chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Injection site reaction, area was very red, firm and weeping following injection. No treatment given.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1 week after vaccine c/o redness and swelling at site. Tender to touch no c/o fever.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot# reported as L034660 with an expiration date 04-FEB-2018 (doses and route of administration were not reported). Administered doses of RECOMBIVAX HB experienced temperature excursion of 34.3 degrees Fahrenheit for 24 hours and 15 minutes, on an unknown date. No adverse effect were reported. Digital data logger was involved. On an unknown date, reported as currently, there was a second temperature excursion of 48 degrees Fahrenheit for 3 hours but none vaccine was administered to the patient. Lot number L034660 is an invalid lot number for RECOMBIVAX HB. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warm to touch area at imm. site. Afebrile. 3x4 cm area non tender.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 17-NPV-2016, an unspecified patient was administered and expired dose of ZOSTAVAX (lot # L028284 expiration date: 28-OCT-2016) (dosing details and anatomical location unknown) subcutaneous. No adverse effects reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Eyelid disorder, Eyelid irritation, Eyelid pain, Eyelid rash
Clinical narrative: This spontaneous report was received from a 70 year old female consumer referring herself. The patient had no medical history, concurrent conditions or drug reactions/allergies reported. On an unknown date in 2015 reported as "towards the end of the summer in 2015", the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (Lot #, expiration date, strength, dose and frequency were not reported). No concomitant therapies were reported. On approximately 25-OCT-2016, the patient developed shingles, furthermore she developed a rash on her face, eyes and ears. The patient also had a lot of eye irritation since an unspecified date. On an unknown date, the patient visited her physical, who treated her with cephalexin and other unspecified medications, which helped her to clear up her single symptoms (recovering), but she was still experienced some pain and irritation around her eyes(not recovered). No laboratories or diagnostics studies were performed. No Product Quality Complaint (PQC) was involved. The causality between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 70 year old female consumer referring herself. The patient had no medical history, concurrent conditions or drug reactions/allergies reported. On an unknown date in 2015 reported as "towards the end of the summer in 2015", the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (Lot #, expiration date, strength, dose and frequency were not reported). No concomitant therapies were reported. On approximately 25-OCT-2016, the patient developed shingles, furthermore she developed a rash on her face, eyes and ears. The patient also had a lot of eye irritation since an unspecified date. On an unknown date, the patient visited her physical, who treated her with cephalexin and other unspecified medications, which helped her to clear up her single symptoms (recovering), but she was still experienced some pain and irritation around her eyes(not recovered). No laboratories or diagnostics studies were performed. No Product Quality Complaint (PQC) was involved. The causality between the events and therapy with ZOSTAVAX was not reported. 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 physician concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236, expiry date: 31-MAR-2018 and lot # M000442, expiry date: 31-MAR-2018, (Strength, dose and route were not reported), which underwent temperature excursions of 31.3 Fahrenheit degrees for 119 hours 15 minutes, 46.5 Fahrenheit degrees for 30 minutes and 30.8 Fahrenheit degrees for 108 hours on unspecified dates. No previous temperature excursions were reported. Data logger was involved. No adverse symptoms were reported. This is one of several reports received from 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 physician concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # L023232, expiry date: 25-FEB-2017 (Strength, dose and route were not reported), which underwent temperature excursions of 31.3 Fahrenheit degrees for 119 hours 15 minutes, 46.5 Fahrenheit degrees for 30 minutes and 30.8 Fahrenheit degrees for 108 hours on unspecified dates. No previous temperature excursions were reported. Data logger was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: TD
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Weakness in right arm and pain at injection site.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K002036, expiration date 10-FEB-2016, 0.5 ml, subcutaneously (SQ)). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that on 10-NOV-2015, the vaccine was exposed to temperature of 55.9 Fahrenheit degrees (F) for 1190 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU4, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. No medical history, concomitant therapies, drug reactions and allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (lot # was either M023380, expiry date 11-MAY-2018 or M028549, expiry date 07-JUN-2018 (the reporter was unable to specify which one was administered)), dose and injection route and site were not reported). Data logger was involved. On an unknown date, the vaccine was stored at temperature of 11.5F (also reported as 12 F), time frame was reported as 18 days and 19 hours. There was no previous temperature excursions. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients (reported as 3 to 4) of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the first dose of VAQTA (dose, route, lot # and expiration date were not reported). It was stated that the patients received the second dose of VAQTA one month after their first dose (dose, route, lot # and expiration date were not reported). No adverse effects were reported. There was no a product quality complaint (PQC) involved. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Pain
Clinical narrative: 1 week of throbbing pain, sore, inflamed, no discoloration at the site of injection.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Arm pain, difficult time moving her arm, myalgias.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Urticaria
Clinical narrative: 11-17-16 Pt. developed hives approximately 6-7 hours after receiving the KINRIX vaccine. Hives were on her arms, trunk, legs. Recommended BENADRYL PO. 11-18-16 Hives were not present in the morning, but developed late morning on arms, face - milder case. 11-21-17 Hives on face very few. Getting milder each day.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Soreness at injection site (shoulder) Redness and swelling - right bi-cep. Slight headache.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Hypoaesthesia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient started feeling arm stiff and numb, and started with fevers of 104F about 1 1/2 hr after getting vaccinated. Later that night she developed a red large hot bump around the injection site. C/O running nose and cough, still not better.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pyrexia, Rhinorrhoea
Clinical narrative: Patient started feeling arm stiff and numb, and started with fevers of 104F about 1 1/2 hr after getting vaccinated. Later that night she developed a red large hot bump around the injection site. C/O running nose and cough, still not better.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Viral rash
Clinical narrative: Patient received vaccine 11/17/16 approximately 4pm. Evaluate in my office for rash. Rash appears to be a viral exanthem 5th's disease. Timing of rash after vaccine of interest.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Pt. given MMR vaccine while pregnant did not know she was pregnant.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, lot # L039638 with an expiration date 23-AUG-2017, lot # L047185 with an expiration date 17-SEP-2017 (doss were not reported). Administered doses of ROTATEQ experienced temperature excursion with temperature range from 46.4 degrees Fahrenheit to 58.24 degrees Fahrenheit for 319 minutes. There was no previous temperature excursion. There was digital logger involved. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from 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 physician and refers to a multiple unspecified patients of an unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates between August 2016 and November 2016, the patients were vaccinated with improperly stored doses of VAQTA lot # I015460 with an expiration date 20-JUL-2017 for (dose and route of administration were not reported). No adverse effect was reported. Administered doses of VAQTA experienced temperature excursion of 0 degrees Celsius for 285 hours and 20 minutes in August 2016, 285 hours an 20 min in September 2016, 223 hours and 20 minutes in October 2016 and 200 hours in November 2016. There was no previous temperature excursion. Digital data logger was involved. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 16-AUG-2016, the patient received the 1st dose of RECOMBIVAX HB (dose, route, lot# and expiration date unknown). On 07-NOV-2016, the patient was in the facility to receive the 2nd dose of RECOMBIVAX HB (dose, route, lot# and expiration date unknown). This was outside the recommendations per the RECOMBIVAX HB prescribing information. No adverse effects were 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 nurse referring to unspecified amount of patients of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On multiple dates, the patient were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # reported as M02734, expiration date 01-JUN-2018, dose, dose number and route were not provided). There was no store information provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Injection site warmth, Wrong technique in product usage process
Clinical narrative: This spontaneous report was received from a pharmacist regarding 2 unspecified female patients (sisters) of unknown age. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were reported as unknown. On 18-NOV-2016, both the patients were vaccinated with GARDASIL 9 (lot # L001312 with expiration date 24-FEB-2017) (dose, frequency, route and anatomical location not reported). The patients' mother not pushed in all of the way. It was unknown whether these doses were the first doses of GARDASIL 9 for these patients. On the same day, the injection site for both patients was "hot to the touch". The outcome of injection site warmth was unknown. Causality assessment was not provided by the reporter. There was no Product Quality Complaint (PQC) involved. 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 registered nurse refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 05-NOV-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, injection (intramuscularly, lot # M020521, expiration date: 17-NOV-2017; dose was not provided). There was no adverse effect reported. The dose of administered vaccine was exposed to the temperature excursion of 0.8 degrees Celsius for 14 minutes. There were no previous temperature excursion. Digital Data Logger was involved. 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 pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (lot# reported as L003959, expiration date: 05-FEB-2017) (dose, route of administration and injection site were not provided). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 11.8 degrees Celsius for 40 hours. Data logger was not involved. The previous excursions were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant also a office manager regarding a 25 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-NOV-2016 or 17-NOV-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M009378, expiration date: 23-APR-2018) (dose, frequency and anatomical location not reported) intramuscular. The administered dose experienced a temperature excursion of 26 F for 18 hours, 52 F for 3 hours on 16-NOV-2016 and 22F for undetermined amount of time on 17-NOV-2016. Previous temperature excursion includes 49 F for 70 hours on 14-NOV-2016. The call was not because of data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received 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 was received from a medical assistant also a office manager regarding a patient of unknown age and gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 16-NOV-2016 or 17-NOV-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot # M032650, expiration date: 31-MAR-2019) (dose, frequency and anatomical location not reported) intramuscular. The administered dose experienced a temperature excursion of 26 F for 18 hours, 52 F for 3 hours on 16-NOV-2016 and 22F for undetermined amount of time on 17-NOV-2016. Previous temperature excursion includes 49 F doe 70 hours on 14-NOV-2016. The call was not because of data logger. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (dose, lot number and expiry date were not reported), intramuscularly. On an unknown date, the patients experienced injection site pain and had a hot lump on the arm. They sought medical attention and contacted the pharmacist. The outcome of the events was unknown. The causality assessment was not provided by the reporter, There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 16-NOV-2016, the patient was inadvertently vaccinated with the doses of PROQUAD (dose, route of administration, lot # and expiration date were not reported) and VARIVAX (subcutaneously; dose, lot # and expiration date were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a physician via a company representative referring to a 13 year old male patient. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were not reported. On 14-OCT-2015, the patient received a dose of GARDASIL 9 (lot#, expiration date, strength, dose, frequency and route unknown). On 01-NOV-2016, the patient received the second dose of GARDASIL 9 (lot#, expiration date, strength date, strength, dose, frequency and route unknown). This was outside the recommendations in the GARDASIL 9 prescribing information. No adverse effects were reported. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored dosed of PROQUAD (doses, route of administration, anatomical location, lot# and expiration were not reported). Administered dose of PROQUAD experienced temperature excursion of 35 degree Fahrenheit for 6 days, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several report 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 was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored GARDASIL 9 injection, intramuscularly (lot # L037554, expiration date: 25-DEC-2017). No adverse effects were reported. It was stated that vaccination with GARDASIL 9 was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received 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 was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (lot # L037554, expiration date: 25-DEC-2017; dose and route of administration were not reported). No adverse effects were reported. It was stated that vaccination with GARDASIL 9 was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection (lot # L037554, expiration date: 25-DEC-2017; dose and route of administration were not reported). No adverse effects were reported. It was stated that vaccination with GARDASIL 9 was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an 8 year old patient of unknown gender. There was no information about concurrent condition, concomitant medication and medical history. On 10-NOV-2016, the patient was vaccinated with a dose of GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017)(dose and route unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored GARDASIL 9 injection, intramuscularly (lot # L037554, expiration date: 25-DEC-2017). No adverse effects were reported. It was stated that the vaccination with GARDASIL 9 was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received 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 was received from a pharmacy student referring to an unspecific number of patients, of unknown age and gender. Medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M018810, expiration date 28-MAY-2016 (route, dose and frequency were not reported). The vaccine was exposed to temperature of -2.1 C, during 4 hours, 6 cycles. The call was because of data logger. No previous temperature excursions and no adverse effects were reported. There was no Product Quality Complain (PQC). This is one of several reports received 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 was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554 with an expiration date 25-DEC-2017, lot#M023169 with an expiration date 13-JUN-2018, lot# M011840 with an expiration date 01-FEB-2018 and lot# M011117 with an expiration date 07-DEC-2017. Administered doses of GARDASIL 9 experienced temperature excursion with temperature range from 46.4 degrees Fahrenheit to 58.24 degrees Fahrenheit for 319 minutes. There was no previous temperature excursion. There was digital data logger involved. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. No medical history, concurrent condition or concomitant medication was provided. On multiple unspecified dates, the patients was vaccinated with improperly stored doses of VARIVAX (lot# was reported as M023324 (invalid), expiration 15-MAY-2018) or (lot# M028553), expiration date 09-JUN-2018) (dose and route unspecified). The vaccines were stored in 3.2 Celsius for 1 hour and 37 minutes. There was no previous temperature excursion. Data logger was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction/allergies or concomitant information was not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 lot #: M028323 with expiration date: 26-SEP-2018, lot #: M023169 with expiration date: 13-JUN-2018 and lot #: M009378 with expiration date: 23-APR-2018 (dose and route were not provided). The reporter stated that the GARDASIL 9 vaccines were exposed to -2.2 C for 41.4 hours and 11.6 C for 149 hours. Additionally, the improperly stored doses were administered from 15-SEP-2016 thru 01-NOV-2016. No adverse event was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested
Sex: F
Vaccine: HPVX
Symptoms: Human papilloma virus test positive
Clinical narrative: Information has been received from an author in a published literature article. The objective was to determine trends in vaccine-type HPV in young women during the 8 years after vaccine introduction, to assess changes in HPV prevalence and characterize herd protection in a community. The authors recruited 3 samples of sexually experienced, 13 to 26 years-old adolescent girls and young women for surveillance studies in 2006-2007 (n - 371), 2009-2010 (n -409) and 2013-2014 (n -400)(thereafter women: N = 1180 from 2006-2014): before widespread vaccine introduction (wave 1) and 3 (wave 2) and 7 (wave 3) years after vaccine introduction. Adolescent and young adult women who were sexually experienced, defined as having had sexual contact (genital-oral or genital-genital with a male or female partner), were eligible to participate using a sequential sampling strategy; those who had participated in the previous surveillance studies were not eligible. Authors determined the prevalence of vaccine-type quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (Manufacturer unknown) among all, vaccinated, and unvaccinated women at waves 1, 2, and 3 adjusted for differences in participant characteristics, then examined whether changes in Human Papillomavirus (HPV) prevalence were significant using inverse propensity score-weighted logistic regression. Among vaccinated participants, vaccine-type HPV prevalence decreased significantly from wave 1 to wave 2 and from wave 1 to wave 3. The same decreases were also significant among unvaccinated participants. The only significant change in any HPV from wave 1 to wave 3 was an increase in any HPV among unvaccinated women. In conclusion, during the first 8 years after HPV vaccine introduction, the prevalence of vaccine-type HPV decreased by >90% in vaccinated young women, demonstrating high effectiveness in a community setting even in sexually experienced young women who may have already been exposed to HPV. This case refers to 26 female patients in wave 2 and 11 female patients of unknown age in wave 3 who participated in the study. On unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (Manufacturer unknown) (strength, dose, frequency and route of administration were not reported). On unknown dates, the patients were positive for Vaccine-Type HPV. The outcome of the event was unknown. The author considered "positive for Vaccine-Type HPV" to be related to Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recomb. Vaccine (Manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from office manager (other health professional) refers to a patient of unknown age. Pertinent medical histories, current conditions and concomitant medications were not reported. On 21-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dosage regimen were not reported) (Lot # M041394, expiry date: 23-MAY-2018) that may have experienced a temperature excursion in transit as it was delivered later than scheduled to the practice. The vaccine was shipped on 18-NOV-2016, and was received on 21-NOV-2016. The vaccine was supposed to be a two-day shipment. Temperature excursion data was unknown since the excursion was related to a late shipment. Data logger was not used to log temperatures and there were no previous excursions. No adverse effects were reported. The outcome of incorrect product storage and no adverse event were unknown. No additional information provided. Lot number M041394 has been verified to be a valid lot number for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Pertinent medical histories, current conditions and concomitant medications were not reported. On 12-NOV-2016 date, the patient was vaccinated therapies included M-M-R II (dosage regimen were not reported) and on 19-NOV-2016 patient was again vaccinated with ZOSTAVAX (dosage regimen were not reported). The minimum spacing between the M-M-R II and ZOSTAVAX was too short. No adverse effects were reported. No further information was provided. Let number M034765 has been verified to be a valid lot number for ZOSTAVAX. Lot number M016233 has been verified to be a valid lot number for M-M-R II. Additional information is not expected as the reporter did not give is consent to contact.
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Information was received from a 46 year old female consumer referring to herself. The patient's drug reactions/ allergies were unknown. The patient's pertinent medical history included chickenpox (at 14 years old) and car accident. Concomitant therapy included warfarin. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route not reported). On an unknown date, the patient experienced fever. The patient did not seek any medical attention. No treatment was given for this event. The outcome of the event was unknown. The relationship between the event and PNEUMOVAX 23 was not reported. Additional information is not expected as there is no consent to contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, multiple patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M000592, expiration date: 12-OCT-2017, lot # reported as M007307 and was invalid lot number for PNEUMOVAX 23, expiration date: 30-OCT-2017) (dose and route not provided). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was 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: Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, multiple patients were vaccinated with improperly stored ROTATEQ (lot # M007298, expiration date: 19-OCT-2017; lot # M005732, expiration date: 19-OCT-2017) (dose and route not provided). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was 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: Information has been received from a nurse concerning unspecified number of patients of unknown age and gender. The patients' concurrent condition, concomitant medications and medical history were not provided. On an unknown dates, the patients were administered improperly stored doses of ROTATEQ (lot # L008054, expiration date 30-NOV-2016; lot # M002252, expiration date 28-FEB-2017) (strength, dose, frequency and route were not reported). It was reported that the vaccines were exposed to a temperature of excursion 14.3 Celsius degree for 10 hours and 42 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was 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 multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, multiple patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M029233, expiration date: 09-AUG-2018; lot # M026309, expiration date: 11-NOV-2018) (dose and route not provided). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 Celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient's information about concurrent condition, medical history, drug reactions/allergies and concomitant therapy was not provided. On 08-NOV-2016, the patient  inadvertently received an expired dose of M-M-R II (expiration date: on an unspecified date in August 2016) (lot# and dose were not reported) subcutaneously. 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 Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB with lot number M025194 and expiration date of 22-MAR-2019 (strength, route of administration and dose were unknown), which was stored at 35 Fahrenheit degrees for 1 hour and 47.5 Fahrenheit degrees for 1 hour. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Dermatitis contact, Rash
Clinical narrative: Information has been received via a field representative from a registered nurse referring to her daughter who was a 20 years old female patient. The patient's concomitant medication, pertinent medical history and drug allergies/reactions were not reported. On an unknown date in September 2016 (reported as "two months ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose and route were unspecified). Within 24 hours of receiving the vaccine, the patient broke out in a rash all over her chest and breasts. The patient was seen by an unspecified nurse practitioner, who said the rash looked like contact dermatitis. The patient was treated by the nurse practitioner with unspecified cortisone cream and frozen peas used as cold compress. The scenario resolved on unspecified date in 2016 and there was no further treatment for the event. No product quality complaint (PQC) was involved. The relationship between the event and GARDASIL 9 was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. The nurse reported that the patient was administered a dose of MERUVAX (dose, route, lot# and expiration date were unknown) on 21-FEB-2007 and a dose of VARIVAX (dose, lot# and expiration date unknown, subcutaneously) on 12-MAR-2007 (Drug use for unapproved schedule). The outcome of drug use for unapproved schedule was unknown. No adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies were not provided. On 13-SEP-2016 and 14-SEP-2016 two doses of improperly stored PROQUAD (dose and frequency unknown) (lot # M015698, expired date 26-SEP-2017) were administered to unspecified patients. The PROQUAD was exposed to 11F for a time frame of 12 hours 35 minutes. No adverse effects reported. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site pain
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 14 November 2016. This case involves an 87-years-old female patient who was vaccinated with a dose FLUZONE HD (batch number, expiration date, dose in series and dose was not reported) via intramuscular route in left arm on 10 October 2016. Patients Illness at time of vaccination was none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as atrial fibrillation and thyroid. Concomitant medications were not reported. On 10 October 2016, same day following the vaccination, the patient had experienced shoulder and arm pain. The arm was tender at the injection site. The pain was constant and interferes with her activities of daily living. The patient was seen by her primary care physician. Relevant laboratory data was reported as none. The tramadol was prescribed to the patient. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 87.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 14 November 2016. This case involves an 87-years-old female patient who was vaccinated with a dose FLUZONE HD (batch number, expiration date, dose in series and dose was not reported) via intramuscular route in left arm on 10 October 2016. Patients Illness at time of vaccination was none and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as atrial fibrillation and thyroid. Concomitant medications were not reported. On 10 October 2016, same day following the vaccination, the patient had experienced shoulder and arm pain. The arm was tender at the injection site. The pain was constant and interferes with her activities of daily living. The patient was seen by her primary care physician. Relevant laboratory data was reported as none. The tramadol was prescribed to the patient. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 85.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to an 85 (also reported as 86) year old female patient. Information about the patient's concurrent condition, medical history or concomitant therapy was not provided. On 11-OCT-2016, the patient was vaccinated with her second dose of PNEUMOVAX 23 (lot # M036161; dose, route and expiration date was not reported) in the right arm. The patient had no illness at the time of vaccination. On the same day, the patient's arm was red on upper right that was advised to take BENADRYL as directed. The outcome of erythema was reported as recovered on an unknown date in 2016. The causality was not reported. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist referring to an 85 (also reported as 86) year old female patient. Information about the patient's concurrent condition, medical history or concomitant therapy was not provided. On 11-OCT-2016, the patient was vaccinated with her second dose of PNEUMOVAX 23 (lot # M036161; dose, route and expiration date was not reported) in the right arm. The patient had no illness at the time of vaccination. On the same day, the patient's arm was red on upper right that was advised to take BENADRYL as directed. The outcome of erythema was reported as recovered on an unknown date in 2016. The causality was not reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain, Blood test normal, Electrocardiogram normal, Flank pain, Human chorionic gonadotropin negative
Clinical narrative: Presented with uncontrollable shaking, fast breathing, abdominal and flank pain.
Age: 38.0
Sex: F
Vaccine: ANTH
Symptoms: Respiratory rate increased, Tremor, Urine analysis normal
Clinical narrative: Presented with uncontrollable shaking, fast breathing, abdominal and flank pain.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Contusion, Injection site pain, Injection site reaction, Musculoskeletal pain
Clinical narrative: Pain at injection site. pain in shoulder and elbow. Bleeding enough to soak bandaid and shirt sleeve about 3 inch oval down arm. Pain continues to present 11/29. Bruise started within 24 hours. Spreads to encompass 5 inches. 11/29 bruise still visible about 2 inches and still blue. Not fading to green like normal bruise. Sharp pain at injection site when move elbow/wrist.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Pain at injection site. pain in shoulder and elbow. Bleeding enough to soak bandaid and shirt sleeve about 3 inch oval down arm. Pain continues to present 11/29. Bruise started within 24 hours. Spreads to encompass 5 inches. 11/29 bruise still visible about 2 inches and still blue. Not fading to green like normal bruise. Sharp pain at injection site when move elbow/wrist.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Laboratory test abnormal, Plasma cells present
Clinical narrative: Pain, erythema and onset of cellulitis  left upper extremity starting at the deltoid and traveling to ac space. 4-5 days later fever to 101.  Labs showed abnormal plasma lymphoid cells.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pain, erythema and onset of cellulitis  left upper extremity starting at the deltoid and traveling to ac space. 4-5 days later fever to 101.  Labs showed abnormal plasma lymphoid cells.