chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 612315) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient's current illness included constipation. The patient's other medications, medical history and prior vaccination was not reported. On 03-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 (route of administration unknown) in the left arm, lot # L004014 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 03-NOV-2015, (route of administration unknown) in the right arm, lot # U5068AA; dose and expiration date unknown). On 04-NOV-2015, patient had left deltoid muscle with about 5 cm x 5 cm round erythema (injection site erythema), hot to touch (injection site warmth) and painful (injection site pain). The outcome of injection site erythema, injection site warmth and injection site pain was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: his report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 612954) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 30-NOV-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported), lot # L007560, dose 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included VAQTA (dose, frequency and lot expiration date were not reported), lot # L013380, dose number 2, vaccination date: 30-NOV-2015, intramuscularly in the left arm, BOOSTRIX, lot # 9N74F, dose number 1, vaccination date: 30-NOV-2015 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm and (MENVEO lot # A15031, dose 1, vaccination date: 30-NOV-2015 (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm. On 01-DEC-2015, the patient experienced injection site erythema, injection site swelling, injection site pruritus and injection site pain. The outcome of injection site erythema, injection site swelling, injection site pruritus and injection site pain were reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613098) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's medical history included allergic rhinitis and obesity. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 01-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L016428, dose number 1, (dose, frequency and lot expiration date were not reported) intramuscularly for prophylaxis. Other suspect therapies included FLUARIX lot # 4JY49, vaccination date: 01-DEC-2015 (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm and MENACTRA lot # U5179AA, vaccination date: 01-DEC-2015 (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm. On unknown dates, the patient experienced injection site erythema and injection site oedema. It was also reported that the patient experienced erythema (Skin 6 x7 cm area) and mild edema on extensor surface of right upper arm surrounding the injected site. The outcome of injection site erythema and injection site oedema were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9, PPV
Symptoms: Injection site erythema, Myalgia, Pain, Peripheral swelling, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613404) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. Patient's medical history included Digeorge syndrome, Juvenile idiopathic arthritis (JIA), ventricular septal defect (VSD) and RAD. Patient had no concurrent illness and concomitant therapies were not reported. On 24-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L019286, dose number 2 (dose, frequency, route, prior vaccination details and lot expiration date were not reported) in the right arm for prophylaxis.  Other suspect therapies included PNEUMOVAX (dose number: 1, vaccinated date: 24-NOV-2015, in the left arm, lot# L003188; dose, frequency, route, prior vaccination details and expiration date unknown) for prophylaxis. On 25-NOV-2015, the patient experienced peripheral swelling with arm swollen twice size on (L) (25.5cm) than (R) (21cm), injection site erythema with erythema patches underside (L) arm from armpit to mid arm (also reported as no redness at injection site), pain, myalgia and warmth and cold. The patient was administered flu shot and PCCV 23 vaccine. The outcome of events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9, PPV
Symptoms: Viral upper respiratory tract infection
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613404) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. Patient's medical history included Digeorge syndrome, Juvenile idiopathic arthritis (JIA), ventricular septal defect (VSD) and RAD. Patient had no concurrent illness and concomitant therapies were not reported. On 24-NOV-2015 the patient was vaccinated with GARDASIL 9 lot # L019286, dose number 2 (dose, frequency, route, prior vaccination details and lot expiration date were not reported) in the right arm for prophylaxis.  Other suspect therapies included PNEUMOVAX (dose number: 1, vaccinated date: 24-NOV-2015, in the left arm, lot# L003188; dose, frequency, route, prior vaccination details and expiration date unknown) for prophylaxis. On 25-NOV-2015, the patient experienced peripheral swelling with arm swollen twice size on (L) (25.5cm) than (R) (21cm), injection site erythema with erythema patches underside (L) arm from armpit to mid arm (also reported as no redness at injection site), pain, myalgia and warmth and cold. The patient was administered flu shot and PCCV 23 vaccine. The outcome of events was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Neck pain, Pain in jaw
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613437) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included unconfirmed absence seizures. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 01-DEC-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported), dose number 1, lot # L013429, via an unknown route in the left arm for prophylaxis. On 01-DEC-2015, the patient experienced headache, pain in jaw and neck pain. The patient was advised rest, fluids and ibuprofen and was offered with a follow up appointment. The outcome of headache, pain in jaw and neck pain were reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Menorrhagia, Menstruation irregular
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 613476) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. Information on patient's medical history and other medications were not reported. The patient had no concurrent illnesses. On 27-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot #, dose and frequency were not reported) via an unknown route for prophylaxis. On 29-SEP-2015, the patient experienced menorrhagia and menstruation irregular. Patient's mother stated that since the vaccination in July, the patient's menstrual cycle was irregular and also had heavy bleeding. The patient was on her periods from 29-SEP-2015 to 04-OCT-2015. The periods again resumed on 18-OCT-2015 till 01-NOV-2015 and again from 21-NOV-2015 to 02-DEC-2015. The outcome of menorrhagia and menstruation irregular was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain, X-ray limb abnormal
Clinical narrative: Pt. states had bruising after flu shot given then starting in Oct/Nov 2016 had pain in left arm and burning sensation that comes and goes. States MD did xray of arm and shoulder and MD stated from wear and tear. Pt states she now cannot lift her arm, very stiff and painful. Started physical therapy and taking anti-inflammatory meds.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Burning sensation, Contusion, Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt. states had bruising after flu shot given then starting in Oct/Nov 2016 had pain in left arm and burning sensation that comes and goes. States MD did xray of arm and shoulder and MD stated from wear and tear. Pt states she now cannot lift her arm, very stiff and painful. Started physical therapy and taking anti-inflammatory meds.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: X-ray limb
Clinical narrative: Pt. states had bruising after flu shot given then starting in Oct/Nov 2016 had pain in left arm and burning sensation that comes and goes. States MD did xray of arm and shoulder and MD stated from wear and tear. Pt states she now cannot lift her arm, very stiff and painful. Started physical therapy and taking anti-inflammatory meds.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist (patient's mother) and refers to an 11 year old female patient. The patient did not have any pertinent medical history. The patient had allergy to azithromycin (ZITHROMAX), amphetamine (ADDERALL), eggs, strawberries, citrus fruit and pineapple. Concomitant therapies included methylphenidate hydrochloride (METADATE CD). On 01-MAR-2017, the patient was vaccinated with a first dose of GARDASIL 9 intramuscularly (dose, lot # and expiry date were not reported) for vaccination. The pharmacist also indicated that the patient received two other not specified vaccines products on the same day. On 08-MAR-2017 (reported as 7 days after receiving the dose), the patient experienced rash on her chin and on one of her hands, location not specified. The patient was treated with diphenhydramine (BENADRYL) and triamcinolone. The rash was not entirely resolved at the time of the report. The causality assessment was not provided. Additional information is not expected as there was no consent to the contact the reporter.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist (patient's mother) and refers to an 11 year old female patient. The patient did not have any pertinent medical history. The patient had allergy to azithromycin (ZITHROMAX), amphetamine (ADDERALL), eggs, strawberries, citrus fruit and pineapple. Concomitant therapies included methylphenidate hydrochloride (METADATE CD). On 01-MAR-2017, the patient was vaccinated with a first dose of GARDASIL 9 intramuscularly (dose, lot # and expiry date were not reported) for vaccination. The pharmacist also indicated that the patient received two other not specified vaccines products on the same day. On 08-MAR-2017 (reported as 7 days after receiving the dose), the patient experienced rash on her chin and on one of her hands, location not specified. The patient was treated with diphenhydramine (BENADRYL) and triamcinolone. The rash was not entirely resolved at the time of the report. The causality assessment was not provided. Additional information is not expected as there was no consent to the contact the reporter.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, HPV9, MNQ, TDAP
Symptoms: Labelled drug-drug interaction medication error, Rash
Clinical narrative: This spontaneous report was received from a pharmacist (patient's mother) and refers to an 11 year old female patient. The patient did not have any pertinent medical history. The patient had allergy to azithromycin (ZITHROMAX), amphetamine (ADDERALL), eggs, strawberries, citrus fruit and pineapple. Concomitant therapies included methylphenidate hydrochloride (METADATE CD). On 01-MAR-2017, the patient was vaccinated with a first dose of GARDASIL 9 intramuscularly (dose, lot # and expiry date were not reported) for vaccination. The pharmacist also indicated that the patient received two other not specified vaccines products on the same day. On 08-MAR-2017 (reported as 7 days after receiving the dose), the patient experienced rash on her chin and on one of her hands, location not specified. The patient was treated with diphenhydramine (BENADRYL) and triamcinolone. The rash was not entirely resolved at the time of the report. The causality assessment was not provided. Additional information is not expected as there was no consent to the contact the reporter.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, drug reactions or allergies, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M015290, expiry date 20-SEP-2017; lot # M022924, expiry date 24-JAN-2018; lot # reported as M03572, expiry date 11-MAR-2018; lot # M040421, expiry date 26-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 27 degrees Fahrenheit for 1 hour and 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician. Sender's Comments: US-009507513-1704USA004640: US-009507513-1704USA004639: US-009507513-1704USA004638.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a physician assistant via company representative and refers to male patient of an unknown age. The patient's medical history included quadriplegia. The patient was at  numerous unspecified medications. On an unknown date, approximately in 2015 (reported as "about 2 years ago"), at the age of 59 years old, the patient was vaccinated once with a dose of ZOSTAVAX 0.65 ml, subcutaneously to prevent shingles (site of administration, lot # and expiration date were not reported). On an unknown date, two weeks after receiving the vaccine, the patient broke out in a rash on "numerous areas on the right side of his body." The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 22-FEB-2017, the nurse reported that the patient was vaccinated with M-M-R II via an unspecified route, reconstituted with the appropriate diluent (strength, dose, Lot # and expiration date were not provided) for prophylaxis. Then, on 21-MAR-2017, the patient was inadvertently "vaccinated too early" (inappropriate schedule of drug administration) with VARIVAX subcutaneously, Lot # M037642 with expiration date: 01-SEP-2018, reconstituted with the appropriate diluent (strength and dose not reported) for prophylaxis. No adverse effect were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Deafness, Laboratory test, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 68-year-old female patient with tinnitus and baseline hearing loss for which the patient was a hearing aid user. There was no information about the patient's pertinent medical history, concomitant therapies, and drug reactions or allergies. On an unspecified date in January 2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, frequency, anatomical location, lot number, and expiration date were not provided) for prophylaxis reported as prevention of shingles. Since being administered ZOSTAVAX, the patient's hearing loss (deafness) and tinnitus had gotten progressively worse whereby, she sought medical attention through a visit to an ear, nose, and throat doctor (ENT), and two hearing doctors which performed an unspecified test. Additionally, on an unknown date in 2017, the patient experienced swelling of her right arm and she felt her arm warm (feeling hot). It was reported that after 5 days, the patient's arm swelling "went down". It was unknown by the reporter if treatment was given for the adverse events. At the time of reporting, it was unknown whether the patient recovered or not from the events of deafness, feeling hot, and tinnitus. The causal relationship between the adverse events and the therapy with ZOSTAVAX was not reported. Upon internal review, the event of deafness was considered to be medically significant. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 68-year-old female patient with tinnitus and baseline hearing loss for which the patient was a hearing aid user. There was no information about the patient's pertinent medical history, concomitant therapies, and drug reactions or allergies. On an unspecified date in January 2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, frequency, anatomical location, lot number, and expiration date were not provided) for prophylaxis reported as prevention of shingles. Since being administered ZOSTAVAX, the patient's hearing loss (deafness) and tinnitus had gotten progressively worse whereby, she sought medical attention through a visit to an ear, nose, and throat doctor (ENT), and two hearing doctors which performed an unspecified test. Additionally, on an unknown date in 2017, the patient experienced swelling of her right arm and she felt her arm warm (feeling hot). It was reported that after 5 days, the patient's arm swelling "went down". It was unknown by the reporter if treatment was given for the adverse events. At the time of reporting, it was unknown whether the patient recovered or not from the events of deafness, feeling hot, and tinnitus. The causal relationship between the adverse events and the therapy with ZOSTAVAX was not reported. Upon internal review, the event of deafness was considered to be medically significant. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 17-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517.
Age: 1.17
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 14 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 17-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 18-OCT-2016, the patient was vaccinated with the first improperly stored dose of  VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 19-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 15 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 20-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499:  US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 1 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 20-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475 :US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515::US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 5-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 14-NOV-2016, the patient was vaccinated with the second improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 1-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004460: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 15-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 16-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885  with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 12 months old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 16-NOV-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with expiration date 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA007652: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517: