chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to two unspecified patients of unknown age and gender. The patients' concurrent conditions and medical histories were not reported. In approximately 2016 (reported as "on unspecified dates starting in March 2016"), the patients were each vaccinated with unspecified improperly stored doses of ROTATEQ oral liquid, orally, which had a lot # of K013868, an expiration date of 27-MAY-2016 (concentration and dose were not reported). Which were exposed to a temperature of 32.4 F for a time frame of 1 h and 15 minutes, without a previous excursion. Additionally, a data logger was involved. Information regarding concomitant therapies was not reported and no product quality complaint was involved. No adverse effect reported. This is one of two reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Diagnosed cellulitis on arm where vaccine was administered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Mass, Pain, Pruritus, Pyrexia, Skin warm
Clinical narrative: Lump as big as silver dollar, warm, raised, itching, painful and fever of 104.4 patient reports. Went to doctor and got steroid shot is taking ibuprofen as well.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant, regarding an unspecified number of patients of unknown gender and age. On unspecified dates the patients were vaccinated with improperly stored doses of VARIVAX (lot # L017998, expiration date 19-MAY-2017), dose and route were not reported. No adverse effects were reported. It was reported that the vaccines were exposed at 7F for 12 hours, and there was a past excursion at 36F for another 12 hours. This was recorded as a result of a digital data logger. This is one of two reports from the same reporter. (see MARRS 1606USA005095). 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 registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 24-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 17.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling, Injection site vesicles, Rash maculo-papular
Clinical narrative: Local swelling on left arm and blistering rash at site of injection (swelling to elbow) from 24-48 hrs, then resolved. Then on day #5 she developed a maculopapular rash across abdomen and thighs. No vesicles.
Age: 44.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema
Clinical narrative: Varicella vaccine administered 6-10-16, localized redness on 6/11/16 and developed into cellulitis on 6/12/16 seen and treated in ER.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of ROTATEQ orally reported lot # L033549 with expiration date of 05-JUN-2017 (dose number was not provided). The patients' concomitant medications were not reported. It was reported by the nurse, that ROTATEQ was exposed to a temperature of 34 degrees F for 12 hours. The aforementioned vaccine had never been involved in any previous temperature excursion. Data logger was stated. Furthermore, no adverse event symptoms were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with unspecified improperly stored dose of GARDASIL 9 which had a lot# of L044475, and expiration date of 12-MAY-2017 (concentration, dose, route and anatomical place of vaccination were not provided). Which were exposed to a temperature of 32.7 for 31 hours. There were no previous excursion and a data logger was involved. Information regarding concomitant therapies was not reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal disorder
Clinical narrative: Patient called 6/13/16, stated he has pain in all joint. Started after vaccination and has gotten worse. States that ibuprofen helps but does not make pain go away. States he has difficulty using TV remote and opening car door. Also states he stepped on a rusty nail 6/5/16.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Between 20-MAY-2016 and 31-MAY-2016 the patients were vaccinated with improperly stored ROTATEQ (lot # L023870, expiration date 20-APR-2017; lot # L035508 expiration date 12-MAY-2017; lot# L039141, expiration date 16-AUG-2017, dose was not reported). The vaccines were exposed to 8.9 Celsius degree for 44 minutes without previous excursion. The issue was due to data logger. No adverse effects were reported. This is on of the several reports 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 certified medical assistant refers to unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Between 20-MAY-2016 and 31-MAY-2016 the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date 06-OCT-2018; lot # M010212 expiration date 21-JAN-2019; route and dose were not reported). The vaccines were exposed to 8.9 Celsius degree for 44 minutes without previous excursion. The issue was due to data logger. No adverse effects were reported. This is one of the several reports 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 as received from a certified medical assistant refers to unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Between 20-MAY-2016 and 31-MAY-2016, the patients were vaccinated with improperly stored VAQTA (lot # L043209, expiration date 17-SEP-2017; lot # L045713 expiration date 14-JAN-2017; route and dose were not reported). The vaccines were exposed to 8.9 Celsius degree for 44 minutes without previous excursion. The issue was due to data logger. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Patient states multiple breakout site which she believe is herpes zoster. Pain, itching, swelling, redness also at injection site. She was prescribed VALTREX on 6/13/16.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Constipation, Headache, Influenza, Myalgia
Clinical narrative: Patient states multiple breakout site which she believe is herpes zoster. Pain, itching, swelling, redness also at injection site. She was prescribed VALTREX on 6/13/16.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Neck pain, Pruritus, Pyrexia, Viral test
Clinical narrative: Patient states multiple breakout site which she believe is herpes zoster. Pain, itching, swelling, redness also at injection site. She was prescribed VALTREX on 6/13/16.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient states multiple breakout site which she believe is herpes zoster. Pain, itching, swelling, redness also at injection site. She was prescribed VALTREX on 6/13/16.
Sex: U
Vaccine: HIBV
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. The patients were vaccinated with doses of improperly stored PEDVAXHIB with lot # L002867 (expired date 11-NOV-2017, dose and route were unknown) on 05-APR-2016, 06-APR-2016, 02-MAY-2016, 03-MAY-2016, 09-MAY-2016 and 13-MAY-2016 and PEDVAXHIB with lot # L051122 (expired date 12-OCT-2018, dose and route were unknown) on unknown dates. The vaccine with lot# L002876 was exposed under 46.3 Fahrenheit (F) for 9 hours on 01-APR-2016, 46.5 F for 70 hours on 04-APR-2016 and 46.6 for 56 hours on 11-APR-2016. The vaccine with lot # L051122 was exposed under 46.6 F for 144 hours on unknown dates. There was no previous excursion. No adverse effect was 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: 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. The patients were vaccinated with doses of improperly stored GARDASIL 9 with lot # L007560 (expired date 15-JUN-2017, dose and route were unknown) on 06-APR-2016, 12-APR-2016, 20-APR-2016, 13-MAY-2016 and 16-MAY-2016 and GARDASIL 9 with lot # L044475 (expired date 12-MAY-2017, dose and route were unknown) on unknown dates. The vaccine with lot # L007560 was exposed under 46.3 Fahrenheit (F) for 9 hours on 01-APR-2016, 46.5 F for 70 hours on 04-APR-2016 and 46.6 for 56 hours on 11-APR-2016. The vaccine with lot # L044475 was exposed under 46.6F for 144 hours on unknown dates. There was no previous excursion. No adverse effect was reported. This is one of several reports 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 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. The patients were vaccinated with doses of improperly stored ROTATEQ with lot # L000568 (expired date 10-JUL-2106, oral, dose unknown) on 05-APR-2016, 03-MAY-2016, 04-MAY-2016 and 09-MAY-2016 and ROTATEQ with lot# L033693 (expired date 31-MAY-2017, oral, dose unknown) on unknown dates. The vaccine with lot # L000568 was exposed under 46.3 Fahrenheit (F) for 9 hours on 01-APR-2016, 46.5 F for 70 hours on 04-APR-2016 and 46.6 F for 56 hours on 11-APR-2016. The vaccine with lot# L033693 was exposed under 46.6 F for 144 hours on unknown dates. There was no previous excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Measles antibody positive
Clinical narrative: Information was received from the authoers published literature, concerning a female child (age unknown). On an unknown date when the patient was a child, she was vaccinated with a dose of M-M-R II (dose and route unspecified). Although she had been vaccinated her measles antibody index (AI) was 0.7 (negative) when she was approximately 26 year old. Then she was vaccinated again with M-M-R II (dose and route unspecified). Her measles index 8 weeks after receiving M-M-R II was 2.06 (positive). The outcome of the event was considered as recovered on an unknown date. This is one of several reports received from the same source (linked with MARRS# 1602USA009550). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter referring to an unspecified number of patients of unknown age and gender. Information about the patients' medical histories and concurrent conditions was not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (administration routes, lot numbers and expiration dates were not provided). No concomitant therapies were reported. On unknown dates, the patients experienced unspecified adverse events. The outcomes of these adverse events were unknown. The reporter did not provide a causality assessment between the events and therapy with GARDASIL. Additional information is not expected, since the reporter can not be contacted.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: 6 hours after vaccination had extreme pain 7/10. Also developed limited movement in arm/shoulder that has lasted over 5 days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt. noticed local injection site pink and itchy the following day. It got larger the next day after on 6/10/16. Patient went to md and he prescriber her antibiotic for 7 day. It has gotten better as of 6/13/16.
Age: 45.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pt states that she began to feel pain in her left deltoid, as well as intense itching which began on 6-11-16. Pt presented with an induration 30 mm in diameter on her left deltoid. Pt still complained of pain and itching at this site on 6-23-16.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report has been received from a nurse practitioner via company representative referring to a 11 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies was unknown by the reporter. On 16-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9, injection (anatomical location of administration was not provided), with lot # L044479, expiration date 12-MAY-2017. Concomitant therapies included generic montelukast sodium (manufacturer unknown), omeprazole (manufacturer unknown), VENTOLIN and melatonin. On the same date, immediately after receiving vaccination, the patient felt faint and lightheaded (dizziness). The nurse practitioner reported that was unknown if she received a treatment for the event. Product quality complain was not involved. The reporter stated that was unknown if the patient sought medical attention, or need hospitalization or performed laboratory diagnostics, also was unknown if the event was life threatening or if the patient received an overdose. At the time of reporting the outcome of faint and lightheaded was reported as recovered on an unspecified date in 2016. The relatedness between the event and GARDASIL 9 was not reported. Lot number L044479 is an invalid lot number for GARDASIL 9 however is valid for ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L032403, expiry date: 26-NOV-2016). Healthcare worker stated that the vaccine underwent a temperature excursion at 9 degree Fahrenheit for 666.5 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration dates. No adverse effects were reported. This is one of the six 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 multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # K002926, expiry date: 26-FEB-2016; lot # L016125, expiry date: 06-MAY-2017). Healthcare worker stated that the vaccine underwent a temperature excursion at 9 degree Fahrenheit for 666.5 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration dates. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning to unspecified number of patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (Lot # L036823: expiration date 24-DEC-2016 and lot # M003486: expiration date 27-MAR-2017) (dose and route were not provided). No adverse effects were reported. There was no product quality complaint 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 healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (therapy type: Digital data logger; lot # L028082, expiry date: 18-SEP-2017, lot # L027282, expiry date: 21-SEP-2017). Healthcare worker stated that the vaccine underwent a temperature excursion at 49.5 degree Fahrenheit for 186 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration date. No adverse effects were reported. This is one of the six reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) concerning 5 month old patient (gender not provide). The patient's pertinent medical history and concurrent conditions were not reported. On 01-JUN-2016, the patient was vaccinated with the first dose of ROTATEQ, per oral route (Lot # and dose were not provided). Concomitant therapies were not reported. There was no product quality complaint involved. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX lot # K023621 and expiration date on 19-FEB-2016, (strength, dose, frequency, route and anatomical location were not reported). No adverse effect was reported and no product quality complaint was involved. 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 healthcare worker refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (therapy type: Digital data logger; lot # K026531, expiry date: 15-APR-2017; lot # L044917, expiry date: 05-OCT-2018). Healthcare worker stated that the vaccine underwent a temperature excursion at 49.5 degree Fahrenheit for 186 hours. There were no previous temperature excursions. Healthcare worker confirmed that the vaccine was administered on unspecified dates before their expiration date. No adverse effects were reported. This is one of the six 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 was received from a registered nurse and refers to four unspecified patients of unknown age and gender. The patients' concurrent conditions and medical histories were not reported. In approximately 2016 (reported as "on unspecified dates starting in March 2016"), the patients were each vaccinated with unspecified improperly stored doses of PEDVAXHIB which had a lot # of L030871, an expiration date of 10-JUN-2016 (concentration, dose, route and anatomical place of vaccination were not reported). Which were exposed to a temperature of 32.4 F for a time frame of 1 hour and 15 minutes, without a previous excursion. Additionally, a data logger was involved. Information regarding concomitant therapies was not reported and no product quality complaint was involved. No adverse effect was reported. This is one of two reports 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 as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 27-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 17.5 hours. Data logger was involved. 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 was received from a registered nurse, referring to 34 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. From On 04-MAY-2016 to 27-MAY-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB lot # L025738 with expiration date on 14-AUG-2017 and lot # L033343 with expiration date on 13-SEP-2017, (strength, dose, frequency, route and anatomical location were not reported). No adverse effect reported and no product quality complaint was involved. Temperature: Min 20.7 degrees F for 13 hours and 46 minutes Max 47.3 degrees F for 12 minutes. (Cumulatively over the course of 2 days 04-MAY-2016 and 05-MAY-2016). Previous excursion: No. Was data logger involved: Yes. 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, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # L013204, with expiry date on 28-JAN-2017, (strength, dose and frequency were not reported). No adverse effect was reported and no product quality complaint was reported. Temperature: 9 Celsius degrees 40 hours, administered (AE), yes, no previous temperature excursion and no data logger involved. Temperature: 9 Celsius degrees. Time frame: 40 hours. Was it administered (AE) ? Yes. Previous temperature excursion? No. Was call because of a "data logger"? No. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 61 year old female patient. Information regarding the patient's concurrent conditions included allergies to penicillin, sulfonamides and codeine.  On 08-APR-2016, the patient was vaccinated with ZOSTAVAX 0.65ml, subcutaneously, lot # L040442 with expiration date of 15-JAN-2017 (dose number was not provided). The patient's concomitant therapies included MAXZIDE. Approximately in 2016, reported as on unspecified time after receiving ZOSTAVAX, the patient developed a "systemic fatigue" (fatigue), muscle pain (myalgia) and redness at the injection site (injection site erythema). The pharmacist stated, that the patient was seen on 28-APR-2016 and she reported the adverse reaction, however no treatment was given for it. Moreover, no laboratory diagnostic studies were performed. It was reported by the pharmacist that on 09-JUN-2016, the patient came back to the pharmacy and stated that the fatigue was present but, the redness was getting better. Furthermore, no product quality issue was involved. The outcome of myalgia was unknown. The relatedness between the adverse events and vaccination with ZOSTAVAX was not reported. Additional information is not expected as consent to contact the physician was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an health professional, referring to 2 unspecified patient of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 21-MAY-2016 or after, the patients were vaccinated with a dose of improperly stored ZOSTAVAX lot # L035505 with expiry date on 16-DEC-2016 (strength, dose, frequency, route, and anatomical location were not reported). Concomitant medications were not reported. No adverse effect reported and no product quality complaint involved. Temperature: 43F. Time frame: 65hours. Was it administered (AE)? Yes. Previous temperature excursion? No. Was call because of a "data logger": Yes. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age and gender. Information on the concurrent conditions and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored GARDASIL immunization series of lot # K011562, expiry date 08-APR-2017 and lot #K008931, expiry date 04-MAR-2017 (dose #, units, frequency, route and anatomical location were not specified). Concomitant medication were not reported. There were no adverse effects reported. There was no Product Quality Complaint (PQC) involved. Temperature and time frame to which the product was exposed was 33 degree Fahrenheit for 72 hours. Temperature and time frame to which the product was exposed previously: 34 degree Fahrenheit for 72 hours and 47 degree Fahrenheit for 12 hours. This is one of several reports received 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 physician refers to multiple unspecified patients of unknown age. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # L028273 with expiry date 19-APR-2018), was exposed to a temperature of 8.4 degree centigrade for a time frame of 3 hours, 50 minutes. There was no previous temperature excursion reported. The call was because of a data logger (therapy type: digital data logger). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hypoaesthesia, Hypoaesthesia oral, Incoherent, Injection site pain
Clinical narrative: This spontaneous report was received from registered nurse via a company representative, concerning a 12 year old female patient. Information on patient's concurrent conditions, pertinent medical history or drug reactions was not reported. On 18-MAY-2016 at 08:00 hours, the patient was vaccinated with a second dose of GARDASIL intramuscularly, (dosage and anatomical location were not reported). Concomitant and co-suspect medications were not provided. On the same date, around 10:00 hours, the reporting Nurse received a call from the patient's mother who informed that her daughter experienced injection site pain, numbness, weakness in her right arm; additionally her tongue felt numb, she had blurred vision in her right eye and had a severe headache. It was also reported that the patient was incoherent and presented delayed responses. The patient sought medical attention and went to the emergency room. She was treated with TYLENOL for the severe headache and was released from the emergency room. No product quality complaint was filled. At the time of this report, it was informed that the patient had recovered from all the events. after 10 hours. However, the severe headache last 36 hours (recovering). The causal relationship between the vaccination with GARDASIL and the events was not reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Vision blurred
Clinical narrative: This spontaneous report was received from registered nurse via a company representative, concerning a 12 year old female patient. Information on patient's concurrent conditions, pertinent medical history or drug reactions was not reported. On 18-MAY-2016 at 08:00 hours, the patient was vaccinated with a second dose of GARDASIL intramuscularly, (dosage and anatomical location were not reported). Concomitant and co-suspect medications were not provided. On the same date, around 10:00 hours, the reporting Nurse received a call from the patient's mother who informed that her daughter experienced injection site pain, numbness, weakness in her right arm; additionally her tongue felt numb, she had blurred vision in her right eye and had a severe headache. It was also reported that the patient was incoherent and presented delayed responses. The patient sought medical attention and went to the emergency room. She was treated with TYLENOL for the severe headache and was released from the emergency room. No product quality complaint was filled. At the time of this report, it was informed that the patient had recovered from all the events. after 10 hours. However, the severe headache last 36 hours (recovering). The causal relationship between the vaccination with GARDASIL and the events 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 physician refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # L043622 with expiry date 03-NOV-2017 and (lot # L048462 with expiry date of 02-DEC-2017, which was exposed to a temperature of -0.7 degree centigrade for a time frame of cumulative total of 36 hours and 40 minutes. There was no previous temperature excursion reported. The call was because of a data logger (therapy type: digital data logger) (Incorrect product stored). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 54 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 23-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: This solicited report has been received from a mother's patient friend, as part of a market research program, concerning to an unknown female patient. The patient's concurrent condition, historical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose and frequency not reported). It was reported that an interview was performed to the patient's mother friend who said that before she and her daughter was taking the vaccine a friend told them that her daughter passed out after getting it (Loss of consciousness). The outcome of the event was reported as unknown. The causality between the event loss of consciousness and therapy with GARDASIL was not reported. Upon internal review, loss of consciousness was considered medically significant. Additional information is not expected as the reporter did not consent for further follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a female patient of unknown age. The patient did not have any pertinent medical history or drug reactions or allergies. The patient's concurrent conditions were not provided. On 12-MAY-2016, the patient was vaccinated with ROTATEQ, orally (lot number and dose were not reported). The patient did not have any concomitant medications. On 14-MAY-2016, the patient developed diarrhoea and a 100 degrees Fahrenheit fever. As a result, the patient was taken to the emergency room; however, no treatment was given for the mentioned events, no laboratory diagnostic studies were performed and the patient was not admitted to the hospital. The patient went home on the same date and, at that time, her status was reported as recovering from the events (reported as "she is doing better"). No product quality complain (PQC) was involved. The reporter did not provide causality assessment between the events and the ROTATEQ. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to multiple unspecified patients. On unknown dates multiple unspecified patients were vaccinated with dose of VARIVAX (lot # L037565, expiration date 29-SEP-2017; lot # L048465, expiration date 02-DEC-2017), which was improperly stored. No adverse effects reported. Additional information has been requested.
Age: 1.35
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Skin lesion
Clinical narrative: Vaccine 6/3/16 on 6/13/16 presented for other medical reasons and asked to check site. Has 70x25 mm ovoid, red, hard, raised lesion on Rt thigh, parent reports after immuniz. never got better and now worse. Dx: Cellulitis.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-JUN-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L046506, expiry date 17-MAY-2017), injection, subcutaneously (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Gaze palsy, Musculoskeletal stiffness, Pallor
Clinical narrative: Right after vaccines were given pt cried out while mom buttoned his pants. When mom picked the child up he stopped crying and stiffened up. Pt. was pale in color, pt. eyes were fixed upwards and to the left, limbs were stiff and arm straight in front of him. Pt was breathing but no response to stimulation. This lasted 1 minute. No other symptoms after.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to BEXSERO. Additional details were provided as follows: The patient's age at vaccine administration was not reported. The reporter reported to a GSK sales representative that at least one patient experienced syncope after receiving BEXSERO. The Sales representative had limited information but reporter had additional information which could be obtained by follow up.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema
Clinical narrative: 1/2" red area at inj site 36 hours following immunization.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 101.3 after immunizations.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 24-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # L040459, expiration date 06-APR-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 27.7 degrees Fahrenheit for 10 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Balance disorder, Dizziness, Dysstasia, Fall, Head injury
Clinical narrative: This case was reported by a consumer via other and described the occurrence of head injury in a female patient who received HAVRIX adult. On 24th May 2016, the patient received HAVRIX adult. On 24th May 2016, less than a day after receiving HAVRIX adult, the patient experienced head injury, ankle injury, fall, sprained ankle, nausea, dizziness, difficulty in standing and balance difficulty. On an unknown date, the outcome of the head injury, ankle injury, fall, sprained ankle, nausea, dizziness, difficulty in standing and balance difficulty were unknown.  It was unknown if the reporter considered the head injury, ankle injury, fall, sprained ankle, nausea, dizziness, difficulty in standing and balance difficulty to be related to HAVRIX adult. Additional details were as follows: This case was reported by a pharmacy via a pharmacy claims management company. Immediately after the vaccination, the patient experienced nausea, dizziness, inability to stand and faintness. The patient lost her balance and fell inside the premises. During the fall, the patient struck head and twisted ankle, resulting in injury to head and ankle. Medical treatment was sought.
Sex: F
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Joint injury, Ligament sprain, Nausea
Clinical narrative: This case was reported by a consumer via other and described the occurrence of head injury in a female patient who received HAVRIX adult. On 24th May 2016, the patient received HAVRIX adult. On 24th May 2016, less than a day after receiving HAVRIX adult, the patient experienced head injury, ankle injury, fall, sprained ankle, nausea, dizziness, difficulty in standing and balance difficulty. On an unknown date, the outcome of the head injury, ankle injury, fall, sprained ankle, nausea, dizziness, difficulty in standing and balance difficulty were unknown.  It was unknown if the reporter considered the head injury, ankle injury, fall, sprained ankle, nausea, dizziness, difficulty in standing and balance difficulty to be related to HAVRIX adult. Additional details were as follows: This case was reported by a pharmacy via a pharmacy claims management company. Immediately after the vaccination, the patient experienced nausea, dizziness, inability to stand and faintness. The patient lost her balance and fell inside the premises. During the fall, the patient struck head and twisted ankle, resulting in injury to head and ankle. Medical treatment was sought.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored M-M-R II Lot # L020188 with expiry date on 03-JUN-2017, (strength, dose, route and anatomical location not reported). No adverse effect was reported and no product quality complaint was reported. Temperature: 9 Celsius degrees. Time frame: 40 hours. Was it administered (AE)? Yes. Previous temperature excursion? No. Was call because of a "data logger"? No. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 26.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 26 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 23-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Sex: U
Vaccine: VARCEL
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. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 17.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours.  Data logger was involved. 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 was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L016959 with expiration date of 12-MAR-2018, lot # L045117 with expiration date of 06-OCT-2018 and lot # L027733 with expiration date of 13-SEP-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was reported by the nurse, that RECOMBIVAX HB was exposed to a temperature of 34 degrees F for 12 hours. The aforementioned vaccine had never been involved in any previous temperature excursion. Data logger was stated. Furthermore, no adverse event symptoms were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions and medical history was not provided. On 25-MAY-2016, the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, subcutaneously (lot # K026365, with an expiration date of 15-MAR-2016). Information regarding the patient's concomitant medications was not reported. No adverse effects were reported. Additional information has been requested.