lot # of the M-M-R II the patient received could be one of the following numbers: lot # K014832 with expiration date: 14-SEP-2016, K021152 with expiration date: 02-NOV-2016 and K015375 with expiration date: 18-SEP-2016. But it was not specified which lot # the patient received. All the lot # had been verified to be a valid lot number for M-M-R II. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On an unspecified day, these patients were vaccinated with improperly stored PNEUMOVAX 23 single dose vial (SDV) (lot # K006681, expiration date: 21-OCT-2015; strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent condition was not provided. On an unknown date the patients were vaccinated with improperly stored GARDASIL (lot# K008931 with expiration date of 04-MAR-2017, lot# K008213 with expiration date of 17-DEC-2015, lot# K011562 with expiration date of 08-APR-2017) (dose strength and route unknown). No concomitant therapy was provided. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Since 23-JUN-2015, the patients were vaccinated with doses of ROTATEQ lot # K022990, expiration date: 26-JUN-2016 which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. In 2012 the patient was vaccinated with the first and second dose of GARDASIL (lot#, expiration date, dose, strength and route unknown). On 14-AUG-2015 the patient came to the physician's office to receive the third dose of GARDASIL (lot#, expiration date, dose, strength and route unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not provided. On 02-JUL-2015, the patient was vaccinated with one dose of improperly stored PEDVAXHIB (lot # K002818, expiry date 10-DEC-2016, dose and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Since 23-JUN-2015, the patients were vaccinated with doses of GARDASIL 9 lot# reported as l006547, expiration date: 04-MAR-2017 which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. Lot number L006547 has been verified to be a non-valid lot number for GARDASIL 9 however it is valid for GARDASIL. This is one of several reports received from the same reproter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 68 year old female patient. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was unspecified by the reporter. On 24-JUN-2015, the patient was vaccinated with the first dose of ZOSTAVAX (lot# L000449, expiration date: 08-MAR-2016) (dose and route of administration were not reported). On an unspecified date approximately in 2015, the patient experienced shingles. The patient sought medical attention via unspecified doctor's office. There was no product quality complaint. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot# K008820 with expired date 19-JUN-2016, lot# K012487 with expired date 03-NOV-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since an unspecified date in May 2015 (exact date unspecified, approximately in 2015), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # K008877, expiration date 24-FEB-2017, dose and route not reported). Information regarding concomitant medications was not reported. No adverse effected reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 77 year old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On 04-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (strength reported as 19400 plaque-forming units (PFU), lot# reported as J008023, expiry date February 2016; dose and route of administration were not reported). There were no concomitant therapies reported. On 13-JUL-2015, the patient experienced shingles. The patient sought medical attention (office visit on an unspecified date). The reporter stated that the patient's physician requested a lot check to see if there were any problems with the ZOSTAVAX the patient received. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The relatedness between ZOSTAVAX and the event was not provided. Lot# J008023 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Pallor, Syncope
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 11 year old male patient. The patient's concurrent conditions and concomitant medicines were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (lot# and expiry date were not provided), 0.5 ml, intramuscularly. On an unknown date, right after administration of GARDASIL 9, the patient turned white and fainted. Nurse laid the patient down, gave him cold compress on injection site and he regained consciousness within minutes. She also gave him some juice (after the patient regained consciousness) but he fainted again for the second time. The patient regained his consciousness within minutes again and nurse kept him in the office for additional 30 minutes for observation. He fully recovered within that 30 minutes and was sent home. The relatedness between the events and therapy with GARDASIL 9 was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since an unspecified date in May 2015 (exact date unspecified, approximately in 2015), the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K016279, expiration date 24-APR-2016, oral, dose not reported). Information regarding concomitant medications was not reported. No adverse effected reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) concerning a 14 year old male patient. No concurrent conditions or medical history were reported. On an unknown date, the patient was vaccinated with his first dose of GARDASIL 9 (dose, lot #, expiration date and route were not reported) and then, on unspecified date, received his second dose of GARDASIL (Lot No., expiration date, dose, route and anatomical location of administration were not reported). No adverse effect reported. It was unknown if the patient sought medical attention. No product quality complaint was involved. At the time of the report, the outcome of interchange of vaccine products was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 10-FEB-2012, the patient was vaccinated with the first dose of ZOSTAVAX (lot #, expiration date, route and site of administration were not reported) and subsequently on 06-AUG-2015, the patient was vaccinated with the second dose of ZOSTAVAX (lot #, expiration date, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K003407 and expiry date: 06-MAR-2016)(dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. No product quality complaint (PQC) was filed. The outcome of incorrect product storage was unknown. This is one of several reports of the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Incomplete course of vaccination, Syncope
Clinical narrative: Information has been received from a medical assistant via field representative referring to a male patient of unknown age. Patient's concurrent condition included anxiety. His relevant medical history and drug reactions/ allergies were unspecified. On an unspecified date in July 2015 (reported as within the last two weeks), the patient was vaccinated with intramuscular dose of GARDASIL (strength, dose, frequency, lot # unspecified). It was confirmed that the vaccine was not GARDASIL 9. Concomitant therapies included Tdap and MENACTRA. Reporting medical assistant stated that the patient fainted in the office after receiving vaccination with GARDASIL. Patient sought medical attention on an unspecified date. No treatment was given for the adverse event. Reporting medical assistant stated that the patient decided not to complete the vaccination series with GARDASIL (inappropriate schedule of drug administration). Outcome of the event, syncope was reported as recovered. Reporting medical assistant did not assessed the causality of the event with respect to vaccination with GARDASIL. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from the Department of Public Health newsletter refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the unspecified patients were vaccinated with doses of M-M-R II injection (strength, dose, route of administration, lot# and expiry date were not reported). It was reported that the patients received two doses of M-M-R II. There were no concomitant therapies reported. On an unknown date, the patients experienced mumps. The outcome of the event was unknown. The relatedness between M-M-R II and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: L008269 and expiry date: 11-MAR-2017) (dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. No product quality complaint (PQC) was filed. The outcome of incorrect product storage was unknown. This is one of the several reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot# reported as L008660, expiration date 10-NOV-2016, dose, frequency and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient (unspecified gender). On 22-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 single dose vials (lot# K021030, expiration date 22-JUN-2016, dose, frequency and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse via Poison and Drug Center (PDC) refers to a patient of unknown gender between the age of 2 years and 5 years old. The patient's relevant medical history, past drug history and concomitant medications were unknown. On 26-MAY-2015, the single dose vial of PROQUAD (Merck) underwent temperature excursions 5.3 degrees Celsius for 2 hours and 8 minutes, on 07-JUL-2015 underwent temperature excursions 8.9 degree celsius for 1 hour and 28 minutes, on 28-JUL-2015 underwent temperature excursions 0.4 degrees celsius for 1 hour and 25 minutes. On 28-JUL-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K020748 and expiration date 30-APR-2016) via injection (dose, frequency and indication were unknown). The patient had not experienced any adverse events. It was unknown if there was any relevant laboratory data. As of 05-AUG-2015, it was unknown if the patient continues on PROQUAD (Merck). This is one of the eight reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB INJ 10/1.0 MCRG/ML (microgram/milliliter) lot # L010595, expiration date- 12-NOV-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. Additional information is not expected because we cannot contact physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) injection (Lot number: L006390 and expiry date: 25-AUG-2016) (dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. No product quality complaint (PQC) was filed. The outcome of incorrect product storage was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and current conditions were not provided. On 12-JUN-2015, the patient was vaccinated with a first dose of GARDASIL 9 (lot #, expiration date, dose and route were not reported). On 13-JUL-2015, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose and route were not reported) as the second dose in vaccination series. No adverse effects were reported. The outcome of interchange of vaccine products was unknown. The relatedness between interchange of vaccine products and suspected therapies was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K003407 and expiry date: 06-MAR-2016) (dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. No product quality complaint (PQC) was filed. The outcome of incorrect product storage was unknown. This is one of the several reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker/medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 27-APR-2015, the patients were vaccinated with exposed to temperatures outside of the recommended range, VAQTA (dose, route of administration were not reported, lot number: K000943, expiry date: 24-SEP-2016, lot number: K012457, expiry date: 04-JUN-2017). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (L.V.N) refers to a multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. In unspecified dates during July 2015, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (dose and route were not reported) lot # K022446 expiry date: 13-MAY-2016, lot# L011080 expiry date: 01-OCT-2016, lot# L005297 expiry date: 17-AUG-2016. There was no concomitant medication provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L006384, expiry date 25-FEB-2017, (dose, frequency and route of administration not provided). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("since 16-APR-2015") the patients were vaccinated with doses of M-M-R II (lot # K002528, expiration date 18-FEB-2016; lot # K005175, expiration date 10-APR-2016) (dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates in 2015 ("since 16-APR-2015") the patients were vaccinated with doses of RECOMBIVAX HB (lot # K021581, expiration date 24-OCT-2016) (dose and route were not reported), which were exposed to temperatures outside of the recommended range. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions of the patient were reported. On 10-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) injection (Lot number: L006390 and expiry date: 25-AUG-2016) (dose, frequency and route not reported). No concomitant medications were reported. No adverse experiences were reported. The outcome of incorrect product storage was unknown. No product quality complaint (PQC) was filed. This is one of the several reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to an unspecified number of unspecified patients of unknown age and gender. Medical history and drug allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot#, reported as L010596, expiration date 06-APR-2017, route of administration, dose and frequency were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient (unspecified gender). On 15-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (lot # K004795 with expiration date: 11-FEB-2016), (strength, dose, frequency and route were not reported), which was improperly storage. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker/medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 27-APR-2015, the patients were vaccinated exposed to temperatures outside of the recommended range ROTATEQ (dose, route of administration were not reported, lot number: K013868, expiry date: 27-MAY-2016, lot number: K023535, expiry date: 22-MAY-2016). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker/medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, since 27-APR-2015, the patients were vaccinated with exposed to temperatures outside of the recommended range GARDASIL (dose, route of administration were not reported, lot number: K005881, expiry date: 14-JAN-2017). No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient (unspecified gender). On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. 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 nurse practitioner refers to an unspecified patient of unknown age and gender. No information on patient's medical history or concurrent conditions was provided. On an unknown date in 2012, the patient was vaccinated with the first dose, and on 18-AUG-2015, with the second dose of GARDASIL injection (dose, route of administration, lot# and expiration date were not provided for both). No information on patient's concomitant medications was provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with PROQUAD (Merck) lot number L007228 and L016395 with expiration date 03-SEP-2016 and 08-OCT-2016, respectively (route was not provided). On an unknown date, there was an incorrect product storage as the unspecified number of patients received the improperly stored PROQUAD (Merck). No adverse event was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. This is one of several reports received from the same source. Additional information has been requested.