chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 21-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several 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 nurse refers to multiple unspecified patients of unknown age and gender. On multiple unknown dates, the patients were vaccinated with improperly stored PROQUAD (Merck) (Lot# L033692; Expiry date: 28-FEB-2017, Lot#L033696; 28-FEB-2017). No adverse effects were reported. This case is one of the two reports from the same reporter. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 3 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 01-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare professional concerning an unspecified number of patients who since January 2015 had been vaccinated with doses of GARDASIL (Batch and lot No. K006960, exp. 19-FEB-2017) (dose and site not reported); doses which on unknown dates underwent temperature excursions. No adverse effects reported. This report is linked to MARRS 1510USA007262, 1510USA007263, 1510USA007264 and 1510USA007265 from the same reporter. Additional information has been requested. Follow up information has been received from a M.A. on 25-NOV-2015. M.A. stated that information was not available on patients over the phone. She reported a written request was needed. Additional information has been requested.
Sex: U
Vaccine: HPV4, HPV4
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medication was provided. On 27-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route, lot # and expiration date were not reported). On 06-OCT-2015, the patient accidentally received a dose of GARDASIL (exact dose, route, lot # and expiration date were not reported) instead of GARDASIL 9 as the second dose of the series. No adverse effects were reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 12 year old patient (patient # 3819) of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 0.4
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 24-JUN-2015, the patient was vaccinated with improperly stored dose of oral ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. 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 licensed vocational nurse and refers to 4 unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of an improperly stored ZOSTAVAX, lot number L011537, expiration date 30-JUL-2016, (dose and route were not reported). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports from the same reporter link. 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 registered nurse refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX (Lot L031274 expiry 19-NOV-2016), ZOSTAVAX (Lot L024997 expiry 06-OCT-2016). No adverse event was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 11 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L000610, expiration date 31-JAN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several 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 was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of an improperly stored VARIVAX, lot number K026386, expiration date 15-DEC-2016, (dose and route were not reported). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. This is one of several reports from the same reporter link. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 16 year old patient (patient #414) of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 28-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several 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 was received from a licensed vocational nurse and refers to 2 unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of an improperly stored PROQUAD, lot number L011080, expiration date 01-OCT-2016, (dose and route were not reported). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was reported. This is one of several reports from the same reporter link. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 12 week old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-JUL-2015 and on 10-SEP-2015, the patient was vaccinated with two separate doses of improperly stored oral, ROTATEQ (doses were not provided) lot # K015816, expiration date: 29-MAR-20016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 3 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-JUL-2015 and on 24-SEP-2015, the patient was vaccinated with two separate doses of improperly stored oral, ROTATEQ (doses were not provided) lot # K015816, expiration date: 29-MAR-2016 and lot # K016261, expiration date: 23-JUN-2016, orally. No adverse effects were reported. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 22-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. 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 healthcare worker refers to a 14 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 24-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an 8 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 21-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified multiple patients of unknown age and gender. There was no concurrent condition or medical history reported. The nurse reported that improperly stored GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017) (dosage, strength and route not reported) were administered to the unspecified multiple patients on unknown dates. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 13 year old patient (patient # 911) of an unknown gender. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 25-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K023432 expiration date 18-JUN-2016. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 19 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored MMR II (lot # K015375, expiration date 19-SEP-2016; lot # L015281, expiration date 30-APR-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 03-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 13-JUL-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K023534 and expiration date 22-MAY-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student and refers to a patient of unknown age and gender. The patient's current conditions, medical history and concomitant medications were not reported. On 09-NOV-2015, the patient was vaccinated with an improperly stored PNEUMOVAX23 injection (lot number L014876, expiry date 13-JAN-2017, strength, dose, frequency and route were not reported) (incorrect product storage). No adverse effect was reported. Product quality complaint was not involved. No further information was available. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician via Pfizer (other company number 2015386420) and refers to a currently 74 years old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot #, expiration date, dose, route of administration and indication were not reported). On an unknown date, the patient experienced drug allergy to PNEUMOVAX23. The patient also experienced arm swelled on an unknown date. The outcome of the events was unknown. The event of drug allergy to PNEUMOVAX23. The relatedness between the event of arm swelled and PNEUMOVAX23 was not reported. This is one of several reports received from the same reporter regarding the same patient. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Large area of swelling, erythema and pain over area of injection site. Low grade fever, fatigue, diffuse arthralgia.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Large area of swelling, erythema and pain over area of injection site. Low grade fever, fatigue, diffuse arthralgia.
Age: 6.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 12-OCT-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number K010211, expiry date 17-JAN-2016; dose and route were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 year old patient of unknown gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K023432 expiration date 18-JUN-2016) (strength, dose, route and site of administration were not provided). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On 13-NOV-2015, the patient was inadvertently vaccinated with (Merck) VARIVAX [lot # K007976, expiry date 03-JUN-2015] (Dose: 0.5 ml, Route: subcutaneous) instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (Lot # K026246, expiration date 28-JAN-2017) and (lot # L011846, expiration date 16-JUN-2017), doses, routes and anatomical locations were not provided. No concomitant medications were reported. No adverse effects reported. No product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.55
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 09-JUL-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). No adverse effects were reported. This is one of several 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 as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ orally, lot # L013188 and expiry date of 02-NOV-2016, after the temperature excursion. No adverse effects were reported. There was no quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis, Myalgia
Clinical narrative: Myalgia and cellulitis.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (also reported as medical assistant) refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 12-OCT-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L016959, expiration date 12-MAR-2018, dose and not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (also reported as medical assistant) refers to an unspecified number of patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. Since 12-OCT-2015, the patients were vaccinated with improperly stored VAQTA (lot # L023232, expiration date 25-FEB-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.49
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 17 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 13-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash
Clinical narrative: This spontaneous report was received from a 60 year old female patient regarding herself. The patient's historical medications included clindamycin and penicillin. The patient's concurrent conditions included asthma, allergy to clindamycin and penicillin. On 16-NOV-2015 the patient was vaccinated with ZOSTAVAX (with batch number-L028285 and expiry date-28-OCT-2016), 1 vial, subcutaneous on her arm. The patient was also on unspecified concomitant medications. On 16-NOV-2015, in the evening the patient began to develop a rash right above the injection site and her arm began to swell and had the swelling had extended from elbow to her shoulder. The patient called her physician on 17-NOV-2015 and went to see him on 18-NOV-2015. The physician told the patient to use BENADRYL and hydrocortisone to treat the swelling and rash. No product quality complaint (PQC) was involved. The outcome of the events was reported as not recovered/not resolved. The causality assessment was not provided. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 year old male patient. No patient's concurrent conditions, medical history or concomitant medications were reported. On an unspecified date in 2000, the patient was vaccinated with a dose of ZOSTAVAX (strength, route, site of administration, Lot#, expiry date were not reported). On an unknown date in 2015, reported as "a few months ago", the patient developed shingles. The outcome of shingles was unknown. The causality assessment between the event and suspect therapy was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patient concurrent conditions and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored GARDASIL (lot # K010215, expiration date 05-MAY-2017, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a 13 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L011846 and expiration date 16-JUN-2017) (dose and route of administration were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 20-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an unspecified healthcare worker refers to a 14 year old patient. No information on patient's medical history, concurrent conditions or concomitant medications was provided. On 17-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 injection, Lot# L000610 with expiration date 31-JAN-2017, Current Procedural Terminology (CPT) 90651 (dose and route of administration were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 0.57
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 23-JUL-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K023534 and expiration date 22-MAY-2016 (dose was not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Concurrent conditions and medical history were not reported. The pharmacist reported that on 02-OCT-2015, the patient received their first dose of PNEUMOVAX 23 (route, lot number and expiration date were unspecified). Concomitant medications were not reported. The pharmacist also reported that an on 23-NOV-2015, the patient received the second dose of PNEUMOVAX 23 (route, lot number and expiration date were not reported). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # K007974, expiration date 03-JUN-2016; K010336, 22-JUL-2016; K015972, expiration date 23-SEP-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patient's pertinent medical history, drug reaction or allergies was provided. On an unknown dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot# L000610, expiration date 31-JAN-2017) (dose and route of administration were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Follow up information has been received on 19-NOV-2015 from a healthcare worker concerning a 25 year old patient. The patient was administered an improperly stored dose of GARDASIL 9 on 23-OCT-2015. Additional information has been requested. Patient's demographics, product information, onset date and narrative have been updated.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored (Merck) VARIVAX (lot#L010148, expiration date 24-MAR-2017; lot#L001324, expiration date 13-JAN-2017; lot#L019999, expiration date 02-JUN-2017; lot#L024252, expiration date 30-JUN-2017; lot#L016123, expiration date 06-MAY-2017; lot#L021216, expiration date 10-JUN-2017, strength, dose and route were unknown). No adverse effects reported. Additional information is not expected as the reporter did not wish further contact.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 30-OCT-2015 the patient was vaccinated with a single dose of ZOSTAVAX (lot#, dose unspecified) subcutaneously. Other suspect and concomitant therapies were not reported. On 04-NOV-2015, the patient was diagnosed with shingles on 11/04/2015 by an unspecified provider. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention via office visit. Additional information is not expected as we did not have the consent to contact the pharmacist.
Age: 1.08
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L010142 and expiration date 24-SEP-2016, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare student referring to an unspecified patient of unknown age and gender. No concurrent or historical conditions were reported. On 17-NOV-2015, the patient inadvertently received an expired dose of PNEUMOVAX 23 (Lot # K005402, expiration date 07-NOV-2015), dose, route and anatomical location were not reported. No concomitant medication was reported. No adverse effects were reported. No product quality complaint was involved. 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 Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (Lot # K010574 and Lot # K011562, expiration date 08-APR-2017), doses, routes and anatomical locations were not provided. No concomitant medication were reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 6 month old patient of unknown gender. Concurrent conditions and medical history were not reported. On 29-JUN-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # K015816 and expiration date 29-MAR-2016 (dose was not provided). No adverse effects were reported. This is one of several 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 was received from a Licensed Practical Nurse referring to an unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since 12-NOV-2015, the patient s were vaccinated with improperly stored doses of PROQUAD (Lot Number reported as L0343931, expiration date 03-MAR-2017) and (Lot number L027634, expiration date 21-JAN-2017), dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from rhe 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 Health care Worker refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-NOV-2015, the patient was vaccinated with improperly stored (Merck) VARIVAX (lot # K010442 EXP date: 22-JUL-2016) (dose, route, therapy type not reported). No adverse symptoms were reported. This case is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 02-NOV-2015 the patient was vaccinated with an expired dose of GARDASIL (lot # H021346, 01-OCT-2015, strength, dose and route were unknown). No adverse effects reported. 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 Licensed Practical Nurse referring to an unknown number of patients of unknown age and gender. No concurrent or historical conditions were reported. Since 12-NOV-2015, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (Lot Number reported as L026403, expiration date 15-JUL-2017), dose, route and anatomical location were not provided. No concomitant medication was reported. No adverse effects reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pemphigoid, Rash, Rash pruritic, Skin irritation
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 75 year old female patient. Concurrent conditions or pertinent medical history were not reported. The patient had no drug reactions or allergies. On an unspecified day in August 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L013546, expiration date: 17-JUL-2016) (dose, route of administrations and frequency were unspecified). Concomitant therapies were not reported. On an unknown date in 2015 (also reported as 4 to 6 weeks ago), the patient developed an irritating, itchy rash on her arms and torso, then, she visited an unspecified healthcare provider on an unspecified date and was diagnosed with bullous pemphigoid. It was reported that she was treated with an unspecified dose of prednisone along with unspecified topical cortisone creams. It was also stated that no intervention to prevent serious criteria was necessary, that pemphigoid was not significant disability or incapacity or life threatening, that no hospitalization was required and that no product quality complaint was involved. At the time of the report, the outcome of pemphigoid was reported as not recovered. The relatedness of ZOSTAVAX with pemphigoid was not reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health professional referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, these patients were vaccinated with doses of improperly stored RECOMBIVAX HB (lot # reported as 1025738, expiration date: 14-AUG-2017, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 15 year old patient of an unknown gender. Medical history and concurrent conditions were not provided. On an unspecified date in June 2015, the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route, lot number and expiration date were not reported0. No adverse effect reported. There was no a PQC involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that, on 17-NOV-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K010968, expiration date 07-NOV-2015) 0.65 ml once (strength and route were not provided). Concomitant therapies were not reported. No adverse effects were reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Hypersensitivity, Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Upper arm swollen, hard, red from shoulder to elbow - mom used ice on arm and gave pt. BENADRYL - went to outpt. Clinic, given steroids and BACTRIM for possible infection.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Upper arm swollen, hard, red from shoulder to elbow - mom used ice on arm and gave pt. BENADRYL - went to outpt. Clinic, given steroids and BACTRIM for possible infection.
Age: 5.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Upper arm swollen, hard, red from shoulder to elbow - mom used ice on arm and gave pt. BENADRYL - went to outpt. Clinic, given steroids and BACTRIM for possible infection.
Age: 62.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Chills, Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 62 year old female patient who reported for herself. The patient's concurrent conditions included hypercholesterolemia. She did not have any immunocompromising conditions. There was no history of drug allergies or reactions. In 2003, the patient had received 1 dose of PNEUMOVAX 23. On 14-NOV-2015, the patient was vaccinated with PNEUMOVAX 23 lot # L035686 for pneumonia. The patient also stated that "My doctor gives everyone a dose of PNEUMOVAX 23 every 5 years". Concomitant medications were none. On 14-NOV-2015, in the evening of the same day, she developed a 102 degree fever and her arm down to her elbow got very swollen. The patient's arm also became very inflamed and bright red and she couldn't move the vaccinated arm. Patient also mentioned she had a headache and she got chills and just felt sick. The patient went to an unspecified urgent care facility where she was diagnosed with a cellulitis infection as a result of the vaccination. The patient underwent blood test and flu test on an unknown date in November 2015. The patient received MOTRIN and doxycycline (unknown manufacturer) as treatment in response to the events. The outcome of the events was resolving as the patient stated that she was almost fully recovered. Causality assessment was not provided. The patient required as lot # check for PNEUMOVAX 23. There was no product quality complaint involved. Additional information has been requested.