chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to her son as a 15 year old male patient. No pertinent medical history was reported. On an unknown date in June 2014, the patient was vaccinated with GARDASIL 9 dose 3, 1 dose every 6 months, in the arm. No concomitant therapies were reported. After a couple of months on an unknown date approximately in 2014, the patient experienced hypersensitivity and broke out in hives. No lab diagnostics studies performed. Patient sought medical attention. No Product Quality Complaint (PQC) was involved. The outcome of events was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 10-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX lot # K020187, expiration date 27-JAN-2016 (dose and route unknown), which was improperly stored. There is no adverse event reported. Additional information has been requested.
Age: 1.05
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 12 month old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 15-JUN-2015 the patient was vaccinated with 0.5ml dose of VARIVAX (Merck) (unspecified lot# but could include lot # K026386, expiration date 15-DEC-2015 or lot# K020757, expiration date 31-OCT-2016) which had been exposed to temperatures outside of the recommended range, subcutaneously. No adverse effect had been reported. This is one of several 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 as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On 26-MAR-2015, the patient was vaccinated with improperly stored ZOSTAVAX (lot # K010628, expiration date: 30-OCT-2015) 0.65 ml, subcutaneously. No adverse effects 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: Information was received on 17-JUN-2015 from a registered nurse regarding an unspecified number of patients of unknown age and gender. The nurse reported that an unspecified number of unspecified patients received doses of improperly stored VAQTA on unspecified dates. No adverse effect reported. No further information was provided. This is one of three reports received from the same reporter (other linked MARRS #1505USA000525 and 1505USA000532). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency, route were not reported). Concomitant medications were not reported. On an unknown date, the patient developed shingles like rash. The outcome of shingles like rash was unknown. The causality of shingles like rash was not reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. The concurrent condition and medical history was not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (dose, route and lot details unspecified). The concomitant medications were not reported. There were no known adverse events. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a patient of unknown demographics. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL. No concomitant medications were reported. On an unknown date, the patient experienced injection site pain after receiving GARDASIL. The product was confirmed to be GARDASIL and not GARDASIL 9. The outcome of injection site pain is unknown. The reporter did not assess the causality of the injection site pain with GARDASIL. 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 nurse refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) subcutaneous (dose, lot number were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: Information has been received from a female patient of unknown age concerning herself. No relevant medical history or concurrent conditions were reported. On 09-MAY-2015 the patient was vaccinated with GARDASIL (lot#, expiration date, dose and route not reported) (Exposure during pregnancy). On 06-JUN-2015, the patient was 5 weeks pregnant with Last Menstrual Period (LMP) of 01-MAY-2015 and Estimated Date of Delivery (EDD) of 05-FEB-2016. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 19-MAY-2015, the patient was administered with improperly stored dose of M-M-R II (lot # K016153, expiration date 24-SEP-2015, dose was unknown) subcutaneously. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HBHEPB
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patients were vaccinated with improperly stored COMVAX, (strength, lot #, dose and frequency were not reported). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. There was no additional information to report. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored PROQUAD subcutaneous (dose, lot number were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 14 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 31 year old female patient. On 16-JUN-2015, the patient was vaccinated a dose of PROQUAD (Merck) (dose: 0.5 ml, lot # and expiration date were not reported). The patient needed vaccination for both M-M-R II and VARIVAX (Merck) and was given PROQUAD (Merck). There was no adverse effect reported. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a pharmacist (also reported as physician) via other company Pfizer regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2005 (reported as 10 years ago), the patient was vaccinated with PNEUMOVAX 23 (Lot number, dose and route of administration were not reported). On an unknown date the patient experienced significant reaction. The outcome of significant reaction was unknown. The reporter did not provide the relatedness of the event with PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Information has been received from a healthcare student referring to a currently 25 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with her third dose of GARDASIL in her arm (dose, route and lot# were not reported) in a year, after her second dose of GARDASIL was administered (dose, route and lot# were not reported). No concomitant medication was given. On an unknown date the patient experienced irritation and red at the injection on the patient's arm. No treatment was given for the adverse events. No lab diagnostics studies were performed. The outcome of the events was reported as recovered on an unknown date. It was unknown if the patient sought medical attention. Additional information is not expected as there was no consent to be contact with physician.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 01-MAY-2015, these patients were vaccinated with VARIVAX (Merck) (lot# K026386, expiration date 15-DEC-2016; lot# K020757, expiration date 31-Oct-2016; lot# K016132, expiration date 24-SEP-2016; dose and route not reported) which underwent supported temperature excursions. No adverse effects were reported. This is one of several 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 as received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot number reported as: L011535, expiration date: 03-JUL-2016, (administration route was not reported). No concomitant therapies were reported. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse event was reported. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality issue reported. This is one of the many reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date in May 2011, the patient received 2 doses of CERVARIX. On an unknown date in December 2012, the patient was vaccinated with first dose of GARDASIL (lot#, dose and route of administration were not reported). On an unknown date in June 2013, the patient was vaccinated with second dose of GARDASIL (lot#, dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient complained of redness and tenderness around injection site. Patient stated the left upper arm was hot to the touch. Patient was told to seek medical attention.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Myalgia
Clinical narrative: Joint pain and muscle pain.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Area around the site had become quite red and swollen and extremely itchy.  Like a very large hive.  Slightly painful to the touch, but not extremely so.  The symptoms worsened at night to the point that I was mildly concerned about an allergic reaction.  The next morning the swelling seemed less and the area much less itchy, but increasing in size.  By 06/20/2015 at noon the red area had grown to nearly cover my upper arm.  Slightly warm to the touch.  I'm waiting till 06/22/2015 to see about going to my doctor about it.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Musculoskeletal pain, Periarthritis, X-ray limb
Clinical narrative: Onset severe shoulder pain. Limited movement. Resisted with worsening pain and continued very limited movement let shoulder. One week later saw primary doctor. Diagnosis adhesive capsular US. Hospitalized June with steroid injection. Severe pain severe limited movement. Saw orthopedic MD June 19. Continue with symptoms now eight weeks after Prevnar 13 with worsening of symptoms.
Age: 70.0
Sex: F
Vaccine: MEN
Symptoms: Arthralgia, Erythema, Local swelling, Musculoskeletal pain, Pain
Clinical narrative: Reddened, swollen, sore area upper left arm well below site of injection. Shoulder and elbow painful. Not any better on 06/20/15. Using ice packs and ibuprofen.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Irritability, Lethargy, Pyrexia
Clinical narrative: She had a fever of 101.8, a dose of Ibuprofen brought it down, then afternoon was up to 106 temporally and now not drinking and very irritable and lethargic.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Contusion, Malaise, Petechiae
Clinical narrative: Patient was going to Dr. as he had not been feeling well.  When we got there, he was covered in bruising and petechia.
Age: 0.52
Sex: F
Vaccine: DPP
Symptoms: Injection site erythema, Injection site mass, Irritability, Pyrexia
Clinical narrative: Fever, fussing, red circle where shot was given, large lump where shot was given.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: PREVNAR administered 6/17/15. Tenderness and redness by 6/18/15. Worsening redness, swelling, warmth to touch to deltoid area.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Day after shot upper back of arm red and raised with swelling, hot and itchy. Called pharmacy 2 days after shot. Came in 3 days after. More swelling and past elbow. Saw MD. Not skin infection.
Age: 24.0
Sex: M
Vaccine: HEPAB, TYP
Symptoms: Loss of consciousness, Thirst
Clinical narrative: Patient passed out for about 30-60 sec about 5 min after receiving the vaccines. When he awoke he was thirsty and drank some water. Was fine at 15 min or so. Said it happened before with vaccine -> decreased BP, anxiety and decreased blood sugar.
Age: 72.0
Sex: U
Vaccine: PNC13
Symptoms: Administration site swelling, Injection site erythema
Clinical narrative: Redness and swelling/puffiness around the area of administration. Treatment per Dr levofloxacin 750 mg (1 po d x 5 days).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Patient complains of arm pain and rash. Explained possible side effects at time of injection. Patient sates arm is painful and slightly swollen with rash.
Age: 3.0
Sex: U
Vaccine: HBHEPB
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 3 year old patient of unknown gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with COMVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 8 month old patient of unknown gender. No medical history, current conditions and concomitant therapies were reported. On 01-JUN-2015, the patient received the first dose of ROTATEQ orally (lot # expiration date and dose were not reported). No adverse event was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: This spontaneous report has been received from a female patient of unknown age, who was reporting on herself. No information regarding the patient's pertinent medical history, concurrent conditions or concomitant medication was provided. On 28-MAY-2015 (reported as "a week ago today"), the patient was vaccinated with the first dose of ZOSTAVAX dose reported as "one time vaccine", lot#, expiry date, route of administration and injection anatomical location were unspecified. On 30-MMAY-2015, 48 hours after the vaccination, the patient experienced soreness, redness the size of a quarter or 50 cent piece. The patient's pharmacist recommended her to use BENADRYL 4 times a day. The soreness and redness started to get smaller and at the time of this report, it was 4 times a size. The patient sought medical attention. The relatedness between ZOSTAVAX and the events was unknown. Additional information is not expected as no contact details are available for the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On an unknown dates, the patients received doses of VAQTA (lot #, dose, route and site of administration were not reported) that were improperly stored. No adverse experiences were 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: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K008140 with expiration date: 30-MAR-2016 and lot # reported as # L002048 with expiration date: 09-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history was not reproted. On 17-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL lot # K008931, expiration date reported as 04-MAR-2017 (dose, route and site of administration were not reproted). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's medical history was not reported. On 18-JUN-2015, the patient was vaccinated with one dose of improperly stored GARDASIL lot # K008931, expiration date reported as 04-MAR-2007 (dose, route and site of administration were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. on 09-JUN-2015, the patient was inadvertently vaccinated with ZOSTAVAX vial of 19,400 PFU (plaque forming units) (strength, dose, route and lot number or batch number unspecified). No concomitant medications were not reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. The reporter's causality assessment was not provided. No further information was provided. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 88 year old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 15-NOV-2013, the patient was vaccinated with the first dose of ZOSTAVAX (dose and route of administration were not provided) lot # J006827, expiration date 14-SEP-2014 (reported as 01-FEB-2014). On 28-APR-2015, the patient was vaccinated with the extra dose of ZOSTAVAX (dose and route of administration were not provided) lot # K015308, expiration date 17-DEC-2015. The patient had not reported any adverse effects. 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 Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients received an unspecified number of improperly stored doses of PEDVAXHIB (dosage, route and lot # not provided). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients received an unspecified number of improperly stored doses of ROTATEQ oral (dosage and lot # not provided). No adverse experiences were reported. This is one of several 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 registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 18-DEC-2014, the patient was vaccinated with a improperly stored dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine 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 was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 02-FEB-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine 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 was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 24-MAR-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine 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 was received from a registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 24-MAR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions and medical history was provided. On the unknown dates, multiple unspecified patients were vaccinated with improperly stored M-M-R II (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports from the same reporter source. 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 registered nurse and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On 24-MAR-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, route, lot number and expiration date were not provided). Concomitant medication was not provided. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of nine reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. The nurse reported that 9 doses of M-M-R II (lot# and expiration date were not reported) that were improperly stored were inadvertently administered to the patients on an unspecified dates(route of administration, dose and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information is not expected, the reporter does not wish to be contacted.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. The nurse reported that the 5 improperly stored doses of VAQTA (lot# K005958, expiration date: 09-FEB-2017) were inadvertently administered on the following dates: 17-APR-2015, 27-APR-2015, two doses were administered on 29-APR-2015 and 26-MAY-2015 (route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information is not expected, the reporter does not wish to be contacted.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with doses of ZOSTAVAX lot # K016324, expiration date: 24-DEC-2015, (administration route was not reported), which were exposed to defrost cycling (incorrect product storage). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with an improperly stored dose of ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL, (dose and route, lot # and expiration date were not reported). No adverse effects were reported. The patient's concomitant therapies were not reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 83 year old female patient with pertinent medical history, drug allergies and concomitant medication unspecified by reporter. On 20-MAY-2015 (also reported as 20-MAY-2016), the patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number L006381 and expiration date 25-MAY-2016). On 21-MAY-2015, 24 hours following the administration of ZOSTAVAX, the patient experienced a localized injection site reaction that consisted of swelling, and the red itchy rash. There was no treatment given to the patient for the events. Patient's lab diagnostics studies were reported as unspecified. The outcomes of the events were not reported. The patient sought medical attention (she was seen at the pharmacy). The relatedness between the events and the ZOSTAVAX therapy was not reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Ophthalmic herpes zoster, Pruritus, Rhinalgia, Vision blurred
Clinical narrative: This spontaneous report was received from an 81 year old female patient (health professional), with drug hypersensitivity to penicillin, regarding herself. The patient's pertinent medical history was not reported. Approximately in May 2013, reported as "2 years ago", the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration date were not provided). No concomitant  therapies were reported. On an unknown date in January 2015, the patient was diagnosed with shingles in her left eye by the dermatologist who she works with, who referred the patient to an ophthalmologist, for the treatment of the shingles in her eye. The reporting healthcare worker stated that almost 5 months had past since diagnosis was made, and she was still having itching her head (left side) and her left eye's vision was still blurry, and she was still experiencing pain on her left side of the nose. The patient also stated that she did not have blisters from shingles anymore. The patient was treated with many different types of eye drops, one of which was prednisolone eye drops, and VALTREX tablets. It was also reported that the patient had a routine blood work made on an unspecified date (no results provided). The outcome of herpes zoster was reported as not recovered. The reporter did not provide a causality assessment for the adverse event. 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 nurse refers to a patient of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug allergies were not reported. On 12-MAY-2015, the patient was vaccinated subcutaneously with a dose of VARIVAX (Merck) (lot # K011804 and expiration date 21-AUG-2016). The reporter stated that the administered dose of VARIVAX (Merck) was improperly stored. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a patient's friend as part of a Market Research for ZOSTAVAX, refers to a 55 year old female patient. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot number and expiration date were not reported). No co-suspect and concomitant therapies were reported. On an unknown date the patient experienced itching on and off for 3 months after received ZOSTAVAX. The outcome of pruritus was reported as recovered/resolved quit sequelae (on an unknown date). The reporter considered pruritus to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (C.M.A) concerning multiple patients (unspecified number) of unknown age and gender. No concurrent conditions or medical history were reported. Multiple patients were vaccinated with an improperly stored GARDASIL (Lot No., expiration date, dose, route and date of administration were not reported). No concomitant therapy was provided. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. The medical assistant reported that the patients were administered an unspecified number of improperly stored doses of oral, ROTATEQ (lot # K006960, expiration date: 19-FEB-2017; and lot # reported as: K017576, expiration date: 12-JUN-2016) oral liquid (frequency were not reported) on unspecified dates since 21-MAY-2015. No adverse effects reported. Concomitant medications were not reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. The medical assistant reproted that the patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # K006960, expiration date: 19-FEB-2017) (route of administration and frequency were not reported) on unspecified dates since 21-MAY-2015. No adverse effects reported. Concomitant medications were not reported. This is one of two reports from the same source. 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 nurse refers to a patient of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug allergies were not reported. On 24-APR-2015, the patient was vaccinated subcutaneously with a dose of VARIVAX (Merck) (lot # K011804 and expiration date 21-AUG-2016). The reporter stated that the administered dose of VARIVAX (Merck) was improperly stored. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On an unknown dates, the patients received doses of RECOMBIVAX HB (lot #, dose, route and site of administration were not reported) that were improperly stored. No adverse experiences were reported. This is one of 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # J012567 with expiration date: 30-JAN-2016, J013394 with expiration date: 25-AUG-2016 and lot # reported as: L006229 with expiration date 17-AUG-2017 and L001626 with expiration date: 06-OCT-2016 (dose and route of administration were not reported). No adverse effects were reported. 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 healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On an unknown dates, the patients received doses of PNEUMOVAX 23 (lot #, dose, route and site of administration were not reported) that were improperly stored. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L001311 with expiration date 06-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL lot # L007531 with expiration date: 04-NOV-2016 and lot # K007264 with expiration date 02-MAR-2017 (dose and route of administration were not reported). No adverse effects were reported. 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 healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II lot # reported as: K014832 with expiration date: 14-SEP-2016, K021152 with expiration date: 02-NOV-2016 and K015375 with expiration date: 18-SEP-2016 (dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On an unknown dates, the patients received doses of GARDASIL (lot #, dose, route and site of administration were not reported) that were improperly stored. No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to unspecified number of patients of unkonwn age and gender. On unknown dates, the patients received an unspecified number of improperly stored doses of GARDASIL (dosage, route and lot # not provided). No adverse experiences were reported. This is one of several 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 pharmacist and healthcare worker refers to a patient of unknown demographics. The patient's medical history and concurrent conditions were not reported. On 12-JUN-2015 at 16:51, the patient was vaccinated with a dose of ZOSTAVAX (lot # K026365, expiration date: 15-MAR-2015, dose and anatomical location was unknown) which was exposed to temperature outside of the recommended range. Concomitant medications were unspecified by reporter. No adverse effect was observed or reported. The outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. On June 2015 (reported as since 10-JUN-2015), the patient were administered doses of improperly stored VARIVAX (Merck), (lot #, dose and site of administration were not reported) subcutaneously. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. The patients medical history was not reported. In June 2015 (reported as since 10-JUN-2015), the patient were administered doses of improperly stored PROQUAD (Merck), (lot #, dose and site of administration were not reported) subcutaneously. No adverse effects were reported. This is one of several 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 nurse refers to a patient of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug allergies were not reported. On 20-MAY-2015, the patient was vaccinated subcutaneously with a dose of VARIVAX (Merck) (lot # K011804 and expiration date 21-AUG-2016). The reporter stated that the administered dose of VARIVAX (Merck) was improperly stored. There was no adverse effect reported. This is one of several 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 as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored ROTATEQ, (dose and route, lot # and expiration date were not reported). No adverse effects were reported. The patient's concomitant therapies were not reported. This is one of two reports from the same source. 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 nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. The nurse reported that 10 improperly stored doses of ROTATEQ were inadvertently administered to the patients on an unspecified dates (lot#, expiration date and dose were not reported; route of administration defaulted to oral). No adverse events were reported. This is one of several reports received from the same source.